In the chapter 3-Life Cycle Approach, the subsection 'Critical Thinking Through the Life Cycle' has been added, and in the chapter 8-Efficiency Improvements, the subsection 'Using Tools and Automation' has been included in addition to some wording adjustments.The structure of the main part with its 8 chapters (1-Introduction / 2-Key Concepts / 3-Life Cycle Approach / 4-Life Cycle Phases / 5-Quality Risk Management / 6-Regulated Company Activities / 7-Supplier Activities / 8-Efficiency Improvements) has remained unchanged.Which basic changes / extensions can be found in GAMP®5 2nd Edition? The new edition can be ordered on the ISPE website. The progress of IT environments in recent years has made it necessary to revise and extend the guide.Īs the basic structure of GAMP®5 is still well suited to the current IT landscape and to the validation of computerised systems, GAMP®5 has been published as 2nd Edition at the end of July 2022, in particular with extensions to the appendices, instead of GAMP®6.
Version 5 has been available in several languages since 2008. GAMP®5, now supplemented by several Good Practice Guides, is a globally accepted standard for the validation of computerised systems. GMP Courses & Conferences on Site (in hotels).
