Board Developments
The Board is still unchanged. There was a Board meeting on 4 November 2024 on site before the Equipment Qualification Forum where topics were discussed for 2025.

Guideline Developments

• Revised chapters “Categorization”, “CARA” and Remote/video assisted FAT/SAT are finalized and were presented at the Equipment Qualification Forum   
• Collection of more practical examples to bring into the appendices (more content). Can later be transferred into small ECA Booklets and videos    
• The Guide was simplified and launched as version 3.0 at the Equipment Qualification Forum with the new name Good Practice Guide Qualification and Validation (subtitle will remain unchanged)  

Surveys
Surveys about AI in qualification projects and regarding DoE were successfully completed. The result of the AI survey was implemented in a workshop at the Equipment Qualification Forum. One result was a “GMP-Song”.

For all courses and conferences coming up, please see the current validation courses & conferences programme.

More information is also available at the Validation Group website.

Board Developments
There are no changes planned within the board. The board meeting was held in November in Berlin.

Guideline Developments
The group is working on an Update of its Visual Inspection Guide. It is also discussing a possible update of the CCIT position paper as well.

Surveys
A survey within the group to ascertain the current state of the art with regard to visual inspection in the pharmaceutical industry is planned for the first half of 2025.

Events
The annual conference/meeting of the group is planned for end of October in Vienna, Austria.

For further information, please see the Visual Inspection Group website.

Take a look at the current Visual Inspection courses & conferences.

Board Developments
We are delighted to welcome Dr Christoph Peter from Peter Auditing, previously Vice President Global System Quality at BioNTech, as part of the Board. His many years of expertise will support us in many tasks and decisions and we look forward to working together.

Guideline Developments
Further information on the white paper on patient-centric specifications was collected and discussed. The guideline is now being written and the review will take place at the next Board meeting in April 2025.

Events
The annual on-site meeting is planned as part of the PharmaCongress in April 2025. In addition, further training courses such as Freezing Cells, Virus free Transduction in Cell Therapies, Handling of biological Raw Materials & APIs and the beginner course ATMP – short & simple have been developed in co-operation with the Board.

Find out more on the ATMP Group website.

Please also take a look at the events programme concentrating on ATMP topics.

Board Developments and Resolutions

After ten successful years in the EQPA Board of Directors, Tor Gråberg retired and resigned from the Board. Tor joined the Board in 2014 as Health Authorities representative (Swedish MPA) and after his move to AstraZeneca as industry representative. He has been a great support to EQPA, especially through his large network and his extensive knowledge of regulatory processes. The Board would like to express its sincere thanks for all his support. He will be succeeded by Ewa Rybak, Quality Assurance Head/QP at JJP Biologics, Poland. Ewa already supports EQPA as a speaker at the QP Education Course (Module B).

Further, after productive 12 years, Niina Taylor has announced that she will be stepping down from the IMP Working Group Leadership Team. Niina would like to express her thanks to the other members of the leadership team for the opportunity to be part of such a prestigious group.  Rebecca Haywood from Pfizer, UK, will be taking her place on the leadership team. From a Commercial and Clinical Analytical background, Rebecca gained her Qualified Person status while the UK was still a member of the EU. In her most recent role at Pfizer, Rebecca is releasing IMPs for use in clinical studies worldwide.

A Board Meeting was held on 29 November in Amsterdam – with the following agenda:

• Open tasks from last Board Meeting
• Feedback for QP Forum 2024 and ideas for QP Forum 2025
• Feedback from experience with Engagement Board
• Discuss new draft objectives to finalise them
• Status of the website update

Surveys
Survey on Impact of CTR on IMP QPs
The new EU Clinical Trial Regulation (536/2014) (CTR) introduces a new mechanism for clinical trial approval in the EEA. CTIS, developed by the European Medicines Agency (EMA), is now the single-entry point for CTAs in the EEA. Initial submissions under the Clinical Trial Directive (2001/20/EC) (CTD) are no longer possible. With a short survey, the EQPA wanted to know how the new regulation, and related guidelines, have affected IMP QPs in the relevant aspects of clinical trials. The results of the survey were shared and discussed at the IMP Pre-conference of the Qualified Person Forum on 27 Nov 2024 in Amsterdam.

