GAMP5

GAMP5 (Good Automated Manufacturing Practice, second edition published in 2022 by ISPE) is the reference guide for validating computerized systems in a GMP environment. It structures systems into four criticality categories (from standard OS to custom software) and defines documentation and testing levels proportionate to risk. We systematically use it to frame the validation deliverables of an automation project: GAMP risk analysis, validation plan, URS-FDS-test traceability, change control, retirement plan. The second edition integrates Agile and DevOps approaches, cloud, artificial intelligence and machine learning, which profoundly changes how we validate modern systems (MES SaaS, data platforms, predictive process models) without challenging the fundamental principles of criticality and patient risk.