Module 11 Slide 1 of 19 WHO - EDM

Basic Principles of GMP

Materials

Part One Section 13

Module 11 Slide 2 of 19 WHO - EDM

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 3 of 19 WHO - EDM

Materials

Principle Objective of the pharmaceutical manufacturer:

produce finished products combination of materials

Materials combined: active pharmaceutical ingredients auxiliary materials(excipients) packaging materials

Special attention

Module 11 Slide 4 of 19 WHO - EDM

Part One 13.2–13.3

Materials

General requirements for materials All incoming materials and finished products:

quarantined after receipt, – until released for use– distribution

stored– under appropriate conditions– orderly fashion (batch segregation)– materials management– stock rotation (FIFO or EEFO))

Module 11 Slide 5 of 19 WHO - EDM

Part One 13.4–13.7

Materials

Starting Materials – I Purchasing

Suppliers

Consignment: integrity seal order delivery note supplier’s labels

Cleaned and labelled

Module 11 Slide 6 of 19 WHO - EDM

Part One 13.8–13.11

Materials

Starting Materials – II Damaged containers

Different batches in one consignment

Starting material label: name and internal code batch number(s), (supplier and manufacturer on

receipt) status expiry date or re-test date

Sampled containers identified

Module 11 Slide 7 of 19 WHO - EDM

Materials

Examples of Labelling of Starting Materials

Name ofMaterial and/ orinternal codeControl/Batch No.

StatusQuarantined/Released/Rejected

(Colors may be used)Expiry date orretest dateDate Signature

Module 11 Slide 8 of 19 WHO - EDM

Part One 13.12–13.15

Materials

Starting Materials – III Use only released material

Dispensing: designated persons written procedure accurately weighed clean, labelled containers

Independent checks material and weight

Dispensed material: kept together and labelled

Module 11 Slide 9 of 19 WHO - EDM

Part One 13.16–13.20

Materials

Packaging materials I Primary and printed materials:

as for starting materials– purchasing, handling and control

No unauthorized access

Storage and transport avoid mix-ups issue and return: SOP

Module 11 Slide 10 of 19 WHO - EDM

Part One 13.16–13.20

Materials

Packaging materials II

Specific reference number for batch or consignment

Packaging department checks: quantity, identity and conformity

Outdated or obsolete material

Module 11 Slide 11 of 19 WHO - EDM

Part One 13.21–13.22

Materials

Intermediate and bulk products

Appropriate conditions

Purchased: as starting materials

Module 11 Slide 12 of 19 WHO - EDM

Part One 13.23–13.24

Materials

Finished products

Quarantine until released

Storage conditions

Evaluation and documentation product release

Module 11 Slide 13 of 19 WHO - EDM

Part One 13.25–13.28

Materials

Rejected and recovered materials

Rejected materials Clearly marked Stored separately in restricted areas Action

Reprocessing: exceptional procedure and records batch number additional testing

Module 11 Slide 14 of 19 WHO - EDM

Part One 13.25–13.28

Materials

Rejected and recovered materials

Recovery: prior authorization additional testing

Module 11 Slide 15 of 19 WHO - EDM

Part One 13.29–13.30

Materials

Recalled products and returned goods Recalled products:

identified stored separately access controlled fate

Returned goods: SOP: decision regarding the fate nature of product, storage conditions history, time lapse records

Module 11 Slide 16 of 19 WHO - EDM

Part One 13.31–13.33

MaterialsReagents and culture media

Recorded upon receipt or preparation

Reagents: preparation in accordance with SOP label:

– concentration, standardisation factor, shelf-life, date that re-standardisation is due, storage conditions

– signed and dated

Culture media: positive and negative controls

Module 11 Slide 17 of 19 WHO - EDM

Part One 13.34–13.37

MaterialsReference standards

Official reference standards use only as per monograph storage

Reference standards prepared by the producer: tested, released stored in same way as official reference standards

Secondary or working standards: appropriate checks and tests regular intervals based on official reference standards

Module 11 Slide 18 of 19 WHO - EDM

Part One 13.38–13.40

Materials

Waste materials and miscellaneous materials

Waste materials proper and safe storage toxic and flammable materials

– separate, enclosed, as per legislation not allowed to accumulate

– collected for safe disposal– regular intervals

Miscellaneous rodenticides, insecticides, sanitizing material contamination risks