-
United States
- 21 CFR cGMP Part 211 CDER Guidance to GMP for Active Pharmaceutical Ingredients
- Device GMP Part 820
- Blood GMP Part 606
- Sterile Drug Products Produced by Aseptic Processing
- Guide to Inspection of Lyophilization of Parenterals
- Parenteral Society Leak Rate Specification
-
Computer Validation
- Guidance to Part 11
- Legacy Systems
-
Europe
- European Guide to Good Manufacturing Practices - Vol 4
- Annex 1 Manufacture of Sterile Medicinal Products
- Proposed Amendment to Annex 1 - Sep 2005
- Particulates ISO14644-11999
- Testing & Monitoring ISO14644-22000
- Guidelines on Test Methods for Environmental Monitoring for Aseptic Dispensing Facilities - QASIG