GMP Auditor Association Developments September through December 2025

Board Meetings and Resolutions

A Board Meeting was held vis MS-Teams on 09 December. Main task was to discuss the progress made on the GMP Auditor Handbook revision and update. Completion of all reviews should be done by mid-January. A follow-up meeting is scheduled for early February,

Guideline Developments

The work on Version 3.0 of the Handbook has started. Three new subjects will be added:

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

Subject leads, support and reviewers have been allocated

Surveys

A survey was published to better understand how AI is influencing and supporting the work of GMP auditors. The survey aimed to explore two main aspects:

• How auditors are currently using or plan to use AI tools in their daily work, and
• How auditors approach the evaluation of AI providers and AI-driven applications in GMP-regulated environments.

The survey included 11 questions. All responses were collected anonymously and will be summarised and published on the website of the European GMP-Auditor Association.

Events

The programme for the next GMP-Auditor Forum was finalised and published as a Conference for GMP-Auditors to Exchange Experience. The conference will be held on 23/24 June 2026 in Barcelona, Spain.