03 January 2023
European QP Association Activities in the second half of 2022
What the European QP Association was working on in the second half of 2022 is summarized below.
Board meetings and resolutions
A Board Meeting was held on 02 December face to face in Berlin. Agenda was:
- Open tasks from last Board Meeting incl. update to the QP Code of Practice/ EQPA Code of Conduct
- Feedback for QP Forum 2022 and ideas for QP Forum 2023
- Update IMP Working Group
- IWG interaction 2022 and outlook 2023 - alignment on general positions
- possible political and other threats and their influence on application of GMP and whether this will need attention also by EQPA
- Projects: Chapter 4 and Annex 11 update
Developments on the Board
Brenda Van Assche was winding down her responsibilities in the IMP Working Group after seven very successful years of excellent work. The Committee’s has taken the decision to appoint Katrien Himpens as Brenda’s successor with the aim of maintaining the same spread of pharmaceutical company size. Katrien is Director Quality Assurance and Qualified Person at Janssen, Pharmaceutical Companies of Johnson and Johnson.
Cheryl Chia was invited to join the EQPA Board of Directors. Cheryl is an independent consultant since 2019, providing advice and acting as QP if necessary to pharmaceutical companies that are developing their organisations in Europe. Cheryl was originally a hospital pharmacist in England and made the switch to Industrial Pharmacist when she moved to the Netherlands in 2002. There she worked for 7 years at Organon N.V. in various roles and for 10 years at Amgen Europe B.V. in various roles including Production QA, QP and RP and Supply Chain.
Gudeline Developments
White Paper on Annex 21 and fiscal importation
EQPA has published a paper in the download section of the members’ area discussing “Developments on GMP classification of fiscal imports”. Background: The potential need for an Annex 21, finally published in February 2022, was identified during the development of Annex 16 – when the authors concluded that not all topics around importation could be clarified. One dominant and main driver for the new Annex 21 is thus the existence of fiscal importation and whether such concepts of international money transactions crossing outside boarders of the EU should be handled according to GMP regulations or not. The issue was legally complex. Annex 16 was cleared to be published in 2016, the solution on fiscal importation was expected to come with Annex 21. It did not.
David Cockburn, Georg Goestl, Ulrich Kissel have a finalised a document on Professional Code of Conduct (Ethics for the Qualified Person) which will become part of the current EQPA Code of Practice for QPs as a new Chapter one. Publication will be done via mailings and video on EQPA website, Linked-In and magazines.
Surveys
National requirements for QPs beyond EU requirements
EU law is built on parent acts including directive 2001/83/EC and since end of January 2022 the Regulations 536/2014 on Clinical Trials (CTR) and Regulation 2019/6 on Veterinary Medicines (VMR). EudraLex Volume 4 includes a common interpretation of how to comply with EU legislative expectations. The specific responsibilities of the QP are not really numerous as defined in directive 2001/83/EC. However, EQPA knows from discussions and previous surveys that countries may add specific additional requirements and personal responsibilities for QPs beyond this directive and the GMP Guides.
With this survey sent out end of July with a reminder end of August, EQPA was looking for more insight in this. Results should also support argumentation for a better harmonization across the Member States.
Annex 21
After a rather long development phase, Annex 21 Importation of medicinal products was published in February 2022. It defines the different roles of manufacturers and QPs working with such manufacturers involved in importation. Its transition period ended by 25 August 2022. With this survey sent out late November, EQPA wanted to learn more about the impact of this new guideline on QPs – e.g. which compliance gaps may have been identified and how successful they have been closed. The survey particularly addresses responsibilities of QPs involved in importation scenarios.
Events
QP Forum
The 17th QP Forum was held as a hybrid conference on 01/02 December. Delegates could choose whether to join live on-site in Berlin or live online on a screen.
Two parallel Pre-Conference Sessions were preceding the Forum on 30 November: Investigational Medicinal Products and Quality Culture
The hybrid version of the Forum was very successful. About 350 delegates have joined over the three days (approx. 2/3 on-site and 1/3 online)
Miscellaneous:
EQPA is working with other stakeholders on an industry follow-up on COVID-19 & supply chain activities: As a follow-up of the EMA-IWG-Industry meeting, industry would like to provide to the IWG the feedback on the EMA-IWG action item: ‘The Interested Parties are invited to provide suggestions for consideration by IWG on potential alternative measured to manage expiring GMP-certificates at the end of 2022’.
A paper for the EMA GMP/GDP IWG on Qualified Persons (art. 48 of Directive 2001/83/EC) Practical Experience Requirements was prepared by EQPA/ECA (lead) and EFPIA. During the GMP/GDP IWG meeting with Interested Parties in March 2022, the lack of harmonisation in the interpretation and transposition of the practical experience requirements for Qualified Persons (QPs) laid down in EU legislation was presented. A proposal was therefore made to harmonise approaches, for example through guidelines. The Commission’s representative at the meeting invited the Interested Parties to submit a proposal directly to the Commission in the context of the ongoing revision of the EU general pharmaceuticals legislation. EQPA, together with ECA Foundation (ECA) and EFPIA wrote a problem statement with a detailed proposal and rational.
Suggestion to amend Directive 2001/83/EC on Requirements for the Qualified Persons
During the meeting of the GMDP Inspectors Working Group (IWG) meeting with Interested Parties the lack of harmonisation in the interpretation and transposition of the practical experience requirements for Qualified Persons (QPs) laid down in EU legislation was discussed. A proposal was therefore made to harmonise approaches, for example through guidelines. Grasping that the underlying cause of the problem is because of the terminology used in the EU legislation (Dir 2001/83/EC), the Commission’s representative at the meeting invited the Interested Parties to submit a proposal directly to the European Commission in the context of the ongoing revision of the EU general pharmaceuticals legislation.
The European Qualified Persons Association (EQPA), together with ECA Foundation (ECA) proposed to amend Directive 2001/83/EC on Requirements for the Qualified Persons.
EU Commission DG SANTE Unit B4 will now make will make a proposal for the revision of article 49 taking into account the suggested changes!
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