Guidance for Industry. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

U.S. Dpt of Health and Human Services – Food and Drug Administration - Table of contents: I. Introduction. II. Quality Management. III. Personnel. IV. Building and Facilities. V. Process Equipments. VI. Documentation and records. VII. Material Management. VIII. Production and in-process controls. IX. Packaging and identification labelling of APIs and Intermediates. X. Storage and distribution. XI. Laboratory Controls. XII. Validation. XIII. Change control. XIV. Rejection and re-use of materials. XV. Complaints and recalls. XVI. Contract manufacturers. XVII. Agents, brokers, traders, distributors, Re-packers and re-labellers. XVIII. Specific guidance for APIs manufactured by cell culture / fermentation. XIX. APIs for use in clinical trials. X. Glossary.

Note: Q7A means the Expert Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Copies of this document are available from:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129098.pdf

http://www.fda.gov/cder/guidance/index.htm

http://www.fda.gov/cber/guidelines.htm