MATERIALS-MANAGEMENT-_Khadiah-Ade-Abolade.ppt

MATERIALS MANAGEMENT
KHADIJAH ADE-ABOLADE MPH. FPCPharm.
Chief Regulatory Officer/Lead Inspector
Drug Evaluation & Research
NAFDAC

OBJECTIVES
• To discuss the requirements for materials
management in pharmaceutical
manufacturing
• Highlight specific requirements for the
different types of materials in
pharmaceutical manufacturing

OUTLINE
• Types of pharmaceutical materials
• General requirements for materials
management
• Specific requirements for the different types
of materials
• Conclusion

TYPES OF PHARMACEUTICAL
MATERIALS
• Starting materials
• Packaging materials
• Intermediate and bulk products
• Finished products
• Rejected materials
• Recalled products
• Returned goods
• Reagents and culture media
• Reference standards
• Waste materials
• Miscellaneous materials

PERSONNEL
• Personnel performing work affecting the material or
product quality, including third parties, should have
an adequate combination of training, education, and
experience to carry out that work.
• Personnel dealing with hazardous materials should
be given specific training and should be provided
with the necessary protective equipment.

PERSONNEL
• Wear clean protective
apparel to protect
materials and products
from contamination by
personnel activities
• Personnel dealing with
hazardous materials
should be given specific
training and should be
provided with the
necessary protective
equipment.

SOURCING
• Purchasing
Not an administrative activity
Staff responsible for purchasing of materials, have
sufficient knowledge of the materials, products and
their suppliers
To ensure that the correct materials are supplied,
purchase materials direct from the API manufacturer
or reputable suppliers

SOURCING
• Supplier Qualification
A system that assures that a supplier’s product
is produced under controlled conditions,
resulting in consistent quality conformance.
Based on the principle of defect prevention,
rather than defect detection and inspection
QC and other relevant departments should
evaluate and approve suppliers based on their
history, nature of the materials and ability of the
suppliers to meet established specifications

SOURCING
• Supplier Qualification
Audit of the supplier’s manufacturing facility,
where possible or by proxy.
Confirm the quality systems in place at the
supplier end meet GMP
Establish that material quality will meet your
quality speciﬁcations
Capacity to meet your production needs
Where a material may be supplied from more
than one plant of the supplier, each plant must
be treated as a separate entity for certiﬁcation
purposes.

SOURCING
• Transportation and Materials in Transit
Pharmaceutical starting materials should be
transported in accordance with procedures such
that:
The identity of the product is not lost.
The product does not contaminate and is not
contaminated by other products.
Adequate precautions are taken against spillage,
breakage, misappropriation and theft.
Appropriate environmental & storage conditions
are maintained.

SOURCING
• Transportation and Materials in Transit
 Transportation of materials containing
hazardous substances in safe, suitably
designed, secured containers and vehicles.
 Immediate cleaning of spillages according to
written procedures to prevent possible
contamination, cross-contamination and
hazards.
 Damage to containers and any other event or
problem that occurs during transit must be
recorded and reported

RECEIPT
• Receiving and dispatch bays
Materials and products should be protected from
weather during loading and offloading.
An area to clean incoming materials and containers
should be provided.
The SOP for receiving materials is an important
SOP.
Ensure that the correct materials are received from
the correct supplier in the correct quantity and other
relative quality parameters

RECEIPT
• Consignment Checks
Each consignment of materials should be
accompanied by the manufacturer’s COA of the
batch and the MSDS of the material
Note that the supplier’s COA may be accepted
provided the FPP manufacturer has established the
reliability of the supplier’s analysis through
appropriate periodic validation of the supplier’s
results and on-site audits of supplier’s facilities.
The COA must be original or authenticity should be
assured

RECEIPT
Inspection for possible
contamination,
tampering and damage,
and any suspect
containers or, if
necessary, the entire
delivery should be
quarantined for further
investigation.

RECEIPT
Cleaning of all containers before taking into the
premises, proper labelling with relevant information
(e.g. status, name of the material, reference code
etc.).
 Where additional labels are attached to the
containers, the original information should not be
lost e.g. expiry dates

STORAGE
• Materials should be handled and stored in a manner
as to prevent degradation, contamination and cross-
contamination
• Appropriate temperature and relative humidity
conditions within defined limits provided, controlled,
monitored and recorded
• Materials should be stored on pallets or racks to
facilitate cleaning, inspections, and pest trap
placement.
• Orderly manner using proper materials management
principles and stock rotation (FEFO)

STORAGE
ON THE LABEL MEANS
“Do not store over 30 °C” from+2°Cto+30°C
“Do not store over 8°C” from+2°Cto+8°C
“Do not store below 8 °C” from+8°Cto+25°C
“Protect from moisture” no more than 60% relative humidity in normal
storage conditions; to be provided to the
patient in a moisture-resistant container.
“Protect from light” to be provided to the patient in a light-
resistant container.

