GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance.
Reflecting current regulatory expectations and good practices, the the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.
Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline Guides offer practical answers to the complex, dynamic challenges facing facility designers today by addressing GMP and non-GMP regulations.
ISPE’s Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance.
ISPE Good Practice Guides (GPGs) provide information or advice on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible.
Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.
Reading Roundup: Top Blog Posts from April 2016
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Clinical Labeling of Medicinal Products: EU Clinical Trial Regulation
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Design Considerations for WFI Distillation Systems Part 2
Thursday, 28 Apr 2016 18.04