02 July 2024
European QP Association Activities in the first half of 2024
What the European QP Association was working on in the first half of 2024 is summarized below.
Board Meetings and Resolutions
EQPA Engagement Board
During the QP Forum 2023 a new initiative to establish a new platform to selected EQPA members was made public. Volunteers who want to engage on a regular basis in the new EQPA Engagement Board were looked for. The group was successfully kicked-off and met three times since December 2023 – TCs are foreseen every 6 weeks. A first target is to learn to know each other, build trust and experience how to best work together in this setup which is new for all involved. First project was to create a job description.
Surveys
Survey on EMA Q&A on remote certification / confirmation
In July 2023 EMA published three Q&As to clarify expectations on remote certification by QPs across Europe. The Q&As were provided in response to discussions held during the yearly joint meeting in early 2023 between the EU GMP and GDP inspectors working group (IWG) and interested parties including ECA/EQPA. In preparation for the 2024 joint IWG –Interested Parties meeting the IWG requested feedback as to whether the Q&As had been useful to QPs. EQPA set-up a membership survey to collect feedback on the usefulness of these Q&As. The results of this survey were discussed with IWG on March 7th, 2024 during the joint IWG-Interested Parties meeting.
A total number of 120 responses with 103 coming from EU member states were considered in this survey allowing some interesting insights and conclusions. The non-EU responses were in some cases used as reference sample.
Survey on Chinese Counterespionage Law
China has revised its counter-espionage law. Compared to the previous version, the new version expands the government's powers to combat espionage and emphasises the role of the public in this task. In theory, activities carried out as part of an audit or inspection can now also be punishable by law. Espionage suspects may be prevented from leaving China by order of the national security authorities at provincial level or higher. This provision also applies to foreigners.
For that reason the EQPA as well as the GMP Auditor Association asked for feedback with regard to their members’ awareness, understanding and implication of the Chinese revised counterespionage law. Results can be found in the survey section of the members’ area.
Survey on the use of QPSHARE
A short survey was created to get valuable insights into its usage, awareness, and areas for improvement. Responses have been collected from 170 survey participants. Only 22 (13%) were aware of the QPSHARE database before receiving the survey. Overall, it can be said that the database and, in particular, the possibility of carrying out joint activities such as joint audits or sharing audit reports is not used very often. This may be mainly due to a lack of knowledge of the database. The EQPA can only encourage its members to utilise the database and the opportunities it offers to save resources.
Survey results on the QP’s position within the MIAH organization
The survey results summary report on the QP’s position within the MIAH organization have been published in the “Members’ Surveys” section.
Please check the Members' Survey Results section in the members' area to read detailed reports on the survey results.
Miscellaneous
EMA Meeting with Interested Parties on 07 March
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties, on 07 March 2024. EMA provided an update on the activities of the IWG in 2023, with focus on the regulatory flexibilities in light of the COVID-19 pandemic, the progress on IWG Drafting groups on guidelines and Q&As, developments concerning Mutual Recognition Agreements as well the outlook for 2024 with areas of focus for the GMDP IWG.
ECA/EQPA provided feedback on the general process of revision of the GMP guidelines, and proposed areas for consideration for improvement of this process to maintain the consistency and integrity of the overall guidelines. The GMP IWG recognised the need to maintain the consistency and integrity of the GMP guidelines, and ensured that when a guideline is being drafter or revised, consideration on impact to other sections is given.
EQPA provided detailed feedback on the results of a EQPA survey on the published Q&A on remote certification. The overall feedback was that the guidance is considered useful, and more QPs are considering remote certification following the clarifications. The survey also identified that a more standardised approach between the MSs is still an area for improvement.
The IWG acknowledged the survey results and supported the interested parties to continue monitoring the implementation and report any further updates.
Following the meeting, the Interested Parties sent a letter to provide feedback to the attention of the GMDP IWG. IPs greatly appreciate the interaction and feedback during that meeting and want to build on that experience and point out opportunities for improvement, especially with respect to the communication in both directions by discussing details on topics of mutual interest.
Meetingwith EDQM
EDQM wants to foster regular exchange with industry associations and has contacted EQPA. A first meeting was held on 11 March 2024 for a further introduction and sharing ideas. EDQM will organise a meeting in the second half of this year to discuss current issues and collaborative measures for 2025. In general, measures would be supported by both sides to raise awareness about the European Pharmacopoeia and other activities of the EDQM.
Publications
EQPA Newsletter
A new issue of the EQPA Newsletter was published including articles on the results of the surveys on the position of the QP in the MIAH organization, Remote Certification and QPShare.
Events
QP Forum
The EQPA Board has decided to offer this year's QP Forum (28/29 November 2024, Amsterdam) as on-site only Conference. A lot of hot topics for QPs have been identified and will be discussed in the various presentations. After a Key Note by the Executive Director of the European Medicines Agency, Emer Cooke, a lot of hot topics for QPs will be discussed in the various presentations and interactive sessions.
Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 27 November: Investigational Medicinal Products, Quality Oversight for MAHs and one on Liability.
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