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Gamp 5 guidelines pdf1/13/2024 GAMP® 5 is the latest standard of the guideline it was released in February 2008 by the International Society for Pharmaceutical Engineering, also known as ISPE. In essence, GAMP represents a structured approach to validating computer systems in digital pharmaceutical products. Created in 1991 by pharmaceutical professionals, it was specifically designed to address industry needs and meet the evolving expectations of the FDA and regulatory bodies in Europe for computer system compliance and validation. GAMP - or the Good Automated Manufacturing Practice - is the definitive industry guideline for creating compliant computer systems. ![]() To create a computer-based system that serves its purpose in a reliable, transparent, and most importantly safe way, companies developing pharmaceutical products need to meet various predefined requirements. Read on to learn more about who it applies to, its contents, requirements, and systems validation according to GAMP® 5!Ĭomputer-based systems validation in regulated industries is no walk in the park. ![]() A detailed overview of Good Automated Manufacturing Practice guidelines (GAMP® 5).
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