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.
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.
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.
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”.
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.
PQLI Guides and GPGs provide information on global solutions to implementation challenges of International Council for Harmonisation (ICH) guidances.
Investigational Products Publications have been created to bring new investigational trial materials professionals quickly up to speed with the terms and related information they need to be successful in their field.
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.
These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines.
Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence.
Discussion Papers promote discussion and creates awareness on new or emerging topics; they often solicit feedback, gauge interest, and seek member or industry input. They may state a problem, provide the tentative exploration of solutions and options, and may suggest potential next steps.