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This topic has appeared in the English Wikipedia rankings 1 time. It first appeared on 2026-06-19 and was most recently seen on 2026-06-19.
GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering 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 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. One of the core principles of GAMP is that quality cannot be tested into a computerized system but must be built into the system at each stage of the life cycle of the computerized system. As a result, GAMP covers all aspects of the life cycle, for concept to implementation, operation and retirement. Standard operating procedures (SOPs) are essential for compliant computerized systems and processes that can affect the quality of the finished product, as well as for the implementation and operation of the computer system itself.
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