Regulatory guidance

  1. Annex 1 to the EU Guide to Good Manufacture Practice, Vol 4: Manufacture of Sterile Medicinal Products, Aug 1, 1998.
  2. Annex 15 to the EU Guide to Good Manufacture Practice, Vol 4: Qualification and Validation, Sept. 2001
  3. Aseptic Processing of Health Care Products, Part 1: General Requirements, Draft International Standard ISO 13408-1, June 2001
  4. FDA-CDER Guideline on General Principles of Process Validation, Food and Drug Administration, Rockville, MD, USA, May, 1987
  5. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing, Food and Drug Administration, Rockville, MD, USA, June, 1987
  6. Good Automated Manufacturing Practice (GAMP 96) - Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture, ISPE
  7. Pharmaceutical Inspection Co-operation Scheme (PIC/S), Recommendations on the validation of aseptic processes, Oct 1999.
  8. Pharmaceutical Inspection Co-operation Scheme (PIC/S), Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation, Aug. 2001
  9. Process Validation: Form-Fill-Seal for Pharmaceuticals, Health Canada, Health Protection Branch, September 16, 1996.
  10. USP 25, Chapter 1116, Microbiological Evaluation of Clean Rooms and Other Controlled Environments., (2002)

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