10 differences between GAMP5 1st and 2nd Edition

In September 2022 ISPE released the GAMP5 2nd Edition. This guide embraces the new and progressive CSA approach for software validation in relation to the established CSV guidelines. But what are the differences between this first and second edition of the GAMP5? We highlight the 10 most important differences.

1. Non-linear recognition

The GAMP5 2nd Edition acknowledges the (largely) non-linear, agile and more cyclical nature of modern software development. Iterative, incremental, and exploratory models are therefore emphasized.

2. Non-linear recognition

There is a shift from traditional documents such as IQs, OQs and PQs to risk-based records of information, kept in appropriate systems, taken the life cycle of modern software into account.

3. Critical Thinking

Both the GAMP5 2nd Edition and the FDA’s new guidelines (draft and released in September 2022) crystallize around the concept of critical thinking, including guidance of key areas of automated system adoption.

4. Updating development annexes

The areas of GAMP5 that focus on user requirements specifications (URS) and functional/design specifications have been customized to reflect modern, flexible software.

5. Appendix on the electronic production of updated data

The Annex takes into account the emergence of cloud-based technology and blockchain and also clarifies new expectations around electronic records, signatures and audit trails.

6. ITIL

Multiple appendices have been updated to reflect the modern ITIL approach to software development and to clarify connections between key areas.

7. New appendix on blockchain and distributed ledger technology

In addition to the adjustments to the electronic production of records section, blockchain and ledger technology have also been considered.

8. New appendix on AI and machine learning

The GAMP5 2nd Edition recognizes the increasingly important role of artificial intelligence (AI) and machine learning.

9. New appendix on use agile within a GxP environment

GAMP5 2nd Edition encourages an agile, critical-thinking and risk-based approach to the assurance of digital tools.

10. New annex on modern infrastructure and infrastructure management

Modern GxP infrastructure is outlined as well as how new digital tools should be implemented and applied.