- FDA Guideline On General Principles Of Process Validation (1987)
- WHO Supplementary Training Modules: Validation, Water, Air Handling Systems
- FDA’s Draft Process Validation Guidance (2008)
- EMEA Process Validation – Note for Guidance on Process Validation (2001)
- ICH Q7: GMP’s for API’s
- PDA Technical Report #42 : Process Validation of Protein Manufacturing
- Sterile Drug Products Produced by Aseptic Process: GMP’s
- Annex 15: EU Guidance Qualification and Validation (Medicinal Products)
- ICH Q8: Pharmaceutical Development
posted on June 21, 2013 by
