Good automated manufacturing practice

GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE [1]) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (previously 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 computerized system used in the development, manufacturing and distribution of medicinal products have the required quality.

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