Pharmaceutical Facility Publications and Guidance Documents ISPE International Society for Pharmaceutical Engineering

GAMP 5: A Risk Based Approach to Compliant GxP Computerized Systems adds pragmatic and practical business information that aims to achieve compliant computerized techniques that are fit for meant use in an effective and positive manner, while also allowing innovation and technological advances. Reflecting latest regulatory expectations and good practices for computerized/computerized methods, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for better compliance and first-rate, effectivity, and cost discounts. They usually focus on the “how”.

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