European QP Association Activities in the second half of 2021
What the European QP Association was working on in the second half of 20221 is summarized below.
Board meetings and resolutions
A Board Meeting was held on 06 December. Agenda was:
Feedback QP Forum 2021
Review of meeting minutes board meeting 2020
IMP Working Group Update
Current and Possible future projects
Planning the QP Forum 2022
Guideline developments EQPA Code of Practice for QPs:
After a major revision in 2020, Annex 1 of the document was now completely revised based on a survey and feedback from members. Annex 1 summarises the EU member states’ national requirements for becoming a Qualified Person and other national specifics.
The assessment of the Survey “QP qualification requirements in different member states” was written by Ulrich Kissel and reviewed by David Cockburn.
The survey focused on the professional route to becoming a QP and related topics. EQPA is grateful again for its members’ strong engagement resulting in a wealth of data, which was analyzed in the respective assessment. As usual in such surveys the outcome can only reflect the variety of responses received. Responses from different participants may differ only slightly or sometimes, even conflict. Given the responses result from individual experiences, the authors had no desire to filter them in any way. The assessment is available on the website and in EQPA membership Letter.
Survey on QP Integration in Organizational Structure
Chapter 2 of the EU GMP Guide defines key personnel to be available at a pharmaceutical manufacturing company and respective responsibilities while at the same time providing some flexibility regarding the personnel taking responsibility. Depending on the organizational structure, it has to be carefully defined who takes what responsibility. With this survey EQPA would like to get an overview on how today’s organizations operate. With the results also intends to contribute to a better clarification in the current GMP Guide with a better basis for influencing and commenting on potential upcoming revisions.
Benchmark IMP Batch Certification/Regulatory Compliance Check
Depending on individual organisations and processes established, the batch certification may happen at different points in time. With a short survey as a benchmark, the IMP Working Group wanted to gain an overview of the current practices and possible changes coming along with the upcoming Clinical Trial Regulation.
Reflection Paper GMP and MAH
On 23rd July 2021 the Reflection paper on Good Manufacturing Practice and Marketing Authorization Holder was published by EMA in its final version. QPs need to have a good understanding of the contents of this new reflection paper and may need to work on identifying and closing gaps in interactions with the MAH not previously given adequate attention. These considerations provided the basis for a survey covering the main topics of the Reflection Paper.
QP Forum: This year's QP Forum on 02/03 December was again only available as a Live Online Conference. As all lectures in the main Forum and the Pre-Conference Sessions were held consecutively delegates could follow them at their screen.