Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 9/16
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In 2016, the FDA adopted the 2000 ICH GMP Guide for Active Pharmaceutical Ingredient (API) Manufacturers as an FDA guidance document.
Computer System topics include
- Validation
- Qualification
- Documentation
- Security
- Record protection
- Record retention
- Audit trails
- Change control
- SOPs
- Back-ups
- Incident investigation.
See sections 2.22, 2.23, 5.4, 6.1, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation guidelines.
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