European QP Association Developments September through December 2025

Board Developments

Board Meeting
A Board Meeting was held on 28 November in Barcelona. Agenda was:

• Changes in Board
• Open tasks from last Board Meeting
• New "Governance principles" ECA and sub-groups
• Feedback for QP Forum 2025 and ideas for QP Forum 2025

Change in the EQPA Board of Directors
After eight successful years on the EQPA Board of Directors, Georg Göstl has retired and stepped down from his position on the Board. Georg joined the Board in 2017 and has been a great support to the European QP Association, particularly through his active involvement in various EQPA initiatives. The Board would like to express its sincere appreciation and gratitude for his outstanding commitment and valuable contributions.
Georg Göstl will be succeeded by Patryk Jegorow, Qualified Person and Head of Quality Compliance and Systems, Biologics Operating Unit, at Takeda, Ireland. Patryk has already been supporting the EQPA as a member of the IMP Working Group and as a speaker at the QP Forum and the QP Education Course (Module A).

New Task Force
The EQPA IMP Working Group announced the formation of a PSF Taskforce for early 2026. The goal is to interpret survey results and work together on key challenges.
With a Call for Participants, the IMP Working Group is looking for active participants.

Surveys

Survey on Audit Trails
The new Annex 11 draft from 2025 elaborates audit trails in more detail. In 12.10 Availability to QP it states: "Audit trail reviews with direct impact on the release of a product should be available to the QP at the time of batch release." With this survey, EQPA wanted to get feedback regarding the QP's personal experience with audit trails, interpretation of the proposed requirement 12.10. of Annex 11 (draft 2025) and the use of such available audit trails. Results will published early 2026.

Survey on the PSF (Survey by the IMP QP Working Group)
The Product Specification File (PSF) has continued to be a topic of interest and was recently revisited during the QP Forum 2023 in Vienna. With this survey, the IMP QP Working Group wanted to gain further insight and an updated overview of practices and procedures across different companies. Results will be published on the IMP QP website.

Miscellaneous

Membership Cards
EQPA discontinues the European QP Association membership cards that have been sent out for many years. More and more colleagues are choosing to opt out of receiving postal mail. Furthermore, EQPA also wants to strengthen the commitment to sustainability. Access to all information and services available in the members' area of the EQPA website will remain unaffected.

Publications

Special EQPA Newsletter
A special newsletter edition was published discussing one century from the QP's beginning to the QP of the future. This article was written by Ulrich Kissel together with David Cockburn.
This special EQPA Newsletter issue was uploaded to the download section of the members' area.

Events

QP Forum
This year's EQPA QP Forum was marked by anniversary celebrations, inspiring speeches and valuable exchanges between experts. The event kicked off with a very special moment - not only is the EQPA celebrating its 20th anniversary, but the role of the Qualified Person itself can look back on an impressive 50 years since it was first enshrined in European GMP regulations. A real highlight followed immediately afterwards: Patricia Kelly, singer, songwriter, keynote speaker and member of the Kelly Family, inspired the audience with an emotional talk about resilience, courage and motivation. Her personal stories and messages visibly touched the audience and provided a special goose bump moment at the start of the event.
After this inspiring opening, the forum turned its attention to a variety of current and practical topics. In the interactive sessions and specialist presentations, participants engaged in intensive discussions on key issues.
The pre-conference sessions held the day before provided the perfect introduction to the forum. Practical groups explored key topics in detail, ranging from regulatory changes and challenging QP issues to specific case studies and workshops.