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ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
1	Introduction
2	Quality Management
3	Personnel
4	Buildings and Facilities
5	Process Equipment
6	Documentation and Records
7	Materials Management
8	Production and In-Process Controls
9	Packaging and Identification Labelling of APIs and Intermediates
10	Storage and Distribution
11	Laboratory Controls
12	Validation
13	Change Control
14	Rejection and Re-use of Materials
15	Complaints and Recalls
16	Contract Manufactures (including Laboratories)
17	Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
18	Specific Guidance for APIs Manufactured by Cell Culture/Fermentation
19	APIs for Use in Clinical Trials
20	Glossary

	ICH Q7 Implementation Working Group - ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients: Questions & Answers

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