SUMMER TRAINING REPORT

AT
MANGALAM DRUGS & ORGANICS LTD.

Submitted in partial fulfillment of requirement of BBA PROGRAMME

PREPARED BY:
PURVI SHAH
AEMAN MALIK
NIDHI RATHOD
KHUSHBU RABARI
KANCHI BHANSALI
JIGNESHA THAKKAR
TYBBA (SEMESTER 5)
UNDER THE GUIDANCE OF
Prof. ANJALI PATEL
ROFEL BBA & BCA COLLEGE, VAPI

VEER NARMAD SOUTH GUJARAT UNIVERSITY

SURAT
GIDC RAJJU SHROFF ROFEL INSTITUTE OF MANAGEMENT
STUDIES BBA- PROGRAMME, VAPI

CERTIFICATE

This is to certify that PURVI SHAH, NIDHI RATHOD, KHUSBHU RABARI,

AEMAN MALIK, KANCHI BHANSALI AND JIGNESHA THAKKAR has
satisfactorily completed Summer Training Project (Departmental Studies)

Based on the declaration made by the candidate and associated as a guide for carrying
out this word, I recommended this project for evaluation as a part of the BBA
PROGRAMME of VEER NARMAD SOUTH GUJARAT UNIVERSITY.

Date: - ____________ PROF. ANJALI

PATEL

Place: - ___________

The project is forwarded to V.N.S.G.U. Surat for Viva.

Date: - ____________
_______________
DR. PRIYAKANT VED
(Principal)
Place: - ____________
 ACKNOWLEDGEMENT

We would like to express my special thanks of gratitude to ROFEL BBA and BCA
College, Vapi, affiliated to Veer Narmad South Gujarat University, Surat for giving
me opportunity to do the project on topic which gave me wide exposure on various
departments. We would also like to thank our principal DR. PRIYAKANT VED for
his constant cooperation.

We would like to express my deep sense of gratitude to MANGALAM DRUGS

AND ORGANICS LTD. For giving us chance to undertake training in their
organization and we are very much thankful To Mrs. FALGUNI for giving their
precious time and guiding us during the project tenure.

Thereafter we would like to thank my Internal Guide Asst. PROF. ANJALI PATEL
for their guidance and support. We would also like to thank all the faculty members,
who guided me to complete this project.

Last but not least, we would also like to thank all those who have contributed their
time and support in preparation of the project

Thank you all from bottom of our heart.

PURVI SHAH
NIDHI RATHOD
KHUSHBU RABARI
KANCHI BHANSALI
JIGNESHA THAKKAR
AEMAN MALIK
 DECLARATION

PURVI SHAH, NIDHI RATHOD, KHUSBHU RABARI, AEMAN MALIK,

KANCHI BHANSALI AND JIGNESHA THAKKAR of ROFEL BBA AND BCA
College, Vapi affiliated to Veer Narmad South Gujarat University, Surat. We hereby
declare that this project is solely done by us and to the best of my knowledge. No
such work has been previously submitted by any person for a degree or diploma at
this or any other institution. The information derived from secondary sources has
been duly acknowledged in the text and list of references provided.

PURVI SHAH _______________

NIDHI RATHOD _______________
AEMAN MALIK _______________
KHUSHBU RABARI _______________
KANCHI BHANSALI _______________
JIGNESHA THAKKAR ________________
 EXECUTIVE SUMMARY

This is the internship report based on the one-month internship program that we had
successfully completed in Mangalam drugs and organics Ltd from 01.07.2024 to
31.07.2024 As being completely new to practical, corporate world setting, every hour
spent in the company gave us some amount of experience all the time all of which
cannot be explained in words. Nevertheless, this knowledge will be useful for our
career.
This report is based on every department of Mangalam drugs and organics Ltd. In this
report the overall functions of every department are discussed. There is a clear
explanation of each and every function which we were able to gather. This report is
divided into 8 chapters. The first chapter of this report deals with introduction that
presents the overall picture of the company in order to understand the company on
which the study is carried on, the second chapter of this report discusses the details of
production department of Mangalam. The third chapter is about the finance
department which shows the financial status of the company of past two years and
different ratios calculated on the basis of financial statements. The fourth chapter is
the HR department which focuses on every function done in the HR department. Fifth
chapter focuses on the functions of purchase department. Seventh chapter illustrates
different aspects of quality checking department of the company. Eight chapter
provides information about the different safety measures taken by the company.
Mangalam’s development includes a creation of a strongly-bonded culture;
maintaining discipline; continuously adapting to changes resulting from both internal
and external environments; developing human resources through ongoing
development and evaluation initiatives; and completing tasks and goals within a given
time frame. The belief is, creating a good and learning company is more important
than presenting a profitable company.

i
 LIST OF FIGURES

1. FIGURE 1.1- IMAGE OF MANAGALM DRUGS AND ORGANICS

2. FIGURE 1.2 - FLOW GRAPH REPRESENTING COMPANY’S FOCUS

MANUFACTURING

3. FIGURE 1.3 - MISSION OF COMPANY

4. FIGURE 1.4 - ILLUSTRATION OF COMPANY’S ORGANISATION

STRUCTURE

5. FIGURE 1.5 – CSR ACTIVITY OF COMPANY

6. FIGURE 1.6 - CSR ACTIVITY OF COMPANY

7. FIGURE 1.7 - CSR ACTIVITY OF COMPANY

8. FIGURE 1.8 - CSR ACTIVITY OF COMPANY

9. FIGURE 1.9 - CSR ACTIVITY OF COMPANY

10. FIGURE 1.10 - CSR ACTIVITY OF COMPANY

11. FIGURE 1.11 - EDOM LOGO

12. FIGURE 1.12 - CDSCO LOGO

13. FIGURE 1.13 - EUROPEAN MEDICINE AGENCY LOGO

14. FIGURE 1.14 - NATIONAL MEDICAL PRODUCTS ADMINISTRATION

LOGO

15. FIGURE 1.15 - WHO LOGO

16. FIGURE 1.16 - MINISTRY OF FOOD AND DRUGS

17. FIGURE 2.1 - TYPES OF PRODUCT COMPANY MANUFACTURE

18. FIGURE 2.2 - STAGES OF PRODUCTION

19. FIGURE 2.3 - ANALOGUE IMAGE OF REACTORS

ii
20. FIGURE 2.4 - ANALOGUE IMAGE OF REACTORS

21. FIGURE 2.5 - ANALOGUE IMAGE OF PURIFICATION

22. FIGURE 2.6 - ANALOGUE IMAGE OF VACCUM DRYING

23. FIGURE 2.7 - ANALOGUE IMAGE OF VACCUM DRYING

24. FIGURE 2.8 - ANAGLOUE OF PURIFICATION REACTORS

25. FIGURE 2.9 - ANAGLOUE IMAGE OF RECEIVER TANK

26. FIGURE 2.10 - ANAGLOUE IMAGE OF SPARKLING TANKS

27. FIGURE 2.11 - ANAGLOUE IMAGE OF CRYSTALLIZATION

28. FIGURE 2.12 - ANAGLOUE IMAGE OF CENTRIFUGE MACHINE

29. FIGURE 2.13 - ANAGLOUE IMAGE OF DRYER MACHINE

30. FIGURE 2.14 - CONEMILL MACHINE

31. FIGURE 2.15 - MULTIMILL MACHINE

32. FIGURE 2.16 - VIEW PASSAGE

33. FIGURE 2.17 - WASTAGE ROOM

34. FIGURE 2.18 - ANAGLOUE IMAGE OF PASS BOX

35. FIGURE 3.1 – INTRODUCTION TO MARKETING

36. FIGURE 3.2 – 4Ps OF MARKETING

37. FIGURE 3.3 – – PRODUCT LIFE CYCLE

38. FIGURE 3.4 - ALEMBIC PHARMACUTICAI LTD LOGO

39. FIGURE 3.5 – AARTI INDUSTRY LTD LOGO

40. FIGURE 4.1 - CYCLE OF ACCOUNTING

iii
41. FIGURE 4.2 - STAFF STRUCTURE AT MANGALAM DRUGS AND
ORGANIC IN ACCOUNTING DEPARTMENT

42. FIGURE 4.3 – TYPE OF TAXES

43. GRAPH 4.1 -CURRENT RATIO

44. GRAPH 4.2 - LIQUIDITY RATIO

45. GRAPH 4.3 - NET PROFIT RATIO

46. GRAPH 4.4 - DEPT EQUITY RATIO

47. GRAPH 4.5 - OPERATING MARGIN RATIO

48. GRAPH 4.6 - TRADE RECEIVABLE TURNOVER RATIO

49. GRAPH 4.7 - INVENTORY TURNOVER

50. GRAPH 4.8 -TRADE PAYABLES TURNOVER RATIO

51. GRAPH 4.9 - RETURN ON INVESTMENT

52. FIGURE 5.1 - IMAGE REGARDING HUMAN RESOURCE MANAGEMENT

53. FIGURE 5.2 - HRM DEPARTMENT OF MANGALAM DRUGS AND

ORGANICS

54. FIGURE 5.3 – RECRUITMENT

55. FIGURE 5.4 - NEED FOR RECRUITMENT IN MANGALAM DRUGS AND

ORGANICS

56. . FIGURE 5.5 - SOURCES OF RECRUITMENT

57. . FIGURE 5.6 - RECRUITMENT AND SELECTION PROCESS OF COMPANY

58. . FIGURE 5.7 - IMPORTANCE AND IDENTIFICATION OF TRAINING AND

DEVELOPMENT PROGRAMME

59. . FIGURE 5.8 - TYPE OF TRAINING IN MANGALAM DRUGS AND

ORGANICS

60. . FIGURE 5.9 - TRAINING MODULE USED BY COMPANY

iv
61. . FIGURE 5.10 - INDUCTION TRAINING

62. . FIGURE 5.11 - SCHEDULING OF TRAINING

63. . FIGURE 5.12 - EVALUATION OF TRAINING BY COMPANY

64. FIGURE 5.13 - PERFORMANCE MANAGEMENT SYSTEM FOR

MANGALAM DRUGS AND ORGANICS

65. FIGURE 5.14 - ROLE OF HOD, HR AND EMPLOYEE IN PERFORMANCE

MANAGEMENT SYSTEM

66. FIGURE 5.15 - ADMINISTRATION DEPARTMENT OF MANGALAM

DRUGS AND ORGANICS

67. FIGURE 5.16 - EMPLOYEE RELATED

68. FIGURE 6.1 - FUNCTIONS OF PURCHASE DEPARTMENT

69. FIGURE 6.2 SUPPLIER EVALUATION AND QUOTATION

70. FIGURE 6.3 - PURCHASE ORDER CREATION

71. FIGURE 6.4 - PROCUREMENT OF ENGINEERING ITEMS

72. FIGURE 6.5 - MANAGEMENT OF MISCELLANEOUS ITEMS

73. FIGURE 7.1 - TYPES OF WAREHOUSES IN COMPANY

74. FIGURE 7.2- TESTING STAGES OF RAW MATERIAL

75. FIGURE 7.3- PACKING MATERIAL

76. FIGURE 7.4- WEIGHING OF GOODS

77. FIGURE 7.5 - TYPES OF STORAGES

78. FIGURE 7.6- IMAGE OF FORK LIFT

79. FIGURE 7.7 - IMAGE OF PLATFORM TROLLEY

80. FIGURE 7.8 - IMAGE OF HOIST

v
81. FIGURE 7.9 - MEDIUMS OF TRANSPORTATION

82. FIGURE 7.10 - ILLUSTRATION OF RETURN FINISHED GOODS

83. FIGURE 7.11 - LAYOUT OF FINISHED GOODS STOREAGE

84. FIGURE 8.1 - KEY COMPONENTS OF QSM

85. FIGURE 8.2- BENEFITS OF QSM

86. FIGURE 8.3 - ORGANISATIONAL STRUCTURE OF QUALITY

ASSURANCE DEPARTMENT

87. FIGURE 8.4 - KEY COMPONENTS OF QUALITY ASSURANCE

88. FIGURE 8.5 - KEY COMPONENTS OF QUALITY CONTROL

89. FIGURE 8.6 - PROCESS OF DRUG MASTER FILE

90. FIGURE 9.1 - TYPES OF WASTE

91. FIGURE 9.2 - HEALTH COMPONENTS

92. FIGURE 9.3 - BENEFITS

93. FIGURE 9.4 - IMAGE OF FIRE EXTINGUISHER

94. FIGURE 9.5 - IMAGE OF PPE KIT

95. FIGURE 9.6 - STEPS OF HOW TO USE FIRE EXTINGUISHER.

vi
 LIST OF TABLES

1. TABLE 1.1 - PRODUCT PORTFOLIO OF COMPANY

2. TABLE 1.2 - CONTACT DETAILS OF COMPANY

3. TABLE 2.1 - PREVENTIVE MAINTENANCE SCHEDULE

4. TABLE 2.2 - ROLES AND RESPONSIBILITIES DURING OPERATION OF

EJECTOR AND VACUUM PUMPS

5. TABLE 2.3 - LIST OF PURIFICATION REACTORS

6. TABLE 5.1 - ROLES AND RESPONSIBILITIES

FOR RECRUITMENT OF EMPLOYEES, JOINING AND
RELIEVING FORMALITIES

7. TABLE 5.2 - ANNEXURE DETAILS UNDER RECRUITMENT OF

EMPLOYEES, JOINING AND RELIEVING FORMALITIES

8. TABLE 5.3 - AREA APPLICABLE UNDRE RECRUITMENT OF

EMPLOYEES, JOINING AND RELIEVING FORMALITIES

9. TABLE 5.4 - ROLES AND RESPONSIBILITIES FOR GENERAL CLEANING

AND HOUSEKEEPING

10. TABLE 5.5 - PROCEDURE OF FOR GENERAL CLEANING AND

HOUSEKEEPING

11. TABLE 5.6 - ROLES AND RESPONSIBILITY OF SECURITY

12. TABLE 6.1 - - ROLES AND RESPONSIBILITY OF VENDOR EVALUATION

13. TABLE 6.2 - ROLES AND RESPONSIBILITY OF PROCUREMENT OF

CONSUMABLE ITEMS

vii
 INDEX

SR.NO PARTICULARS PAGE N0

1 CHAPTER 1 GENERAL INFORMATION 1-18

2 CHAPTER 2 PRODUCTION DEPARTMENT 19-56

3 CHAPTER 3 MARKETING DEPARTMENT 57-64

4 CHAPTER 4 ACCOUNTING DEPARTMENT 65-100

5 CHAPTER 5 HUMAM RESOURCE DEPARTMENT 101-139

6 CHAPTER 6 PURCHASE DEPARTMENT 140-153

7 CHAPTER 7 WAREHOUSE DEPARTMENT 154-174

8 CHAPTER 8 QUALITY SYSTEM MANAGEMENT 175-189

DEPARTMENT

9 CHAPTER 9 ENVIRONMENT, HEALTH AND 190-200

SAFETY DEPARTMENT

10 BIBLOGRAPHY 201

11 CONCLUSION 202-204

viii
ix
CHAPTER 1: GENERAL
INFORMATION

1
1.1 ABOUT COMPANY

Mangalam Drugs & Organics Limited commenced its

manufacturing of Active Pharmaceutical Ingredients
(APIs) and Intermediates at VAPI – Gujarat in 1977.
It has a multi-product manufacturing facility on two
locations, and an in-house Research & Development
laboratory recognized by the Department of Scientific
& Industrial Research, Delhi Government of India.
Over the last three decades, Mangalam has acquired
worldwide reputation as a single stop destination for
frontline Anti-malaria.
FIGURE1.1

We also have a diversified product range having synergies in operations and

economies of scale. Mangalam is amongst the top companies in Asia in all the
products it makes; and is also the largest manufacturer of some of its products in the
world.

There focus is in manufacturing:

1. ACTIVE PHARMA INGREDIENTS (APIs)

2. INTERMEDIATES
3. SPECIAL CHEMICALS

Along with the WHO-GENEVA GMP, MFDS Korea

Certification and EDQM approval for its API manufacturing
plant, the company is also in an agreement with the prestigious
Clinton Health Access Initiatives (CHAI) under its Fight
Malaria Program for supply of anti-malaria APIs worldwide.

FIGURE1.2

2
1.2 PRODUCT PORTFOLIO OF COMPANY

3
TABLE 1.1

4
1.3 VISION OF COMPANY

To be a persistently customer engaged API manufacturing company in the healthcare

business and thereby achieving growth in the industry by:

● Transparency in business policies

● Attaining globally competitive cost of its products
● Enhancing the value we deliver to stakeholders
● Committing to corporate responsibility
● Creating an environment that fosters achievement, innovation and
teamwork

1.4 MISSION OF COMPANY

They are committed to satisfy our customers’ needs & expectations. They understand
& believe that they can meet commitments to customers by:

● Adopting Current Good Manufacturing

Practices
● Emphasis on environmental protection
● Employee - Vendor Involvement
● Quality management system with continual
improvement

FIGURE 1.3

5
1.5 BOARD OF DIRECTORS

Mr. Govardhan M Dhoot

Chairman & Managing Director

Shri G. M. Dhoot has a commerce background and more

than four decades of experience in the chemical and
pharma industry. He has been the driving force behind
the phenomenal expansion and diversification of the
company over the last decade.

Mr. Brijmohan M Dhoot

Whole-time Director

Shri B. M. Dhoot has a commerce background and

more than 40 years’ experience in chemical and
pharma industry

Mrs. Nidhi Mundada

Independent Director

Mrs. Nidhi Mundada has 5+ years of experience in

diverse sectors – Financial Services, FMCG and I.T.
She considers herself as a hands-on person and enjoy
working in a fast-paced environment. She has the good
fortune of having contributed in setting up strategies
and executing them end-to-end at companies like
Infosys, HUL, Citi and Dinshaw’s.

Shri RUKMESH DHANDHANIA

INDEPENDENT DIRECTOR.

6
 Rukmesh Dhandhania has done masters in
Marketing Management and has a 10 years’
experience in Agency Business.

Dr. Praveen Saxena

|Independent Director

Dr. Praveen Saxena has done M.Sc. (Gold

Medal) and Ph.D. in Physics from Delhi
University. He is an international expert
and has over 50 research publications in
international journals, and has represented
India’s interests in Renewable Energy in
various multilateral organizations and
international forums

Shri
Rakesh
K.
Milwani
(Non-Executive Non-Independent
director)

Shri Rakesh K. Milwani is a Chartered

Accountant from Institute of Chartered
Accountants of India and comes with
over of 37 years of experience as a
Practicing Chartered Accountant
enriching himself with expertise in Financial Services. He has also
completed his Bachelor’s Degree of Commerce and Bachelors Degree
of Law.

7
1.6 ORGANISATION STRUCTURE

Mangalam Drugs and Organics appears to have a hierarchical organizational

structure, likely with departments such as production, research and
development, sales and marketing, finance, and human resources. This structure
allows for clear lines of authority and communication, facilitating efficient
operations within the company. The organization structure of the company is as
follows:

1. PRESIDENT/ VICE PRESIDENT

2. SENIOR GENERAL MANAGER / DEPUTY GENERAL MANAGER /

ASSISTANT GENERAL MANAGER

(PRODUCTION)

3. SENIOR GENERAL MANAGER / DEPUTY GENERAL MANAGER /

ASSISTANT GENERAL MANAGER

(CUSTOMER QUALITY ASSURANCE)

4. SENIOR GENERAL MANAGER / DEPUTY GENERAL MANAGER /

ASSISTANT GENERAL MANAGER

(TECHNICAL SERVICES)

5. SENIOR GENERAL MANAGER / DEPUTY GENERAL MANAGER /

ASSISTANT GENERAL MANAGER

(ADMIN)

6. SENIOR GENERAL MANAGER / DEPUTY GENERAL MANAGER /

ASSISTANT GENERAL MANAGER

(ENVIRONMENT AND SOCIAL)

7. SENIOR MANAGER / DEPUTY MANAGER / ASSISTANT

MANAGER

8
8. SENIOR EXECUTIVE MANAGER / DEPUTY EXECUTIVE

MANAGER / ASSISTANT

EXECUTIVE MANAGER

9. SENIOR OFFICER / JUNIOR

OFFICER

10. SENIOR CHEMIST

11. JUNIOR ENGINEER

12. ASSISTANT /SUPERVISOR

13. TRAINEE

14. SKILLED WORKER

15. SEMI SKILLED WORKER

16. DRIVER

17. PEON / OFFICE BOY

FIGURE 1.4

9
1.6 SWOT ANALYSIS OF COMPANY

● STRENGTH

Mangalam Drugs & Organics Ltd. has several strengths that contribute to its standing
in the industry:

1. THREE DECADES OF EXPERIENCE AND EXPERTISE

With over 30 years in the field, Mangalam Drugs has accumulated extensive
knowledge and experience. This long-term presence in the market indicates stability
and reliability, which can enhance trust among customers and partners.

2. ESTABLISHED BRAND NAMES

Having well-known brand names helps in maintaining a strong market presence.
Established brands are often associated with quality and trustworthiness, making it
easier for the company to attract and retain customers.

3. IN-HOUSE MANUFACTURING FACILITIES

Mangalam Drugs' state-of-the-art manufacturing facilities ensure high standards in
production, quality control, and research and development. In-house facilities allow
for better control over the manufacturing process, leading to consistent product
quality and innovation.

4. PROVEN LEADERSHIP
Effective and experienced leadership is crucial for navigating the competitive
pharmaceutical industry. Proven leaders can make strategic decisions that drive
growth, manage challenges, and sustain the company's vision and mission.

5. EXTENSIVE MARKETING NETWORK IN INDIA AND ABROAD

10
A wide-reaching marketing network helps in distributing products efficiently and
reaching a broad customer base. It also aids in the global expansion of the company's
market, increasing its footprint and revenue opportunities both domestically and
internationally.

 WEAKNESS
Mangalam Drugs & Organics Ltd. faces several weaknesses that can impact its
operations and growth:

1. DEPENDENCY ON RAW MATERIALS

Reliance on specific raw materials, especially if sourced from limited suppliers or
regions, can pose significant risks. Any disruption in the supply chain, such as price
fluctuations, shortages, or geopolitical issues, can affect production schedules and
profitability.

2. REGULATORY CHALLENGES
The pharmaceutical industry is heavily regulated, with strict compliance
requirements for manufacturing, quality control, and distribution. Navigating these
regulations can be complex and costly. Non-compliance or delays in meeting
regulatory standards can lead to legal issues, fines, or the inability to bring new
products to market.

3. COMPETITION
The pharmaceutical sector is highly competitive, with numerous players vying for
market share. Mangalam Drugs faces competition from both domestic and
international companies, which can lead to price wars, pressure on profit margins, and
the need for continuous innovation to maintain a competitive edge.

4. MARKET VOLATILITY
Economic fluctuations and market volatility can impact consumer spending,
investment in new drugs, and overall industry growth. Factors such as changes in
healthcare policies, economic downturns, or shifts in consumer preferences can lead
to unpredictable market conditions, affecting sales and profitability.

11
  OPPORTUNITIES

Mangalam Drugs & Organics Ltd. has several opportunities that can drive its future
growth and success:

1. EXPAND PRODUCT PORTFOLIO

By diversifying its product offerings, Mangalam Drugs can tap into new market
segments and reduce dependency on a few key products. Introducing new drugs,
formulations, or therapeutic categories can help in attracting a broader customer base
and increasing revenue streams.

2. INVEST IN R&D
Investing in research and development is crucial for innovation and staying ahead of
competitors. R&D efforts can lead to the development of new and improved drugs,
more efficient manufacturing processes, and breakthroughs in drug delivery systems.
This can enhance the company’s competitive edge and enable it to meet emerging
market demands.

3. SUSTAINABILITY INITIATIVES
Implementing sustainability practices can improve operational efficiency and reduce
environmental impact. Initiatives such as reducing waste, optimizing resource use,
and adopting green technologies can not only lower costs but also enhance the
company’s reputation among environmentally conscious consumers and investors.

4. TECHNOLOGICAL ADVANCEMENTS

12
Embracing new technologies in manufacturing, quality control, and distribution can
significantly boost efficiency and product quality. Technologies like automation, AI,
and big data analytics can streamline operations, improve decision-making, and
enhance customer service.

 THREATS

Mangalam Drugs & Organics Ltd. faces several threats that could impact its business:

1. EXCHANGE RATE FLUCTUATIONS

As an exporter, the company is vulnerable to changes in currency exchange rates.
Fluctuations can affect profitability by increasing costs or reducing revenue when
converting foreign earnings back to the local currency.

2. TECHNOLOGICAL CHANGES
Rapid technological advancements can render existing processes and products
obsolete. Keeping up with these changes requires continuous investment in new
technologies, which can be costly and challenging.

3. LEGAL RISKS
The pharmaceutical industry is subject to stringent regulations and legal standards.
Non-compliance can result in lawsuits, fines, and damage to the company's
reputation. Additionally, patent disputes and intellectual property issues can pose
significant risks.

