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