ICH Q7A is a worldwide harmonized GMP guideline for active pharmaceutical ingredients (chemical and biological), which covers all GMP aspects of manufacturing, quality control and trading.

ICH Q7A - GMP for APIsThis document was abstracted by the International Conference of Harmonisation (ICH).

Pharmaceutical manufacturers should know this guideline to make sure that their suppliers are in compliance with the necessary GMP rules.

A good company in your office and when you are away.

Part of this booklet is a full index so that you can find the right passage straight away.

Table of contents:
- Introduction
- Quality Management
- Personnel
- Buildings and Facilities
- Process Equipment
- Documentation and Records
- Materials Management
- Production and In-Process Controls
- Packaging and Identification Labelling of APIs and Intermediates
- Storage and Distribution
- Laboratory Controls
- Rejection and Re-Use of Materials
- Complaints and Recalls
- Contract Manufacturers (including Laboratories)
- Agents, Brokers, Traders, Distributors, Repackers and Relabellers
- Specific Guidance for APIs Manufactured by Cell Culture/Fermantation
- APIs for Use in Clinical Trials
- Glossary
- Index