Basic Principles of GMP
Materials
14
Module 11 | Slide 1 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
Module 11 | Slide 2 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
Module 11 | Slide 3 of 25 2012
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 14.3–14.6
Module 11 | Slide 4 of 25 2012
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
14.7 – 14.10
Module 11 | Slide 5 of 25 2012
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
14.11 – 14.14
Role of validated computer system
Module 11 | Slide 6 of 25 2012
Basic Principles of GMP
Damage to and problems
with containers
Recorded and reported
to QC
Investigated
Module 11 | Slide 7 of 25 2012
Materials
Examples of Labelling of Starting Materials
Name of
Material and/or
internal code
Control/
Batch No.
Quarantined/Released/Rejected
Status
(Colours may be used)
Expiry date or
retest date
Date Sign a t u r e
Module 11 | Slide 8 of 25 2012
Basic Principles of GMP
Procedure for sampling followed - containers
labelled
Module 11 | Slide 9 of 25 2012
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
14.15 – 14.18
Module 11 | Slide 10 of 25 2012
Basic Principles of GMP
Module 11 | Slide 11 of 25 2012
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 14.19 –14.20
Module 11 | Slide 12 of 25 2012
Basic Principles of GMP
Module 11 | Slide 13 of 25 2012
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 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
Module 11 | Slide 15 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
Module 11 | Slide 16 of 25 2012
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
14.28
Module 11 | Slide 17 of 25 2012
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
14.29 – 14.31
additional testing considered by QC
Module 11 | Slide 18 of 25 2012
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
14.32 – 14.33
Action taken to be recorded
Module 11 | Slide 19 of 25 2012
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) 14.34 – 14.36
Module 11 | Slide 20 of 25 2012
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 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 2012
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
14.41, 14.43
Module 11 | Slide 22 of 25 2012
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 – 14.45
Module 11 | Slide 23 of 25 2012
Materials
Miscellaneous materials
Miscellaneous
Rodenticides, insecticides
Fumigating agents
Sanitizing material
No contamination risk to equipment, starting
materials, packaging materials, in-process
materials, finished products 14.46
Module 11 | Slide 24 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?
Module 11 | Slide 25 of 25 2012