4. PUBLIC HEALTH ISSUES

Outbreaks of diseases, pandemics, or changes in public health policies can disrupt
supply chains, affect demand for certain drugs, and strain the company’s resources.
These issues can lead to unpredictable market conditions and operational challenges.

13
1.7 CORPORATE SOCIAL RESPONSIBILITY
(CSR ACTIVITIES)

To extend their solidarity & support to

the community during the covid-19
pandemic, Mangalam drugs has stepped
up and donated 6 lacs to Shreyas
Medicare for implementing a pipeline
for their oxygen plant; and 6.45 lacs to
Haria Rotary charitable trust for the
procurement of a ventilator.

FIGURE 1.5

Mangalam drugs and organics limited

supported in preservation of rich cultural and
philosophical heritage by contributing funds
in digitization of manuscripts

14
 FIGURE 1.6

Mangalam drugs and organics limited

have celebrated world environment day
at our both the units and we have
planted total 40 nos. Plant nearby our
factory premises.

FIGURE 1.7

Mangalam
drugs and
organics
limited
donated
hydroxychloroquine tablets to various government
authorities and hospitals to support the treatment of the
global covid-19 pandemic.

FIGURE 1.8

Mangalam drugs & organics limited has

contributed under the CSR activities and
provided the water purifiers to the Sanskar
English School, Gangapur, Aurangabad and
C.P.S. Gangapur (girls) no.2, Zilla Parishad
School, Gangapur, Aurangabad.

FIGURE 1.9

Mangalam drugs and organics under CSR

activities has started lunch once in a week
(every Saturday) for blind students of

15
‘pragnamandir” (school for the blind & school for the physically challenged) of
Manavkalyan trust, Navsari

FIGURE 1.10

1.8 ACCREDITATION

EUROPEAN DIRECTORATE FOR

THE QUALITY OF MEDICINE AND
HEALTHCARE

FIGURE 1.11

CENTRAL DRUGS STANDARD CONTROL ORGANISATION

FIGURE 1.12

16
 EUROPEAN MEDICINE
AGENCY

FIGURE 1.13

NATIONAL MEDICAL PRODUCTS ADMINISTRATION

FIGURE 1.14

WORLD HEALTH
ORGANIZATION

FIGURE 1.15

MINISTRY OF FOOD AND DRUG SAFETY

17
 FIGURE 1.16

1.10 CONTACT DETAILS OF COMPANY

REGISTER OFFICE Mangalam Drugs & Organics Limited

Rupam Building, 3rd Floor,
239, P D’ Mello Road (Near GPO),
Mumbai – 400 001, Maharashtra, INDIA

LOCATION OF COMPANY MANGALAM DRUGS AND ORGANIC

(VAPI) LTD (UNIT- 2)
Plot No. 1203, phase 3, GIDC,
Vapi, Gujarat, 396195

CORPORATE IDENTIFICATION NUMBER L24230MH1972PLC116413

CONTACT NUMBER +91-22-6261-6200/6300/8787

TELEPHONE NUMBER +91-22-62619090

FAX NUMBER +91-22-22619090

EMAIL ID [email protected]

Contact person for queries/grievances Ms. Nisha Waghela

TABLE 1.2

18
CHAPTER 2: PRODUCTION
DEPARTMENT

19
2.1 INTRODUCTION TO PRODUCTION DEPARTMENT

20
Mangalam drugs and organic's production facilities are equipped with advanced
technology and comply with international standards, ensuring the production of high-
quality pharmaceuticals. These facilities are designed to support large-scale
manufacturing and are continually updated to incorporate the latest advancements in
pharmaceutical production.

● PRODUCTION HEAD:
This is the highest authority in the production department and it is responsible for
overseeing the entire manufacturing process. It ensures the compliance with
regulations, and optimizing production efficiency.

● MANAGER:
It comprises mid-level managers who oversee various sections of the production
process. It ensures adherence to schedules, manage resources, and handle
administrative duties.

● EXECUTIVE INCHARGE:
There are specialized officers who ensure quality control, compliance with safety
standards, and the implementation of specific production protocols.

● OPERATORS:
There are skilled workers who operate machinery and equipment, carry out
manufacturing processes, and ensure smooth operation on the production floor.

☞ PRODUCTION OFFICE
Mr. Anwar Pathan oversees the production operations at Mangalam Drugs and
Organics.

21
His role involves managing the entire production process, ensuring compliance with
regulatory standards, optimizing production efficiency, and maintaining high-quality
products

The production office plays a pivotal role in coordinating and managing the
manufacturing processes at Mangalam Drugs and Organics.

● FUNCTION:
Central hub for managing production processes.

● RESPONSIBILITIES:
Few responsibilities of production department
1. Production planning and scheduling.
2. Quality control and assurance.
3. Inventory management and procurement coordination.
4. Process optimization and efficiency improvement.
5. Health and safety compliance.
6. Communication and coordination between departments.
7. Resource allocation and utilization monitoring.
8. Performance monitoring and reporting for continuous improvement.

● GOAL:
Ensure smooth production operations, maintain quality standards, and drive efficiency
to meet production targets and customer demands

2.2 PRODUCTS AND SERVICES PRODUCE AND TYPE

OF PRODUCTION SYSTEM USED

MANGALAM DRUGS AND ORGANICS, produces both type of product:

22
 1. INTERMEDIATE PRODUCT
2. FINAL PRODUCT

MANGALAM DRUGS AND ORGANICS USES INTERMEDIATE

PRODUCTION SYSTEM

Mangalam Drugs and Organics Ltd. utilizes an INTERMEDIATE production system

to manufacture a variety of pharmaceutical products, especially anti-malarial APIs
and intermediates. This system allows the company to flexibly produce small batches
and custom orders, adapting quickly to market demands. Key features include
versatile machinery, a skilled workforce, a job shop layout for efficient transitions
between products, and stringent quality control measures. The strategic benefits
include meeting diverse market needs, optimizing resources, supporting R&D, and
maintaining high compliance standards. Despite challenges in scheduling and
inventory management, the system enables Mangalam Drugs to effectively manage
complex production requirements and sustain its competitive edge.

FIGURE 2.1

Some of products are listed below:

1. ANTI-MALARIA
● Amodiaquine Hydrochloride (USP/ IP/ IH)
● Artemether (Ph. Int./ IP)

23
 ● Artesunate (Ph. Int./ IP)
● Dihydroartemisinic (Ph. Int.)
● Lumefantrine (USP/ Ph. Int./IH)
● Primaquine Phosphate (USP/EP/BP/IP)
● Piperaquine Phosphate (IH)
● Pyrimethamine (USP/EP/Ph. Int./IP/IH)
● Pyronaridine Tetraphosphate (IH)
● Sulfoxide (USP/EP/Ph. Int./IP/IH)

2. ANTI- RETROVIRAL
● Atazanavir Sulphate (Ph. Int./ IP/IH)
● Dolutegravir Sodium (IH)
● Efavirenz (USP/Ph. Int./IP)
● Emtricitabine (USP/Ph. Int./IP)
● Tenofovir Disoproxil Fumarate (Ph. Int./IP/IH)
● Tenofovir Alafenamide Fumarate (IH)

3. ANTI-HYPERTENSIVE
● Bisoprolol Fumarate (USP/EP)
● Furosemide (USP/EP/BP/IP)

4. ANTI-INFLAMMATORY
● Nimesulide (EP/BP)

5. ANTI-CONVULSANT
● Pregabalin (EP/IP

2.3 RAW MATERIAL PROCUREMENT FOR

PRODUCTION

Mangalam Drugs and Organics procure raw materials from various sources like
suppliers, distributors, or even directly from manufacturers. They have a procurement

24
team that ensures the quality, quantity, and timely delivery of these materials to
support their production process.

Production department sends production slips to the Quality Assurance (QA)

department as a standard procedure in manufacturing. This step ensures that the
products meet quality standards before they are released for distribution or further
processing. The production slip typically includes details about the production
process, such as batch numbers, quantities produced, and any relevant specifications.
QA then inspects the products based on these criteria to verify their quality and
compliance.

● RAW MATERIAL USED:

1. Dichloromethane
2. Chloroquine
3. Quinine
4. Mefloquine
5. Pyrimethamine
6. Sulfadoxine
7. Sulfones
8. Tetracyclines
9. Acetone
10. Ethyl Acetate
11. Ethanol
12. Methylene
13. Dimethyl formamide

25
FIGURE 2.2

26
2.4 STAGE 1: CHEMICAL REACTIONS OF RAW
MATERIALS

The production department at Mangalam Drugs and Organics Company is committed

to the efficient and safe manufacturing of high-quality chemical products. Here's a
summary of our production process:

● FOR EXAMPLE:
To produce acetonitrile through chemical reaction for further processing and
utilization in various applications.
As Mangalam Drugs and Organics is a manufacturer, they likely use acetonitrile as a
raw material in various chemical processes. Acetonitrile is a versatile solvent
commonly used in organic synthesis, pharmaceutical manufacturing, and other
chemical processes

● PROCESS OVERVIEW:
1. Raw materials are meticulously weighed using weighing balance WB-2A-02 to
ensure accurate quantities for each batch.
2. Acetonitrile undergoes a chemical reaction to produce the desired product.
3. The resulting crude product is transferred to a modular system for further
processing.

● CHEMICAL REACTION
During production, acetonitrile may undergo various chemical reactions depending on
the specific process and the intended end products. Some common reactions involving
acetonitrile include:

27
1. HYDROGENATION:
Acetonitrile can be hydrogenated to form ethylamine, a building block for various
pharmaceuticals and organic compounds. This reaction typically involves the use of a
catalyst such as nickel or palladium.

2. NITRILE HYDROLYSIS:
Acetonitrile can undergo hydrolysis in the presence of water and acid or base
catalysts to form acetic acid or acetamide. This reaction is important in the production
of these chemicals for use in various industries.

3. GRIGNARD REACTIONS:
Acetonitrile can react with alkyl or aryl magnesium halides (Grignard reagents) to
form ketones through nucleophilic addition followed by hydrolysis. This reaction is
valuable in organic synthesis for creating complex molecules.
These are just a few examples of the chemical reactions that acetonitrile can undergo
during production processes at Mangalam Drugs and Organics. The specific reactions
employed will depend on the desired end products and the expertise of the company's
chemists and engineers.

● CRUDE MOLECULE
A "crude molecule" typically refers to a molecule that is in its natural or
unrefined state, without undergoing purification or processing.

The crude molecule of Acetonitrile, also known as methyl cyanide, has the chemical
formula CH3CN. It consists of a methyl group (CH3) attached to a nitrile group (CN).
This simple structure makes acetonitrile a versatile starting material for various
chemical reactions and synthesis processes in industries such as pharmaceuticals,
agrochemicals, and fine chemicals.

28
 ● PRODUCTION FACILITY:
1. Reactor Configuration: The production facility houses 25 reactors within the 2A
plant building. These reactors are distributed across two floors:
First Floor: 15 reactors, with 11 in one area room and 4 in another area room.
Second Floor: 10 reactors.

2. Reactor Design: Each reactor is equipped with following

Jacket inlet for precise temperature control during chemical reactions.
Additional lines for introducing reagents at specific stages.
Vapor columns to facilitate separation and purification processes.

3. Receiver Tank System: Upon completion of the reaction, the product is

transferred to receiver tanks before being directed to subsequent reactors for
further processing.

4. Operating Conditions: Reactors operate under controlled conditions, maintaining

a pressure of 7 kg and a temperature of 165°C to ensure optimal reaction kinetics
and product quality.

5. Material Transfer: The process involves the transfer of both solid and liquid
materials between reactors, ensuring seamless continuity and efficiency in
production.

6. Glass Reactors: Three reactors are specially designated as glass reactors,

providing visibility and facilitating observation during reactions.

29
● PREVENTIVE MAINTENANCE SCHEDULE
EQUIPMENT NUMBER MAINTENANCE
FREQUENCY

Reactor RE-2A- 102 Half yearly

Reactor RE-2A-103 Half yearly

Reactor RE-2A- 108 Half yearly

Reactor RE-2A- 109 Half yearly

Reactor RE-2A-110 Half yearly

Reactor RE-2A-111 Half yearly

Reactor RE-2A-112 Half yearly

Reactor RE-2A-116 Half yearly

Reactor RE-2A-117 Half yearly

Reactor RE-2A-118 Half yearly

Fluid bed dryer FB 2A 102 Yearly

TABLE 2.1

● ANALOGUE IMAGE OF REACTORS

30
 FIGURE 2.3 FIGURE 2.4

2.5 STAGE 2: PURIFICATION OF CRUDE MOLECULE

Purification in Mangalam Drugs and Organic Company Likely refers to the

process of removing impurities from drugs or organic compounds they produce.
This process ensures the final product meets quality standards and is safe for
consumption or use. It could involve various techniques such as filtration,
distillation, crystallization, or chromatography

The “purification “of acetonitrile typically involves several steps to be Acetonitrile is

often purified through fractional distillation. This the process takes advantage of the
differences in boiling points between acetonitrile and its impurities. Acetonitrile has a
relatively low boiling point (81.6°C), allowing it to be separated from higher boiling
point impurities.

1. SOLVENT EXTRACTION:

Another method involves solvent extraction, where acetonitrile is mixed with a

selective solvent that preferentially extracts impurities, leaving behind purified
acetonitrile. Common solvents used for extraction include water and polar organic
solvents.

2. ADSORPTION:

Adsorption techniques, such as activated charcoal or molecular sieves, can be used to

remove impurities from acetonitrile. The impurities are adsorbed onto the surface of
the adsorbent, while the purified acetonitrile passes through.

31
3. DISTILLATION UNDER REDUCED PRESSURE:

To remove any remaining volatile impurities, distillation under reduced pressure

(vacuum distillation) can be employed. This technique lowers the boiling point of
acetonitrile, allowing for purification at lower temperatures.

4. CHROMATOGRAPHY:

For high-purity applications, chromatographic techniques such as column

chromatography or high-performance liquid chromatography
(HPLC) may be used. These methods separate acetonitrile from impurities based on
differences in their chemical properties.

● ANALOGUE IMAGES OF PURIFICATION

32
 FIGURE 2.5

2.6 STAGE 3: DRYING OF PURIFIED PRODUCT

Drying is the process of removing moisture or solvent from a substance to make

it dry. In pharmaceutical manufacturing, drying is often used to remove water
or solvents from raw materials, intermediates, or final products to improve
stability, prevent degradation, and facilitate handling and storage. There are
various drying methods such as air drying, vacuum drying, freeze drying, and
spray drying, each suitable for different applications and materials.

● SAFETY MEASURES
Mangalam drugs and organic company have separate room for drying their products.
Before entering the room worker, visitor & head members have to follow some safety
measures. The safety measures for workers are such as head cap, nose mask, hand
gloves and shoe cover.

● TEMPERATURE
The temperature in a drying room for acetonitrile in a pharmaceutical company can
vary depending on the specific drying method being used and the requirements of the
process. For the molecular sieve drying method, the temperature is typically kept at
ambient or slightly elevated temperatures (around 20-30°C) to facilitate the drying
process without causing excessive evaporation of the solvent.
It's important to note that the specific temperature and conditions may vary based on
the equipment used, the scale of the operation, and the specific requirements of the
pharmaceutical process. Therefore, it's crucial to follow established procedures and
guidelines to ensure the drying process is conducted effectively and safely.

33
 ● ROOM FACILITIES
In that room there are some trolleys, which they fit in their drying equipment. That
trolley is basically washed after using it once a time. The duration for washing a
trolley can vary depending on the cleaning method, the degree of dirtiness, and the
specific washing equipment used. In a pharmaceutical setting where cleanliness and
sterility are critical, the washing process is usually thorough and can take anywhere
from 15 minutes to over an hour per trolley. This includes pre-rinsing, washing with
detergent or cleaning solution, rinsing, and sometimes sanitizing or sterilizing steps.
In that trolley material is being used for drying.
Mangalam Drugs and Organics vacuum drying processes to ensure the purity and
quality of their products, including acetonitrile.

Vacuum drying, or drying under reduced pressure, can be effective for removing
moisture from acetonitrile at lower temperatures. This method minimizes the
risk of thermal degradation and is commonly used in industries where
preserving the integrity of the product is crucial.

Rotary vacuum drying is used in MANGALAM DRUGS AND ORGANICS

Rotary vacuum drying is a continuous process used to remove moisture or solvents
from materials under reduced pressure. It involves feeding the material into a rotating
drum dryer, where it is exposed to heated surfaces while being subjected to vacuum
conditions. This promotes evaporation of moisture or solvents, which are then drawn
out of the drum by a vacuum pump. The rotation of the drum ensures thorough
mixing and uniform drying of the material. This method is favored for its continuous
operation and ability to handle large quantities of material efficiently.

34
These drying methods are likely part of Mangalam Drugs and Organics' quality
control processes to ensure that their products, including acetonitrile, meet the
required purity and quality standards for their intended applications.

The product after drying would still be acetonitrile. Drying is a process applied to
acetonitrile to remove impurities and moisture, ensuring it meets the required purity
standards. So, the name of the product remains acetonitrile.

● ANALOGUE IMAGE OF ROTARY VACUUM DRYING

FIGURE 2.6 FIGURE 2.7

35
2.7 STAGE 4: INTERMEDIATE PRODUCT

In pharmaceutical manufacturing, INTERMEDIATE production refers to the

production process that starts and stops as needed based on specific customer orders
or varying production needs.

● EXAMPLES OF INTERMEDIATE PRODUCTS

1. Primaquine Phosphate
2. Lime Putdrive
3. Chloroquine phosphate
4. Amodiaquine hydrochloride
5. Aciclovir
6. Pyronaridine triphosphates

● INTERMEDIATE PRODUCTS ARE FURTHER USE IN

MANGALAM DRUGS AND ORGANICS FOR:

1. NEW PRODUCT DEVELOPMENT: It supports the introduction of new

products by allowing for smaller test batches to be produced, evaluated, and adjusted
before full-scale production. This minimizes the risk associated with launching new
products.

2. CUSTOMIZATION AND PERSONALIZATION: INTERMEDIATE

production can cater to customized and personalized product demands, especially
relevant in pharmaceuticals where specific formulations may be required for different
patients.

36
3. SUPPLY CHAIN MANAGEMENT: This approach improves supply chain
management by aligning production schedules with supply chain capabilities,
reducing lead times, and enhancing responsiveness to supply chain disruptions.

4. MARKET RESPONSIVENESS: It allows the company to respond quickly to

market trends and changes in consumer preferences, ensuring that the product
offerings remain relevant and competitive.
● INTERMEDIATE ROOM

An INTERMEDIATE room in a pharmaceutical company would be a space

designated for production that occurs on an as-needed basis. This room can be set up
to handle various production tasks, accommodating the flexible nature of
INTERMEDIATE manufacturing.
Some quantity in which INTERMEDIATE products are store:
1. 54 kg
2. 108 kg
3. 111 kg
4. 406.99 kg
5. 821.7 kg

● INTERMEDIATE COLD STORAGE

INTERMEDIATE cold storage refers to storage solutions that are used as needed to
store products requiring specific temperature conditions temporarily. This type of
storage is crucial for maintaining the integrity of temperature-sensitive
pharmaceuticals during INTERMEDIATE production processes

● CONCLUSION

The INTERMEDIATE production at Mangalam Drugs and Organics provides several

key advantages. By producing in batches, Mangalam Drugs and Organics can also
optimize production costs, minimize waste, and reduce inventory holding costs. This
combination of flexibility, efficiency, and cost-effectiveness helps the company
maintain competitive in a rapidly changing market.

37
☞ STANDARD OPERATING PROCEDURE FOR
OPERATION OF EJECTOR AND VACUUM PUMPS

● OBJECTIVE

To establish the procedure for the safe and efficient operation of ejector and vacuum
pumps used in various processes within a pharmaceutical manufacturing environment.

● SCOPE

This SOP is applicable to all vacuum pumps and ejector pumps used in production
and quality control departments.

● RESPONSIBILITIES

ROLES RESPONSIBILITIES

Operators It is responsible for operating the pumps

according to the SOP.

Quality Control (QC) Analysts It ensures the pumps are maintained and
operated as per the guidelines.

Maintenance Team: It is responsible for regular maintenance

and troubleshooting.

TABLE 2.2

38
 ● PROCEDURE FOR EJECTOR PUMP

1. PREPARATION:
It ensures the ejector pump is clean and in good working condition.
It verifies that all connections and fittings are secure.
2. OPERATION:
It opens the main valve to start the flow of driving fluid (e.g., steam, water).
Gradually open the suction valve to allow the process fluid to enter the ejector.
It monitors the pressure and flow rates to ensure they are within the specified ranges.
3. SHUTDOWN:
It closes the suction valve first.
Gradually shut off the driving fluid to avoid any sudden changes in pressure.
It ensures the system is depressurized before performing any maintenance.

● PROCEDURE FOR VACUUM PUMP

1. PREPARATION:
First, place the vacuum pump on a sturdy and leveled surface.
It ensures all connections, including silicon or rubber tubing, are secure and properly
attached to the required apparatus.
2. OPERATION:
Turn on the power supply and the main switch of the vacuum pump.
Then, Monitor the system to ensure proper vacuum creation.
Avoid letting any liquid enter the pump to prevent damage.
3. SHUTDOWN:
Turn off the pump and the main power supply after use.

39
Disconnect the tubing and clean the pump according to the cleaning SOP.

● CLEANING AND MAINTENANCE

It regularly inspects the pumps for any signs of wear and tear. It cleans the exterior
and interior components as required, ensuring no residue is left inside the pump. They
schedule periodic maintenance checks to ensure optimal performance

2.8 STAGE 5: TESTING OF INTERMEDIATE PRODUCT

Testing INTERMEDIATE products in a pharmaceutical and organic chemistry

context, such as in Mangalam Drugs and Organics, involves a series of rigorous
procedures to ensure product quality, consistency, and safety. Here are the key steps
typically involved in this process:

1. SAMPLING:
Random and statistically determined sample sizes from batches.

2. ANALYTICAL TESTING:
Physical (appearance, solubility), chemical (HPLC, GC, spectroscopy),
microbiological (contaminants), and dissolution tests.

3. STABILITY TESTING:
Accelerated and long-term testing under different conditions.

4. VALIDATION AND VERIFICATION:

Ensuring testing methods are reliable and effective.

5. DOCUMENTATION AND COMPLIANCE:

Following SOPs and meeting regulatory standards.

6. QUALITY CONTROL AND ASSURANCE:

In-process checks, final product testing, and detailed batch records.

40
 7. DATA ANALYSIS AND REPORTING:
Statistical analysis and comprehensive reporting.

8. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA):

Identifying issues and implementing solutions.

2.9 STAGE 6: PURIFICATION OF INTERMEDIATE

PRODUCTS

The purification process for INTERMEDIATE products in pharmaceutical

manufacturing, such as at Mangalam Drugs and Organics, involves several essential
steps. Initially, filtration is used to remove solid impurities from the reaction mixture.

Purification reactors are designed to remove impurities from Chemical substances,

enhancing the purity of the final product. They typically Involve a combination of
chemical reactions and physical processes to achieve the Desired level of purification.
These reactors can operate under various conditions. Such as different temperatures,
pressures, and pH levels, depending on the specific requirements of the purification
process.

MANGALAM DRUGS AND ORGANICS has two wings namely

● 2B
● 2C

41
 2B 2C

1. RE-2B-1001 1. RE-2C-1001
Capacity -4.0Kl

2. RE-2B-1002 2. RE-2C-1002
Capacity -3. kL

3. RE-2C-1003
Capacity -2500L

4. RT-2C-1001
Capacity -250L

5. RT-2C-1003A
Capacity -250L

6. RT-2C-1002
Capacity -250L

Purification reactors in each wing are as followed:

TABLE 2.3

● ANALOGUE IMAGES OF PURIFICATION REACTORS

42
 FIGURE 2.8

☞ STANDARD OPERATING PROCEDURE FOR

OPERATION OF REACTORS (OP.PRD.001)

● PURPOSE:
The purpose of the SOP and the importance of proper reactor operation in Mangalam
drugs and organic company

● SCOPE:
Specify the reactors covered by this SOP and any specific products or
Processes they are used for.

● RESPONSIBILITIES:
Outline the responsibilities of personnel involved in operating
The reactors, including operators, supervisors, and quality control personnel.

● SAFETY PRECAUTIONS:
Detail safety measures to be followed before, during, and after reactor operation,
including personal protective equipment (PPE), emergency procedures, and handling
of hazardous materials.

● EQUIPMENT SETUP:
Provide instructions for setting up the reactors before operation, including calibration
of instruments, verification of utilities, and ensuring cleanliness.

● STARTUP PROCEDURE:
43
Step-by-step instructions for starting up the reactor, including heating, mixing, and
any other necessary operations.

● PROCESS MONITORING:
Describe methods for monitoring key process parameters such as temperature,
pressure, agitation speed, and pH throughout the operation
● ADJUSTMENT AND CONTROL:
Guidelines for making adjustments to process parameters based on monitoring data to
ensure product quality and consistency.

● SAMPLING AND ANALYSIS:

Procedures for taking samples during the operation for analysis, including sampling
locations, frequency, and testing methods.

