Transcription of Annex 6 WHO good manufacturing practices for sterile ...
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Annex 6 WHO good manufacturing practices for sterile ...
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.
266 is required for this. ISO 14644-2 (6) provides information on testing to demonstrate cont inued compl iance w ith the ass igned cleanl iness class ifi cation. Clean room and clean-air device monitoring
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