WHO TRS 961, 2011 Annex 6

WHO TRS (Technical Report Series) 961, 2011 Annex 6 

WHO Good Manufacturing Practices For Sterile Pharmaceutical Products 


Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Prequalification of Medicines Programme, clarifying, editorial modifications have been proposed. These changes were adopted for maintenance purposes. In order to ease reading the full guideline has been reproduced again as an Annex to the current report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Click on the any titles below for complete guidelines


 1. General considerations

 2. Quality control

 3. Sanitation

 4. Manufacture of sterile preparations

 5. Sterilization

 6. Terminal sterilization

 7. Aseptic processing and sterilization by filtration

 8. Isolator technology

 9. Blow/fill/seal technology

10. Personnel

11. Premises

12. Equipment

13. Finishing of sterile products


Further reading

WHO TRS (Technical Report Series) 961, 2011 Annex 6

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