GAMP®5 2nd Edition released!

Background

GAMP®5, now supplemented by several Good Practice Guides, is a globally accepted standard for the validation of computerised systems. Version 5 has been available in several languages since 2008. The progress of IT environments in recent years has made it necessary to revise and extend the guide.

As 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. The new edition can be ordered on the ISPE website.

Which basic changes / extensions can be found in GAMP®5 2nd Edition?

• 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.
• 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.
• In the management appendices, the appendices M 11 "Infrastructure" and M 12 "Critical Thinking" have been added as well as some minor changes in the wording.
• In the Development Appendices, in addition to some wording changes, Appendix D 2 "Functional Specifications" has been removed and 4 new appendices have been introduced - D 8 "Agile Software Development", D 9 "Software Tools", D 10 "Distributed Ledger Systems (Blockchain)", D 11 "Artificial Intelligence and Machine Learning (AL/ML)".
• In the Operation Appendices, besides some wording adjustments, the appendix O 7 "Repair Activity" has been removed.
• In the Special Topics Appendices, Appendix S 5 "Managing Quality within an Outsourced IS/IT Environment" has been removed.
• In the General Appendices, the previous Appendix G 1 "GAMP Good Practice Guide Summary" has been removed.

Summary

GAMP®5 2nd Edition is not a new guideline but a revision of the existing guide. Therefore, the designation as GAMP®5 2nd Edition is certainly appropriate. A content analysis of the Guide will appear in an upcoming newsletter. The upcoming courses from the ECA Certified Computer Validation Manager program will deal with the contents and their interpretations in detail.