STORAGE
• Integrated pest management and control programs
which should typically involve a combination of both
chemical and non-chemical prevention and control
techniques.
• Rodents can usually be controlled by the placement
of baitless traps; the use of poison bait is not
acceptable in a pharmaceutical establishment.
• Insects are frequently eliminated by the use of
electric exterminators, whereas birds may be
trapped

STORAGE
• Storage Areas
• Sufficient capacity to allow the orderly storage of the
various categories of materials
• Designed to ensure good storage conditions, they
should be clean and dry and maintained within
acceptable temperature limits
• Required special storage conditions should be
provided, checked, monitored and recorded
• Adequate ventilation, air filtration, air heating and
cooling, exhaust system shall be provided within the
storage areas

STORAGE
• Storage Areas
• Any system replacing physical quarantine should
provide equivalent security
• Physical or other equivalent validated (e.g.
electronic) segregation should be provided for the
storage of rejected, expired, recalled or returned
materials or products
• Rejected materials and products should be identified
and controlled under a quarantine system designed
to prevent their use until a final decision is taken on
their fate.

STORAGE
• Storage Areas
• Highly active and radioactive materials, narcotics
and other hazardous, sensitive and/or dangerous
materials and pharmaceutical products, as well as
substances presenting special risks of abuse, fire or
explosion, (e.g. combustible liquids and solids and
pressurized gases) should be stored in a dedicated
area that is subject to appropriate additional safety
and security measures.

QUALITY CONTROL
Sampling
• There should be a separate sampling area for
starting materials in a controlled environment
• Sampling facilities should be designed to:
Prevent contamination of the opened container and
the materials;
Prevent cross-contamination by other materials,
products and the environment and;
Protect the sampler and the material during the
sampling procedure.

QUALITY CONTROL
Sampling
• Possibility that containers of starting materials may
be incorrectly labeled, steps to ensure that only the
correct materials are used.
• ID testing the contents of each container can
provide the necessary assurance to check
mislabeling of the containers and therefore mix-ups
• Partial mislabelling of a delivery represents a greater
potential hazard than a complete mislabelling of all
the containers in a delivery

QUALITY CONTROL
Sampling
• The containers from which samples were taken for
analysis, should be identified and carefully sealed
after sampling.
• Samplers should be adequately trained and
knowledgeable in the practical aspects of sampling
and should record details of any signs of
contamination, deterioration or tampering in the
sampling record.
• Sampling tools and implements should be made of
inert materials and kept scrupulously clean.

QUALITY CONTROL
Sampling
• Sampling Plan- must ensure that a representative
sample of the batch is taken and consider the
criticality and variability of the material, past quality
history of the supplier and the quantity needed for
analysis.
• Sampling plans are not recommended for sampling
of APIs for identiﬁcation tests

QUALITY CONTROL
Sampling
• Sampling Plan- Examples
The “n” plan- when the material is considered
uniform and is supplied from a recognized source. n
= 1 + √N
The “p” plan- when the material is uniform, is
received from a recognized source and the main
purpose is to test for identity. p = 0.4 √N
The “r” plan- when the material is suspected to be
non-uniform and/or is received from a source that is
not well known. r = 1.5 √N
• N = number of containers in consignment

QUALITY CONTROL
Testing
• There should be specifications for materials and
products.
• Specifications and standard test methods in
pharmacopoeias or suitably developed
specifications or test methods
• The tests to be performed should be described in
the documentation on standard test methods.
• Only starting materials released by the responsible
officer in QC and within their shelf-life should be
used in manufacturing

QUALITY CONTROL
Retention Samples
For potential future evaluation of the quality of
batches of materials and products and not for future
stability testing.
Appropriately identified, representative of each
batch of material/product shall be retained.
Enough to conduct at least 2 comprehensive
analyses
Stored in the same immediate container-closure
system in which the material/product is marketed or
in one that has essentially the same characteristics.
Retained for 1 year after the expiration date of the
materials/products

GENERAL REQUIREMENTS
• All incoming materials and finished products
quarantined after receipt or processing
until released for use or distribution
stored
 under appropriate conditions
 orderly fashion (batch segregation)
 materials management
 stock rotation (FEFO)
• Materials for cleaning, lubrication, and pest control
 Not in direct contact with product
 Suitable grade, e.g. food grade

STARTING MATERIALS
• APIs & Excipients
• Purchasing – important operation
• From approved suppliers – if possible, direct from
the manufacturer
• Specifications for materials
• Consignment checks
 Integrity of package
 Seal intact
 Corresponds with the purchase order
 Delivery note
 Supplier’s labels
• Cleaned and labelled with information

