Guidance Documents

Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations. ISPE Members receive a discount on Guidance Documents.

GAMP

GAMP Good Practice Guides

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 advances.
Reflecting current regulatory expectations and good practices for automated/computerized systems, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

Good Practice Guides

Reflecting current regulatory expectations and best practices, Good Practice Guides (GPGs) help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

Baseline Guides

Created with input from various global regulatory agencies, Baseline Guides are intended to establish a compliant minimum acceptable (baseline) approach to the topic area. They typically focus on the “what”.

APQ

This Guide Series is part of ISPE’s newest initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity.

PQLI

Product Quality Lifecycle Implementation (PQLI) Guides provide information on global solutions to implementation challenges of International Council for Harmonisation (ICH) guidances.

Guides

Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.

Handbooks

Handbooks provide a comprehensive ready reference, with concise information on a particular topic, occupation, or process. They are structured to give quick answers in specific topic areas.

IP Publications

Affiliate Publications

Initiatives