This document provides an overview of Good Manufacturing Practice (GMP) requirements for materials used in pharmaceutical manufacturing. It discusses specific requirements for different types of materials including starting materials, packaging materials, intermediates, finished products, and more. The objectives are to review GMP requirements for each material type and examine common problems associated with materials compliance. The document outlines general material controls such as supplier approval, material receipt checks, quarantine, storage conditions, labeling, and change control.

1. Module 11 | Slide 1 of 25 2012
Basic Principles of GMP
Materials
14

2. Module 11 | Slide 2 of 25 2012
Materials
Objectives
 To review specific requirements for each type of material:
 Starting materials
 Packaging materials
 Intermediate and bulk products
 Finished products
 Rejected and recovered materials
 Recalled products
 Returned goods
 Reagents and culture media
 Reference standards
 Waste materials
 Miscellaneous materials
 To examine (in groups) the problems associated with materials,
and how to overcome them

3. Module 11 | Slide 3 of 25 2012
Materials
Principle
 Objective of the pharmaceutical manufacturer
 produce finished products for patient's use from a
combination of materials
 Materials combined
 Active pharmaceutical ingredients and
 Excipients (auxiliary materials)
 Packaging materials
 Materials include also
 Gases, solvents, reagents, process aids, etc.
 Special attention 14.1, 14.2

4. Module 11 | Slide 4 of 25 2012
14.3–14.6
Materials
General requirements for materials
 Materials for cleaning, lubrication, and pest control
 Not in direct contact with product
 Suitable grade, e.g. food grade if possible
 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)
 Water – suitable for use

5. Module 11 | Slide 5 of 25 2012
14.7 – 14.10
Materials
Starting Materials – I
 Purchasing – important operation
 From approved suppliers – if possible, direct from the producer
 Specifications for materials
 Consignment checks
 Integrity of package
 Seal intact
 As per purchase order
 Delivery note
 Supplier’s labels
 Clean containers and label – ensure information readable

6. Module 11 | Slide 6 of 25 2012
14.11 – 14.14
Materials
Starting Materials – II
 Report damage to containers
 Separate different batches in one delivery
– sampling, testing and release
 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 system

7. Module 11 | Slide 7 of 25 2012
Basic Principles of GMP
 Damage to and problems
with containers
 Recorded and reported
to QC
 Investigated

8. Module 11 | Slide 8 of 25 2012
Materials
Examples of Labelling of Starting Materials
Name of
Material and/or
internal code
Control/
Batch No.
Status
Quarantined/Released/Rejected
(Colours may be used)
Expiry date or
retest date
Date Signature

9. Module 11 | Slide 9 of 25 2012
Basic Principles of GMP
Procedure for sampling followed - containers
labelled

10. Module 11 | Slide 10 of 25 2012
14.15 – 14.18
Materials
Starting Materials – III
 Use only QC released material if within shelf-life
 Dispensing
 designated persons
 written procedure
 ensure that correct materials are accurately weighed
 clean, properly labelled containers
 Independent checks - recorded
 material and weight or volume
 Dispensed material kept together and labelled

11. Module 11 | Slide 11 of 25 2012
Basic Principles of GMP

12. Module 11 | Slide 12 of 25 2012
14.19 –14.20
Materials
Packaging materials - I
 Primary and printed packaging materials
 purchasing, handling and control same as for starting
materials
 Printed packaging materials:
 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

13. Module 11 | Slide 13 of 25 2012
Basic Principles of GMP

14. Module 11 | Slide 14 of 25 2012
14.21 – 14.23
Materials
Printed and primary packaging materials - II
 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
 Destroyed
 Disposal record

15. Module 11 | Slide 15 of 25 2012
Basic Principles of GMP
Intermediate and bulk
products
 Kept under appropriate
conditions e.g. temperature
 If purchased as such
 Handled on receipt as
though these are
starting materials
14.24 – 14.25

16. Module 11 | Slide 16 of 25 2012
Basic Principles of GMP
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
14.26 – 14.27

17. Module 11 | Slide 17 of 25 2012
14.28
Materials
Rejected materials
 Rejected materials and products
 Clearly marked
 Stored separately in restricted areas
 Action – returned to supplier/destroyed, etc. in timely manner
 Action approved by authorized personnel – records
maintained

18. Module 11 | Slide 18 of 25 2012
14.29 – 14.31
Materials
Rejected, reworked and recovered materials
 Rework and recovery
 Only in exceptional cases
– Risks involved have been evaluated and the quality of
final product will not be affected
– Specifications are met
– Defined procedure
– Records maintained
– New batch number
 additional testing considered by QC

19. Module 11 | Slide 19 of 25 2012
14.32 – 14.33
Materials
Recalled products and returned goods
 Recalled products
 Identified
 Stored separately
 Secure area - access controlled
 Decision taken on their fate
 Returned goods
 Destroyed unless suitable quality
 SOP: decision regarding their fate (relabeling, resale, etc.)
– Consider: nature of product, special storage conditions,
condition, history, time elapsed since issue
 Action taken to be recorded

20. Module 11 | Slide 20 of 25 2012
14.34 – 14.36
Materials
Reagents and culture media
 Records for receipt or preparation
 Reagents
 Preparation in accordance with SOP
 Appropriately labelled:
– concentration, standardization factor, shelf-life, date that
re-standardization is due, storage conditions
– signed and dated
 Culture media
 positive and negative controls each time prepared and used
 Inoculum size appropriate
(See separate training module)

21. Module 11 | Slide 21 of 25 2012
14.37 – 14.40, 14.42
Materials
Reference standards - I
 Official reference standards
 Use preferable whenever these exist
 Only for the purpose as per monograph
 Storage conditions – see label
 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

22. Module 11 | Slide 22 of 25 2012
14.41, 14.43
Materials
Reference standards - II
 Reference standards labelled with information including
 Name of material
 Batch, lot or control number
 Date of preparation
 Shelf-life
 Potency
 Storage conditions
 Stored and used in an appropriate manner

23. Module 11 | Slide 23 of 25 2012
14.44 – 14.45
Materials
Waste materials
 Waste materials
 proper and safe storage when awaiting disposal
 toxic substances and flammable materials:
– in suitably designed, separate, enclosed areas as per
national legislation
 not to be allowed to accumulate
– collected in suitable containers for removal to collection
points
– safe and sanitary disposal
– regular and frequent intervals

24. Module 11 | Slide 24 of 25 2012
14.46
Materials
Miscellaneous materials
 Miscellaneous
 Rodenticides, insecticides
 Fumigating agents
 Sanitizing material
No contamination risk to equipment, starting
materials, packaging materials, in-process materials,
finished products

25. Module 11 | Slide 25 of 25 2012
Materials
Group session
 List specific aspects of GMP requirements, in relation to the
groups of materials listed below, that you would assess when
inspecting a manufacturer
 Printed packaging materials
 Thermolabile materials
 Water
 Sterile materials
 Identify three materials that present problems in your
experience
 What are some of the problems that you have experienced
before and during inspection of materials?