WHO good manufacturing practices.
- Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
pdf, 4.82Mb
Volume 2, 2nd updated edition - Good Manufacturing Practices for Pharmaceutical Products: Main Principle [pdf 632kb]
Annex 4, WHO Technical Report Series 908, 2003 - Good manufacturing practices: requirement for the sampling of starting materials (amendment)
Annex 2, WHO Technical Report Series 929, 2005 - Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
- Active pharmaceutical ingredients (bulk drug substances)
Annex 2, WHO Technical Report Series 957, 2010 - Pharmaceutical excipients [pdf 7Mb]
Annex 5, WHO Technical Report Series 885, 1999 - Sterile pharmaceutical products [pdf 1Mb]
Annex 4, WHO Technical Report Series 957, 2010 - Biological products [pdf 1.5Mb]
Annex 3, WHO Technical Report Series 834, 1993 - Pharmaceutical products containing hazardous substances [pdf 1Mb]
Annex 3 WHO Technical Report Series 957, 2010 - Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
Annex 7, WHO Technical Report Series 863, 1996 - Herbal medicinal products [pdf 4Mb]
Annex 3, WHO Technical Report Series 937, 2006 - Radiopharmaceutical products [pdf 632kb]
Annex 3, WHO Technical Report Series 908, 2003 - Water for pharmaceutical use
Annex 3, WHO Technical Report Series 929, 2005 - Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
Annex 2, WHO Technical Report Series 937, 2006 - Validation
Annex 4, WHO Technical Report Series 937, 2006
Risk analysis
- Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals [pdf 632kb]
Annex 7, WHO Technical Report Series 908, 2003
Training materials
- WHO Basic Training Modules on GMP
(Includes an introduction, resource and study pack for trainers)
- WHO supplementary training modules on GMP
(Includes drafts of GMP for Validation, Water, and Air Handling Systems)
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