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Chapter
- Introduction
- Quality Management
- Personnel
- Building and Facilities
- Process Equipment
- Documentation and Records
- Material Management
- Production and In- Process controls
- Packaging and identification Labeling of API’s and Intermediates
- Storage and Distribution
- Laboratory Controls
- Validation
- Change Control
- Rejection and Re-Use of Materials
- Complaints and Recalls
- Contract Manufacturers (Including Laboratories)
- Agents, Brokers, Traders, Distributors , Repackers and Relabellers
- Specific Guidance for API’s Manufactured by cell Culture / Fermentation
- API’s for Use in Clinical Trials
- Instructions for Evaluation
- Evaluation Questionnaire.
