Ich ppt

Presented by-
Mukul Sunil Tambe.
M. Pharm Sem. II
Pharmacology
Roll no. 8Tuesday, October 10, 2017 1

CONTENTS:
1. • INTRODUCTION
2. •HARMONIZATION EFFORTS
3. •BASIC PRINCIPLES
4. •Q 11 GUIDELINE
5. •CTD
6. •REFERENCES
2Tuesday, October 10, 2017

INTRODUCTION
International Conference on Harmonization of
Technical Requirements for Registration of
Pharmaceuticals for Human Use.
Agreement between Europe, Japan and US regulatory
Authorities.
Joint initiative involving both Regulators and Industry
as equal partners.
Main focus on Technical Requirements for medicinal
products containing new drugs.
Tuesday, October 10, 2017 3
Ref.: Forensic Pharmacy by B.S. Kuchekar
Pg. No. 16.16 – 16.25

Establishment of ICH
• The International
Conference on
Harmonization of Technical
Requirements for the
Registration of
Pharmaceuticals for Human
Use (ICH) was established
in 1990 as a tripartite
venture representing
regulatory bodies and
research-based industry.
Ref.:
http://apps.who.int/medicinedocs/en/d
/Jh2993e/4.html

INTRODUCTION (Contd.)
 Achieve greater harmonization
in interpretation and
application of Technical
guidelines.
 More economical use of
Human, Animal and Material
Sources.
 Elimination of unnecessary
delay in global development.
 Availability of safe, quality and
efficacious new medicines.
 Promote patient health.
Tuesday, October 10, 2017 5Ref.: Forensic Pharmacy by B.S. Kuchekar

MISSION
Make recommendations towards
achieving greater harmonization
in Interpretation and Application
of Technical Guidelines and
Requirements for
Pharmaceutical Product
Registration.
Ref.:
https://www.slideshare.net/naveenniper
/ich-guidelines-12769383

ICH Organizational Structure
The ICH structure consists of the
• ICH Steering Committee
• Global Cooperation Group (GCG)
• ICH MedDRA Management Board
• ICH Coordinators,
• ICH Secretariat and
• ICH Working Groups.
Tuesday, October 10, 2017
Ref.:
https://www.slideshare.net/mdgayas70/
ich-guidelines-seminar
7

Global Cooperation Group
(GCG)
• The ICH Global Cooperation Group (GCG)
was formed on March 11, 1999, as a
subcommittee of the ICH Steering Committee.
• It is made up of one representative from each
of the six parties on the ICH Steering
Committee, plus the IFPMA.
• The ICH Observers, WHO, Canada and EFTA
are also part of the GCG.
Ref.:
8

ICH parties
• EU
• EFPIA (European federation of pharmaceutical industries’ associations)
• MHLW (Ministry of health, Labor and welfare, Japan)
• JPMA (Japan Pharmaceuticals manufacturers Association)
• US FDA
• PhRMA (The Pharmaceutical Research and Manufacturers of America)
• Observers : WHO, TPP(Canada)
• International Federation of Pharmaceutical
Manufacturer’s Association
6 Parties of ICH
Ref.:
9

1. •INTRODUCTION
2. • HARMONIZATION EFFORTS
5. •CTD
6. •REFERENCES

INTERNATIONAL
HARMONIZATION:
The process of standardizing laws, regulations and
practices to facilitate the expansion, fairness and
efficiencies of competing in globalized economy.

INNOVATION
SCIENCE

HARMONIZATION EFFORTS
ICH 2009-2010
1st ICH Guideline on Gene Therapy
Progress on interface between ICH and Standards
Development Organization.
Expansion of Global Cooperation Group
Global Harmonization Task Force
Efforts to harmonize medical device regulatory
requirements and terminology
Asia Pacific Economic Cooperation
 Life Science Innovation Forum 2009
Pharmaceutical Inspection Cooperation Scheme
Ref.:
https://www.slideshare.net/NailaKanwal
/harmonization-and-its-impact-theme2

