WHO good manufacturing practices

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)