Transcription of Annex 7 WHO guidelines on transfer of technology …
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Annex 7 WHO guidelines on transfer of technology …
285 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing1. Introduction2. Scope3. Glossary4. Organization and management5. Production: transfer (processing, packaging and cleaning)6. Quality control: analytical method transfer7. Premises and equipment8. Documentation9. Qualifi cation and validationReferences2861. IntroductionThese guiding principles on transfer of technology are intended to serve as a framework which can be applied in a fl exible manner rather than as strict rigid guidance. Focus has been placed on the quality aspects, in line with WHO s transfer of processes to an alternative site occurs at some stage in the life-cycle of most products, from development, scale-up, manufacturing, production and launch, to the post-approval transfer of technology is defi ned as a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites.
286 1. Introduction These guiding principles on transfer of technology are intended to serve as a framework which can be applied in a fl exible manner rather than as strict
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