What’s new with GAMP5 and how will it affect you?

Donna Foulis Date published: Aug 02, 22 Last updated: Aug 30, 22

As the definitive guide for validation and assurance of computer systems used in pharmaceutical companies, a second edition of GAMP5 was released in July 2022. The revisions widened the scope to match the way software tools have evolved and become more widespread in their use. Ideagen’s Stephen Ferrell is a contributing author to the guide, read on to find out what are the changes, why they’re important and who they will affect.

Changes to GAMP5 guidelines

The GAMP5 guidelines have been revised and updated in line with the advancement of technology and the increasingly prevalent role it plays within the industry. It looks at the full lifecycle of a system and manages new versions and releases in line with compliance activities.

This update comes after 13 years of the regulation in its current form. With life sciences historically having been slow to adapt to technology, these updates ensure that GAMP5 remains relevant for today’s world and covers the advances that have happened in technology over the past decade.

The extended version expands on the following areas:  

• Agile
• Use of Software Tools
• AI/ML
• Blockchain
• Pharma 4.0

What are the new changes to GAMP5?

These changes are being driven by the 4 C’s – contemporary, compliance, computer software assurance and cloud. Below is a breakdown of what’s new to GAMP5, which areas have significant updates and what has been removed and consolidated into another area:

New to GAMP5

• Appendix D8- agile 
• Appendix D9- software tools 
• Appendix D10- distributed ledger systems (blockchain) 
• Appendix D11- artificial intelligence/ machine learning 
• Appendix M11- IT infrastructure 
• Appendix M12- critical thinking 

Significant updates

• Appendix D5 testing of computerised systems
• Appendix D1- specifying requirements 
• Appendix S2- electronic production records 

Removed to be incorporated into another appendix

• Appendix D2- functional specifications 
• Appendix 07- repair 
• Appendix S5- managing quality an outsourced IS/IT environment 

Stephen Ferrell goes into more depth in the webinar on each of these appendix's.

What is GAMP5?

GAMP5 is a best practice guide for validating computer systems for appropriate use within the pharmaceutical industry. GAMP stands for Good Automated Manufacturing Practice and is published by the International Society for Pharmaceutical Engineering to ensure best practice for the making and use of automated systems.

GAMP5 focuses on a risk-based approach to computer software validation to help organisations achieve and maintain compliance with key standards. GAMP5 isn’t a regulation in itself, it’s a set of guidelines for maintaining best practices to be compliant. Validation is essentially a process that checks that a software product does what it says it can do and will be able to perform all the functions that users need it for.

What should you do next?

Stephen Ferrell dives into the GAMP5 changes in depth in a recent webinar, hosted by KENX, covering exactly what they mean for your organisation and what to do to ensure you’re compliant and up to date. Watch back here: Registration (gotowebinar.com)