● CLEANING AND MAINTENANCE:

Instructions for cleaning the reactor and associated equipment after operation,
including disassembly, cleaning agents, and sanitation procedures. Also, include
preventive maintenance tasks to ensure equipment reliability.

● QUALITY ASSURANCE:
Specify quality control measures to be followed during reactor operation, including
documentation requirements, in-process testing, and deviation handling procedures.

● SHUTDOWN PROCEDURE:
Step-by-step instructions for safely shutting down the reactor after operation,
including cooling, draining, and cleaning procedures.

● DOCUMENTATION AND RECORD KEEPING:

Requirements for documenting all aspects of reactor operation, including process
parameters, deviations, sampling results,

● TRAINING REQUIREMENTS:
Specify training requirements for personnel involved in

44
Operating the reactors, including initial training and ongoing competency
Assessments.

● REFERENCES:
Provide references to relevant documents, standards, and regulations
Governing reactor operation in pharmaceutical manufacturing.

2.10 STAGE 7: SPARKLING PROCESS

A sparkler room in a pharmaceutical company is a specially designed area used for

the safe handling and processing of flammable or explosive materials. These rooms
are equipped with safety features such as proper ventilation, explosion-proof
equipment, and fire suppression systems to prevent and manage potential hazards.
The term "sparkler" refers to the risk of sparks or static electricity that could ignite
flammable substances, hence the need for stringent safety measures in these rooms.
Mangalam drugs & organic Ltd have their two separate sparkler rooms. One is
SPARKLER ROOM 2B & another is SPARKLER ROOM 2C.
In the sparkler room 2B, there are 3 filter and 1 receiver tank and in sparkler room 2C
also have 3 filter and 1 receiver tank... These filters and tanks keep separately for the
use of different products. After purification the product carry out in this room for the
filtration of liquid products, especially those involving hazardous or flammable
materials. These rooms are designed to provide a controlled environment that
minimizes the risk of ignition from static electricity or other sources of sparks.

● ANALOGUE IMAGES OF RECEIVER TANK AND

SPARKLING TANKS

45
 FIGURE 2.9 FIGURE 2.10

☞ SOP for Operation of Sparkler Filter & Secondary Filter

(OP PRD 009)

 PURPOSE:
To provide standardized procedures for the operation, cleaning, and maintenance of
the sparkler filter and secondary filter to ensure consistent product quality and safety.

● SCOPE:
Applicable to the filtration processes using sparkler and secondary filters in the
sparkler room of the pharmaceutical manufacturing facility.

● RESPONSIBILITIES:
• Operators: To follow the SOP as written and report any deviations.
• Supervisors: To ensure compliance with the SOP and provide training.
• Maintenance Personnel: To perform regular maintenance and troubleshooting.

● EQUIPMENT AND MATERIALS:

1. Sparkler filter
2. Secondary filter
3. Personal protective equipment (PPE)
4. Cleaning agents and sanitizers
5. Maintenance tools

● PROCEDURE:
1. PRE-OPERATION CHECKS:
(A) Inspection: Inspect the filter units for any visible damage or wear.
(B) PPE: Ensure that all personnel are wearing appropriate PPE.

46
(C) Environment: Confirm that the sparkler room is clean and free of any ignition
sources.
(D)Materials: Ensure that all materials to be filtered are prepared and verified.

2. SETUP:
(A)Assembly: Assemble the sparkler filter according to the manufacturer’s
instructions.
(B)Connection: Connect the filter to the appropriate lines (inlet and outlet).
(C)Secondary Filter: Set up the secondary filter in line with the sparkler filter for
additional filtration.

3. OPERATION:
(A) Starting the Process: Open the inlet valve slowly to allow the product to enter the
sparkler filter. Monitor the pressure gauge to ensure it is within the operational range.
(B) Filtration: Adjust the flow rate to optimize filtration efficiency. Observe the outlet
for clear, filtered product flow. Regularly check for any signs of blockage or pressure
build-up.
(C) Secondary Filter: Monitor the secondary filter for any signs of clogging. Ensure
the secondary filter maintains the required flow rate and pressure.

4. SHUTDOWN:
(A)Stop the Inflow: Gradually close the inlet valve to stop the flow of the product.
(B) Drain: Open the drain valve to remove any remaining product from the filters.
(C)Disassembly: Carefully disassemble the filters for cleaning.

5. CLEANING AND MAINTENANCE:

(A) Cleaning: Clean the filters with appropriate cleaning agents. Rinse thoroughly to
remove all cleaning residues.
(B)Inspection: Inspect filter components for wear and replace any damaged parts.
(C) Reassembly: Reassemble the filters ensuring all seals and gaskets are properly
positioned.

47
(D) Record Keeping: Document the cleaning and maintenance activities in the
logbook.

6. SAFETY CONSIDERATIONS:
• Ensure proper ventilation in the sparkler room.
• Handle all materials and cleaning agents according to their safety data sheets (SDS).
• In case of an emergency, follow the company’s emergency response procedures.

2.11 STAGE 8: CRYSTALLIZATION

Crystallization in the context of Mangalam Drugs and Organics likely refers to the
process of purifying organic compounds through the formation of crystals. In the
pharmaceutical industry, crystallization is a crucial step in manufacturing drugs to
ensure their purity and efficacy. Mangalam Drugs and Organics might use
crystallization techniques to produce high-quality pharmaceutical ingredients or final
drug products.

Safety measures during the crystallization process typically include:

1. PERSONAL PROTECTIVE EQUIPMENT (PPE):
Ensure that workers wear appropriate PPE such as gloves, safety glasses, and lab
coats to protect against chemical exposure.

2. VENTILATION:
Work in a well-ventilated area or use a fume hood to prevent inhalation of harmful
vapors or dust particles.

3. CHEMICAL HANDLING:
Follow proper handling procedures for chemicals, including storage, mixing, and
disposal, to minimize the risk of spills or accidents.

4. TEMPERATURE CONTROL:
Monitor and control the temperature carefully to avoid overheating or sudden changes
that could lead to dangerous reactions.
48
 5. EQUIPMENT MAINTENANCE:
Regularly inspect and maintain equipment such as stirring devices, heating elements,
and cooling systems to ensure safe operation.

6. EMERGENCY RESPONSE:
Have appropriate emergency response protocols in place, including access to safety
showers, eyewash stations, and fire extinguishers.

7. TRAINING:
Provide comprehensive training to all personnel involved in the crystallization
process on safety procedures, chemical hazards, and emergency protocols.

The room dedicated to crystallization might be referred to as the "crystallization

room" or "crystallization chamber."
As for the reactors named "Re-2b-1003" and "Re-2b-1004," they are likely specific
pieces of equipment used for gas-liquid reactions. These reactors could be vessels or
chambers designed to facilitate controlled chemical reactions between gases and
liquids, often used in industrial processes for the production of various chemicals or
pharmaceuticals.

● ANALOGUE IMAGES OF CRYSTALLIZATION

49
 FIGURE 2.11

2.12 STAGE 9: POWDER PROCESSING

Mangalam Drugs & Organics Limited engages in extensive powder processing

operations as part of its manufacturing of Active Pharmaceutical Ingredients (APIs)
and intermediates. The company has facilities designed to handle powder processing
with strict environmental controls, including temperature and humidity management
systems. These facilities are equipped with advanced air handling units to maintain
the necessary conditions for both the production areas and microbiology labs.

● SAFETY MEASURES:
Gowning procedures, including masks, gloves, and shoe covers, are mandatory for
personnel entering the area.
Visitors wear white full-body disposal gowns, while audit personnel wear yellow full-
body disposal gowns.
Two distinct rooms, 2B and 2C, equipped with appropriate filtration systems ensure a
controlled environment.
A viewing passage with glass allows for observation without compromising safety.

● FUNCTIONAL AREAS:

A) CENTRIFUGE AREA: Here, materials undergo crystallization and are

transformed into mother liquor. The centrifuge separates the weight cake from the
mother liquor, facilitating further processing.

B) SPARE ROOM: This area serves as a storage space for the weight cake,
allowing for moisture removal to enhance the quality of the product.

50
C) DRYER ROOM: Equipped with a rotary dryer, this room is designated for
drying the weight cake, ensuring optimal moisture levels for downstream processing.

D) CONEMILL AND MULTIMILL: The cone-mill, located in room 2C,

and the multi-mill, situated in room 2B, are utilized for milling particles to desired

specifications, refining the powder for subsequent stages.

E) JETMILL: Upon customer request, the jet-mill is employed to achieve micro-

particle sizes, catering to specific product requirements and applications.

F) SIFTER & PACKING ROOM: In this area, the processed powder is

sieved and meticulously packed into drums, ensuring uniformity and quality. Two
designated in-charge personnel oversee operations to maintain efficiency.

G) WASHING ROOM: All used equipment and scoops are thoroughly cleaned
in this dedicated washing area post-packaging, maintaining hygiene standards and
preventing cross-contamination.

H) WASTE ROOM: Waste materials undergo a waste-to-best process in this

room, exemplifying the company's commitment to sustainability and responsible
waste management practices.

Overall, the powder processing area at Mangalam Drugs & Organics Company
exemplifies a harmonious integration of safety protocols, advanced machinery, and
meticulous process control, ensuring the production of high-quality powdered
products while prioritizing safety and environmental responsibility.

51
 ● ANALOGUE IMAGES OF POWDER PROCESSING
PROCESS

CENTRIFUGE MACHINE DRYER MACHINE

FIGURE 2.12 FIGURE 2.13

CONEMILL MACHINE MULTIMILL MACHINE

FIGURE 2.14 FIGURE 2.15

VIEW PASSAGE WASTAGE ROOM

FIGURE 2.16 FIGURE 2.17

52
2.13 STAGE 10: TESTING PROCESS OF FINISHED
GOODS

1. REQUIRED VERIFICATION

Mangalam Drugs and Organics ensures that all finished products adhere to stringent
regulatory guidelines from bodies such as the FDA (U.S. Food and Drug
Administration) and EMA (European Medicines Agency). Compliance with Good
Manufacturing Practice (GMP) standards is verified to ensure product quality and
safety.

2. CHEMICAL AND PHYSICAL TESTING

Purity Testing: Comprehensive tests are conducted to verify the purity of active
pharmaceutical ingredients (APIs) and other chemicals.
Identification Testing: Rigorous procedures are employed to ensure correct
identification and characterization of substances.
Impurity Profiling: Advanced analytical techniques are used to detect and quantify
any impurities or contaminants present in the product.

3. FUNCTIONAL TESTING

Pharmacokinetic and Pharmacodynamic Testing: Studies are performed to assess

the drug's behavior in the body, including absorption, distribution, metabolism, and
excretion, as well as its physiological effects.
Bioavailability Testing: Evaluations are conducted to determine the proportion of the
drug that enters the bloodstream and is available for therapeutic effect.

53
4. STABILITY TESTING

Long-term Stability Testing: Products are monitored over extended periods to

ensure they remain effective and safe under recommended storage conditions.
Accelerated Stability Testing: Products are exposed to elevated conditions to predict
shelf life and identify potential degradation products.

5. MICROBIOLOGICAL TESTING

Sterility Testing: Rigorous tests ensure that the product is free from microbial
contamination.
Endotoxin Testing: Procedures are implemented to detect and quantify bacterial
endotoxins that could cause adverse reactions.

6. PERFORMANCE TESTING

Dissolution Testing: The rate at which the drug dissolves is assessed to determine its
bioavailability.
Uniformity of Dosage Units: Tests are conducted to ensure that each dosage unit
contains the appropriate amount of the active ingredient.

7. USABILITY TESTING

Packaging Testing: The integrity and functionality of the packaging are verified to
ensure it adequately protects the product and is user-friendly.

54
8. COMPLIANCE TESTING

Regulatory Compliance: Products are thoroughly reviewed to ensure they meet all
relevant regulatory requirements and standards.
Documentation Review: All testing and manufacturing processes are meticulously
documented to maintain traceability and accountability.

9. USER ACCEPTANCE TESTING (UAT)

User acceptance testing is conducted with healthcare professionals and patients to

gather feedback and ensure that the product meets their needs and expectations.

10. BATCH RELEASE TESTING

Quality Control (QC) Testing: Each batch undergoes final testing to confirm it
meets all specified criteria before release to the market.

11. POST-MARKET SURVEILLANCE

Mangalam Drugs and Organics continuously monitors the product’s performance in

the market and collects data on any adverse effects or issues that arise during real-
world use.

CONCLUSION
The comprehensive testing process at Mangalam Drugs and Organics is designed to
ensure that all finished products meet the highest standards of quality, safety, and
efficacy. Through rigorous testing and continuous monitoring, Mangalam Drugs and
Organics remains committed to delivering reliable and effective pharmaceutical and
chemical products to the market.

55
2.14 STAGE 11: QUARANTINE PROCESS

At Mangalam Drugs and Organics, finished products are quarantined in a controlled

area, labeled, and accompanied by batch records. They undergo visual inspection and
rigorous testing. Test results are reviewed, and compliant batches are approved and
moved to storage, while deviations are investigated and addressed.

● DE DUST ROOM

In Mangalam Drugs and Organics, the "De-Dust Room" is likely a designated area
within their manufacturing facility where products or materials undergo a process to
remove dust particles or contaminants. This room plays a crucial role in maintaining
product quality and cleanliness standards. The de-dusting process may involve
various techniques such as air filtration systems, vacuuming, or specialized equipment
to ensure that the final product meets stringent quality control requirements.

● QUARANTINE ROOM

In Mangalam Drugs and Organics, the quarantine room serves as a critical area where
finished products are held temporarily before undergoing thorough quality control
checks. This room is designed to isolate products from the rest of the manufacturing
environment to prevent any contamination or mix-ups. Products in the quarantine
room are labeled and accompanied by comprehensive documentation, including batch
records and production data.

56
 ● PASS BOX
A pass box, or transfer hatch, is used in controlled environments like cleanrooms,
labs, and quarantine facilities to transfer materials without compromising containment
or cleanliness. It typically features interlocked doors to prevent cross-contamination,
is made of cleanable materials like stainless steel, and may include HEPA/ULPA
filters and UV sterilization.

● ANALOGUE IMAGE OF PASS

FIGURE 2.16

57
CHAPTER 3: MARKETING
DEPARTMENT

58
3.1 INTRODUCTION TO MARKETING DEPARTMENT
IN MANGALAM DRUGS AND ORGANICS

The marketing department at Mangalam Drugs and Organics plays a crucial role in
promoting the company's diverse range of products, including anti-malarial APIs and
specialty chemicals. With over three decades of industry experience, Mangalam
Drugs emphasizes a customer-centric approach and strong regulatory compliance, as
evidenced by their WHO-Geneva and EDQM certifications. Their strategy includes
robust R&D capabilities supported by an in-house laboratory recognized by the
Department of Scientific & Industrial Research, enabling continuous innovation.
Internationally, Mangalam Drugs leverages partnerships with organizations like the
Clinton Health Access Initiative to expand their market reach and combat malaria
globally.
The leadership team, led by
Chairman Govardhan M.
Dhoot, drives the company's
strategic growth and maintains
a focus on customer
engagement and regulatory
adherence, ensuring Mangalam
Drugs remains a key player in
the pharmaceutical industry.

FIGURE 3.1

59
3.2 FOUR Ps OF MARKETING

A. PRODUCT:
1.ANTI-MALARIA
 Amodiaquine Hydrochloride (USP/ IP/ IH)
 Artemether (Ph. Int./ IP)
 Artesunate (Ph. Int./ IP)
 Dihydroartemisinic (Ph. Int.)
 Lumefantrine (USP/ Ph. Int./IH)
 Primaquine Phosphate (USP/EP/BP/IP)
 Piperaquine Phosphate (IH)
 Pyrimethamine (USP/EP/Ph. Int./IP/IH)
 Pyronaridine Tetraphosphate (IH)

2.ANTI- RETROVIRAL
 Atazanavir Sulphate (Ph. Int./ IP/IH)
 Dolutegravir Sodium (IH)
 Efavirenz (USP/Ph. Int./IP)
 Emtricitabine (USP/Ph. Int./IP)
 Tenofovir Disoproxil Fumarate (Ph. Int./IP/IH)
 Tenofovir Alafenamide Fumarate (IH)

3.ANTI-HYPERTENSIVE
 Bisoprolol Fumarate (USP/EP)
 Furosemide (USP/EP/BP/IP)

4.ANTI-INFLAMMATORY
 Nimesulide (EP/BP)

5.ANTI-CONVULSANT

B. PROMOTION:

60
Mangalam Drugs and Organics promotes their products:

1.INTERNATIONAL EXHIBITIONS
Participates in major industry events like CPhI Worldwide in Frankfurt and other
exhibitions to showcase their products and connect with global clients and partners.

2. COLLABORATIONS:
Partners with notable organizations such as the Clinton Health Access Initiative
(CHAI) to support global health initiatives, particularly in the fight against malaria.

3.CERTIFICATIONS:
Highlights their compliance with high-quality standards through certifications like
WHO-GMP and EDQM approvals, which boost their credibility and reliability.

C.PLACE:

Mangalam Drugs and Organics Ltd. employs a well-defined distribution channel to

ensure their products reach both domestic and international markets efficiently.
Here’s an outline of their distribution channel:

1.DOMESTIC DISTRIBUTION:
Direct Sales: The Company sells directly to key customers and partners within India.
Network of Distributors: A network of regional distributors helps in extending their
reach across various states and cities in India

2.INTERNATIONAL DISTRIBUTION:
Global Partnerships: Collaborations with organizations such as the Clinton Health
Access Initiative (CHAI) for the global supply of anti-malaria APIs.
Technology Transfers: Agreements to transfer technology for manufacturing anti-
malaria APIs in Africa, which helps in localizing production and improving
distribution efficiency within the continent.
D.PRICE:

61
Mangalam Drugs and Organics Limited's products in INR:

1.ANTI-MALARIA: ARTEMETHER
₹8,200 to ₹24,600 per kg

2.ANTI-RETROVIRAL: ATAZANAVIR SULPHATE

₹41,000 to ₹82,000 per kg

3. ANTI-HYPERTENSIVE: BISOPROLO, FUMARATE

₹4,100 to ₹12,300 per kg

4.ANTI-INFLAMMATORY: NIMESULIDE
₹16,400 to ₹32,800 per kg

5.ANTI-CONVULSANT: PREGABALIN
₹65,600 to ₹98,400 per Kg

These prices are indicative and can vary based on bulk purchase agreements, purity
specifications, and market conditions.

FIGURE 3.2

62
3.3 PRODUCT LIFE CYCLE

The product life cycle (PLC) of Mangalam Drugs and Organics Limited's
products can be described in the following stages:

1. INTRODUCTION

 RESEARCH AND DEVELOPMENT

Products are developed in their in-house DSIR-approved R&D lab.

 REGULATORY APPROVALS
Products must obtain necessary certifications (WHO-GMP, EDQM) for compliance.

 MARKET ENTRY
New APIs and intermediates are introduced to the market through strategic
partnerships and collaborations, such as with the Clinton Health Access Initiative.

2. GROWTH

 MARKET PENETRATION
Increased marketing efforts and participation in international exhibitions like CPhI
Worldwide to promote products.

 INCREASING DEMAND
Growing demand for APIs, especially in the anti-malarial and anti-retroviral
segments, leads to scaling up production.

 EXPANSION
Entering new markets and increasing distribution channels both domestically and
internationally.

FIGURE 3.3
3. MATURITY
63
  PEAK SALES
Products reach their peak sales as they become well-established in the market.

 BRAND STRENGTH
Strong market presence and brand reputation due to quality and reliability.

 COMPETITIVE LANDSCAPE
Face competition from other manufacturers, necessitating continuous innovation and
cost management.

4. DECLINE

 MARKET SATURATION
Demand for certain products may start to decline due to market saturation or new,
more effective alternatives.

 REDUCED PRICES
Prices may drop due to increased competition and reduced demand.

 PRODUCT PHASE-OUT
Some products may be phased out if they are no longer profitable or relevant.

☞ STRATEGIES FOR MANAGING THE PRODUCT LIFE

CYCLE

 INNOVATION
Continuous R&D to introduce new and improved products.

 DIVERSIFICATION
Expanding the product portfolio to include new therapeutic areas.

 MARKET ADAPTATION
Adjusting marketing and distribution strategies to adapt to changing market
conditions.

By understanding and managing the different stages of the product life cycle,
Mangalam Drugs and Organics can effectively sustain their market presence and
continue to grow in the competitive pharmaceutical industry.

64
3.4 MAJOR COMPETITORS OF MANGALAM
DRUGS AND ORGANICS

In the pharmaceutical and API manufacturing sector in Vapi, Gujarat, India,

Mangalam Drugs and Organics Limited faces competition from several companies.
Here are some notable competitors:

1.ALEMBIC PHARMACEUTICALS LTD:

Alembic Pharmaceuticals competes strongly with Mangalam Drugs and Organic Ltd.
due to its broad product portfolio, global
presence, emphasis on innovation, robust
manufacturing capabilities, and strong
financial performance. These factors
collectively enhance Alembic's
competitive edge in the pharmaceutical
industry. Known for its wide range of
pharmaceutical formulations and APIs.
FIGURE 3.4

2.AARTI INDUSTRIES LTD:

Specializes in manufacturing and supplying APIs and intermediates. Aarti Industries
Limited (AIL) is competitive against
Mangalam Drugs and Organics Limited
(MDOL) due to its larger scale, advanced
technology, extensive R&D capabilities, and
strong market presence in specialty
chemicals and pharmaceutical intermediates.

FIGURE 3.5

65
CHAPTER 4: ACCOUNTING
DEPARTMENT

66
4.1 INTRODUCTION TO ACCOUNTING DEPARTMENT
IN MANGALAM DRUGS AND ORGANICS

The company's accounting procedures encompass various stages, starting from the
preparation of invoices to the finalization of financial statements. The following
outlines the typical accounting workflow at Mangalam:

1. Recording transactions: This involves documenting financial transactions such

as sales, purchases, expenses, and payments in
appropriate accounting records, such as
journals or ledgers.
2. Posting to ledgers: After transactions are
recorded, they are posted to the appropriate
accounts in the general ledger, ensuring that
each account reflects the correct balance.
3. Reconciling accounts: Regularly comparing
account balances in the general ledger to
supporting documentation, such as bank
statements or invoices, to ensure accuracy and
identify discrepancies.
4. Preparing financial statements: Using the
information from the general ledger, financial
statements such as the income statement FIGURE 4.1
balance sheet, and cash flow statement are prepared to provide an overview.
5. Closing the accounting period: At the end of a reporting period (e.g., month,
quarter, or year), the accounting records are closed to prepare for the next period.
This involves adjusting entries, closing temporary accounts, and preparing the
trial balance.
6. Internal controls: Implementing procedures and policies to safeguard assets,
prevent fraud, and ensure compliance with laws and regulations. This includes
segregation of duties, authorization procedures, and regular audits.

67
 ● STAFF STRUCTURE AT MANGALAM DRUGS AND

ORGANICS IN ACCOUNTING DEPARTMENT

Mangalam Drugs and Organic Company's accounting department comprises a

dedicated team responsible for managing financial transactions, maintaining records,
and ensuring compliance with accounting standards. The team consists of the
following key personnel:

1. GENERAL MANAGER (GM):

Oversees the overall operations of the accounting department, including financial
reporting, budgeting, and compliance with regulatory requirements.

2. SENIOR MANAGER:
Assists the GM in overseeing day-to-day accounting activities, supervising staff, and
implementing financial policies and procedures.

3. DEPUTY MANAGER (DY Manager):

Manages specific accounting functions or projects, such as cost analysis, inventory
management, or financial planning.

4. SENIOR ASSISTANT:
Supports the accounting team by performing various
administrative tasks, data entry, and documentation.

5. OFFICER:
Responsible for executing routine accounting tasks,
such as invoice processing, reconciliations, and
preparing financial reports.

FIGURE 4.2

68
4.2 SOME TYPES OF TAXES INCURRED BY
MANGALAM DRUGS AND ORGANICS.

1. INCOME TAX

● OBJECTIVE:
The objective of this project is to outline the income tax procedures to be followed by
the accounting department of Mangalam Drugs and Organic Company. These
procedures will ensure compliance with tax regulations and efficient management of
tax payments throughout the fiscal year.

● INCOME TAX FILING:

1. QUARTERLY ADVANCE TAX PAYMENTS:

Mangalam Drugs and Organic Company will make quarterly advance tax payments
based on their estimated annual income. For example, if the estimated annual income
tax liability is 1 lakh, the company will pay 25,000 each quarter.

2. QUARTERLY TURNOVER REPORTING:

Before the 15th of each month following the end of the quarter, the company will
report its turnover to accurately calculate the advance tax payment for the upcoming
quarter.

3. YEAR-END TAX PAYMENT:

At the end of the fiscal year, the company will reconcile its actual income tax liability
with the advance tax payments made throughout the year. Any remaining tax liability
will be paid before the end of the fiscal year.

4. FINAL TAX PAYMENT:

Any outstanding tax liability after reconciliation will be paid within the specified
timeframe, typically before the end of the fiscal year.

