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GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

Posted on 4 January 202227 May 2023 by Shiva Kumar

GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11 What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5. GAMP describes a set of principles and procedures that help ensure that pharmaceutical…

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