Positive impacts of Harmonization
Established a set of standards
for the manufacturing
processes of new drugs.
Agree on one set of scientific
rules to running clinical trials.
Reducing Expenses (In terms
of Research animals and
human testing).
Faster Approvals
Harmonized documentation.
Ensured similar application
process for drug approval in
all countries.
Ensured that research
findings from one member
country will be accepted by
all other countries (With
some exceptions)
Provision of quality drugs
with Efficacy.
Ref.:

Drawbacks of Harmonization
Public accountability is missing.
Reduced the safety tests with
respect to trials
Potentially weaken the public
health.
Limit Competition.
Raised the cost of medicine.
Threatened the production of
inexpensive generic drugs.Tuesday, October 10, 2017 15
Ref.:

1. •INTRODUCTION
3. • BASIC PRINCIPLES
5. •CTD
6. •REFERENCES

BASIC PRINCIPLES

Ref.:

SAFETY GUIDELINES
• S1A – S1C:
CARCINOGENICITY
STUDIES
• S2: GENOTOXICITY
STUDIES
• S3A – S3B:
TOXICOKINETICS &
PHARMACOKINETICS
• S4: TOXICITY TESTING
• S5: REPRODUCTIVE
TOXICOLOGY
• S6: BIOTECHNOLOGICAL
PRODUCTS
• S7A – S7B:
PHARMACOLOGY STUDIES
• S8: IMMUNITOXICOLOGY
STUDIES
• S9: NON CLINICAL
EVALUATION FOR
ANTICANCER
PHARMACEUTICALS
• S10: PHOTOSAFETY
EVALUATION
• S11: NONCLINICAL
SAFETY TESTING
Ref.:
http://www.ich.org/products/guidelines
/safety/article/safety-guidelines.html

EFFICACY GUIDELINES
• E1: CLINICAL SAFETY FOR
DRUGS USED IN LONG-
TERM TREATMENT
• E2A – E2F:
PHARMACOVIGILANCE
• E3: CLINICAL STUDY
REPORTS
• E4: DOSE RESPONSE
STUDIES
• E5: ETHNIC FACTORS IN
THE ACCEPTABILITY OF
FOREIGN CLINICAL DATA
• E6: GOOD CLINICAL
PRACTICE
• E7: CLINICAL TRIALS IN
GERIATRIC POPULATION
• E8: GENERAL
CONSIDEARTIONS FOR
CLINICAL TRIALS
• E9: STATISTICAL
PRINCIPLES FOR CLINICAL
TRIALS
• E10: CHOICE OF CONTROL
GROUP IN CLINICAL
TRIALS
• E11: CLINICAL TRIALS IN
PEDIATRIC POPULATION
Ref.:
/efficacy/article/efficacy-guidelines.html

EFFICACY GUIDELINES
(CONTD.)
• E12: CLINICAL
EVALUATION BY
THERAPEUTIC
CATEGORY
• E14: CLINICAL
EVALUATION OF QT
• E15: DEFINITIONS IN
PHARMCOGENETICS /
PHARMACOGENOMICS
• E16: QUALIFICTION OF
GENOMIC BIOMARKERS
• E17: MULTI-REGIONAL
CLINICAL TRIALS
• E18: GENOMIC
SAMPLING
Ref.:
/efficacy/article/efficacy-guidelines.html

MULTIDISCIPLINARY
• M7: GENOTOXIC
IMPURITIES
• M8: eCTD
• M9:
BIOPHARMACEUTICS
CLASSIFICATION
SYSTEM-BASED
BIOWAIVERS
• M10: BIOANALYTICAL
METHOD VALIDATION
• M1: MEDDRA
TERMINOLOGY
• M2: ELECTRONIC
STANDARDS
• M3: NONCLINICAL
SAFETY STUDIES
• M4: CTD
• M5: DATA ELEMENTS
ANDSTANDARDS FOR
DRUG DICTIONARIES
• M6: GENE THERAPY
Ref.:
/multidisciplinary/article/multidisciplin