69
 ● GOVERNMENT SOFTWARE USAGE:
Income tax e-filing portal

2. TDS (TAX DEDUCTED AT SOURCE)

TDS are of two types in MANGALAM DRUGS AND ORGANIC

1. EMPLOYEES
TDS (Tax Deducted at Source) on employee salaries is a mechanism where
employers deduct a certain amount of tax from the salary payable to the employee
before making the payment. This deducted tax is then deposited with the government
on behalf of the employee. Form 24Q is used for filing TDS returns for salaries.
Employers deduct TDS from employees' salaries and deposit it with the government

2. CONTRACTORS AND OTHERS

TDS on payments made to contractors is also governed by the Income Tax Act. When
a person or entity makes a payment to a contractor for services rendered, they are
required to deduct TDS at the prescribed rates before making the payment. Form 26Q
is used for filing TDS returns on payments other than salaries. The payer, in this case,
deducts TDS from payments made to
contractors and files Form 26Q to report
and deposit the TDS with the
government

70
 FIGURE 4.3

3.GOODS AND SERVICES TAX

● GSTR -1:
In Mangalam drugs & organic company, GSTR-1 is a monthly or quarterly return that
summarizes all outward supplies or sales of goods and/or services by a registered
taxpayer. It includes details such as the invoice-wise value of supplies made, the
taxable value, and the tax amount. In GST Form GSTR-1, sales are reported in detail.
This form captures all the outward supplies of goods and services made by a taxpayer.
It includes information such as:
1. Invoice Details
2. HSN (Harmonized System of Nomenclature) Code
3. Taxable Value
4. Tax Amount
5. Export and Interstate Sales
6. Amendments to Sales Invoices.

● GSTR-3B:
Is a monthly self-declaration that taxpayers must file. It contains summarized details
of outward supplies, input tax credit (ITC) claimed, and the amount of tax paid.
Unlike GSTR-1, which is a detailed return, GSTR-3B is a simplified return. They
compare the total taxable value and tax amount with the previous month's return to
ensure consistency and accuracy. They might also compare the Input Tax Credit

71
(ITC) claimed in the current period with the ITC claimed in previous periods to
identify any discrepancies or unusual patterns. Overall, while preparing the GSTR-3B
return, taxpayers may conduct several comparisons to ensure that the data provided is
correct and matches their records and other GST returns.

MANGALAM DRUGS AND ORGANICS lies under 4 tax slab 0% Tax Rate, 5%
Tax Rate, 12% Tax Rate, 18% Tax Rate

4.3 FINANCIAL RISK MANAGEMENT

Mangalam Drugs & Organics Limited employs comprehensive risk management

strategies to mitigate financial risks arising from its operations, including market risk,
credit risk, and liquidity risk.

● CREDIT RISK
The company manages credit risk associated with receivables from customers and
investments in debt securities by assessing individual customer characteristics. Credit
risk from balances with banks and financial institutions is managed by the treasury
department, ensuring investments are made with approved counterparties and within
credit limits.

● LIQUIDITY RISK
Mangalam Drugs & Organics Limited ensures sufficient liquidity to meet its
obligations under normal and stressed conditions. It maintains a balance between
continuity of funding and flexibility through surplus funds, bank overdrafts, bank
loans, debentures, and inter-corporate loans. The company has access to various
funding sources, minimizing the risk associated with refinancing its debt.

● MARKET RISK

72
The company faces market risk related to changes in interest rates, foreign currency
exchange rates, commodity prices, and the market value of its investments. This risk
is managed by monitoring market-sensitive financial instruments and assessing
concentration risk related to commodity prices and investment market values.

● INTEREST RATE RISK

Mangalam Drugs & Organics Limited exposure to changes in market interest rates
primarily relates to its debt obligations with floating interest rates. The company
monitors and manages interest rate risk to minimize fluctuations in the fair value and
future cash flows of financial instruments.

4.4 SEBI MATTER OF MANGALAM DRUGS AND

ORGANICS

1. BACKGROUND:
SEBI investigated trading activities of certain entities in Mangalam Drugs and
Organics Limited from March 17, 2015, to December 31, 2015.

2. ALLEGATIONS:
SEBI issued a Show Cause Notice (SCN) in December 2019, alleging compliance
lapses related to preferential allotment of warrants in September 2015.

3. SEBI ORDER:
SEBI passed an order on September 22, 2020, citing violations of various regulations
and imposing restrictions on the company and certain entities/individuals, along with
monetary penalties.

73
4. APPEAL TO SAT:
The company and related parties appealed to the Securities Appellate Tribunal (SAT)
on November 6, 2020, seeking relief and stay orders.

5. SAT INTERIM ORDER:

SAT granted interim relief on December 10, 2020, staying SEBI's order provided an
amount was deposited within four weeks, pending the appeal's outcome. The
appellants deposited Rs. 25 Lakhs.

6. FINAL SAT ORDER:

On June 27, 2022, SAT pronounced its order in favor of Mangalam Drugs and
Organics Limited, quashing SEBI's order against the company.

7. CURRENT STATUS:
The final order's implications and subsequent actions are awaited, marking a
significant development in the legal proceedings concerning the SEBI matter.

4.5 NOTES TO FINANCIAL STATEMENTS FOR THE

YEAR ENDED MARCH 31, 2023

Mangalam Drugs and Organics Limited commenced its manufacturing of Active

Pharmaceutical Ingredients (APIs) and Intermediates at VAPI – Gujarat in 1977. It
has a multi-product manufacturing facility on two locations, and an in-house Research
and Development laboratory recognized by the department of Scientific and Industrial
Research, Delhi Government of India (DSIR).

SIGNIFICANT ACCOUNTING POLICIES

1.1 BASIS OF PREPARATION OF FINANCIAL STATEMENTS

The financial statements of the Company have been prepared in accordance with
Indian Accounting Standards (Ind AS) notified under section 133 of the Companies
Act, 2013 read with Rule 3 of the Companies (Indian Accounting Standards) Rules,
2015 as amended from time to time and presentation requirement of Division II of
schedule III of the Companies Act, 2013
74
 1.2 BASIS OF ACCOUNTING
The Company maintains its accounts on accrual basis following the historical cost
convention, except for certain financial instruments that are measured at fair values in
accordance with Ind AS. Further, the guidance notes / announcements issued by the
Institute of Chartered Accountants of India (ICAI) are also considered, wherever
applicable, except to the extent where compliance with other statutory promulgations
override the same requiring a different treatment.

1.3PRESENTATION OF FINANCIAL STATEMENTS

The Balance Sheet, Statement of Profit and Loss and Statement of Changes in equity
are prepared and presented in the format prescribed in the Schedule III to the
Companies Act, 2013 (“the Act”). The disclosure requirements with respect to items
in the Balance Sheet and Statement of Profit and Loss, as prescribed in the Schedule
III to the Act, are presented by way of notes forming part of the financial statements

4.6 STATEMENT OF PROFIT AND LOSS OF

MANGALAM DRUGS AND ORGANICS FOR YEAR
ENDED MARCH 2023

Year ended
PARTICULARS March 31,2023
1.Revenue from operations 37,019.54

2.Other Operating Incomes 205.75

3.Total Revenue from Operations 37,225.29

4.Other Income 43.56

5.Total Revenue 37,268.85

6.Expenses

75
Cost of material consumed 27,744.95

Purchased of Stock in Trade 1,535.52

Changes in inventories of finished goods, Stock in

(4, 216.11)
Trade and Work in progress

Employee benefits expense 3,461.23

Finance cost 1,275.13

Depreciation and amortization expense 1,098.89

Other Expenses 6,147.86

Total Expenses 37,047.47

7.Profit/(loss) before exceptional items and tax 221.38

8.Exceptional items -

9.Profit/(loss) before tax 221.38

10.Tax expense: 94.38

Current Tax 39.06

Mat credit entitlement (36.92)

(2) Short /Excess Provision of Tax (4.76)

Deferred tax 97.00

11.Profit/(loss) for the period 127.00

Items that will not be reclassified to profit or loss

Remeasurements of the defined benefit plans 17.61

Income tax relating to above (5.13)

12.Total Other Comprehensive Income 12.48

13.Total Comprehensive Income for the period 139.48

14.Earnings per equity share (Face value per equity share

Rs. 10)

76
Basic (In Rs.) 0.80
Diluted (In Rs.) 0.80

4.7 CASH FLOW STATEMENT OF MANGALAM

DRUGS AND ORGANICS FOR YEAR ENDED IN
MARCH 2023

PARTICULAR MARCH 2023

A: Cash Flow from operating activity
net profit before tax and extraordinary items 221.38
Add / (Less)
Depreciation & amortization 1098.89
interest expenses 1275.13
Dividend income (0.05)
Gain/loss on sale of fixed assets 0.33
Assets Discarded
Gain/loss on sale of investment
Prov of Diminution in value of investment
remuneration of the defined benefit plan 17.60
Operating Profit before Working capital changes: 2613.28
Adjustment for:

77
(Increase)/decrease in short term loans and advances (0.95)
(Increase)/decrease in other current assets (40.52)
(Increase)/decrease in trade receivables (4.28)
(Increase)/decrease in inventory (2036.09)
(Increase)/decrease in other non-current assets 152.97
Increase/(decrease) in Other Equity -
Increase/(decrease) in trade payables 4252.56
Increase/(decrease) in other current liabilities (190.40)
Increase/(decrease) in provisions (1118.65)
Increase/(decrease) in current lease liabilities 333.82
Increase/(decrease) in non-current liabilities (164.54)
Increase/(decrease) in deposits -
Increase/(decrease) in non-current lease liabilities 152.50
1336.41
Cash generations from operation 3949.70
add/less
Income tax (pain)/refund 2.62
Net cash from operating activities 3952.31

B: Cash flow from investment activities:

Purchase of fixed assets including Capital WIP (2791.37)
Sale of fixed assets 574.09
Sale/(Purchase) of investments -
Dividend Income 0.05
Net cash from investing activities (2217.23)

C: Cash flow from financial activities

Proceeds/(repayment) of short-term borrowing 247.09
Proceeds/(repayment) of long-term borrowing (633.67)
Interest Paid (1275.13)

78
Dividend paid -
Issue of Share -
Net cash used in financing activities (1661.71)
Net increase / (decrease) in cash and cash equivalents 73.38
Cash and cash equivalents - opening balance 194.69
Cash and cash equivalents - opening balance 194.69
Cash and cash equivalents - closing balance 268.07
Details of cash and cash equivalent at the end of the Period / Year
cash in hand 4.28
Balance in current & fixed deposit accounts 263.80
TOTAL 268.07

4.8 BALANCE SHEET OF MANGALAM DRUGS AND

ORGANICS MARCH 31, 2023

PARTICULAR As at
March 31,2023
Assets

1 Non-Current Assets

(a) Property, Plant and Equipment 10,763.19

(b) Right to Use Asset 1,951.66

©Capital work in progress 640.40

(d)Other intangible Assets 1,521.42

(e) Intangible Assets under Development 308.49

(f) Financial Assets

(i) Investment 0.43

(ii) Others financial assets 30.84

(g)Other Non-Current Asset (Capital Advances) 88.04

2 Current assets

(a) Inventories 13,746.65

79
 (b) Financial Assets

(i) Trade Receivables 4,653.29

(ii) Cash and cash equivalents 268.07

(iii) Bank Balance other than Cash and Cash Equivalents 0.76

(iv) Loans 4.55

(v) Other Financial Assets 729.91

(c) Other current assets (Non-Financials) 1,255.18

Total Assets 35,962.88

EQUITY AND LIABILITIES: -

Equity

(a) Equity share capital 1,582.82

(b) Other Equity 13,612.80

LIABILITIES

1 Non-current Liabilities

(a) Financial Liabilities

(i) Borrowings 1,876.64

(ii) Lease Liability 673.90

(iii) Other financial liabilities 0.05

(b) Deferred tax liabilities (Net) 1,451.59

(c) Other Non-Current liabilities 229.34

2 Current Liabilities

(a) Financial Liabilities

(I) Borrowings 4,956.71

(II) Lease Liability 721.49

(III) Trade Payables

80
 Total Outstanding dues to Micro and small enterprises 1,109.99

Total Outstanding dues of creditors other than micro and small 8,597.28

(IV) Other financial liabilities (other than those specified in item 625.92

(b) other current Liabilities 352.34

(c) Provisions 134.44

(d) current tax liabilities 37.58

Total Equity and Liabilities 35,962.88

4.9 COMPARATIVE STATEMENT ANALYSIS

A comparative analysis statement typically compares two or more entities, such as

companies, products, or strategies, highlighting their similarities, differences,
strengths, and weaknesses. It often serves to inform decision-making processes by
providing insights into which option may be preferable based on various criteria. For
example, "Company A's revenue growth outpaces that of Company B, but Company
B has a stronger market presence in emerging markets.”

Comparative balance sheet and profit and loss statement are financial tools used to
analyze a company's performance over different periods by comparing the financial
data from multiple years. Here's a brief overview of each: Comparative Balance Sheet
a comparative balance sheet presents the financial position of a company at the end of
two or more accounting periods. It allows users to analyze the changes in assets,
liabilities, and equity over time. Comparative Profit and Loss Statement A
comparative profit and loss statement (income statement) shows the revenues,
expenses, and profits over multiple periods. It helps in identifying trends, growth
patterns, and areas of improvement.

● ANALYSIS
Comparing these statements, one can assess:

81
 1. Growth in assets, liabilities, and equity.
2. Changes in revenue and expenses
3. Operational efficiency.
These tools are essential for stakeholders, including management, investors, and
creditors, to make informed decisions.

BELOW WE HAVE:

● COMPARATIVE PROFIT AND LOSS STATEMENT

● COMPARATIVE BALANCE SHEET

Particulars March 2022 March 2023 Absolute Percent

change change

1.Revenue from operations 45,086.16 37,019.54 -8,066.62 -17.89

2.Other Operating Incomes 20.68 205.75 185.07 894.92

3.Total Revenue from Operations 45,106.84 37,225.29 −7,881.55 -17.47

4.Other Income 8.94 43.56 34.62 387.25

5.Total Revenue 45,115.78 37,268.85 −7,846.93 -17.39

6.Expenses

Cost of material consumed 33,907.51 27,744.95 −6,162.56 -18.17

Purchased of Stock in Trade 131.24 1,535.52 1,404.28 1070.01

Changes in inventories of (3,374.86) (4, 216.11) −841.25 24.93

finished goods, Stock in
Trade and Work in progress

Employee benefits expense 3,725.13 3,461.23 -263.9 -7.08

Finance cost 1,116.18 1,275.13 158.95 14.24

Depreciation and amortization 1,024.91 1,098.89 73.98 7.22

expense

Other Expenses 5,812.37 6,147.86 335.49 5.77

Total Expenses 42,342.48 37,047.47 -5295.01 -12.51

82
 7.Profit/(loss) before 2,773.29 221.38 -2551.92 -92.02
exceptional items and tax

8.Exceptional items - - - -

9.Profit/(loss) before tax 2,773.29 221.38 −2,551.91 -92.02

10.Tax expense: 807.55 94.38 -713.17 -88.31

Current Tax 876.13 39.06 -837.07 -95.54

Mat credit entitlement - (36.92) (36.92) -

Short /Excess Provision of Tax 4.66 (4.76) −9.42 -202.15

Deferred tax (73.24) 97.00 170.24 -232.44

11.Profit/(loss) for the period 1,965.75 127.00 -1838.75 -93.54

Items that will not be reclassified

to profit or loss

(1) Remeasurements of the 16.64 17.61 0.97 5.83

defined benefit plans

(2) Income tax relating to (4.85) (5.13) −0.28 5.77

above

12.Total Other Comprehensive 11.79 12.48 0.69 5.85

Income (A)

13.Total Comprehensive Income 1,977.54 139.48 −1,838.06 -92.95

for the period (11+12)

14.Earnings per equity share (Face

value per equity share
Rs. 10)

(1) Basic (In Rs.) 12.42 0.80 −11.62 -93.56

(2) Diluted (In Rs.) 12.42 0.80 −11.62 -93.56

FORMULA:

ABSOLUTE CHANGE= CURRENT YEAR - PREVIOUS YEAR

83
PERCENTAGE CHANGE= (ABSOLUTE CHANGE) X 100
PREVIOUS YEAR
Particulars March 2022 March 2023 Absolute Percentage
change change

Assets

1 Non-Current Assets

(a) Property, Plant and 11,503.24 10,763.19 -740.05 -6.43

Equipment

(b) Right to Use Asset 1,158.27 1,951.66 793.39 68.50

©Capital work in progress 17.96 640.40 622.44 3465.70

(d)Other intangible Assets 834.73 1,521.42 686.69 82.26

(e) Intangible Assets under 552.90 308.49 -244.41 -44.20

Development

(f) Financial Assets

(i) Investment 0.43 0.43 0 0

(ii) Others financial assets 30.73 30.84 0.11 0.36

(g)Other Non-Current Asset 241.11 88.04 -153.07 -63.49

(Capital Advances)

2 Current assets

(a) Inventories 11,710.55 13,746.65 2036.1 17.39

(b) Financial Assets

(i) Trade Receivables 4,649.01 4,653.29 4.28 0.092

(ii) Cash and cash 194.69 268.07 73.38 37.69

equivalents

(iii) Bank Balance other 0.76 0.76 0 0

than Cash and Cash Equivalents

(iv) Loans 3.61 4.55 0.94 26.04

(v) Other Financial Assets 996.50 729.91 -266.59 -26.75

84
 (c) Other current assets (Non- 948.08 1,255.18 307.1 32.39
Financials)

Total Assets 32,842.57 35,962.88 3120.31 9.5

EQUITY AND LIABILITIES

(a) Equity share capital 1,582.82 1,582.82 0 0

(b) Other Equity 13,473.32 13,612.80 139.48 1.04

LIABILITIES

1 Non-current Liabilities

(a) Financial Liabilities

(i) Borrowings 2,510.30 1,876.64 -633.66 -25.24

(ii) Lease Liability 521.40 673.90 116.5 22.34

(iii) Other financial 0.05 0.05 0 0

liabilities

(b) Deferred tax liabilities 1,349.47 1,451.59 102.12 7.57

(c) Other Non-Current 393.88 229.34 -164.54 41.77

liabilities

2 Current Liabilities

(a) Financial Liabilities

(i) Borrowings 4,709.62 4,956.71 247.09 5.25

(ii) Lease Liability 387.67 721.49 324.82 83.79

(iii) Trade Payables

Total Outstanding dues 442.13 1,109.99 667.86 151.06

Total Outstanding dues 5,012.58 8,597.28 3584.7 71.51

(iv) Other financial liabilities 661.45 625.92 -35.53 -5.37

(b) other current Liabilities 1,470.99 352.34 -1118.65 -76.05

(c) Provisions 99.94 134.44 34.5 34.52

85
 (d) current tax liabilities 226.95 37.58 -189.37 -83.44

Total Equity and Liabilities 32,842.57 35,962.88 3,120.31 9.50

FORMULA:
ABSOLUTE CHANGE= CURRENT YEAR - PREVIOUS YEAR

PERCENTAGE CHANGE= (ABSOLUTE CHANGE) X 100

PREVIOUS YEAR
4.10 COMMON SIZE STATEMENT ANALYSIS

A common size statement, also known as a common size financial statement,

expresses each line item as a percentage of a base figure within the same financial
statement. This allows for easy comparison of the relative size of each component. It's
commonly used in financial analysis to identify trends and patterns, especially when
comparing companies of different sizes or industries. For instance, in a common size
income statement, each revenue and expense item are expressed as a percentage of
total revenue, while in a common size balance sheet, each asset, liability, and equity
item are expressed as a percentage of total assets.

Common-size statements are financial statements in which each line item is expressed
as a percentage of a base figure. This allows for easy comparison between different
periods or companies, regardless of size. Common-Size Balance Sheet In a common-
size balance sheet, each item is expressed as a percentage of total assets Common-
Size Profit and Loss Statement In a common-size profit and loss statement, each item
is expressed as a percentage of total revenue

● ANALYSIS
1. Common-size statements are particularly useful for:
2. Comparative Analysis: Easier to compare companies of different sizes or
different periods within the same company.
3. Trend Analysis: Identifying trends in expenses, revenue, and profitability as a
percentage of the total.

86
 4. Benchmarking: Comparing performance with industry averages or
competitors.
These statements are valuable tools for managers, investors, and analysts to
understand the financial health and operational efficiency of a company.

BELOW WE HAVE:

● COMMON SIZE PROFIT AND LOSS STATEMENT

● COMMON SIZE BALANCE SHEET

Particulars Previous Current PY CY

Year year Percentage Percentage

1.Revenue from operations 45,086.16 37,019.54 99.95 99.45

2.Other Operating Incomes 20.68 205.75 0.046 0.55
3.Total Revenue from Operations 45,106.84 37,225.29 100 100
4.Other Income 8.94 43.56 0.02 0.12
5.Total Revenue (3+4) 45,115.78 37,268.85 100.02 100.12
6.Expenses

Cost of material consumed 33,907.51 27,744.95 75.17 74.53

Purchased of Stock in Trade 131.24 1,535.52 0.29 4.12
Changes in inventories of (3,374.86) (4, 216.11) (7.48) (11.33)
finished goods, Stock in
Trade and Work in progress

Employee benefits expense 3,725.13 3,461.23 8.26 9.30

Finance cost 1,116.18 1,275.13 2.47 3.4333333
Depreciation and amortization 1,024.91 1,098.89 2.27 2.95
expense

Other Expenses 5,812.37 6,147.86 12.89 16.52

Total Expenses (6) 42,342.48 37,047.47 93.87 99.44

87
7.Profit/(loss) before exceptional 2,773.29 221.38 6.15 0.59
items and tax (5-6)

8.Exceptional items - - - -
9.Profit/(loss) before tax (7-8) 2,773.29 221.38 6.15 0.59
10.Tax expense: 807.55 94.38 1.79 0.25
(1) Current Tax 876.13 39.06 1.94 0.10
(2) Mat credit entitlement - (36.92) - (0.1)
(2) Short /Excess Provision of 4.66 (4.76) 0.01 (0.01)
Tax

(3) Deferred tax (73.24) 97.00 -0.16 0.26

11.Profit/(loss) for the period (9- 1,965.75 127.00 4.36 0.34
10)

(A) Items that will not be

reclassified

(3) Remeasurements of the 16.64 17.61 0.04 0.05

defined benefit plans

(4) Income tax relating to (4.85) (5.13) (0.01) (0.01)

above

12.Total Other Comprehensive 11.79 12.48 0.03 0.03

Income (A)

13.Total Comprehensive Income 1,977.54 139.48 4.38 0.37

for the period (11+12)

14.Earnings per equity share

(Face value per equity share
Rs. 10)

(3) Basic (In Rs.) 12.42 0.80 0.03 0.002

(4) Diluted (In Rs.) 12.42 0.80 0.03 0.002

FORMULA:

88
COMMON SIZE PERCENTAGE = AMOUNT X 100
TOTAL REVENUE

Particulars Previous Current PY CY

Year year Percentage Percentage

Assets

1 Non-Current Assets

(a) Property, Plant and 11,503.24 10,763.19 35.03 29.93

Equipment

(b) Right to Use Asset 1,158.27 1,951.66 3.53 5.43

Capital work in progress 17.96 640.40 0.05 1.78

(d)Other intangible Assets 834.73 1,521.42 2.57 4.23

(e) Intangible Assets 552.90 308.49 1.68 0.86

(f) Financial Assets

(i) Investment 0.43 0.43 0.001 0.001

(ii) Others financial assets 30.73 30.84 0.09 0.09

(g)Other Non-Current Asset 241.11 88.04 0.73 0.24

(Capital Advances)

2 Current assets

(a) Inventories 11,710.55 13,746.65 35.66 38.22

(b) Financial Assets

(i) Trade Receivables 4,649.01 4,653.29 14.16 12.94

(ii) Cash and cash 194.69 268.07 0.59 0.75

equivalents

(iii) Bank Balance other 0.76 0.76 0.002 0.002

than Cash and Cash Equivalents

(iv) Loans 3.61 4.55 0.01 0.012

(v) Other Financial Assets 996.50 729.91 3.03 2.03

89
 (c) Other current assets (non- 948.08 1,255.18 2.89 3.49
Financials)

Total Assets 32,842.57 35,962.88 100 100

EQUITY AND
LIABILITIES: -

Equity

(a) Equity share capital 1,582.82 1,582.82 4.82 4.40

(b) Other Equity 13,473.32 13,612.80 41.02 37.85

LIABILITIES

1 Non-current Liabilities

(a) Financial Liabilities

(i) Borrowings 2,510.30 1,876.64 7.64 5.22

(ii) Lease Liability 521.40 673.90 1.59 1.87

(iii) Other financial 0.05 0.05 0.0001 0.0001

liabilities

(b) Deferred tax liabilities 1,349.47 1,451.59 4.11 4.04

(c) Other Non-Current 393.88 229.34 1.2 0.64

liabilities

2 Current Liabilities

(a) Financial Liabilities

(i) Borrowings 4,709.62 4,956.71 14.34 13.78

(ii) Lease Liability 387.67 721.49 1.18 2.006

(iii) Trade Payables

Total Outstanding dues to 442.13 1,109.99 1.35 3.09

Micro and small enterprises

Total Outstanding dues 5,012.58 8,597.28 15.26 23.91

(iv) Other financial liabilities 661.45 625.92 2.01 1.74

90
 (b) other current Liabilities 1,470.99 352.34 4,48 0.98

(c) Provisions 99.94 134.44 0.30 0.37

(d) current tax liabilities 226.95 37.58 0.69 0.10

Total Equity and Liabilities 32,842.57 35,962.88 100 100

FORMULA:
COMMON SIZE PERCENTAGE = AMOUNT X 100
TOTAL ASSETS
4.11 INTERPRETATION OF PROFIT AND LOSS
STATEMENT AND BALANCE SHEET

● PROFIT AND LOSS STATEMENT

1. NET REVENUE FROM OPERATIONS:

In the year 2023; revenue from operation decreased by 17.89% as compared to
previous year 2022.

