GMP Auditor Association Developments January through April 2025

Board Developments and Resolutions
An online Board Meeting was held on 03 February. The main objective was to discuss the further development of the handbook. Work on chapters and attachments was finalised for version 2. Further tasks were discussed for version 3 and the following.

Guideline Developments
A lot of work was spent in Version 2 of the handbook:

• The core document and attachment 2 have been revised and improved
• New topics were added:
  o ATMPS
  o Medicinal Cannabis
• An example for an audit agenda was added as well
• Two audit report templates were also added

The whole document was prepared for publication on the website members' area.

Surveys
EMA has published updated GMP Q&A's on the Agency website. Two new questions are dealing with third party audits.

• Is an audit performed by a third party acceptable?"
• What are the expectations for the content of written final assessment of third-party audit reports?"

The GMP Auditor Association has created a survey to gather information on current practices related to the use of contracted third-party auditors for the qualification approval and maintenance of API suppliers. Specifically, it focuses on the key areas laid down in the Q&As.