Publications
The EQPA Good Practice Guide “Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU” has been revised. The chapter on Brexit and consequences (chapter 4.3.4) has been revised once more. In addition, the annex has been updated with information on the national requirements in Poland.

The new version 11.0 of the Guide and the Annex version 2.0 are available again for you as member in the members’ area.

Events
QP Forum
The 19th QP Forum was held on-site on 28/29 November 2024 in Amsterdam.

Three parallel Pre-Conference Sessions were preceding the Forum on 27 November: Investigational Medicinal Products, QP Oversight for "Virtual Companies" and MAHs and one on QP Liability and Indemnification. One of the many highlights was the Keynote and Opening Address by Emer Cooke, Executive Director of the European Medicines Agency.

About 350 delegates joined over the three days, most of them for both, pre-conference sessions and the Forum.

A five star rating was used with five stars meaning very good and one star rather poor. The ratings for the pre-conference sessions, the QP Forum and the parallel sessions was very positive – between 4 and 4.5.

Miscellaneous   
Current topic of the Engagement Board: Sharing responsibilities between QPs.

In the regular exchange between the GMDP inspectors working group (IWG) with interested parties including ECA/EQPA a letter was sent to IWG in October this year seeking for advice on the risk of expired GMP certificates in 2025 if no automatic prolongation nor a replacement based on a new inspection would happen. The IWG has assessed the situation and responded on 9 December 2024. Within the response two specific responsibilities related to GMP certificates have been assigned personally to the QP. The EQPA expressed disagreement to such assignment by additional response on 17 December 2024.

The EQPA members were made aware of IWG´s expectations which would apply from the beginning of 2025 and EQPA’s deviating position. Both letters forwarded to the EMA are available in the EQPA website’s news section.

Continuous updates can also be found at the European QP Association website.

Find out more about the current courses & conferences programme organized and co-sponsered by the European QP Association.

Board Developments and Resolutions
A face-to-face Board Meeting was held on 25 November 2024 in Düsseldorf/Neuss.  
It was agreed to have online Board Meetings as needed in Q1 2025 to review progress. The next in-person meeting will be held during PharmaLab 2025.

Guideline Developments
Possible topics for new guidelines were discussed. No decisions have been made yet.
The priority is to update three existing guidelines:

• OOS Guideline from 2013
• OOE/OOT Guideline from 2016
• APLM Guideline from 2018

Miscellaneous
Newsletters were sent to the members of the Group on a regular basis.

For further information, please see the Analytical Quality Control Group website.

Take a look at the current courses & conferences programme in analytical quality control.

Board Developments and Resolutions
An online Board Meeting was held on 26 September 2024.
The next Board Meeting is planned as a face-to-face meeting during the GMP & GDP Forum 2025 in Barcelona.

Guideline Developments
The review and update of the existing ECA/PQG GDP monograph has been delayed. The project is expected to be finalised in 2025.

Surveys
The survey originally planned for autumn/winter 2024 has been postponed to 2025. Work has begun on a draft of the questions, which is currently under review by the Board members.

Miscellaneous
As in the past, a GDP newsletter has been sent out every month.

Please also see the European GDP Association website for more information.

Get an overview of the current GDP events.

Guideline Developments
GMP-Auditor Handbook
The AUDITOR HANDBOOK ACTION AND MILESTONE Review was sent out to control activities.

Annex 7 for the document “Auditing Cannabis” a audit plan template and a Glossary were written and reviewed and will be added to the Handbook.

An ATMP chapter was written and will be added after review.

For further information, please see the GMP Auditor Assoication website.

Take further a look at the current GMP Auditing training courses & conferences.