WHO TRS (Technical Report Series) 961, 2011 Annex 6
WHO Good Manufacturing Practices For Sterile Pharmaceutical Products
Introduction:
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.
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TABLE OF CONTENTS
4. Manufacture of sterile preparations
7. Aseptic processing and sterilization by filtration
13. Finishing of sterile products
WHO TRS (Technical Report Series) 961, 2011 Annex 6