ICH Q7: GMP Guide for Active Pharmaceutical Ingredients, 11/00
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2000 ICH GMP Guide for API (Active Pharmaceutical Ingredient) manufacturers.
See sections 2.22 (10), 2.23 (8), 5.4, 6.1, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation guidelines.ﾠ
Computer System topics include
- Validation
- Qualification
- Documentation
- Security
- Record protection
- Record retention
- Audit trails
- Change control
- SOPs
- Back-ups
- Incident investigation.
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