This year's event on 25/26 June 2024 in Barcelona (Spain) already took place.
The next Forum will be held in June 2026. The agenda will be announced in January 2026. The GMP Auditor Forum will be held every 2 years.
Read more about this year's event:
The 2024 GMP Auditor Forum
The GMP Auditor Forum 2024, held on 25-26 June in the city of Barcelona, was a cornerstone event for professionals dedicated to Good Manufacturing Practice (GMP) auditing. This year's Forum brought together a diverse group of more than 60 GMP auditors, and industry experts to discuss emerging trends, share best practices and foster a collaborative environment to advance GMP standards.
The Key Highlights
1. Launch of the ECA GMP Auditor Handbook
One of the most anticipated moments of the Forum was the launch of the ECA's newly developed GMP Auditor Handbook. This comprehensive guide has been developed with valuable input from inspectors and experienced industry professionals. It contains practical examples from real projects and addresses the current challenges faced by GMP auditors. The Handbook is an essential resource for both novice and experienced auditors, providing insight into efficient auditing practices.
2. Interactive and facilitated sessions, effective questioning techniques
The Forum excelled in facilitating interactive sessions where participants could actively engage with their peers. These sessions were designed to encourage open discussion, allowing auditors to share their experiences and perspectives on a variety of audit methodologies. Topics ranged from traditional on-site inspections to the increasingly common hybrid and remote auditing approaches. These dialogues provided a platform for participants to discuss the nuances of each method, learn from each other's experiences, and develop more effective audit strategies.
3. The Forum included a series of expert-led presentations covering critical aspects of GMP auditing.
Presenters shared their expertise on technical topics essential for auditors, such as the latest regulatory updates as well as advances in audit technology. These sessions were particularly valuable for auditors looking to enhance their practical skills and keep abreast of industry developments. Networking opportunities
The GMP Auditor Forum also provided ample opportunities for networking, allowing attendees to build professional relationships and share knowledge. Informal networking sessions, coffee breaks and a social event allowed attendees to connect with peers from around the world, discuss common challenges and share solutions. These interactions are critical to fostering a global community of GMP auditors committed to maintaining high standards of manufacturing practice.
Conclusion
The 2024 GMP Auditor Forum in Barcelona was a resounding success, providing attendees with a wealth of knowledge and networking opportunities. Please find some pictures taken at the 1st GMP Auditor Forum here.
The GMP Auditor Forum takes place every 2 years. Therefore, the next Forum will be held in June 2026 and the agenda will be published in January 2026.
Release of ECA´s new GMP-Auditor Handbook
Objectives
In this new format, GMP-Auditors can discuss current topics and exchange opinions and experiences with other auditors in moderated session. The presentations will address specific topics deemed important for GMP-Auditors.
A team of experts have developed a new ECA Good Practice Guide “GMP Auditors Reference Handbook”. The guide considers feedback from GMP inspectors, the pharmaceutical industry and suppliers as well as practical experiences from real project cases. Experts working on this guide will be present so participants will have the opportunity to discuss current challenges around GMP Auditing.
All members of the Association will have the possibility to download the current version of the guide free of charge.
Background
Manufacturers are obliged to carry out GMP audits at their suppliers' and contract manufacturers' premises or have them carried out by suitably qualified and trained external auditors. Authorities emphasise the need for on-site audits. However, hybrid versions and complete distant assessments also play an important role in the supplier qualification toolbox.
Auditors play a very important role in the pharmaceutical industry and in the life cycle of pharmaceutical products. Their training and experience, and thus also a mutual exchange, is immensely important here.
What makes a good auditor?
An auditor must certainly have extensive specialist knowledge. This means knowledge of the GMP regulations and their implementation. But an auditor must also have the necessary technical and practical expertise to sufficiently understand and question the audited processes.
To do this, an auditor must be unbiased and independent, know appropriate questioning techniques and be able to apply them. It also requires patience, the ability to listen, persistence and determination. Unfamiliar and new situations must not become a problem.
The ECA Certified GMP Auditor certification programme consists of three modules that provide GMP auditors with specialised knowledge and soft skills, including conflict resolution. And auditors gain experience in their daily professional practice. This new GMP Auditor Forum format aims to present and discuss current topics and promote mutual exchange of opinions and experiences.
Target Audience
This course is designed for both new and experienced GMP auditors who want to network and broaden their overall knowledge.
Moderator
Afshin Hosseiny
Chairman of ECA
Click on the picture to download the complete programme as a PDF.