International Society of Pharmaceutical Engineering
The International Society for Pharmaceutical Engineering (ISPE) is an association that leads scientific, technical and regulatory advancement of the pharmaceutical lifecycle.
ISPE publishes guidance for pharmaceutical industry best practice and regulatory expectations.
- GAMP Good Practice Guides
GAMP (Good Automated Manufacturing Practice) is a set of guidelines and best practices designed to ensure the proper validation and compliance of automated systems used in manufacturing, helping companies meet regulatory requirements. - 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”. - 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”. - 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.