ECA Group Update September through December 2022
Please see the ECA Foundation Interest Groups' report to find out what they were working on and accomplished in the four months from September through December 2022.
European QP Association (EQPA)
Brenda Van Assche was winding down her responsibilities in the IMP Working Group after seven very successful years of excellent work. EQPA would like to extend their heartfelt thanks to Brenda for her outstanding service to the board and her energizing and inspiring contribution to the success of the organisation.
The Committee 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 JSC at Janssen, Pharmaceutical Companies of Johnson and Johnson.
Further details were shared during the Board Meeting on 02 Dec 2022. There also was a formal announcement at the IMP QP Pre-Conference to the 2022 QP Forum and a written announcement in the EQPA news after the Forum.
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 seven years at Organon N.V. in various roles and for ten years at Amgen Europe B.V. in various roles including Production QA, QP and RP and Supply Chain.
A Board Meeting was held on 02 December face to face in Berlin – with the following agenda:
- 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
New Professional Code of Conduct
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 the EQPA website, in Linkedin and in magazines.
Survey on 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 in November, the 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. That’s why the new survey particularly addresses responsibilities of QPs involved in importation scenarios.
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 joined over the three days (approx. 2/3 on-site and 1/3 online). A five star rating was used - with five stars meaning very good and one star rather poor. The rating was very positive: The overall average rating of the pre-conference session on IMPs was 4.1 stars (result might have been influenced by the technical problems online delegated were facing in the morning), the pre-conference session on Quality Culture delegates rated with 4.2 stars. The overall average rating of day one of the QP Forum was 4.0 stars, day two was rated with 4.2 stars.
Suggestion to amend Directive 2001/83/EC on Requirements for the Qualified Persons
During the GMDP Inspectors Working Group (IWG) meeting with Interested Parties, on 10 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 discussed. A proposal was therefore made to harmonise approaches, for example through guidelines. Grasping that the underlying cause of the problem is 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 a proposal for the revision of article 49 taking into account the suggested changes!
European QP Association website
Find out more about the current courses & conferences programme organized and co-sponsered by the European QP Association.
Pharmaceutical Microbiology Group
Olivier Guenec is taking on new responsibilities at Sartorius and therefore announced to leave the Board in 2023. He will be succeeded by Erric Clement Arakel from Sartorius.
The Board Meeting took place at PharmaLab end of November in Neuss. In future there will be a face-to-face meeting before PharmaLab and before/after the European Microbiology Conference and a virtual meeting in the other two quarters.
New Annexes for Guideline
During the Board meeting, the two annexes (on microbial identification methods) to the Deviation Guide were approved by the Board.
Cooperatiobn with ATMP Group
It was decided to invite Sabine Hauck, Chair of the ATMP Group, to the Board Meetings, as there is a lot of overlap, especially in the microbiological QC of ATMP.
Pharmaceutical Microbiology Group website
Take a look at the current courses & conferences programme in pharmaceutical microbiology.
The Board is still unchanged. The group met on-site mid of November.
New Version of Guide
The version 2.2 of ECA´s Integrated Qualification and Validation Guide was published at the „Qualification and Validation Forum mid of November. 40 delegates from 12 countries welcomed the new version. The new version was discussed intensively, especially the chapter categorisation and electronic validation documentation. Further, the wish for a simplified version, especially for suppliers, came up.
For 2023 the plans are:
- Finalisation of the open chapters “Categorization” and “CARA”
- Collection of more practical examples to bring into the appendices (more content). Can later be transferred into small booklets and videos
- Rephrasing from “pharmaceutical manufacturers” to “regulated firms” (or similar), ideally by the group members who are also dealing with food products
- Addition of a small section about most important GEP activities / process flows being a prerequisite for successful qualification
- Simplification of the guide for easy understanding by all
Like the years before the ECA offers courses on “Process Validation, Cleaning Validation, Process Understanding and about Ongoing/Continued Process Verification and a course about practical use of the Good Practice Guide Integrated Qualification and Validation Guide online and on-site. The Qualification and Validation Forum in Nov 23, is also in planning. For all courses and conferences coming up, please see the current validation courses & conferences programme
European GDP Association
The European GDP Association has finalised the programme for the GDP part of the GMP & GDP Forum 2023 (20-22 June 2023 in Barcelona). The programme was published.
Membership cards for the European GDP Association members were issued. Cards are valid for one calendar year (January to December 2023).
European GDP Association website
Get an overview of the current GDP events.
Visual Inspection Group
The Visual Inspection Guide as well as the CCIT Position Paper will not be changed due to the new Annex 1. The CCIT paper has been updated to version 2.1 in October (editorial change in chapter 4.3: Stopper height of vials specified more precisely)
Survey on Visual Inspection Conference
Felix Krumbein develops a survey which will be used in the context of the next Visual Inspection Conference in order get some information of the audience.
Visual Inspection Group website
To find out what courses/conferences are coming up, please see the current events overview.
Dr Ulrike Herbrand, CRL became a new member of the Board and attended the Board Meeting mid of October for the first time.
The Board Meeting took place online mid of October. During the meeting, the activity plan for 2023 was discussed as well as the content for the ATMP session at the PharmaCongress, and potential further topics were evaluated.
A two day ATMP Track was conducted during PharmaLab for the first time. The second day was organised in cooperation with the Microbiology Group. The track was very well attended (seating in the room needed to be extended for day two).
Please also take a look at the events programme concentrating on ATMP topics.
Data Integrity & IT Compliance Group
New Version of Guideline
Version 3 of the ECA DI Guide was published in December 2022. The new version is available as a free copy for the members of the DI & IT Compliance Group.
Comments on Guidelines
The group prvided comments on the FDA draft guideline “CSA - Computer Software Assurance” in November 2022.
Starting a discussion to comment the EU GMP Annex 11 concept paper. Deadline for the comments: 16 January 2023.
Data Integrity & IT Compliance Group website
Here you will get to the courses and conferences focusing on data integrity & IT compliance issues.