QUALITY GUIDELINES
• Q1A – Q1F: STABILITY
• Q2: ANALYTICAL
VALIDATION
• Q3A – Q3D:
IMPURITIES
• Q4A – Q4B:
PHARMACOPOEIAS
• Q5A – Q5E: QUALITY
OF
BIOTECHNOLOGICAL
PRODUCTS
• Q6A – Q6B:
SPECIFICATIONS
• Q7: G.M.P.
• Q8: PHARMACEUTICAL
DEVELOPMENT
• Q9: QUALITY RISK
MANAGEMENT
• Q10:
PHARMACEUTICAL
QUALITY SYSTEM
• Q11: DEVELOPMENT
AND MANUFACTURE OF
DRUG SUBSTANCES
• Q12: LIFECYCLE
MANAGEMENT
Ref.:
/quality/article/quality-guidelines.html

1. •INTRODUCTION
4. • Q 11 GUIDELINE
5. •CTD
6. •REFERENCES

 Issued in Nov. 2012
 Development and Manufacture of Drug Substances
Quality Principles for Manufacturing Process
Development:
1. Drug-substance quality linked to drug product
2. Process-development tools
3. Approaches to development
4. Drug-substance CQAs
5. Linking material attributes and process parameters to drug
substance CQAs
6. Design space Ref.:
http://www.pharmtech.com/understand
ing-ich-q11-fdas-guidance-development-

DOCUMENTATION REQUIRED:
 An overall summary of the development process including: CQAs;
description of design stages; description of material attributes;
description of process parameters; and description and
development of design spaces should be provided.
 CQAs of the drug substance shall be listed.
 A detailed discussion of the manufacturing process history needs to
be provided.
 Manufacturing development studies, including risk assessments
employed in support of commercial development, including the
control strategy, must be provided.
(CONTD.)
Ref.:

DESCRIPTION OF PROCESS & PROCESS
CONTROL EMPLYOED IN MANUFACTURING:
 Material-selection process
 Selection of starting materials for synthetic drug
substances
 Selection of starting materials for semisynthetic drug
substances
 The selection of source and starting materials for
biotechnical/biological drug substances
(CONTD.)
Ref.:

DESCRIPTION OF PROCESS & PROCESS
CONTROL EMPLYOED IN MANUFACTURING:
(CONTD.)
Control strategy:
 Controls employed for raw
materials
 Controls associated with
the design manufacturing
process
 In-process controls (i.e.,
testing and process control
points)
 Controls placed on the drug
substance (e.g., release
testing)
 Submission of relevant
information:
 Description of manufacturing-
process controls
 Controls employed for
materials
 Controls for identified critical
process steps
 Controls for the drug substance
 Container closure systemsRef.:

 PROCESS VALIDATION:
 EMPLOYMENT OF CTD FORMAT FOR INFORMATION
SUBMISSION:
 LIFECYCLE MANAGEMENT:
 Process-development activities
 Technology-transfer activities
 Process-validation studies
 Change-management activities
(CONTD.)
Ref.:

1. •INTRODUCTION
5. • CTD
6. •REFERENCES

COMMON TECHNICAL
DOCUMENT
• M4 GUDELINE (July 2003)
• The agreement to assemble all the Quality, Safety
and Efficacy information in a common format
• Organized into 5 modules
• Module 1 is region specific and Modules 2, 3, 4
and 5 are intended to be common for all regions
Ref.:
http://www.ich.org/products/ctd.html

1. •INTRODUCTION
5. •CTD
6. • REFERENCES

REFERENCES
1. Forensic Pharmacy by Dr. B. S. Kuchekar, A. M. Kadtare
and Sachin Itkar, Nirali Prakashan, Page no. 16.16 –
16.25
2. https://www.slideshare.net/naveenniper/ich-
guidelines-12769383
3. http://slideplayer.com/slide/4789228/
4. https://www.slideshare.net/NailaKanwal/harmoniza
tion-and-its-impact-theme2
5. https://www.slideshare.net/bharathpharmacist/ich-
guidelines-39685947
6. http://www.ich.org/products/guidelines/
7. ICH Q 11 Step 4 GuidelinesTuesday, October 10, 2017 34

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