2. OTHER OPERATING INCOME:

In the year 2023; Other Operating Income increased by 894.92% as compared to the
previous year 2022.

3. COST OF MATERIAL CONSUMED:

In the year 2023; Cost of material consumed decreased by 18.17% as compared to
previous year 2022.

4. CHANGES IN INVENTORIES OF FINISHED GOODS, STOCK

IN TRADE AND WORK IN PROGRESS:
In the year 2023; change in inventories of finished goods, Stock in Trade and Work in
progress increased by 24.93% as compared to previous year 2022.

5. EMPLOYEES BENEFIT EXPENSE:

91
In the year 2023; employee benefit expenses decreased by 7.08% as compared to the
previous year 2022.

6. FINANCE COST:
In the year 2023; finance cost increased by 14.24% as compared to previous year
2022.

● BALANCE SHEET

1. NON-CURRENT ASSETS:
• Property, Plant, and Equipment: Decreased by 740.05 INR, a percentage change of -
6.43%.
• Right to Use Asset: Increased by 793.39 INR, a percentage change of 68.50%.
• Capital Work in Progress: Increased by 622.44 INR, a percentage change of
3465.70%.
• Other Intangible Assets: Increased by 686.69 INR, a percentage change of 82.26%.
• Intangible Assets under Development: Decreased by 244.41 INR, a percentage
change of -44.20%.
• Financial Assets: Various changes, but mostly negligible.

2. CURRENT ASSETS:
• Inventories: Increased by 2036.10 INR, a percentage change of 17.39%.
• Financial Assets (Trade Receivables, Cash and Cash Equivalents, Loans, Other
Financial Assets): Various changes, with some increases and decreases.
• Other Current Assets (Non-Financial): Increased by 307.10 INR, a percentage
change of 32.39%.

3. TOTAL ASSETS:
Increased by 3120.31 INR, a percentage change of 9.5%.

92
4. EQUITY AND LIABILITIES:
• Equity: Mostly stable with minor changes.
• Non-Current Liabilities: Various changes, with some liabilities decreasing and
others increasing.
• Current Liabilities: Significant increases in some categories, such as Trade Payables
and Total Outstanding Dues to Creditors.

4.12 RATIO ANALYSIS AND ITS INTERPRETATION

● CURRENT RATIO: CURRENT ASSET

CURRENT LIABILITY

FOR YEAR 2021-2022, CURRENT RATIO = 18503.2 = 1.42

13011.33
FOR YEAR 2022-2023, CURRENT RATIO = 20658.41 = 1.25
16535.75

● INTERPRETATION

The ideal current ratio, a measure of a company's ability to pay short-

term obligations, generally falls between 1.5 and 2.0. This range indicates
that the company has enough assets to cover its liabilities comfortably
while maintaining liquidity.

93
 In the year of 2023, current
assets have decreased as
compared to previous year
then to they are almost
equivalent to pay current
liabilities i.e., 1.25 times
more than current
liabilities.
Whereas in 2022 current
assets are more than of
current liabilities i.e.,1.42
times.

GRAPH 4.1

● LIQUIDITY RATIO: CURRENT ASSETS - INVENTORIES

CURRENT LIABILITIES

FOR YEAR 2021-2022, LIQUIDITY RATIO = 6792.65 = 0.52

13011.33
FOR YEAR 2022-2023, LIQUIDITY RATIO = 6911.76 = 0.42
16535.75

● INTERPRETATION

Liquidity ratios are financial

metrics used to measure a
company's ability to pay off its
short-term obligations using its
most liquid assets.
A good liquid ratio is anything
greater than 1. In the year 2023

94
ratio is lesser than 1 i.e., 0.41 times this is caused by decrease in current
assets and liabilities in the year 2022, liquidity ratio is 0.52 times

GRAPH 4.2

● NET PROFIT RATIO: NET PROFIT

TOTAL REVENUE

FOR YEAR 2021-2022, NET PROFIT RATIO = 1965.75 = 0.04

45106.84
FOR YEAR 2022-2023, NET PROFIT RATIO = 127 = 0.003
37225.9

● INTERPRETATION

The net profit ratio, also known as

net profit margin, is a financial
metric that measures the percentage
of each dollar of revenue that
translates into net profit after all
expenses have been deducted.
A good net profit is between 0 to 8.
In the year 2023, net profit ratio

95
was 0.04 caused by profit. Whereas its fall in 2022, net profit ratio is
0.003

GRAPH 4.3

● DEPT EQUITY RATIO:

TOTAL BORROWING &LEASE LIABILITIES
TOTAL EQUITY

FOR YEAR 2021-22, DEPT = 8790.58 = 0.58

15056.63
FOR YEAR 2022-23, DEPT =
8854.65 = 0.58

15195.63

● INTERPRETATION:

The debt-to-equity ratio (D/E

ratio) is a financial metric used
to measure the proportion of a

96
company's financing that comes from creditors (debt) versus shareholders
(equity).
A good debt-to-equity ratio is generally around 1 or less. The debt-to-
equity ratio of 0.582 indicates that the company has 58.2 of debt for
every rupee of equity. This suggests a moderate use of debt, reflecting a
balanced financial structure with reasonable financial risk
GRAPH 4.4

● OPERATING MARGIN RATIO: OPERATING INCOME

NET SALES
FOR YEAR 2021-22, TOTAL EQUITY= 3889.48. = 0.09
45106.84
FOR YEAR 2022-23, TOTAL EQUITY= 1496.51 = 0.04
37225.29

● INTERPRETATION:

The operating margin ratio,

also known as operating
profit margin or operating
income margin, is a financial
metric that measures the
profitability of a company's
core business operations.
A good operating margin
ratio typically falls in the
range of 10% to 15%. The

97
operating margin ratio of 9% and 4.02% means the company makes 9 and
4.02 in operating profit for every rupee of sales, indicating modest
profitability and potential for cost management improvements.

GRAPH 4.5

● TRADE RECEIVABLE TURNOVER RATIO:

NET CREDIT SALES

AVERAGE TRADE RECEIVABLE

FOR YEAR 2021-2022, TRADE RECEIVABLE TURNOVER

RATIO
= 45106.84 =8.95
5040.12
FOR YEAR 2022-2023, TRADE RECEIVABLE TURNOVER
RATIO
=37225.29= 8.00
4651.15

● INTERPRETATION

The trade receivable turnover ratio

measures how efficiently a
company collects payments from
its customers. A turnover ratio of
5-10 could be considered
reasonable.
In summary, a trade receivable
turnover ratio of 8.95 for 2021-

98
2022 indicates strong efficiency in collecting payments, while a ratio of
8.00 for 2022-2023 shows a slight decrease in that efficiency, though it
remains relatively high.

GRAPH 4.6

● INVENTORY TURNOVER: COST OF GOODS SOLD

AVERAGE INVENTORY

FOR YEAR 2021-2022, INVENTORY TURNOVER RATIO

= 30532.65=3.48
8784.65
FOR YEAR 2022-2023, INVENTORY TURNOVER RATIO
=23528.85= 1.85
12728.60

● INTERPRETATION

The Inventory Turnover Ratio

measures how many times a
company's inventory is sold
and replaced over a specific
period.
For pharmacies, the typical
inventory turnover ratio ranges
from 5 to 10.
The significant decline from
3.48 to 1.85 suggests the need
for a thorough analysis of both
sales’ performance and

99
inventory management practices to identify and address the underlying
issues.

GRAPH 4.7

● TRADE PAYABLES TURNOVER RATIO:

OPERATING INCOME
NET SALES

FOR YEAR 2021-2022, TRADE PAYABLES TURNOVER RATIO

= 45,106.84. = 9.18
4,914.41

FOR YEAR 2022- 2023, TRADE PAYABLES TURNOVER RATIO

= 37,225.29. = 4.90
7,598.30

● INTERPRETATION

The Trade Payables Turnover

Ratio measures how quickly a
company pays off its suppliers.
An ideal Trade Payables
Turnover Ratio might fall
between 6 to 9 times per year.
In summary, while the high ratio
in 2021-2022 indicates quick
payments, the lower ratio in
2022-2023 suggests slower

100
payments. The reasons behind this change could vary, including strategic
cash management, financial constraints, or renegotiated supplier terms.

GRAPH 4.8

● RETURN ON INVESTMENT:
DIVIDEND INCOME + PROFIT ON SALE OF INVESTMENT
AVERAGE INVESTMENT

FOR YEAR 2021-2022, RETURN ON INVESTMENT = 8.94 = 0.78

11.39
FOR YEAR 2022 - 2023, RETURN ON INVESTMENT = 0.05 = 0.12
0.43

● INTERPRETATION

Inventory turnover is a financial ratio that measures how many times a

company sells and replaces its inventory during a specific period, usually
a year.
Ideal ROI ratio, aiming for an
ROI of 10%-20% is often
considered healthy and
sustainable for many
businesses. The ROI for 2021-
2022 was very strong, the
significant drop in 2022-2023
suggests challenges that need to
be addressed to improve the
company's financial
performance and restore higher
profitability.

101
 GRAPH 4.9

CHAPTER 5: HRM / PERSONNEL

DEPARTMENT

102
5.1 WHAT IS HUMAN RESOURCE MANAGEMENT?

According to Flippo, Human Resource Management is the planning, organizing,

directing & controlling of the procurement, development, compensation,
integration, maintained, reproduction of human resource to the end that
individual, organizational and social objective are accomplished.”

HRM is responsible for the entire lifecycle of an employee's term in an organization.

Right from planning their recruitment their needs, and issues during their tenure to
when the exit the company.

Main objective of the HR department is to build the future ready organization by

undertaking sustained efforts towards skill development, competency mapping and
succession planning.

HRM focuses on investing in employees,

ensuring their safety, and managing all
aspects of staffing, from hiring to
compensation and development Human
resource management is the strategic
approach to nurturing and supporting
employees and ensuring a positive
workplace environment.

FIGURE 5.1

103
5.2 HUMAN RESOURCE IN CONTEXT OF MANGALAM
DRUGS AND ORGANICS

Mangalam Drugs & Organics Ltd. has grown consistently at a rapid pace. The
company is all set to take the challenges of the next generation’s requirements and to
notch it up with even faster growth in the future. We believe in the essence of the
human factor and its role in making the whole organization successful. The key to
their success has always been our ability to attract and retain talented people.

In MANGALAM DRUGS AND ORGANICS, HRM department is divided into

FIGURE 5.2

104
5.3 HRM LEADERSHIP TEAM OF COMPANY

The leadership team at Mangalam Drugs Company consists of four key heads:

● HR DIRECTOR
Responsible for overseeing the overall HR strategy and ensuring alignment with the
company's objectives. They may focus on strategic planning, organizational
development, and leadership development

● RECRUITMENT MANAGER
Manages the recruitment process, including sourcing, screening, and hiring candidates
to fill open positions within the company. They may also be responsible for
developing recruitment strategies and building relationships with external partners.

● EMPLOYEE RELATIONSHIP MANAGER

Handles employee relations issues, including conflict resolution, disciplinary actions,
and grievance procedures. They may also develop and implement policies and
procedures to promote a positive work environment and ensure compliance with
employment laws and regulations.

● TRAINING & DEVELOPMENT MANAGER

Coordinates training programs and initiatives to enhance employee skills and
competencies. They may design and deliver training sessions, assess training needs,
and evaluate the effectiveness of training programs.

105
5.4 HRM ORGANIZATION STRUCTURE OF COMPANY

Mangalam Drugs and Organics has split its HRM department into two units to
effectively manage different aspects of human resource management. One unit
handles recruitment, training, and development, while the other focuses on
employee relations, performance management, and benefits administration.

1. HUMAN RESOURCE
2. ADMINISTRATION

The HR department function is:

● Recruitment
● Training and development
● Performance Management.

The Administration department oversees:

● Housekeeping
● General Rules
● Canteen Management
● Wages/Salary administration
● Labor management
● Security management

Now let's look at all the functions individually

106
5.5 WHAT IS RECRUITMENT?

Recruitment is the HR function of the company. Recruitment refers to the

process of identifying, attracting, interviewing, selecting, hiring and onboarding
employees. In other words, it involves everything from the identification of a
staffing need to filling it.

The process typically involves identifying the need for a new employee, advertising
the position, reviewing applications, conducting interviews, and making a hiring
decision. It's crucial for organizations to effectively recruit to ensure they have the
right talent to achieve their goals.

Depending on the size of an organization, recruitment is the responsibility of a range

of workers. Larger organizations may have entire teams of recruiters while others
only a single recruiter. In small outfits, the hiring manager may be responsible for
recruiting. In addition, many organizations outsource recruiting to outside firms.
Companies almost always recruit
candidates for new positions via
advertisements, job boards, social media
sites, and others. Many companies utilize
recruiting software to more effectively
and efficiently source top candidates.
Regardless, recruitment typically works
in conjunction with, or as a part of
human resource.

FIGURE 5.3

107
5.6 NEED FOR RECRUITMENT IN MANGALAM
DRUGS AND ORGANICS

IN MANGALAM DRUGS AND ORGANICS, need for recruitment arises when

employee strength does not match employee strength chart which is prepared
once in a year.

Mangalam Drugs Company conducts recruitment drives periodically, typically on an

annual basis, to assess its staffing requirements and plan for future growth. This
comprehensive approach ensures that the company maintains an optimal employee
strength to meet operational demands and strategic objectives.

Recruitment is crucial for businesses to ensure they have the right talent to achieve
their goals. It helps in filling vacancies, fostering diversity, bringing in fresh
perspectives, and maintaining competitiveness in the market.

Effective recruitment ensures that MANGALAM

DRUGS AND ORGANICS can attract individuals
with the necessary skills, expertise, and cultural fit
to drive its success.

FIGURE
5.4

108
5.7 SOURCES OF RECRUITMENT IN MANGALAM
DRUGS AND ORGANICS

Mangalam Drugs Company's recruitment process is a vital component of its human

resources strategy, ensuring the acquisition of top talent to drive organizational
success. The company employs a multi-faceted approach to recruitment,
encompassing both external and internal sources.

☞ EXTERNAL SOURCES OF RECRUITMENT

External sources of recruitment are channels used to find candidates outside of
an organization to fill job openings.

MANGALAM DRUGS AND ORGANICS recruit from following external

sources:
● JOB BOARDS AND WEBSITE
Mangalam Drugs Company leverages popular online platforms such as
Naukri.com and LinkedIn to reach a wide pool of qualified candidates. These
platforms provide access to a diverse range of professionals actively seeking
employment opportunities.

● PLACEMENT AGENCIES:
The company collaborates with reputable placement agencies specializing in
pharmaceutical industry talent acquisition. These agencies offer expertise in
sourcing, screening, and presenting candidates tailored to the company's needs

109
☞ INTERNAL SOURCES OF RECRUITMENT

An internal source of recruitment refers to the process of hiring employees

from within an organization. Internal recruitment relies on employee
references, tapping into the existing talent pool to identify potential
candidates for vacant positions.

MANGALAM DRUGS AND ORGANICS recruit from following internal

sources:

● EMPLOYEE REFERENCE

An employment referral is a hiring process in which an existing employee of a

company recommends a friend, acquaintance, or contact for an open position within
the organization. Referral programs are a common recruitment strategy used by many
organizations to tap into their employees' networks and find high-quality candidates.
Employee referrals not only streamline the recruitment process but also contribute to
fostering a culture of engagement and loyalty
within the organization.

FIGURE 5.5

110
5.8 RECRUITMENT AND SELECTION PROCESS OF
COMPANY

Mangalam Drugs Company employs a meticulous selection process to identify and

onboard the most suitable candidates for various roles within the organization. The
selection journey encompasses several stages, ensuring comprehensive evaluation and
alignment with the company's values and requirements.

The selection process is designed to ensure that the chosen candidate not only
possesses the necessary qualifications and skills but also aligns.
The selection process at Mangalam Drugs and Organics involves several stages to
identify the most suitable candidates for vacant positions.

FIGURE 5.6

111
1. SCREENING:
Initial screening of resumes to shortlist candidates meeting the required qualifications
and experience.

2. EMAIL CORRESPONDENCE:
Communication with shortlisted candidates via email to schedule further assessments.
Communication with shortlisted candidates via email to schedule further assessments.

3. PERSONAL INTERVIEW:
Face-to-face interviews to evaluate candidates' interpersonal skills, personality fit, and
alignment with the company culture. Candidates undergo a face-to-face personal
interview to assess their interpersonal skills, communication abilities, and overall
suitability for the role.

4. INTERVIEW APPLICATION:
Completion of an interview application form to gather additional information about
candidates' background and qualifications. Completion of an interview application
form to gather additional information about candidates' background and
qualifications.

5. HR INTERVIEW:
Discussion with HR representatives to assess candidates' overall suitability for the
role and organizational fit. Subsequently, candidates engage in an interview with HR
representatives to evaluate their compatibility with the company culture, values, and
organizational fit.

6. TECHNICAL INTERVIEW:
Evaluation of candidates' technical skills and expertise relevant to the position
through specialized interviews conducted by technical experts. Discussion with HR
representatives to assess candidates' overall suitability for the role and organizational
fit.

112
 7. NEGOTIATION:
Negotiation of salary, benefits, and other terms of employment with selected
candidates. Upon successful evaluation, negotiations regarding salary, benefits, and
other employment terms take place between the company and the selected candidate.

8. OFFER LETTER:
Issuance of formal offer letters to successful candidates, outlining the terms and
conditions of employment. Finally, a formal offer letter is issued to the chosen
candidate, outlining the terms and conditions of employment and officially
welcoming them to Mangalam Drugs Company.

By following a rigorous recruitment and selection process, Mangalam Drugs and

Organics Company ensures that it attracts and retains high-caliber talent
capable of contributing to its ongoing success and growth in the pharmaceutical
industry.

113
☞ STANDARD OPERATING PROCEDURE FOR
RECRUITMENT OF EMPLOYEES, JOINING AND
RELIEVING FORMALITIES

● PURPOSE
To lay down the procedure for recruitment, joining and relieving formalities of
employees.
● SCOPE
This procedure is applicable for recruitment joining and relieving formalities
of all employees at Mangalam Drugs and Organics.
● ROLES AND RESPONSIBILITIES

Roles Responsibilities
● To search / identify suitable
candidate and arrange interview
Designated personnel of HR ● To complete joining and relieving
formalities

● To prepare manpower planning

● To ensure the implementation and
Head HR compliance of SOP

Concerned HOD ● To give manpower planning

● To implement the procedure

described in SOP
● To ensure compliance of SOP
head site QA

Head CQA ● To ensure compliance of SOP

TABLE 5.1

114
● RECRUITMENT OF EMPLOYEES, JOINING AND
RELIEVING FORMALITIES:

1. MANPOWER PLANNING:
OBJECTIVE:
To ensure adequate staffing based on organizational needs, work requirements,
attrition rates, technological advancements, and expansion plans.
PROCEDURE:
Regular assessment of manpower requirements in alignment with organizational
goals.
Analysis of workload, skill gaps, and future demands to determine staffing needs.
Consideration of factors such as attrition rates, changes in technology, and business
expansion plans.
Collaboration between HR and departmental heads to forecast manpower
requirements accurately.

2. COMPETENCE CRITERIA:
OBJECTIVE:
To establish minimum competency criteria for the selection of candidate.
PROCEDURE:
Refer to Annexure-1 for minimum competence criteria while selecting candidates,
ensuring alignment with job requirements.
Consider additional factors beyond Annexure-1 as necessary to meet specific job
demands and organizational standards

3. SELECTION PROCESS:
OBJECTIVE:
To identify and recruit suitable candidates through various sources.
PROCEDURE:
Explore multiple sources including private recruitment consultants, government
employment exchanges, digital platforms, advertisements, personal references, and
educational institutes.

115
Require candidates to fill out the Interview Application Form as per Annexure-2.
Conduct online interviews (telephonic or video conference) when necessary, with the
Interview Application Form completed during the personal interview or at the time of
joining.
Offer positions to selected candidates only after obtaining a medical fitness certificate
from the company authorized doctor.

4. JOINING FORMALITIES:
OBJECTIVE:
To ensure a smooth onboarding process for new employees.
PROCEDURE:
Upon arrival, security personnel escort the new employee to the HR department for
joining formalities.
HR personnel complete the joining formalities, including filling out the New
Employee Checklist.
New employees provide their signature in Annexure-4 as part of the joining process.
Update the specimen signature card of all employees annually for verification
purposes.
Assign a unique employee code to each new employee following the format
"XYYY".

5. RELIEVING FORMALITIES:
OBJECTIVE:
To ensure a smooth and organized transition process for departing employees while
maintaining compliance with company policies and legal requirements.
PROCEDURE:
1. Resignation Notification
Specify the process for employees to formally submit their resignation, including the
required notice period.
2. Exit Interview
Describe the procedure for conducting exit interviews to gather feedback from
departing employees regarding their reasons for leaving and their experiences with
the organization.

116
3. Handover of Responsibilities
Detail expectations for employees to complete pending tasks, transfer knowledge, and
hand over responsibilities to relevant team members or successors.
4. Return of Company Property
Outline the items that employees are required to return upon resignation, such as
laptops, access cards, uniforms, and any other company-owned equipment or
materials.
5. Clearance Procedure
Define the clearance process that departing employees must complete, including
settling outstanding dues, returning borrowed materials, and obtaining clearance from
various departments.
6. Documentation and Formality
Specify the paperwork and documentation required for processing the employee's
resignation, including resignation letters, exit interview forms, and any other relevant
forms or documents.
7. Final Settlement
Explain the timeline and process for calculating and disbursing the employee's final
settlement, including salary, benefits, and any other entitlements.
8. Exit Formalities Checklist:
Provide a checklist summarizing all the steps and formalities that departing
employees need to complete before their last working day.
9. Acknowledgment and Feedback
Request departing employees to acknowledge receipt of company property return,
final settlement, and completion of exit formalities.
Encourage employees to provide feedback on their overall experience with the
organization and suggestions for improvement.
10. Closure and Documentation Retention
Ensure all necessary paperwork and documentation related to the employee's
departure are properly filed, retained, and archived for record-keeping and future
reference.

117
 ● ANNEXURE DETAILS:

ANNEXURE 1 Competence criteria

ANNEXURE 2 Interview application form

ANNEXURE 3 Checklist for new employee

ANNEXURE 4 Specimen signature card

ANNEXURE 5 Exit interview form

TABLE 5.2

● AREA APPLICABLE

SR NO. AREA

1. Corporate quality assurance

2. Quality assurance

3. Human resource
TABLE 5.3

● CONCLUSION
This SOP serves as a guideline for the systematic execution of manpower
planning and selection procedures at Mangalam Drugs and Organics
Company. Adherence to these procedures ensures the recruitment of qualified
candidates who meet the organization's competency criteria and contribute to
its success.

118
 ● SOURCE
SOP OF MANGALAM DRUGS AND ORGANICS (GP.HR 001)

5.9 IMPORTANCE AND IDENTIFICATION OF

TRAINING AND DEVELOPMENT PROGRAMME

A training and development program plays a vital role in fostering employee

growth, improving job performance, enhancing employee engagement and
retention, and ultimately contributing to the overall success and competitiveness
at MANGALAM DRUGS AND ORGANICS. Training and development at
Mangalam Drugs and Organics are crucial for maintaining competitiveness,
driving growth, and ensuring long-term success in the pharmaceutical industry.

Here's a summary of the process for identifying training and development programs
at Mangalam Drugs and Organics:

1. SKILLS ASSESSMENT: Evaluate the

current skills and competencies of employees
through assessments and performance reviews.
2. FEEDBACK COLLECTION: Gather
feedback from employees, managers, and
stakeholders to understand training needs and
areas for improvement.
3. GAP ANALYSIS: Compare current skills
with desired skills for each role to identify
training gaps.
4. TECHNOLOGY AND INNOVATION:
Identify emerging technologies and trends that
may impact job roles and skills requirements.
FIGURE 5.7

119
5.10 TYPE OF TRAINING IN MANGALAM DRUGS AND
ORGANICS

120
 FIGURE 5.8

Work-wise training and department-wise training serve different purposes within an

organization like Mangalam Drugs and Organics:

1. Work-wise Training:
Focuses on the specific skills, knowledge, and competencies required to
perform individual job roles effectively.
Tailored to the responsibilities and tasks associated with each position within
the company. Addresses the unique needs of employees based on their job
functions, ensuring they have the necessary expertise to excel in their roles.
Examples include production techniques for production workers, sales
strategies for sales representatives, and research methodologies for scientists.

