GMP Auditor Association Developments January through April 2026

Board Developments

An online meeting was held on 06 February. Topic was the status and further development of the GMP-Auditor Handbook and the envisaged three new chapters:

• Auditing a Packaging Company
• Conducting a Closing Meeting
• Guidance on AI in auditing

Next steps were defined.

Guideline Developments

GMP Auditors Reference Handbook: The ECA's GMP Auditor Association has been developing the GMP Auditors Reference Handbook to cover key principles of an audit. It includes practical examples and templates - and was now published as version 4.0 in the members' area on the GMP Auditor Association website. The new version further comprises revisions and improvements as well as new chapters on auditing a Packaging Company, conducting a Closing Meeting and utilisation of Artificial Intelligence (AI) in Auditing.

Surveys

Survey on The Impact of Artificial Intelligence on GMP Auditing
A survey was published to better understand how AI is influencing and supporting the work of GMP auditors.
Artificial Intelligence (AI) is rapidly finding its way into many aspects of pharmaceutical and biotech operations, including quality systems, data management, and even auditing activities. To better understand how AI is influencing and supporting the work of GMP auditors, the European GMP-Auditor Association invited its members to participate in a short survey. A total of 137 respondents completed the survey, which consisted of 11 primarily closed questions. This report was published on the website of the association and summarises the key insights and highlights trends.

Miscellaneous

Publication: David Abraham has written an article on the "Utilisation of Artificial Intelligence (AI) in Auditing", which was published in ECA's GMP Journal (Issue 46 2026).

GMP-Auditor Forum: Registration is open for the GMP-Auditor Forum, a Conference for GMP-Auditors to exchange experience. The conference will be held on 23/24 June 2026 in Barcelona, Spain

The ECA Foundation maintains a total of 10 Interest Groups. You can find out more about these groups and their developments on the ECA Foundation website. And if you are not yet a member of the GMP Auditor Association, simply sign up for membership here. Membership is free of charge.