STARTING MATERIALS
• Different batches in one delivery/consignment
• Starting materials labelled
 Name and internal code
 Supplier's batch number(s) and
manufacturer's on receipt
 Status (e.g. quarantine, on test, etc.)
 Expiry date or retest date
• Role of validated computer systems
• Sampled" containers identified

STARTING MATERIALS
• Use only QC released material if within shelf-life
• Dispensing
 Designated persons
 Written procedure
 Correct materials accurately weighed
 Clean, properly labelled containers
• Independent checks and record
 Material and weight or volume
• Dispensed material
 Kept together and labelled

PACKAGING MATERIALS
Primary and printed packaging materials
 Purchasing, handling and control
 as for starting materials
Printed packaging materials: particular attention
 Stored in secure conditions with authorized access
 Roll labels where possible in place of cut labels
 Loose materials stored and transported in separate,
closed containers - to avoid mix-ups
 Issued by designated personnel
 SOP for issue and returns

PACKAGING MATERIALS
Primary and printed packaging materials
• Each delivery or batch: specific reference number or
identification mark
• Delivery to packaging department
 Check quantity, identity and conformity to
packaging instructions
• Outdated or obsolete material
• Printed packaging materials: particular attention
 Destroyed
 Disposal records

INTERMEDIATE AND BULK
PRODUCTS
• Kept under appropriate
conditions
• If purchased as such
 Handled on receipt
as though these are
starting materials

Finished products
• Held in quarantine until
their final release
• Then stored as usable
stock under suitable
storage conditions
• Evaluation and
documentation necessary
for release
 Product release
procedure
 Batch record review
and related procedure

REJECTED MATERIALS
• Should be identified and controlled under a
quarantine system designed to prevent
inadvertent use in manufacturing.
• The Agency should be notified of decision to
destroy or return to supplier.
• Disposal should be in accordance with approved
procedures and environmental regulations

REPROCESSED AND
REWORKED MATERIALS
• A pharmaceutical product may be reprocessed
provided the subsequent meets appropriate
standards, specifications & characteristics.
• QC should consider additional testing of
reprocessed products.
• Rework of finished pharmaceutical products IS
NOT PERMITTED

RECALLED PRODUCTS
• Recalled products
 Identified
 Stored separately
 Secure area - access controlled
 Decision taken on their fate

RETURNED GOODS
• Returned goods
 Destroyed unless suitable quality
 SOP: decision regarding their fate (relabelling,
resale, etc.)
 Consider: nature of product, special storage
conditions, condition, history, time elapsed
since issue
 Action taken to be recorded

REAGENTS AND CULTURE
MEDIA
• Records of receipt or preparation
• Reagents
 Preparation in accordance with SOP
 Appropriately labelled:
 Concentration, standardization factor, shelf-life, re-
standardization due date, storage conditions
 Signed and dated
• Culture media
 Positive and negative controls each time prepared
and used
 Inoculum size appropriate

REFERENCE STANDARDS
• Official/Primary Reference Standards
 Use preferable whenever these exist
 Only for the purpose as per monograph
 Storage conditions
• Reference standards prepared by the producer
 Tested, released and stored in the same way as official
standards
 In a secure area
 A responsible person
• Secondary or working standards
 Appropriate checks and tests at regular intervals
 Standardized against official reference standards –
initially and at regular intervals

REFERENCE STANDARDS
• Reference standards labelled with information
including:
 Name
 Batch, Lot or Control number
 Date of preparation
 Shelf life
 Potency
 Storage conditions
• Stored and used in the appropriate manner

WASTE MATERIALS
• Proper and safe storage when awaiting disposal
• Toxic substances and flammable materials:
 In suitably designed, separate, enclosed areas
as per regulation
• Not to be allowed to accumulate
 Collected in suitable containers for removal to
collection points
 Safe and sanitary disposal
 Regular and frequent intervals

MISCELLANEOUS MATERIALS
• Rodenticides, insecticides, fumigating agents
• Sanitizing materials
• No contamination risk to equipment, starting
materials, packaging materials, in-process
materials, finished products

CONCLUSION
• “Garbage in, Garbage out”
• Compliance with the requirements for
materials management in pharmaceutical
manufacturing will lead to the good quality,
safe and efficacious products

References
• NAFDAC GMP Guidelines for Pharmaceutical Products 2016
• Nally, J.D. (2007). Good Manufacturing Practices for Pharmaceuticals
6th Ed. Pg. 71-82
• Ogbeide E. (2011) Presentation on Control of Pharmaceutical Starting
Materials
• WHO TRS 986 Annex 2; Good manufacturing practices for
pharmaceutical products: Main principles
• WHO TRS 929 (2005). Annex 4; Guidelines for sampling of
pharmaceutical products and related materials
• WHO. Quality Assurance of Pharmaceuticals: A compendium of
guidelines and related materials. Vol. 2 2nd Ed.

MATERIALS-MANAGEMENT-_Khadiah-Ade-Abolade.ppt

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