Gamp 5 guidelines pdf

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One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. Good automated manufacturing practice ( GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

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