Guidance Documents

Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to help your company build on current best practices to meet and exceed regulatory standards.

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”.

ISPE 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) approachto the topic area. They typically focus on the “what”.

PQLI

PQLI Guides and GPGs provide information on global solutions to implementation challenges of International Council for Harmonisation (ICH) guidances.

Guide

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.

Clinical Materials

IP Pubs

Initiatives