2. Department-wise Training:
Encompasses training programs that are designed to meet the collective needs
of entire departments or functional areas within the organization.
Addresses broader goals and objectives specific to each department, such as
improving efficiency, ensuring compliance, or fostering innovation.
May include training on department-specific processes, procedures, and
policies that are relevant to all employees within that department.
Examples include quality standards training for the Quality Control
department, market analysis training for the Marketing department, and safety
procedures training for the Production department.

121
5.11 TRAINING MODULE USED BY COMPANY

1. PLANNED TRAINING:
Planned training involves a systematic approach to preparing and delivering
training programs within an organization.
Planned training ensures that employees receive effective and relevant training
to meet organizational goals and improve performance.

2. GENERAL TRAINING:
It covers essential areas such as Communication, Soft Skills, Time
Management, Safety Awareness, and GMP Awareness.

3. ADDITIONAL TRAINING:
Special attention is given to CAPA (Corrective and Preventive Actions)
training, which involves identifying and addressing issues promptly. Extra
training sessions, typically lasting 1-2 hours, are conducted to address specific
needs and changes within the organization.

This approach underscores the

company's commitment to quality,
compliance, and employee
development, ensuring continued
success in the pharmaceutical
industry.

122
 FIGURE 5.9

5.12 INDUCTION TRAINING

The induction training program at Mangalam Drugs and Organic Company serves as
a comprehensive onboarding process for new employees. It covers essential aspects
such as rules, regulations, and company policies to ensure compliance and familiarity
with organizational standards from the outset. Key components of the induction
training program include:

1. RULES AND REGULATIONS: New employees are introduced to the rules and
regulations governing the workplace, including
safety protocols, ethical guidelines, and company
policies.

2. TIMING: Clear guidance is provided on

appropriate timing for work hours, breaks, and
other schedule-related matters, ensuring
adherence to organizational timelines and
productivity standards. FIGURE
5.10

3. DRESS CODE: Employees receive detailed instructions regarding the company's

dress code standards, emphasizing the importance of professional appearance and
uniformity among team members.

CONCLUSION:
Mangalam Drugs Company's commitment to training evaluation and induction
programs underscores its dedication to employee development and operational
excellence. By ensuring continuous learning and adherence to organizational

123
standards from the onset, the company cultivates a culture of excellence and
professionalism among its workforce.

5.13 SCHEDULING OF TRAINING

For training sessions at MANGALAM DRUGS and

ORGANICS, consider factors like the number of
employees, their roles, and the topics to be covered.
Company schedule sessions during quieter periods
to minimize disruption. Also, think about whether
it's best to have all staff together or split into
smaller groups based on department or job
function.

FIGURE 5.11

5.14 EVALUATION OF TRAINING BY COMPANY

The evaluation of training at MANGALAM

DRUGS AND ORGANICS Company is a
systematic process aimed at assessing employee
learning outcomes and identifying areas for
improvement. If employees score less than 80%
in their training assessments, retraining

124
initiatives are implemented to address any knowledge gaps and reinforce
learning.

FIGURE 5.12

5.15 PERFORMANCE MANAGEMENT SYSTEM FOR

MANGALAM DRUGS AND ORGANICS

"Performance Management System" refers to a structured process or framework used

by organizations to monitor, evaluate, and improve the performance of individuals,
teams, and the organization as a whole. It typically involves setting goals, providing
feedback, assessing performance, and implementing strategies for improvement.

● NEED OF PERFORMANCE MANAGEMENT SYSTEM

Performance management is essential for Mangalam Drugs and Organics to ensure
strategic alignment, identify strengths and weaknesses, optimize resources, and
foster employee development. By monitoring key metrics and implementing
targeted strategies, the company can enhance its overall performance and achieve
its goals effectively.

● FREQUENCY OF PERFORMANCE MANAGEMENT

SYSTEM
The Performance Management System (PMS) at
Mangalam Drugs and Organic Company is
conducted annually, with additional periodic
evaluations and recommendations to ensure
optimal employee performance and development.
PMS is conducted once a year, providing a
comprehensive assessment of employee performance
and growth opportunities.

125
 FIGURE 5.13
● PROHIBITION PERIOD
Following the Performance Appraisal (PA) process, a prohibition period is
implemented to allow for a focused improvement period before subsequent
evaluations.
In various contexts, such as employment contracts or legal agreements, a prohibition
period may prevent individuals or entities from engaging in specific activities, such as
competing with a former employer, soliciting clients, or disclosing confidential
information.
These periods are often put in place to protect the interests of parties involved
and to ensure fair competition or compliance with regulations.

● UTILIZATION FORECASTS
Performance Management System (PMS) involves predicting how efficiently
employees and resources will be utilized to achieve organizational goals. This process
includes defining key performance indicators (KPIs), gathering historical data,
analyzing current workloads, forecasting future demand, allocating resources, and
monitoring performance.
By implementing utilization forecasts, organizations can optimize resource
allocation, improve productivity, and achieve better performance outcomes.

● APPRAISER'S COMMENT
Appraiser comments in a performance management system are essential for
providing specific, constructive feedback on an employee's performance. They
address key performance indicators, accomplishments, challenges overcome, and
areas for further development.

126
☞ ROLE OF HOD, HR AND EMPLOYEE IN
PERFORMANCE MANAGEMENT SYSTEM.

● HOD INVOLVEMENT:
Soft Skills Training Identification: HODs identify training needs related to soft
skills development, such as communication and leadership, to enhance employee
effectiveness.
Job Skills Utilization: HODs assess employee job skills utilization and make
recommendations for promotions or rotations based on performance and potential.

● HR INVOLVEMENT:
Holidays: The HR department oversees holiday scheduling and ensures compliance
with company policies and statutory requirements.
Recommendations: HR Head recommends employees for confirmation and
evaluates their performance, providing valuable insights for decision-making.
HR collaborates with HODs to provide suggestions and support for performance
improvement and career development initiatives.

● EMPLOYEE INVOLVEMENT:
Goal Setting: They actively
participate in setting their performance
goals aligned with organizational
objectives.
Feedback Exchange: They engage
in regular feedback discussions with

127
managers, providing insights into their performance and receiving constructive
feedback for development.
FIGURE 5.14

5.16 ADMINISTRATION DEPARTMENT OF

MANGALAM DRUGS AND ORGANICS

The Administration department at Mangalam Drugs and Organic Company oversees

various essential functions to ensure smooth operations and compliance with
regulations.

● HOUSEKEEPING:
The department maintains cleanliness and hygiene standards throughout the premises,
creating a safe and pleasant work environment.

● CANTEEN MANAGEMENT:
It manages the company canteen, providing nutritious meals for employees and
ensuring food safety and quality. Food is made somewhere else and brought to
company to ensure hygiene and quality.

● LABOR MANAGEMENT:
The Administration department handles the management of labor resources, including
attendance tracking, scheduling, and addressing employee concerns.

● GENERAL RULES MANAGEMENT:

It enforces company policies and general rules to promote discipline, safety, and
adherence to regulatory standards.

● WAGES/SALARY ADMINISTRATION:

128
The department is responsible for the administration of wages and salaries, ensuring
timely and accurate payment to employees in compliance with legal requirements.

● SECURITY MANAGEMENT:
It oversees security measures within the company premises, implementing Standard
Operating Procedures (SOPs) to safeguard assets, personnel, and information.

The Administration department plays a crucial role in maintaining a conducive

work environment, supporting employee welfare, and upholding organizational
efficiency and
compliance.

FIGURE 5.15

129
☞ STANDARD OPERATING PROCEDURE FOR
GENERAL CLEANING AND HOUSEKEEPING

● PURPOSE
To lay down the procedure for general cleaning and housekeeping.

● SCOPE
This SOP applicable for general cleaning and housekeeping pure reduce at
Mangalam Drugs & Organics Ltd.

● ROLES AND RESPONSIBILITIES

Roles Responsibilities

Workman To clean the respective area

Designated personnel of HR To monitor the activities

Head HR To ensure the compliance of the SOP

Head site QA To implement the procedure described in

the SOP

TABLE 5.4

130
 ● PROCEDURE

Frequently of cleaning in each area is defined below

SR. No Area Frequency of cleaning

1 Path way of entire premises Daily

2 All staircases Daily

3 All department offices Daily

4 Lunch room Daily

5 Electric panel room Daily

6 Chilling plant Daily

7 Worker change room Daily

8 RM/PM Store Daily

9 Security cabin Daily

10 TOC room Daily

11 All toilets Daily

12 Boiler room Daily

TABLE 5.5

● DAILY CLEANING:
(i) All department offices
(ii) All staircases

131
(iii) Lunch room
(iv) Occupational health center
(v) Security office
(vi) Pathways of the factory area
(vii) Chilling plant
(viii) Electric room
(ix) Toilet cleaning

● WEEKLY CLEANING:
(i)Water cleaning
(ii)Window panes
(iii) Cobwebs

● MONTHLY CLEANING:
i) Terraces of all buildings

● CONCLUSION

(SOP) for the administrative department at Mangalam Drugs and Organics could
involve summarizing your enthusiasm for contributing to the company's goals,
highlighting your relevant skills and experiences, and expressing your commitment to
excellence in administrative functions.

132
☞ STANDARD OPERATING PROCEDURE FOR
RESPONSIBILITY OF SECURITY

● PURPOSE
To layout the procedure for the responsibility of security personnel.

● SCOPE
This SOP is applicable the security personnel of Mangalam Drugs and Organics

● ROLES AND RESPONSIBILITY

Roles Responsibilities

security personnel (role) To follow the procedure described

Designed personnel of HR (role) To monitor and ensure the activity

Head HR (role) To monitor and ensure the activity

To ensure the compliance
To arrange security service

Head site QA (role) To implement the procedure described in

133
 the SOP
To ensure compliance of the SOP

TABLE 5.6

● PROCEDURE
HR department shall arrange the security for the security of the company's premises.
HR department shall provide training according their predefined job responsibility
HR personnel shall hand over the specimen signature of authorized person to the
security person for man and material movement as per annexure-1
HR personnel shall ensure that the security staff on duty is well dressed, alert and fit
for the job all the time

HR personnel ensure that the functions assigned to security person are performed in
correct manner
HR personnel shall also check all the records of security department on daily basis or
as and when required

GENERAL RESPONSIBILITY OF SECURITY

1. Security officer shall depute guards for better watch and supervision at
different area of factory
2. Security personnel shall take rounds at regular intervals of time and stay alert
for any abnormal activities.

● HANDLING OF EMPLOYEES / CONTRACTUAL

WORKERS

134
1. TIMEKEEPING:
Security personnel shall record the incoming and outgoing time of all employees in a
register as required.
Maintain records for 24 months as per statutory requirements.

2. SECURITY CHECKS
Ensure that employees and workers entering or exiting the company premises do not
carry prohibited items such as gutkha, pan tobacco, cigarettes, matchboxes, mobile
phones, pen drives, etc. Employees are not permitted to take any material from the
factory without proper authorization.

3. MOBILE PHONE AND LAPTOP POLICY

Prohibit the carrying of mobile phones and laptops by all employees, except for those
authorized by the HR department or senior management.

4. OUTGOING EMPLOYEE PROCEDURE

Provide outgoing gate passes to employees leaving the company premises during
duty hours. Gate passes must be signed by the respective department head/in-charge
and HR personnel.

5. EMPLOYEE ATTENDANCE REPORTING

Security personnel shall inform the HR department head of the time of arrival of
employees/workers and record their names in the attendance register.

6. CONTRACTUAL WORKER PROCEDURE

Obtain specimen signatures from skilled contractual workers involved in
manufacturing activities as per Annexure-2

● HANDLING OF VISITORS

1. VISITOR TIMEKEEPING:
135
 Security personnel shall record the incoming and outgoing time of all visitors in a
register.
Maintain accurate records of visitor movements.

2. VISITOR ARRIVAL NOTIFICATION:

Inform appropriate personnel upon the arrival of visitors to the company premises.

3. VISITOR REGISTER MAINTENANCE:

Maintain a visitor register as per Annexure-9, documenting details of all visitors.

4. VISITOR ACCESS CONTROL:

Allow visitor’s entry into the company premises only during working hours and after
preparing visitor gate passes.

5. PHOTOGRAPHY POLICY:
Strictly prohibit photography inside the company premises to safeguard intellectual
property and security.

6. SECURITY CHECKS FOR VISITORS:

Ensure visitors do not carry prohibited items such as gutkha, pan, tobacco, cigarettes,
matchboxes, mobile phones, pen drives, or laptops.

● HANDLING OF INWARD/ OUTWARD MATERIAL

The handling of inward and outward materials with security responsibility involves
ensuring the integrity and safety of all materials entering and leaving the premises.

1. INWARD MATERIAL HANDLING

Conduct thorough inspections of incoming materials to verify quantity and quality.

136
 Implement measures such as tamper-evident packaging and seals to prevent
unauthorized access or tampering.
Store incoming materials securely in designated areas to prevent loss or damage.
Document all inward material transactions and maintain detailed records for
traceability.

2. OUTWARD MATERIAL HANDLING

Package outgoing materials securely to prevent damage during transportation.
Verify the identity and authorization of individuals responsible for handling outgoing
materials.
Implement procedures for loading and shipping materials safely and efficiently.
Maintain records of outgoing material transactions, including shipping documents
and receipts.

3. SECURITY RESPONSIBILITY
Assign specific individuals or teams responsible for overseeing the security of inward
and outward material handling processes.
Train staff on security protocols, including identification of suspicious activities and
reporting procedures.
Conduct regular audits and inspections to ensure compliance with security measures
and identify any vulnerabilities.
Collaborate with relevant authorities or security agencies to address security
concerns and enhance protection measures as needed.

By establishing robust security measures and assigning clear responsibilities,

Mangalam Drugs and Organics can effectively manage the handling of inward and
outward materials while ensuring the integrity and security of their operations.

137
 ● CONCLUSION:
This SOP outlines the procedures and responsibilities of security personnel at
Mangalam Drugs and Organics Company concerning the handling of employees,
contractual workers, and visitors. Adherence to these guidelines ensures the safety,
security, and compliance of all individuals within the company premises

5.17 EMPLOYEE RELATED

Employee relations in HRM encompasses various aspects aimed at fostering

positive relationships between employees and the organization.
Key topics include grievance handling, communication, engagement, diversity
and inclusion, rights and responsibilities, work-life balance, benefits and
recognition and rewards.
These topics are vital for creating a supportive work environment and ensuring the
well-being and satisfaction of employees.

Let's look some of it:

1. NUMBER OF EMPLOYEES
Number of Employees means the count of full-time and part-time workers engaged at
a business site every regular working day during a calendar year. A company with
fewer than 100 employees is generally considered a small-sized business, while one
with between 100 and 1,500 employees is a medium-sized business. Here no. of
Employees of Mangalam drugs & organic are given below:

138
 ● Mangalam Drugs & Organic have 1,001 to 5,000 employees in India.
● There are 210 staff members in the Mangalam Drugs & Organic company in
their Vapi unit.
● Also, there are 200 contractual workforces in Vapi unit

2. FRINGE BENEFITS PROVIDED

Fringe benefits are the additional benefits offered to an employee, above the stated
salary for the performance of a specific service. Mangalam drugs & organic give
these fringe benefits to their employees:

● Birthday leave
● Anniversary leaves
● Paternity leave for male employees (2 days)
● Full attendance incentives
● Free cost Mediclaim for the employee, employee’s spouse and for two
children of employee
● Employee daughter scholarship scheme
● Canteen facilities
Providing canteen facilities or subsidizing food can contribute to employee
satisfaction, well-being, and productivity by offering them convenient and
affordable meal options during work hours
Subsidiary food - Rs.50
For workers - Rs 5
For staff - Rs 15

139
 3. GRIEVANCES HANDLING
Grievance handling in HRM involves addressing employee complaints or
dissatisfaction through clear channels, impartial investigations, timely resolutions,
and preventive measures. It aims to foster trust, fairness, and a positive work
environment, contributing to overall employee satisfaction and organizational
success.

In MANGALAM DRUGS AND ORGANICS all the grievances occurred till date
are been solved informally

Grievance handling at Mangalam Drugs and Organics is likely a structured process

involving several steps. Here's a breakdown based on the information you provided:

● REGISTER OF GRIEVANCES:
Employees or stakeholders can submit their grievances informally, either in person or
through written applications.

● HOD MANAGEMENT PANEL DISCUSSION:

140
The grievance may be discussed with the Head of Department (HOD) and relevant
managers in a panel discussion format to understand the issue better and explore
potential solutions.

● INVESTIGATION:
After the discussion, there may be an
investigation into the grievance to gather more
information and assess its validity.

● RESOLUTION:
Once the investigation is complete, the
company can work towards resolving the
grievance by taking appropriate actions, such
as implementing changes or addressing concerns raised. FIGURE 5.16

CHAPTER 6: PURCHASE
DEPARTMENT

141
6.1 INTRODUCTION TO PURCHASE DEPARTMENT
OF MANGALAM DRUGS AND ORGANICS
142
Mangalam Drugs and Organics is a leading pharmaceutical and organic products
company that aims to provide high-quality medicines and organic goods to its
customers. The Purchase Department is a critical function within the organization,
responsible for sourcing raw materials, intermediates, and finished products from
various suppliers to ensure the smooth operation of the manufacturing process and
timely delivery of products to customers.

The Purchase Department at Mangalam Drugs and Organics is responsible for

managing the procurement process of raw materials, intermediates, and finished
products. The department operates through a combination of in-house and external
resources, including a team of dedicated procurement professionals, a network of
suppliers, and various software tools for managing the procurement process.

FUNCTIONS OF PURCHASE DEPARTMENT ARE:

FIGURE .6.1

6.2 SOURCING RAW MATERIALS

143
 ● PLANNING PHASE:
Conduction of planning is done to determine the type, quantity, and timing of raw
materials required for production.
Purchase department collaborates with production and inventory departments to align
procurement with production schedules and inventory levels.
Purchase department maintains a tentative procurement schedule to optimize
inventory management and minimize stock outs or overstocking.

● SUPPLIER EVALUATION AND QUOTATION:

Purchase department source quotations from multiple suppliers for each raw material
requirement. They evaluate supplier quotations based on factors such as price, quality,
delivery time, payment terms, and past performance. They also review supplier
capabilities, certifications, and compliance with regulatory standards. They select the
most suitable supplier based on a comprehensive
review and analysis.

FIGURE 6.2

● PURCHASE ORDER CREATION:

144
 They negotiate with favorable supply
conditions with the selected supplier, including
pricing, payment terms, delivery schedules, and
quality assurance measures.
They ensure that all terms and conditions are
clearly documented in the Purchase Order (PO)
to avoid misunderstandings or disputes.
They obtain approval from relevant
stakeholders and management before finalizing
the PO.
They transmit the PO to the supplier electronically FIGURE 6.3
or via mail, ensuring timely
acknowledgment and confirmation.

● FOLLOW UP AND PAYMENT:

Purchase department maintain regular communication with suppliers to track the
status of pending orders, resolve any issues or delays, and ensure on-time delivery.
Then they monitor supplier performance and adherence to agreed-upon terms and
conditions.
Purchase department process payments promptly upon receipt of goods and
satisfactory completion of delivery, adhering strictly to the payment terms specified in
the PO. They maintain accurate records of all procurement transactions, including
POs, invoices, receipts, and payment documentation.

145
6.3 PROCUREMENT OF ENGINEERING ITEMS
To assist with the procurement process of engineering items at Mangalam Drugs and
Organics, the purchase department typically follows these steps:

FIGURE 6.4

146
 1. IDENTIFICATION OF NEEDS:
Determining the engineering items required for the company's operations. This
involves understanding the company's operational requirements and determining the
specific engineering items needed to support those operations. This could include
machinery, equipment, tools, spare parts, or any other engineering-related products
necessary for production or maintenance

2. SUPPLIER IDENTIFICATION:
The purchase department researches and identifies potential suppliers who can
provide the required engineering items. This may involve leveraging existing supplier
relationships, conducting market research, or seeking recommendations from industry
contacts.

3. REQUEST FOR QUOTATION (RFQ):

Once suppliers are identified, the purchase department issues RFQs to solicit
competitive bids. The RFQ includes detailed specifications of the required items, such
as technical requirements, quantities needed, quality standards, delivery schedules,
and any other relevant terms or conditions.

4. QUOTATION EVALUATION:
The purchase department evaluates the received quotations based on various factors,
including price, quality, delivery time, warranty terms, supplier reputation, and
reliability. This evaluation helps determine the best value proposition for the
company. Evaluate received quotations based on factors such as price, quality,
delivery time, and supplier reliability.

5. NEGOTIATION:
After reviewing the quotations, the purchase department may engage in negotiations
with the shortlisted suppliers to finalize the terms of the agreement. Negotiations may
involve discussions on pricing, payment terms, delivery schedules, bulk discounts, or
any other terms relevant to the transaction.

147
 6. PURCHASE ORDER (PO) ISSUE:
Once negotiations are concluded, the purchase department issues purchase orders to
the selected suppliers. The PO formally outlines the agreed-upon terms and
conditions, including item descriptions, quantities, prices, delivery dates, shipping
instructions, payment terms, and any other relevant terms.

7. SUPPLIER FOLLOW-UP:
Throughout the procurement process, the purchase department maintains regular
communication with suppliers to monitor progress and ensure adherence to agreed-
upon delivery schedules. Any deviations or delays are addressed promptly to
minimize impact on operations.

8. RECEIPT AND INSPECTION:

Upon receipt of the ordered engineering items, the purchase department conducts
thorough inspections to verify that the products meet the specified quality standards
and conform to the agreed-upon specifications. Tests include hydro test and pressure
test. Any discrepancies or issues are documented and addressed with the supplier as
necessary.

9. PAYMENT PROCESSING:
Once the received items pass inspection and meet the required standards, the purchase
department initiates the payment process according to the agreed-upon payment
terms. Timely payment is essential for maintaining good supplier relationships and
ensuring future cooperation.

10.SUPPLIER RELATIONSHIP MANAGEMENT:

Building and nurturing positive relationships with suppliers is crucial for long-term
success. The purchase department continues to engage with suppliers, providing
feedback, addressing concerns, and exploring opportunities for collaboration or
improvement.

6.4 MANAGEMENT OF MISCELLANEOUS ITEMS

148
Mangalam Drugs and Organics excels in managing the procurement of miscellaneous
items critical to its daily operations. By adopting a diverse procurement strategy, the
company ensures the timely acquisition of office supplies, maintenance tools, and
safety equipment from reputable suppliers. Through meticulous supplier selection and
evaluation, Mangalam Drugs and Organics prioritizes reliability and cost-
effectiveness, fostering strong partnerships.

The company's emphasis on cost efficiency is evident through consolidated

purchasing, inventory optimization, and negotiation of favorable terms. Quality
assurance remains paramount, with regular audits and compliance checks ensuring
adherence to standards. Mangalam Drugs and Organics maintains transparent
communication with suppliers, facilitating continuous improvement and innovation.

With streamlined procurement processes and a

steadfast commitment to quality, Mangalam
Drugs and Organics effectively manages
miscellaneous items procurement, bolstering its
operational resilience and supporting sustained
growth.

FIGURE 6.5

6.5 STANDARD OPERATING PROCEDURE FOR

VENDOR EVALUATION

149
 ● PURPOSE
To lay down the procedure for evaluation of vender for procurement
of raw materials and packing material.

● SCOPE
This procedure is applicable for the evaluation of all the raw material /
packing material received at Mangalam drugs and organic Ltd.

● ROLES AND RESPONSIBILITIES

Roles Responsibilities

•To evaluate the vender as per

Designated personnel of purchase procedure
•To review the vendor evaluation
data.

•To review and approve vender

evaluation data
Head site QA •To implement the procedure
described
in the SOP.
•To ensure compliance of the SOP.

Head CQA •To ensure compliance of the SOP

TABLE 6.1

● PROCEDURE

150
Vendor evaluation shall be performed in first month of the year (+30 working days)
for the material purchase from January to December of previous year. Vendor
evaluation shall be done on yearly basis.
Vendor evaluation shall be performed directly soft copy as per Annexure-1 for
the manufacturer and supplier of the material.
Incase manufacturer or supplier is same then detail shall be mentioned.
Purchase personnel shall enter the detail in Annexure-1 in the RMAR/PMAR
. From the QC department or regular basis considering following parameters but
not limited to:
● Quality of material required
● Contract condition
● Delivery timeline
● Service like transportation & quantity
● Commercial aspects
● Rejection
During inter transfer of raw materials if testing performed.at one site and same
material is sent to another site.
Incase no consignment is received from a particular vender or supplier vender
evaluation shall be not be performed.
Vendor evaluation data shall be verified by purchase designer on regular basis.
In any abnormal result observed purchase designee shall immediately inform
to head site Q.A.
According vender evaluation form (Annexure-1) shall be updated and
necessary action shall be taken. Increase of abnormal like quality, requalification
procedure shall be followed
as per SOP No.GP.QA.017 (vender management policy).

