European GMP Auditor Association issues Version 4.0 of Auditor Handbook

Auditing is one of the fundamental tools to assist businesses to ensure they are fulfilling their obligations to their shareholders, customers and of course the relevant regulators. It is therefore not surprising that the pharmaceutical industry has placed the auditing in the heart of its Quality Management System.

The ECA's GMP Auditor Association therefore has been developing the GMP Auditors Reference Handbook to cover key principles of an audit. It includes practical examples and templates - and is now available 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.

If you are not a member yet, simply sign up for membership - it is free of charge.

To get to know the Guide in more detail, you may want to attend this year's GMP Auditor Forum on 23/24 June 2026 in Barcelona, Spain. Experts working on this guide will be present there, and you will also have the opportunity to discuss current challenges around GMP Auditing at the event.