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1. Basic Principles of GMP
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Module11 Slide1of25 2012
Materials
14

2. Materials
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Module11 Slide2of25 2012
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. Materials
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Module11 Slide3of25 2012
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. 14.3–14.6
Materials
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Module11 Slide4of25 2012
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. 14.7 – 14.10
Materials
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Module11 Slide5of25 2012
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. 14.11 – 14.14
Materials
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Module11 Slide6of25 2012
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. Basic Principles of GMP
 Damage to and problems
with containers
 Recorded and reported
to QC
 Investigated
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Module11 Slide7of25 2012

8. Materials
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Module11 Slide8of25 2012
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. Basic Principles of GMP
Procedure for sampling followed - containers
labelled
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Module11 Slide9of25 2012

10. 14.15 – 14.18
Materials
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Module11 Slide10of25 2012
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. Basic Principles of GMP
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Module11 Slide11of25 2012

12. 14.19 –14.20
Materials
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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. Basic Principles of GMP
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Module11 Slide13of25 2012

14. 14.21 – 14.23
Materials
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Module11 Slide14of25 2012
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. 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
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Module11 Slide15of25 2012

16. 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
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Module11 Slide16of25 2012

17. 14.28
Materials
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Module11 Slide17of25 2012
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. 14.29 – 14.31
Materials
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Module11 Slide18of25 2012
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. 14.32 – 14.33
Materials
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Module11 Slide19of25 2012
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. 14.34 – 14.36
Materials
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Module11 Slide20of25 2012
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. 14.37 – 14.40, 14.42
Materials
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Module11 Slide21of25 2012
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. 14.41, 14.43
Materials
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Module11 Slide22of25 2012
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. 14.44 – 14.45
Materials
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Module11 Slide23of25 2012
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. 14.46
Materials
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Module11 Slide24of25 2012
Miscellaneous materials
 Miscellaneous
 Rodenticides, insecticides
 Fumigating agents
 Sanitizing material
No contamination risk to equipment, starting
materials, packaging materials, in-process materials,
finished products

25. Materials
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Module11 Slide25of25 2012
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?