ECA Group Update May to August 2023
Find out what the ECA Foundation Interest and Working Groups were working on and accomplished between May and August 2023.
Analytical Quality Control Group
The second online Board meeting 2023 took place mid of June. The main topic was the development of new AQCG guidelines. A face-to-face meeting is scheduled on 20 November 2023 in connection with this year’s PharmaLab Congress in Neuss, as several board members will be part of the speakers team.
The group is working on the ECA AQGC Analytical Instrument and System Qualification (AISQ) Guideline. A draft was reviewed during the board meeting in June, and some comments were incorporated.
Dr Christopher Burgess (Advisory Board Chairman) gave a talk on “Lifecycle approaches for establishing ‘Fitness for Intended Use’ of Analytical Instruments and Systems, USP <1058>, in order to support and maintain ‘Fitness for Purpose’ of Analytical Procedures USP <1220>” at the Eurachem workshop in Berne on 22 and 23 May 2023.
For further information, please see the Analytical Quality Control Group website.
Take a look at the current courses & conferences programme in analytical quality control.
There was a meeting of the Qualification/Validation Task Force (partly) on-site end of June 2023. The next board meeting is planned for 13 November 2023 online.
The Group's Good Practice Guide Integrated Qualification and Validation is under continuous development:
- Finalisation of the open chapters “Categorization” (with feedback from a regulator) and “CARA”
- Collection of more practical examples to include in the appendices (more content) – with the purpose to transfer them into small ECA booklets and videos
- Rephrasing from “pharmaceutical manufacturers” to “regulated firms” (or similar), ideally by those 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
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.
European GDP Association
In May 2023, Laura Ribeiro decided to step down from her position as Board member.
An online Board meeting took place on 26 June 2023. Since many board members were unable to attend this meeting, there will be another board meeting in November.
As mentioned in the goals section of the 2023 Business Plan, it is planned to review and update the RP Code of Practice and add UK’s new requirements, which should be started in the near future. Further details will be discussed at the next meeting in November.
Please also see the European GDP Association website for more information.
Get an overview of the current GDP events.
Visual Inspection Group
Next Board Meeting is planned for 25 September 2023 in Vienna.
Two points on the agenda of the board meeting concern changes to the ECA Guide.
The Visual Inspection Group website is continuously updated with further developments.
To find out what courses/conferences are coming up, please see the current events overview.
Niina Taylor will leave the board because of private reasons. To replace her, Julie Van Kerschaver, Janssen, was appointed as new member. The position of the Vice Chair was taken over by Dr Ulrike Herbrandt.
The next Board meeting is scheduled live in November 2023 at this year’s PharmaLab Congress in Neuss.
Participation in the Public Draft Guidelines:
- EMA consultation: Concept Paper on the development of a guideline on the quality aspects of mRNA vaccines
- Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Find out more on the ATMP Group website.
Please also take a look at the events programme concentrating on ATMP topics.
Pharmaceutical Microbiology Group
After Dr Marcel Goverde decided to withdraw from the Board, André Kriegeskorte has now been appointed to the Board of the group. André is an experienced microbiologist and biotechnologist from GSK.
The next meeting of the Board will be held on-site on 20 November in Neuss/Düsseldorf at the PharmaLab Congress.
Given the increasing importance of NGS (Next Generation Sequencing) and the new scheduled pharmacopoeial chapters on NGS related to viruses, which is expected in 2024, a new NGS Task Force was set up. A first kick-off meeting of this new Task Force was already held on 2 August. It is composed as follows:
- Oleg Kruth, Paul Ehrlich Institute – Chair
- Christine Farrance, CRL – Vice Chair
- Sven Deutschmann, Roche
- Hans-Joachim Anders, Novartis
- Daniel Männle, Novartis,
- Dominik Meisohle, Boehringer Ingelheim
- Thomas Meindl, LS Laboratory
- Michael Ruffing, Boehringer Ingelheim
- Olaf Stamm, Charles River
- Bernice Westrek, MSD
- Thierry Bonnevay Sanofi
- Inanc D. Ersreim, Thermo Fisher Scientific
- Sandra Lorenz, Boehringer Ingelheim
Please also take a look at the Pharmaceutical Microbiology Group website for more as well as at the current courses & conferences programme in pharmaceutical microbiology.
European QP Association (EQPA)
A proposal and aid was developed as “speaker advise” to close potential gaps between the speakers’ unawareness and EQPA’s general aligned positions and interpretations. There is no intent to limit the dispute on opposing positions, but much rather to limit confusion in the audience around shared conflicting positions. EQPA’s understanding of EU law is that in summary the QP has a statutory duty to ensure that the legal requirements are met before certifying a batch, but is not responsible for putting the necessary measures in place. That is the responsibility of the Manufacturing/Import Authorisation Holder and its senior management – by putting in place a comprehensively designed and correctly implemented Pharmaceutical Quality System (PQS).
New version of the “Code of Practice for QPs”
In January the Good Practice Guide “Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU” underwent a comprehensive revision, and a new chapter on "Ethics for the Qualified Person – A Professional Code of Conduct” was added. Now the entire guide has been revised again. Besides general linguistic changes and a structural review for clarity, the following amendments were made:
- New elaborated chapter on Brexit and consequences
- Revision of chapter on clinical trials, adoption to Clinical Trial Regulation
- Update on all references to the Clinical Trial Regulation, Veterinary Medicines Regulation and ATMP Regulation/GMP Part IV
- Integration of Annex 21 for importation
- Integration of EQPA survey results as appropriate
The new version 10.0 of the Guide is available again for you as member in the members’ area.
The results of a survey on Annex 21 were summarised and published in the EQPA Members Journal and on the Website. The total of 110 responses were considered, which allow some interesting insights and conclusions.
Comments to Revision of the EU general pharmaceuticals legislation
Together with the ECA, the EQPA provided official feedback to the planned revision of the EU general pharmaceutical legislation.
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.