ISO standards
- ISO 14644- 7 : Clean Room and Associated control environment separative devices (Clean air hoods, glove boxes, isolators and mini environments)
- ISO 10648-2 : Containment Enclosures-Part 2: Classification according to leak tightness & associated checking methods.
USFDA Guidelines
- USFDA - 21 CFR part 211: Current Good manufacturing Practice for finished pharmaceuticals
- 21 CFR Part 11- Electronic Signatures & Records
EU - GMP Guidelines
- Guideline Part 1
- Annex 1 – Good Manufacturing Practice of Medicinal Products for Human and Veterinary use
- Annex 11 – Computerized Systems
- Annex 15 – Qualification and Validation
WHO Guidelines
- QAP (12/16/06) – Quality Assurance of Pharmaceuticals
- WHO Expert Committee on specifications for Pharmaceuticals Preparations
- WHO volume 2 – Good manufacturing practices and inspection
ASME-BPE
Standards for Construction of pressure vessels, piping, process connection & valves.
PICS Guidelines
- P1007-6 – Validation of Aseptic Process
- PE009-11 – Guide of Good Manufacturing Practice for Medical Products
GAMP
- GAMP 5: Good Automated Manufacturing Practices.
