The industry association ISPE, has released in July 2022 a new edition of Good Automated Manufacturing Practice, (GAMP), the global guideline for validation and quality assurance of quality-critical computerised systems in Life Science. GAMP 5, Second Edition, is largely based on the same overarching principles for computerized systems in GxP as described in the previous GAMP 5 edition published in 2008.
One reason why the GAMP guidelines have been so successful globally and have become a kind of industry standard for both life science companies and life science suppliers is that they have continuously reflected existing technology developments. Innovation and technological advances in recent years have led to the need to review and update the guideline.
The first edition of GAMP was published by the International Society for Pharmaceutical Engineering (ISPE) in 1994 and GAMP is now a recognised guideline worldwide, having been published in several versions over the years, most recently with GAMP 5, 2008.
Some of the adaptations that have been made in GAMP 5 Second Edition include support for agile and iterative approaches, and now both linear and iterative approaches are described for several types of processes. The new edition also addresses and encourages the expanded use of system and software tools instead of traditional paper-based documentation for information, requirements, specifications, testing and traceability, etc.
The Second Edition of GAMP 5 continues to describe risk-based thinking at all stages of a system's lifecycle, as part of adapting what activities need to be performed to ensure that a quality-critical system is Compliant. A further update is that it includes clarification that an initial risk assessment should be carried out prior to the project phase and that risk assessment should then be carried out on an ongoing basis throughout the project and the lifecycle of the system. The new edition also includes guidance on the application of Artificial Intelligence (AI), Machine Learning, blockchain and cloud solutions, which is a good complement to the previous edition.
Want to know more about the GAMP 5 guideline or need support? We can help you wherever you need support. Get in touch and we will tell you more about what GAMP 5 and the new version can mean for you. GAMP 5 will also be offered as a modular training in our new E-learning platform. Link to the training.
