Basic Principles of GMP
Materials
14
Module 11
|
Slide 1 of 25
January 2006
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
Module 11
|
Slide 2 of 25
January 2006
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
Module 11
|
Slide 3 of 25
January 2006
14.1, 14.2
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
Module 11
|
Slide 4 of 25
January 2006
14.3–14.6
Materials
Starting Materials – I
 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
14.7 – 14.10
Module 11
|
Slide 5 of 25
January 2006
Materials
Starting Materials – II
 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
Module 11
|
Slide 6 of 25
January 2006
14.11 – 14.14
Basic Principles of GMP
Module 11
|
Slide 7 of 25
January 2006
Basic Principles of GMP
 Damage to and problems
with containers
 Recorded and reported
to QC
 Investigated
Module 11
|
Slide 8 of 25
January 2006
Materials
Examples of Labelling of Starting Materials
Name of
Material and/or
internal code
Control/
Batch No.
Quarantined/Released/Rejected
(Colours may be used)
Status
Expiry date or
retest date
Date
Module 11
|
Slide 9 of 25
Signature
January 2006
Materials
Starting Materials – III
 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
14.15 – 14.18
Module 11
|
Slide 10 of 25
January 2006
Basic Principles of GMP
Module 11
|
Slide 11 of 25
January 2006
Materials
Packaging materials - I
 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
14.25–14.20
 SOP for issue and returns
Module 11
|
Slide 12 of 25
January 2006
Basic Principles of GMP
Module 11
|
Slide 13 of 25
January 2006
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
14.21 – 14.23
Module 11
|
Slide 14 of 25
January 2006
Basic Principles of GMP
Intermediate and bulk
products
 Kept under appropriate
conditions
 If purchased as such
 Handled on receipt as
though these are
starting materials
14.24 – 14.25
Module 11
|
Slide 15 of 25
January 2006
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
Module 11
|
Slide 16 of 25
January 2006
14.26 – 14.27
Materials
Rejected, reworked and recovered 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
14.28
Module 11
|
Slide 17 of 25
January 2006
Materials
Rejected, reworked and recovered materials
 Rework and recovery
 Should be exceptional cases
 Only if:
– Risks involved have been evaluated and the quality of
final product will not be affected
– Specifications are met
– Defined procedure
– Records maintained
14.29 – 14.30
– New batch number
 additional testing to be considered by QC
Module 11
|
Slide 18 of 25
January 2006
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 (relabelling, resale, etc.)
– Consider: nature of product, special storage conditions,
condition, history, time elapsed since issue
14.32 – 14.33
 Action taken to be recorded
Module 11
|
Slide 19 of 25
January 2006
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
restandardization is due, storage conditions
– signed and dated
 Culture media
 positive and negative controls each time prepared and used
 Inoculum size appropriate
14.34 – 14.36
Module 11
|
Slide 20 of 25
January 2006
Materials
Reference standards - I
 Official 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
14.37 – 14.40, 14.42
 Appropriate checks and tests at regular intervals
 Standardized against official reference standards – initially and
at regular intervals
Module 11
|
Slide 21 of 25
January 2006
Materials
Reference standards - II
 Reference standards labelled with information including
 Name
 Batch, lot or control number
 Date of preparation
 Shelf-life
 Potency
 Storage conditions
 Stored and used in an appropriate manner
14.41, 14.43
Module 11
|
Slide 22 of 25
January 2006
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
14.44
Module 11
|
Slide 23 of 25
January 2006
Materials
Miscellaneous materials
 Miscellaneous
 Rodenticides, insecticides, fumigating agents
 Sanitizing material
 No contamination risk to equipment, starting materials,
packaging materials, in-process materials, finished products
14.45
Module 11
|
Slide 24 of 25
January 2006
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?
Module 11
|
Slide 25 of 25
January 2006