Annex 5 WHO biosafety risk assessment and …

265 World Health OrganizationWHO Technical Report Series No 941, 2007 Annex 5 WHO biosafety risk assessment and guidelines for the production and quality control of human infl uenza pandemic vaccines This document provides guidance to national regulatory authorities and vaccine manufacturers on the safe production and quality control of human infl uenza vaccines produced in response to a threatened pandemic. The document details international biosafety expectations for both pilot-scale and large-scale vaccine production and control and is thus relevant to both development and production activities. It should be read in conjunction with the WHO Laboratory biosafety Manual (1) and replaces the earlier WHO guidance Production of pilot lots of inactivated infl uenza vaccines from reassortants derived from avian infl uenza viruses: Interim biosafety risk assessment (2).

267 Summary International biosafety expectations for both the pilot-scale and large-scale production of human vaccines for a response to a pandemic infl uenza strain,

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  Assessment, Biosafety, Risks, Biosafety risk assessment and

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