Transcription of Annex 2 WHO good practices for pharmaceutical …
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Annex 2 WHO good practices for pharmaceutical …
69 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 2 WHO good practices for pharmaceutical microbiology laboratoriesBackgroundThe WHO Expert Committee on Specifi cations for pharmaceutical Preparations adopted in 2009 a revised version of the good practices for pharmaceutical quality control laboratories (1).During the inspections carried out when prequalifying laboratories , the inspectors had noticed that some of the texts of these guidelines might benefi t from additional guidance, with a special focus on light of the above, the Expert Committee recommended that the WHO Secretariat initiate the process of developing a new text on good practices for pharmaceutical microbiology following text is proposed to cover this specifi c type of and scope of documentGlossary 1.
71 Introduction and scope of document Pharmaceutical microbiology laboratories may be involved in: — sterility testing; — detection, isolation, enumeration and identifi cation of microorganisms
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