Transcription of Annex 6 WHO good manufacturing practices for …
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Annex 6 WHO good manufacturing practices for …
261 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 6 WHO good manufacturing practices for sterile pharmaceutical products IntroductionFollowing implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Prequalifi cation of Medicines Programme, clarifying, editorial modifi cations 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 Specifi cations for Pharmaceutical Preparations. WHO good manufacturing practices for sterile pharmaceutical products 1. General considerations 2. Quality control 3. Sanitation 4. Manufacture of sterile preparations 5. Sterilization 6. Te r minal sterilization 7. Aseptic processing and sterilization by fi ltration 8.
262 1. General considerations 1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for
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