WHO Good Manufacturing Practices For Active Pharmaceutical Ingredients
Annex 2
WHO Good Manufacturing Practices Guidelines For Active Pharmaceutical Ingredients
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TABLE OF CONTENTS
2.2 Responsibilities of the quality unit(s)
2.3 Responsibility for production activities
2.4 Internal audits (self-inspection)
4.7 Sanitation and maintenance
5.2 Equipment maintenance and cleaning
6.1 Documentation system and specifications
6.2 Equipment cleaning and use record
6.3 Records of raw materials, intermediates, API labelling and packaging materials
6.4 Master production instructions (master production and control records)
6.5 Batch production records (batch production and control records)
6.6 Laboratory control records
6.7 Batch production record review
7.3 Sampling and testing of incoming production materials
8. Production and in-process controls
8.3 In-process sampling and controls
8.4 Blending batches of intermediates or APIs
9. Packaging and identification labelling of APIs and intermediates
9.3 Label issuance and control
9.4 Packaging and labelling operations
11.2 Testing of intermediates and APIs
11.3 Validation of analytical procedures
11.5 Stability monitoring of APIs
11.7 Reserve/retention samples
12.4 Approaches to process validation
12.5 Process validation programme
12.6 Periodic review of validated systems
12.8 Validation of analytical methods
14. Rejection and reuse of materials
14.4 Recovery of materials and solvents
16. Contract manufacturers (including laboratories)
17. Agents, brokers, traders, distributors, repackers and relabellers
17.2 Traceability of distributed APIs and intermediates
17.4 Repackaging, relabelling and holding of APIs and intermediates
17.7 Handling of complaints and recalls
18. Specific guidance for APIs manufactured by cell culture/fermentation
18.2 Cell bank maintenance and record keeping
18.3 Cell culture/fermentation
18.4 Harvesting, isolation and purification
18.5 Viral removal/inactivation steps
19. APIs for use in clinical trials
List of references for related WHO guidelines
General notes: additional clarifications and explanations
WHO Good Manufacturing Practices For Active Pharmaceutical Ingredient
