What is GAMP 5 2nd Edition

GAMP 5 (Good Automated Manufacturing Practice) is a set of guidelines and best practices for automated systems in the pharmaceutical industry, developed by the International Society for Pharmaceutical Engineering (ISPE). The guidelines are intended to ensure that automated systems used in manufacturing, laboratory, and other regulated environments are reliable, fit for purpose, and compliant with relevant regulations.
The 2nd Edition of GAMP 5, published in July 2022, builds upon the original GAMP 5 guidelines released in 2008. The new edition reflects the latest industry trends, technologies, and regulatory expectations, providing updated guidance on various aspects of computerized systems in regulated environments.

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