● CRITERIA FOR DISQUALIFICATION OF VENDOR

151
 1. If audit compliance report from the vendor is found unsatisfactory by the
auditor and the vendor is unable to company.
2. The subsequent vendor audit reveals critical observation that may lead to
Impact on the product quality/patient safety.
3. Trend data reveals quality problems are of the repetition nature.
4. Adulteration of the materials noticed.
5. OOS observed in three consecutive batches or five batches in a year.
6. Critical/major/CGMP noncompliance observed from regulatory
agencies/customers.
7. Based on the vendor evaluation.
8. If any quality issue of the materials/items supplied by the vendor is
reflecting on the finished product quality.
9. Vendor repeatedly fails to supply the material on time as committed.
10. Vendor stops manufacturing of materials for more than four years and/on
no material is purchase from that vendor.
11. Vendor does not company with regulatory requirements.
12. If vendor has made any changes in the process, without informing to
Mangalam drugs and organic
13. If vendor manufacturer the materials at a different site and which has been
not audited by Mangalam drugs and organic
14. If vendor fails to company to terms & condition as mutually agreed in the
technical agreement.
15. Market complaint investigation conclude the quality of input materials has
direct impact on quality, safety, identify & purity of intermediate /API.

● SOURCE: SOP no GP.PU.001

6.6 STANDARD OPERATING PROCEDURE FOR

PROCUREMENT OF CONSUMABLE ITEMS

152
 ● PURPOSE
To lay down the purchase of material/ firm

● SCOPE
This procedure is applicable for procurement of raw material, other material
miscellaneous item at Mangalam drugs and organic ltd

● ROLES AND RESPONSIBILITIES

Roles Responsibilities

• To follow the procedure

Designated personal of • To procure the required material as
Purchase/Head office Purchase. per request.

• To follow procure
Designed personnel of Engineering • To procure the required material as
per request.

• To implementation and compliance

Head site QA with sop.
• To ensure compliance of sop.

Head CQA • To ensure compliance of sop

TABLE 6.2

● PROCEDURE

153
1. Daily or monthly requirements of the material shall be intimated by stores
department to the site purchase department.

2. Designed Designated personnel of site purchase shall forward monthly

material planning to the head office purchase for the procurement of material
by giving all the required details along with tentative schedule. If any change
observed in the planning; it shall be immediately informed to designated
personnel of head office purchase.

3. After sending the required information to head office purchase, designated

personnel of site purchase shall take follow the same as and when required

4. Designated personnel of site purchase shall verify the daily RM/PM stock
statement send by the store department & Co-ordinate with store personnel to
maintain minimum stock.

5. After verification of stock statement, store personnel shall intimated

/informed to the site purchase department for the procurement of material
which aren't planned in advance to avoid any delay of production. Similarly
purchase personnel shall also co-ordinate with other departments for
procurement of other material or any other miscellaneous items.

6. Designated personnel of purchase shall send inquiries & procurement of

quotations to the approved manufacturer or supplier as requirement.

7. After confirmation received from the approved manufactured or supply

designated personnel of purchase shall issue signed to the manufacturer or
supplier as requirements.

8. The site purchase department shall procurement major items like raw
Material, Packing material, engineering items, ETP related R.M, laboratory

154
 chemicals, printing & stationery and electricals items along with other
miscellaneous items.

9. Book, purchase like raw material, packing material engineering items shall be
purchased through head office.

10. Whenever approved manufacturer is unable to supply raw material, packing

materials, proceed as per SOP.GP.QA. 017.Annual Rat Contract shall be
prepared with related supplier /contractor of required.

● SOURCE: GP.PU.002

155
CHAPTER 7: WAREHOUSING

156
7.1 INTRODUCTION TO WAREHOUSING

Warehousing encompasses the storage, handling, and management of goods

within a facility. It involves various activities such as receiving, storing, picking,
packing, and shipping items. Warehouses play a crucial role in the supply chain by
providing a centralized location for storing inventory and facilitating the movement of
goods between suppliers and customers. Effective warehousing practices involve
optimizing space utilization, implementing inventory control systems, ensuring safety
and security of goods, and streamlining logistics operations to minimize costs and
maximize efficiency.

Mangalam Drugs and Organics likely manage their warehousing operations to

ensure efficient storage, inventory management, and distribution of
pharmaceuticals and organic chemicals. This involves maintaining storage
facilities with appropriate infrastructure, implementing inventory management
systems, prioritizing safety and compliance, fulfilling orders accurately and timely,
and integrating technology for streamlining operations.

Warehousing of MANGALAM DRUGS AND

ORGANICS, is divided into:

1. RAW MATERIAL STORAGE

2. PACKING MATERIAL
STORAGE
3. FINISHED GOODS STORAGE

FIGURE7.1

7.2 RAW MATERIAL STORAGE

157
At Mangalam Drugs and Organics, the handling of raw materials involves a series of
procedures and protocols to manage the raw materials used in pharmaceutical and
organic chemical manufacturing processes. This division is dedicated to storing raw
materials used in the manufacturing process. These materials could include
ingredients, components, or materials needed to produce the final products. Effective
handling of raw materials is essential for maintaining product quality and the smooth
operation of manufacturing processes.

● SAFETY MEASURES:
Raw materials are stored in the warehouse with strict adherence to safety measures,
including wearing caps, gloves, and shoes.

● ENTRY AND EXIT:

The warehouse has two gates: one for workers, ensuring they follow safety measures,
and another for materials, where they undergo weighing and vacuuming.

● VACUUM AND WEIGHTING:

Vacuuming can help remove any debris or contaminants from the raw materials.
Weighing the materials accurately is also essential for inventory management and
quality control.
Before quarantine, it's crucial to ensure that raw materials are properly cleaned and
inspected.

7.3 STAGES OF RAW MATERIAL STORAGE

158
 ● QUARANTINE STAGE
Upon receipt, raw materials are placed in a quarantine area designated for materials
awaiting inspection and testing. During this stage, materials are segregated from
approved stock to prevent inadvertent use before their quality is confirmed.
Raw materials are stored separately in designated quarantine areas. During this stage,
materials undergo inspection, testing, and monitoring for contamination or
deterioration.
Materials are taken to a quarantine area where they are labeled with blue labels,
signifying their quarantine status.

● TESTING STAGE
Raw materials in the quarantine area undergo thorough inspection and testing to
ensure they meet quality standards and regulatory requirements. This testing may
include visual inspection, physical testing, and chemical analysis.
Sampling: Samples are taken from each batch of raw materials according to
established sampling plans to ensure they are representative.
Testing Procedures: Various tests are conducted based on the specific requirements
of the pharmacopeial standards or the company's internal specifications.

- Materials undergo sampling by the Quality Control (QC) department, with a

portion placed on yellow labels for testing.
- Typically, 10% of the materials (e.g., 10 bags out of 100) are selected for
testing.

159
 ● APPROVAL STAGE
QC results are reviewed by qualified personnel, such as QC analysts or quality
assurance (QA) professionals, to verify accuracy and completeness. Once the results
are deemed satisfactory and meet all requirements, QC approval is granted.
This approval signifies that the products have passed all necessary tests and meet
quality and safety standards. Once raw materials have passed testing and are deemed
to meet the required specifications, they are approved for use in production. Approved
materials are then transferred from the quarantine area to designated storage locations
within the warehouse for future use.
Materials approved by QC receive a green label, indicating their suitability for
production use.

MATERIAL RETESTING
Raw materials at approval stage are not used within a designated timeframe undergo
retesting every 6 months to ensure quality and potency.

FIGURE7.2

160
☞DISPENSING PROCESS
A dispensing system is used to accurately measure and dispense materials in
manufacturing or laboratory settings.

-It is done by different scoop of different measurements

- The dispensing area calculates the quantity of materials required for
production.
- If, for example, 25 kg of material is required but 40 kg is available, the excess
15 kg remains in the warehouse for future use.

☞ WASHING PROCEDURE
There is a washing room protocol for cleaning and sterilizing scoops used in handling
raw materials at Mangalam Drugs & Organics Company.

To minimizing the risk of cross-contamination and upholding product quality

standards.
Procedure:
1. PREPARATION:
Ensure the washing room is clean and gather used scoops and cleaning materials.
2. WASH WITH WATER:
Thoroughly rinse each scoop with clean water to remove visible residues.
3. WASH WITH MENTHOL:
Disinfect and sanitize the scoops by washing them with menthol solution.
4. OVEN DRYING:
Dry the scoops in an oven at an appropriate temperature and duration.
5.STORAGE:
Store the cleaned and sterilized scoops in designated containers or shelves.

161
☞ RAW MATERIAL STORE OFFICE

For managing incoming raw materials, such as sourcing, quality control, inventory
management, and distribution to various production departments. This office is
staffed by professionals responsible for procurement, quality assurance, and logistics.
Having raw material store in the office can be beneficial for easy access and
inventory management. It ensures that necessary materials are readily available for
various projects or tasks without the need for frequent external procurement.
Additionally, it can streamline workflows and minimize downtime by reducing the
need to wait for deliveries or make last-minute purchases. However, it's important to
manage the store efficiently to avoid overstocking or understocking and to keep track
of usage to optimize inventory levels. The raw material store office at Mangalam
Drugs and Organics, a centralized hub.

In Mangalam Drugs and Organics, the raw material storage office plays a pivotal role
in managing the inventory of raw materials efficiently. Its functions include
overseeing inventory management, coordinating the receipt and inspection of raw
materials, managing quarantine and release processes, organizing storage areas, and
maintaining accurate inventory tracking and documentation. This office ensures that
raw materials meet quality standards, are stored properly, and are readily available to
support production activities while minimizing excess inventory and associated costs.

162
7.4 PACKING MATERIAL STORAGE

In the pharmaceutical industry, the selection and utilization of packing materials play
a crucial role in ensuring the integrity, safety, and presentation of finished products.
Mangalam Drugs and Organics Ltd, as a leading player in the pharmaceutical sector,
recognizes the significance of optimizing its packing material processes to enhance
efficiency, reduce costs, and uphold quality standards.

● MANAGERIAL STRUCTURE
Two managers are appointed for packing material management in MANGALAM
DRUGS AND ORGANICS.

● SAFETY MEASURES
Packing materials are stored in the warehouse with strict adherence to safety
measures, including wearing caps, gloves, and shoes.
Conduct a risk assessment to identify potential hazards related to packing materials
Implement safety protocols for handling, storing, and transporting packing materials

● ENTRY AND EXIT GATE

There is a single entry and exit gate for packing material transportation.
There is installation of security measures such as CCTV cameras and access control
systems.

163
☞ TYPE OF PACKING MATERIAL

1. INTERMEDIATE PRODUCT
2. FINISHED PRODUCT

1. INTERMEDIATE PRODUCT
INTERMEDIATE products in pharmaceuticals typically refer to medications or
treatments that are administered periodically or in a cyclical manner.
INTERMEDIATE product packing
HDP (High-Density Polyethylene): HDP is a type of plastic used in packaging due to
its durability and resistance to chemicals. It's commonly used for bottles, containers,
and bags.

2. FINISHED PRODUCT
In the pharmaceutical industry, a finished product refers to a medication or
therapeutic item that has completed all stages of manufacturing, including
formulation, production, packaging, quality control testing. It is ready for distribution
and use by patients. Finished products can take various forms, such as tablets,
capsules, injections, creams, or liquids.
Finished product packing
LPD (Low-Density Polyethylene): LPD is
another type of plastic used in packaging,
known for its flexibility and clarity. It's often
used for plastic bags, shrink wraps, and food
packaging.

164
 FIGURE7.3

7.5 FINISHED GOODS STORAGE

This division is designated for storing the final products that have been manufactured
and packaged and are ready for distribution to customers or retailers. This area
ensures that finished goods are organized, easily accessible, and ready for shipping as
orders are fulfilled.

● LIST OF SOME FINISHED GOODS

1. BISOPROLOL FUMARATE
2. PYRIMETHAMINE
3. LUMEFANTRINE
4. EMTRICITABINE
5. TENOFOVIR DISOPROXIL FUMARATE
6. NIMESULIDE
7. AMODIAQUINE HYDROCHLORIDE
8. FUROSEMIDE
9. SULFADOXINE
10. CHLOROQUINE PHOSPHATE

● ENTRY AND EXIT GATE

There is a single entry and exit gate for finished goods transportation
There is installation of security measures such as CCTV cameras and access control
systems

165
☞ WEIGHING OF FINISHED GOODS

Weighing of finished goods is done by Mettler Toledo

Mettler Toledo's reputation for accuracy, reliability, and precision makes their
equipment a valuable asset for companies like Mangalam Drugs and Organics that
prioritize quality and compliance in their operations.

Weighing of finished goods takes place three time:

1. Initial Weighing: This could happen immediately after the production process
is completed. It ensures that the finished goods meet the required weight
specifications and quality standards before further processing or packaging.

2. Intermediate Weighing: This might occur after packaging process, when it

reaches finished goods storage. It allows for monitoring any changes in weight
or quantity and ensures consistency throughout the manufacturing process

3. Final Weighing: The final weighing

typically occurs just before the finished
goods are packaged for shipment or
distribution. It is done by QA
department to ensures that the correct
quantity of product is being sent to
customers and helps prevent any
discrepancies or errors in the final
packaged products.

FIGURE7.4

166
☞ CONTAINER LABEL INFORMATION
Following are information mentioned on container of finished goods:
● BATCH NUMBER
● GROSS WEIGHT
● TARE WEIGHT
● NET WEIGHT
● MANUFACTURING DATE
● EXPIRY / RETEST DATE
● DRUM NUMBER
● TOTAL NUMBER OF DRUMS

☞ TYPE OF STORAGES

The finished goods warehouse at Mangalam Drugs & Organics Company employs
specialized storage to maintain product quality and integrity.
● Normal Finished Good Storage:
Temperature limit should be below 25°C to
maintain product stability. Containers should be
positioned to ensure they do not touch the ceiling
or beams, allowing for adequate air circulation and
preventing damage.
● Cold Storage:
Integrated within the normal finished goods
storage area Temperature limits maintained
between 2-8°C to preserve product quality,
particularly for temperature-sensitive items.
FIGURE7.5

167
☞ EQUIPMENT USED FOR HANDLING OF FINISHED
GOODS STORAGE
FORK LIFT
A forklift, also known as fork truck, is a motor-
driven industrial truck used for lifting and
moving goods on a pallet within the premises of
a warehouse, storage facilities and distribution
center. Depending on the design, some Forklifts
allow the operators to sit while driving or
operating the machine.

FIGURE7.6
PLATFORM TROLLEY
Platform trolleys are one of the most widely used
material-handling equipment in warehouses,
factories, and logistics facilities alike. They are ideal
for transporting goods from one place to another with
ease. In general, they are very convenient for both
long-term and short-term purposes.
FIGURE7.7

HOIST
A hoist is a mechanical device used primarily for raising and lowering heavy loads
but occasionally for moving objects horizontally. It usually consists of a block and

168
tackle—a combination of one or more fixed pulleys, a moving pulley with a hook or
other similar means of attaching loads, and a rope (or cable) between them.
FIGURE7.8

☞ TRANSPORTATION OF FINISHED GOODS

In the pharmaceutical industry, maintaining the integrity and efficacy of drugs and
other medical products during transportation is of utmost importance. Here's how
freezer cars and soft boxes are utilized specifically in pharmaceutical logistics:

1.Freezer Cars: Freezer cars equipped with refrigeration systems are used to
transport these temperature-sensitive pharmaceuticals under controlled conditions.
These cars maintain specific temperature ranges, typically between 2°C to 8°C for
refrigerated pharmaceuticals and even lower temperatures for frozen products. By
ensuring that the products remain within the recommended temperature range
throughout transit, freezer cars help prevent degradation and maintain the quality of
pharmaceuticals.

2.Soft Boxes: Soft boxes or thermal insulated containers are commonly used in
pharmaceutical logistics to protect temperature-
sensitive products during transportation. These
containers are lined with insulating materials such as
foam or reflective films that provide thermal
insulation, protecting the contents from temperature
fluctuations. Soft boxes are designed to maintain
specific temperature ranges for extended periods of 75
hours. They come in various sizes and configurations
accommodate. FIGURE7.9

169
☞ STORAGE PROCESS OF RETURN FINISHED
GOODS IN MANGALAM DRUGS AND ORGANICS
Includes various reasons for goods return, which are
● Product defects
● Price differences
● Changes in customer plans
Fluctuations in requirements.

REFUND PROCESS:
The refund process includes how customers initiate
refunds, they also observe the company's verification
process, and the timeline for refund issuance.
FIGURE7.10

☞ STORAGE PROCESS OF REJECTED FINISHED

GOODS IN MANGALAM DRUGS AND ORGANICS
In the rejected area, materials which are rejected by the company which purchase that
product, must be quarantined and stored separately away from other products to
prevent any mishap or accident. The purchase that pharmaceutical product, they
reject that product by giving a letter to our company. In which they write the reasons
why the company rejected that particular product because they did not like the color
or quality of product or any other complaint against the product. Company's QC
(Quality Control) Department identify that the product is actually rejected or not. If
the product is rejected, then it would be disposed as per government guidelines. And
if that is not rejected then it would be sell to other company except that which firstly
rejected.

170
☞ LAYOUT OF FINISHED GOODS STORAGE

FIGURE 7.11

171
 ☞ SOP FOR HANDLING AND DISPATCH ACTIVITIES
AT MANGALAM DRUGS AND ORGANICS

● OBJECTIVE:
Standard Operating Procedure (SOP) for handling dispatch activities at Mangalam
Drugs & Organics Company, ensuring efficient and systematic processes for the
timely and accurate dispatch of products.

1. DISPATCH PREPARATION:
Products are prepared for dispatch according to customer orders and delivery
schedules.

2. QUALITY CHECKS:
Prior to dispatch, products undergo thorough quality checks to ensure they meet
specified standards and regulatory requirements.

3. PACKAGING AND LABELING:

Products are appropriately packaged and labeled to facilitate identification and safe
transportation.

4. DOCUMENTATION:
Necessary documentation, including invoices, packing lists, and shipping labels, is
prepared accurately to accompany each dispatch.
172
5. LOADING AND TRANSPORT:
Dispatched products are loaded onto designated vehicles and transported to their
respective destinations.

6. COLD CHAIN MANAGEMENT:

For temperature-sensitive products, adherence to cold chain management ensures
product integrity during transportation.

7. TRACKING AND MONITORING:

Dispatch activities are tracked and monitored to provide real-time updates on the
status of shipments.

8. COMMUNICATION:
Effective communication channels are maintained with logistics partners and
customers to ensure smooth coordination and resolution of any issues that may arise
during dispatch.

● CONCLUSION:
The SOP for handling dispatch activities at Mangalam Drugs & Organics Company
ensures streamlined processes, adherence to quality standards, and timely delivery of
products to customers. By following these standardized procedures, the company
maintains customer satisfaction and upholds its reputation for reliability in the market.

173
☞ SOP FOR TEMPERATURE AND HUMIDITY
MONITORING AT MANGALAM DRUGS AND
ORGANICS

● OBJECTIVE:
Standard Operating Procedure (SOP) for monitoring temperature and humidity levels
in storage areas at Mangalam Drugs & Organics Company to maintain product quality
and integrity.

1. NORMAL FINISHED GOODS STORAGE:

● Temperature Limit: Products stored in the normal finished goods storage

area must not exceed 25°C to ensure product stability and integrity.

● Monitoring Procedure: Regular monitoring of temperature levels using

calibrated thermometers placed strategically throughout the storage area

● Action Plan: Immediate corrective action is taken if temperature levels

exceed the specified limit, including adjustment of environmental controls and
investigation into potential causes.

● Record Keeping: Maintain detailed records of temperature readings and any

corrective actions taken for regulatory compliance and quality assurance
purposes.

174
2. COLD STORAGE:

● Temperature Range: Cold storage facilities maintain temperature levels

between 2-8°C to preserve the quality of temperature-sensitive products.

● Monitoring Procedure: Continuous monitoring of temperature levels using

automated monitoring systems equipped with alarms to alert personnel of
deviations from the specified range.

● Action Plan: Prompt response to temperature deviations, including

investigation, adjustment of controls, and documentation of corrective actions
taken.

● Backup Systems: Implement backup systems or redundant monitoring

devices to ensure continuous monitoring and minimize the risk of temperature
fluctuations or equipment failure.

3. HUMIDITY MONITORING:

● Humidity Control: Depending on product requirements, humidity levels may

also be monitored to prevent moisture-related damage or degradation.

● Monitoring Procedure: Use hygrometers to measure humidity levels, with

alarms set to trigger when levels exceed specified thresholds

175
 ● Action Plan: Implement measures to regulate humidity levels, such as
dehumidifiers or desiccants, and document any corrective actions taken to
maintain optimal conditions.

4. STAFF TRAINING:

● Training Program: Conduct regular training sessions for warehouse staff on

temperature and humidity monitoring procedures, including proper use of
monitoring equipment and response protocols.

● Awareness: Foster a culture of awareness among employees regarding the

importance of temperature and humidity control in maintaining product
quality and safety.

● CONCLUSION:
The SOP for temperature and humidity monitoring at Mangalam Drugs & Organics
Company ensures the preservation of product quality and integrity through stringent
monitoring, prompt response to deviations, and continuous staff training. By adhering
to these procedures, the company upholds its commitment to delivering high-quality
products to customers while meeting regulatory requirements and industry standards.

176
CHPTER 8: QUALITY SYSTEMS
MANAGEMENT

177
8.1 INTRODUCTION TO QUALITY MANAGEMENT IN
MANGALAM DRUGS AND ORGANICS

Mangalam Drugs and Organics Limited, a prominent player in the pharmaceutical and
chemical industry, has established a robust Quality Systems Management (QSM)
framework to ensure the highest standards of product quality and regulatory
compliance. QSM at Mangalam Drugs encompasses a comprehensive set of policies,
procedures, and practices designed to manage and improve the quality of their
products and operations continuously.

Key Components of QSM at Mangalam Drugs and Organics Limited:

1. QUALITY ASSURANCE (QA)

2. QUALITY CONTROL (QC)
3. REGULATORY AFFAIRS (RA)

Mangalam Drugs and Organics Limited's

QSM is essential for maintaining high
standards of quality and regulatory
compliance in the pharmaceutical
industry.

FIGURE 8.1

178
 ● BENEFITS OF QSM AT MANGALAM DRUGS AND ORGANICS

1. CONSISTENCY IN QUALITY:
By integrating QA, QC, and RA into the QSM framework, Mangalam Drugs ensures
consistent product quality, enhancing customer trust and satisfaction.

2. REGULATORY COMPLIANCE:
The QSM framework helps in maintaining compliance with national and international
regulatory standards, reducing the risk of legal issues and market recalls.

3. OPERATIONAL EFFICIENCY:
Streamlined processes and continuous improvement initiatives contribute to
operational efficiency, reducing waste and increasing productivity.

4. RISK MANAGEMENT:
Proactive identification and mitigation of risks associated with product quality and
regulatory compliance safeguard the company's reputation and financial health.

Mangalam Drugs and Organics

Limited's commitment to quality
through its QSM framework
underscores its dedication to delivering
safe, effective, and high-quality
pharmaceutical products to the market.
By continuously refining their quality
systems, Mangalam Drugs aims to
meet and exceed industry standards
and regulatory requirements.

FIGURE 8.2

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8.2 QUALITY ASSURANCE IN MANGALAM DRUGS
AND ORGANICS

At Mangalam Drugs and Organics Limited, Quality Assurance (QA) plays a critical
role in ensuring that every product manufactured meets the highest standards of
quality, safety, and efficacy. The QA department is integral to the company's Quality
Systems Management (QSM) framework, focusing on the systematic processes that
govern the entire lifecycle of their products.

Organizational structure of quality assurance department in Mangalam drugs and

organic are as followed:

1. HEAD MANAGER
2. EXECUTIVE MANAGER
3. SENIOR OFFICER
4. OFFICER
5. SENIOR CHEMIST
6. CHEMIST

FIGURE 8.3

Quality Assurance (QA) at Mangalam Drugs and Organics Limited, like in any other
pharmaceutical company, follows a comprehensive set of guidelines to ensure high
standards of quality, safety, and regulatory compliance. These guidelines include
international standards, regulatory requirements, and best practices in the industry.

180
Here are some key guidelines that QA typically follows:

1. GOOD MANUFACTURING PRACTICES (GMP)

Good Manufacturing Practices (GMP) are a key aspect of QA, particularly in
industries like pharmaceuticals, where adherence to GMP regulations is essential for
maintaining product quality and safety throughout the manufacturing process. GMP
provides guidelines and standards for manufacturing processes, facilities, equipment,
personnel, and documentation to ensure consistency, reliability, and compliance with
regulatory requirements.

2. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ISO 13485: This standard applies to the design and manufacture of medical devices,
ensuring consistent design and production processes.

3. ICH GUIDELINES
The ICH Q7 guideline provides a comprehensive framework for Good Manufacturing
Practices (GMP) specific to the production of Active Pharmaceutical Ingredients
(APIs). This guideline ensures that APIs are consistently produced and controlled to
the quality standards appropriate for their intended use.

4. PHARMACOPEIA STANDARDS
The Indian Pharmacopoeia (IP) is a critical instrument for maintaining high standards
in the pharmaceutical industry in India. By providing comprehensive and
authoritative guidelines for the quality, safety, and efficacy of pharmaceutical
products, the IP ensures that manufacturers produce safe and effective medicines,
thereby protecting public health and supporting regulatory compliance.

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 ● KEY COMPONENTS OF QA

At Mangalam Drugs and Organics Limited, the Quality Assurance (QA) department
ensures that all processes involved in manufacturing, handling, and distributing
pharmaceuticals adhere to the highest standards of quality and regulatory compliance.
Below are the key components of QA within the company, focusing on material
management, production and in-process controls, storage and distribution, and
complaints and recalls.

1. MATERIAL MANAGEMENT
2. PRODUCTION AND IN PROCESS CONTROLS
3. STORAGE AND DISTRIBUTION
4. COMPLAINTS AND RECALLS

1. MATERIAL MANAGEMENT

● Role of QA:
Material management is crucial for ensuring that all raw materials and components
used in the manufacturing of pharmaceuticals meet predefined quality standards.
Effective material management prevents contamination, mix-ups, and quality issues.

● Key Activities:
Supplier Qualification: Rigorous evaluation and qualification of suppliers to ensure
that raw materials meet quality specifications.

Receipt and Inspection: All incoming materials are carefully inspected upon receipt.
This includes verifying the supplier's certificate of analysis (CoA) and performing
identity, purity, and quality tests

● Example at Mangalam Drugs and organics:

Mangalam Drugs ensures that all active pharmaceutical ingredients (APIs) and
excipients are sourced from qualified suppliers. Upon receipt, materials are
quarantined and tested in their quality control laboratory before being released
for production.

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2. PRODUCTION AND IN PROCESS CONTROLS

● Role in QA:
Production and in-process controls are designed to monitor and control the
manufacturing process to ensure that the final product meets quality specifications.

● Key Activities:
Standard Operating Procedures (SOPs): Detailed SOPs are developed for each
step of the production process to ensure consistency and compliance with GMP.

Process Validation: Validation of manufacturing processes to ensure they

consistently produce products meeting quality attributes

In-Process Testing: Regular sampling and testing during production to monitor

critical parameters and ensure processes remain within control limits.

Deviation Management: Any deviations from the standard process are documented,
investigated, and corrective actions are implemented to prevent recurrence.

● Example at Mangalam Drugs and organics:

During the production of APIs, Mangalam Drugs conducts in-process checks at
various stages, such as reaction monitoring, intermediate testing, and final product
evaluation, to ensure each batch meets the required quality standards before moving
to the next stage.

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3. STORAGE AND DISTRIBUTION

● Role in QA:
Proper storage and distribution practices are essential to maintain the integrity and
quality of pharmaceutical products throughout their shelf life and ensure they reach
customers in optimal condition.

● Key Activities:
Warehouse Management: Controlled storage conditions in warehouses to prevent
product degradation. This includes temperature and humidity control, and segregation
of different materials to prevent cross-contamination.

Distribution Practices: Implementing Good Distribution Practices (GDP) to ensure

products are transported in a manner that maintains their quality.

Traceability: Maintaining records of product distribution to ensure traceability and

facilitate recall if necessary.

● Example at Mangalam Drugs and Organics:

Mangalam Drugs uses climate-controlled storage facilities and follows strict protocols
during transportation to ensure that APIs and finished products are stored and shipped
under conditions that maintain their quality and efficacy.

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4. COMPLAINTS AND RECALLS

● Role in QA:
Handling customer complaints and managing product recalls are critical aspects of
QA to ensure any quality issues are promptly addressed and rectified, thereby
safeguarding patient safety and maintaining regulatory compliance.

● Key Activities:
Complaint Handling System: A robust system for logging, investigating, and
resolving customer complaints. This includes identifying the root cause and
implementing corrective and preventive actions (CAPA).

Recall Procedures: Well-defined procedures for initiating and executing a product

recall. This includes notifying regulatory authorities, customers, and effectively
removing the affected product from the market.

Continuous Improvement: Analyzing complaint and recall data to identify trends

and areas for improvement in the manufacturing and quality assurance processes.

● Example at Mangalam Drugs and Organics

If a batch of product is found to have a quality issue,
Mangalam Drugs' QA department quickly initiates a recall,
notifying all stakeholders and regulatory bodies, and
ensuring that the affected batch is traced and removed from
distribution channels. Detailed investigations are conducted
to determine the cause and implement measures to prevent
future occurrences.

FIGURE 8.4

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8.3 QUALITY CONTROL IN MANGALAM DRUGS AND
ORGANICS

Mangalam Drugs & Organics Ltd. is a prominent pharmaceutical company in India,

known for manufacturing and supplying bulk drugs and chemicals. The Quality
Control (QC) department in such companies is crucial for ensuring that products meet
the required quality standards and regulatory requirements.

● IMPORTANCE OF QUALITY CONTROL DEPARTMENT

IN MANGALAM DRUGS AND ORGANICS

Quality control is vital for maintaining product efficacy, safety, and customer trust. It
helps prevent recalls and legal issues, ensuring the company's reputation and financial
stability. For specific details about the QC processes at Mangalam Drugs & Organics,
it would be best to consult their official documents or contact their QC department
directly.

● REGULATORY COMPLIANCE
The QC department ensures compliance with various regulatory bodies such as:
1. FDA (Food and Drug Administration)
2. WHO (World Health Organization)
3. GMP (Good Manufacturing Practice)
4. ICH (International Council for Harmonization)

186
 ● KEY FUNCTIONS OF QUALITY CONTROL
DEPARTMENT
The Quality Control (QC) department in Mangalam Drugs & Organics Ltd. focuses
on ensuring that all products meet stringent quality standards and comply with
regulatory requirements.

1. RAW MATERIAL TESTING

● Identification: Confirming the identity of raw materials using methods like IR
spectroscopy.
● Purity and Potency: Assessing the purity and potency of raw materials
through techniques such as HPLC and GC.
● Quality Compliance: Ensuring raw materials meet specified quality
parameters before use in production.

2. IN-PROCESS QUALITY CONTROL

● Sampling: Regular sampling of
products during different stages of
production.
● Critical Parameters Monitoring:
Monitoring parameters such as pH,
temperature, and humidity.
● Intermediate Product Testing:
Testing semi-finished products to
ensure they meet quality criteria.

3. FINISHED PRODUCT TESTING

● Physical Testing: Assessing
physical attributes like appearance,
hardness, and dissolution rate
● Chemical Testing: Determining the
chemical composition, potency, and
impurities using techniques like
HPLC, GC, UV, and IR spectroscopy. FIGURE 8.5

187
 4. STABILITY TESTING
● Long-Term Stability Studies: Evaluating product stability under normal
storage conditions over extended periods.
● Accelerated Stability Studies: Testing product stability under stressed
conditions to predict shelf life.
● Shelf-Life Determination: Establishing expiration dates based on stability
data.

5. METHOD DEVELOPMENT AND VALIDATION

● Analytical Method Development: Creating new testing methods tailored to
specific products and requirements.
● Method Validation: Ensuring that analytical methods are reliable, accurate,
and reproducible.

6. EQUIPMENT CALIBRATION AND MAINTENANCE

● Regular Calibration: Routine calibration of instruments to maintain
accuracy.
● Maintenance: Scheduled maintenance and troubleshooting to ensure
continuous, reliable operation of all QC equipment

7. DOCUMENTATION AND COMPLIANCE

● Standard Operating Procedures (SOPs): Adhering to SOPs for all QC act
● Regulatory Compliance: Ensuring all processes comply with regulatory
requirements from bodies such as the FDA, WHO, and GMP standards.

8. TRAINING AND DEVELOPMENT

● Staff Training: Ongoing training programs to keep QC personnel updated on
the latest techniques and regulatory changes.
● Skill Assessment: Regular assessment and certification of QC staff to ensure
competence.

9. QUALITY AUDITS AND INSPECTIONS

188
Conducting regular internal audits to ensure compliance with SOPs and regulatory
requirements. Preparing for and complying with inspections from regulatory
authorities and third-party auditors.

8.4 REGULATORY AFFAIRS DEPARTMENT OF

MANGALAM DRUGS AND ORGANICS

The Regulatory Affairs Department at Mangalam Drugs and Organics Limited is

responsible for ensuring that the company's products comply with all regulatory
requirements. This includes preparing necessary documentation for technology
transfers, product development reports, and Drug Master Files (DMF) for various
regulatory markets.

The department's responsibilities also involve gathering information from different

departments to ensure that manufacturing processes and material specifications align
with submitted DMFs, and addressing any regulatory queries from customers

The Regulatory Affairs team at Mangalam Drugs is headquartered in Vapi, Gujarat,

and the department frequently recruits professionals with qualifications in B.Sc.,
M.Sc., Pharm, or Pharm, with 2-5 years of experience in the field [

Mangalam Drugs and Organics Ltd. has received multiple international certifications
and approvals for their Active Pharmaceutical Ingredients (APIs). Some of the
notable certifications and approvals include;

1. WORLD HEALTH ORGANIZATION (WHO) GENEVA:

12 PRODUCTS APPROVED
2. EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES
(EDQM):
8 PRODUCTS APPROVED
3. KOREAN MINISTRY OF FOOD AND DRUG SAFETY (MFDS):
2 PRODUCTS APPROVED
4. NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA):

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 2 PRODUCTS APPROVED

● PROCESS OF CREATING DRUG MASTER FILE

Creating a Drug Master File (DMF) at Mangalam Drugs and Organics involves
several detailed and regulated steps to ensure compliance with international standards.
Here is an overview of the process:

1. INITIAL PLANNING AND RESEARCH:

Identify the drug substance or product for which the DMF will be prepared. Conduct
thorough research and gather all necessary data on the drug's chemistry,
manufacturing process, and controls (CMC).

2. DATA COLLECTION AND DOCUMENTATION:

Collect comprehensive information from various departments, including R&D,
production, and quality control. Prepare detailed documents such as the Technology
Transfer Document, Product Scale-Up Report, and Product Development Report.

3. COMPILATION OF DMF SECTIONS:

Administrative Information: Includes contact information, list of changes, and
statement of commitment.
Drug Substance Information: Detailed description of the drug substance, including
its nomenclature, structure, and properties.
Manufacturing Information: Detailed description of the manufacturing process,
controls, and batch records.
Quality Control Information: Methods and specifications for testing the drug
substance to ensure its quality.
Stability Data: Data demonstrating the stability of the drug substance under various
conditions.

4. REGULATORY COMPLIANCE:
Ensure that all documentation complies with regulatory guidelines provided by
agencies such as the FDA, EMA, or WHO. Prepare a Drug Master File in accordance

190
with the format specified by the relevant regulatory authority (e.g., CTD format for
the FDA).

5. INTERNAL REVIEW AND VALIDATION:

Conduct a thorough internal review of the DMF to verify the accuracy and
completeness of the information. Perform validation studies to confirm that the
manufacturing process produces a consistent and high-quality product.

6. SUBMISSION AND MAINTENANCE:

Submit the DMF to the regulatory authority. This involves sending both electronic
and paper copies as required. Respond to any queries or requests for additional
information from the regulatory authorities. Maintain the DMF by updating it with
any changes in manufacturing processes, control methods, or product specifications.

7. POST-SUBMISSION
RESPONSIBILITIES:
Ensure that any changes to the drug substance or
manufacturing process are documented and
submitted as amendments to the DMF.Address any
regulatory queries promptly and maintain ongoing
communication with regulatory bodies. For a
specific example, Mangalam Drugs prepares DMFs
for various products, such as anti-malarial and anti-
retroviral APIs, ensuring they meet stringent
international standards.

FIGURE 8.6

191
CHAPTER 9: ENVIRONMENT,
HEALTH AND SAFETY
DEPARTMENT

192
9.1 INTRODUCTION OF EHS DEPARTMENT IN
MANGALAM DRUGS AND ORGANICS

The Environment, Health, and Safety (EHS) department of a company like Mangalam
Drugs and Organic Limited would typically be responsible for ensuring the company
complies with environmental regulations, promotes workplace health, and maintains
safety standards. Environmental, Health, and Safety (EHS) are critical components in
the operations of any industrial organization, especially in the pharmaceutical sector.

● EHS POLICY IN MANGALAM DRUGS AND ORGANICS

Mangalam Drugs & Organics Ltd., a prominent player in the pharmaceutical industry,
has a robust EHS policy to ensure sustainable and safe operations. The key elements
of their EHS policy include:

1. Commitment to Compliance: Adhering to all relevant environmental, health,

and safety regulations and standards.
2. Risk Management: The Identification, evaluation, and controlling risks
associated with their operations to prevent accidents and environmental harm.
3. Continuous Improvement: It regularly reviews and improves EHS practices
to enhance performance.
4. Employee Training and Awareness: It provides ongoing education and
training to employees on EHS issues, practices, and responsibilities.
5. Pollution Prevention: The implementing measures to minimize emissions,
waste, and the use of hazardous materials.
6. Resource Conservation: It promotes efficient use of resources, including
energy and water, to reduce environmental footprint.

193
9.2 ENVIRONMENT COMPONENT
The Environment Department within a company like
Mangalam Drugs and Organic Limited focuses on
managing and mitigating the environmental impact
of the company’s operations. The Environment
Department of Mangalam Drugs and Organic
Limited would typically manage various types of
waste to ensure environmental compliance and
sustainability.
Here are three types of waste, along with how
liquid, solid, and gaseous wastes are typically
managed:

FIGURE 9.1

1. HAZARDOUS WASTE
● SOLID MANAGEMENT: Proper labeling, storage in designated hazardous
waste containers, and disposal through certified hazardous waste disposal
services.
● EXAMPLES: Chemical containers, contaminated PPE, and expired or off-
spec chemicals.

● LIQUID MANAGEMENT: Collection in specially designed containment

systems, treatment through neutralization or other chemical processes, and
disposal by licensed hazardous waste disposal companies.
● EXAMPLES: Spent solvents, waste oils, and process effluents

194
 ● GASEOUS MANAGEMENT: Use of scrubbers, filters, or activated carbon
systems to capture and neutralize harmful emissions before release into the
atmosphere.
● EXAMPLES: Volatile organic compounds (VOCs), acid gases, and other
toxic emissions.

2. NON-HAZARDOUS WASTE
● SOLID MANAGEMENT: Segregation at the source, recycling where
possible, and disposal at sanitary landfills.
● EXAMPLES: Packaging materials, office waste, and non-contaminated
laboratory waste.

● LIQUID MANAGEMENT: Treatment in wastewater treatment plants to

meet regulatory standards before discharge into municipal sewer systems.
● EXAMPLES: Wash water, cooling tower blowdown, and non-contaminated
process water.

● GASEOUS MANAGEMENT: Venting through appropriate systems to

ensure minimal environmental impact and compliance with air quality
standards.
● EXAMPLES: Steam, CO2, and non-toxic process gases.

3. RECYCLABLE WASTE
● SOLID MANAGEMENT: Collection, segregation, and sending to recycling
facilities for materials like paper, cardboard, metals, and certain plastics.
● EXAMPLES: Paper, cardboard, metal scraps, and plastic containers.

● LIQUID MANAGEMENT: Treatment and recovery processes to reclaim usable

components, such as solvents, which can be purified and reused
● EXAMPLES: Used solvents and process water that can be treated and reused.

● GASEOUS MANAGEMENT: Capture and purification systems to recover and

reuse gases where feasible.

195
● EXAMPLES: CO2 capture for reuse in manufacturing processes.

● GENERAL MANAGEMENT PRACTICES

1. MONITORING AND REPORTING:

Regular monitoring of waste streams, maintaining accurate records, and reporting to
regulatory authorities.

2. EMPLOYEE TRAINING:
Training staff on proper waste segregation, handling, and disposal practices.

3. EMERGENCY PREPAREDNESS:
Having contingency plans and spill response measures in place to handle accidental
releases of hazardous materials.

● BENEFITS

1. REGULATORY COMPLIANCE:
Avoiding fines and legal issues through adherence to environmental laws.

2. COST SAVINGS:
Reducing waste and improving efficiency can lead to significant cost savings.

3. BRAND REPUTATION:

196
 Demonstrating a commitment to the environment can enhance the company’s
reputation and appeal to environmentally conscious consumers and investors.

9.3 HEALTH COMPONENT

The Health Department of Mangalam Drugs and Organic Limited would be primarily
focused on ensuring the health and well-being of employees, compliance with health
regulations, and the promotion of a safe and healthy workplace. Here are the key
responsibilities and activities typically managed by such a department:

1. HEALTH RISK ASSESSMENTS:

Identifying potential health hazards in the work-place Conducting assessments to
evaluate the risk level and implementing control measures

2. MEDICAL EXAMINATIONS:
Organizing pre-employment and periodic medical examinations. Monitoring
employees' health to ensure fitness for their roles.

3. WELLNESS PROGRAMS:
Initiating programs focused on fitness, nutrition, stress management, and mental
health. Offering resources such as counseling services, health workshops, and fitness
challenges.

4. HEALTH AND SAFETY TRAINING:

Providing training on the proper use of personal protective equipment (PPE).
Educating employees on hygiene practices, emergency procedures, and first aid.

5. VACCINATION AND IMMUNIZATION:

197
Facilitating vaccination programs for diseases such as influenza, hepatitis, and
COVID-19. Keeping records of employee immunizations.

6. HYGIENE AND SANITATION:

Ensuring high standards of hygiene and sanitation in the workplace. Implementing
cleaning protocols and providing sanitation facilities.

7. MONITORING WORKPLACE CONDITIONS:

Regularly inspecting and monitoring workplace conditions to ensure they are safe and
healthy. Addressing any issues that
could impact employee health, such
as poor air quality or noise levels

8.Mental Health Support:

Providing support for mental health
issues through employee assistance
programs (EAPs). Promoting a
culture that supports mental well-
being and reduces stigma around
mental health.

FIGURE 9.2

198
 ● BENEFITS
1. IMPROVED EMPLOYEE WELL-BEING:
Healthier employees are more productive, have higher morale, and are less likely to
take sick leave.

2. REGULATORY COMPLIANCE:
Adhering to health regulations helps avoid legal issues and potential finds.

3. ENHANCED WORKPLACE SAFETY:

A focus on health contributes to a safer work environment, reducing the likelihood of
accidents and injuries.

4. ATTRACTION AND RETENTION

Companies that prioritize employee health are more attractive to potential hires and
retain existing employees more effectively.

The Health Department at Mangalam

Drugs and Organic Limited would play a
crucial role in maintaining and
promoting the health and well-being of
all employees, ensuring compliance with
health regulations, and fostering a safe
and supportive workplace environment.

199
For specific initiatives and programs, referring to the company's official health and
safety policies or annual reports would provide detailed information

FIGURE 9.3

9.4 SAFETY COMPONENT

● FIRE EXTINGUISHER
In Mangalam drugs and organic
company 282 fire-extinguisher are
available.
Fire extinguishers are suitable for different
types of fires e.g., Class A, B, C, or D. It's
crucial to have the appropriate
extinguishers for the types of fires that
could occur in the facility.
Employees are trained in the proper use of
fire extinguishers, including when
and how to use. FIGURE 9.4

● WORKMEN COMPENSATION POLICY

The workers' compensation policy in Mangalam Drugs and Organic Company would
likely cover employees for injuries or illnesses sustained while performing their job
duties. This policy typically provides benefits such as medical expenses, lost wages,
rehabilitation costs, and disability benefits to employees who suffer work-related
injuries or illnesses.

Specific details of the workers' compensation policy, including coverage limits,

eligibility criteria, claims process, and procedures for reporting injuries, would be
outlined in the company's policy documentation. It's essential for employees to be
familiar with these details and to report any work-related injuries promptly to ensure
they receive the necessary benefits and support.

200
 ● PPE KIT

Personal Protective Equipment (PPE) in Mangalam Drugs and Organic Company

would likely be provided to employees to ensure their safety while performing their
job duties. The specific types of PPE required would depend on the nature of the work
being performed and the potential hazards present in the workplace

201
 FIGURE 9.5

● PRACTICAL TRAINING

We were given practical training

regarding how to use fire extinguisher
and what are the contents of the fire
extinguisher.
Which type of fire extinguisher can be
used in different situations.
They were kind enough to make to
allow us to use one of the fire-
extinguisher for our trial.
We also participate in their
emergency training programmer.

FIGURE 9.6

202
 BIBILOGRAPHY

https://www.mangalamdrugs.com/

203
CONCLUSION FOR MANGALAM DRUGS AND
ORGANICS

CHAPTER 1: GENERAL INFORMATION

Mangalam Drugs and Organic Ltd. is a prominent player in the pharmaceutical and
organic compounds industry. The company is known for its commitment to quality
and sustainability. This chapter has provided an overview of the company's history,
mission, vision, and core values, setting the stage for a deeper understanding of its
various departments and their roles in achieving the company's objectives.

CHAPTER 2: PRODUCTION DEPARTMENT

The production department is the backbone of Mangalam Drugs and Organic Ltd.
This chapter has detailed the processes and technologies employed in manufacturing
high-quality pharmaceutical products. The department's focus on efficiency,
innovation, and adherence to stringent quality standards ensures that the company
remains competitive and meets the demands of its customers.

CHAPTER 3: MARKETING DEPARTMENT

The marketing and sales team has successfully penetrated various markets, both
domestic and international. Their strategic marketing campaigns and customer-centric
approach have significantly contributed to the company's revenue growth.

CHAPTER 4: ACCOUNTING DEPARTMENT

The accounting department plays a crucial role in maintaining the financial health of
the company. This chapter has highlighted the department's responsibilities, including
financial reporting, budgeting, and compliance with regulatory requirements.

204
CHAPTER 5: HUMAN RESOURCE DEPARTMENT

The human resource department is dedicated to managing the company’s most

valuable asset – its employees. This chapter has discussed the various HR functions,
such as recruitment, training, performance management, and employee welfare. A
well-managed HR department ensures a motivated and skilled workforce,
contributing to the overall success of the company.

CHAPTER 6: PURCHASE DEPARTMENT

The purchase department is responsible for sourcing raw materials and other
essentials required for production. This chapter has examined the procurement
processes, supplier relationships, and inventory management strategies. Effective
purchasing practices are vital for cost control and maintaining a steady supply chain.

CHAPTER 7: WAREHOUSING DEPARTMENT

The warehousing department ensures the safe and efficient storage of raw materials,
intermediates, and finished products. This chapter has covered the logistics, inventory
management, and distribution mechanisms in place. Proper warehousing practices
help in minimizing losses, optimizing space, and ensuring timely deliveries.

CHAPTER 8: QUALITY SYSTEM MANAGEMENT

Quality system management is integral to maintaining the high standards for which
Mangalam Drugs and Organic Ltd. is known. This chapter has outlined the quality
assurance protocols, regulatory compliance, and continuous improvement initiatives.
A robust quality management system is crucial for customer satisfaction and
regulatory adherence.

CHAPTER 9: ENVIRONMENT, HEALTH, AND SAFETY

DEPARTMENT:

205
The environment, health, and safety (EHS) department ensure that the company’s
operations are sustainable and safe. This chapter has detailed the EHS policies, risk
management, and safety training programs. Commitment to EHS not only protects the
workforce and environment but also enhances the company’s reputation as a
responsible corporate entity.

OVERALL CONCLUSION

Mangalam Drugs and Organic Ltd. is a well-rounded organization with dedicated

departments working in unison to achieve its strategic goals. Each department plays a
vital role in ensuring the company’s success, from production and procurement to
quality management and environmental safety. By maintaining high standards and
fostering a culture of continuous improvement, Mangalam Drugs and Organic Ltd. is
well-positioned for sustained growth and industry leadership.

206
 LIMITATIONS

There were some barriers that we faced, like

1. As this organization is based on the raw material production of medicines, they
don't have marketing department
2. Company didn't provide us with the names of any suppliers and distributors due
to their policy of secrecy.
3. The company has rule and regulation of not carrying any form of devices in the
company premises. Therefore, there are no live photos in our project.

FINDING

1. We found that there were no cases of accidents.

2. We also found that they are more quality oriented.
3. The plant layout is in well-mannered hence there is very less wastage

LEARNING

In a nutshell, this internship has been an excellent and rewarding experience. We can
conclude that there have been a lot we’ve learnt from my work in this organization.
We believe our time spent in research and discovering it was well worth it and
contributed to finding an acceptable solution to build a fully functional System.
Two main things that we’ve learned is the importance of time-management skills and
self-motivation.

207