ECA Group Update September to December 2023
Read about what the ECA Foundation Interest and Working Groups were working on and accomplished from September through December 2023.
Analytical Quality Control Group
Board Developments
Patrick Jackson, Investigator in Chemistry, Manufacturing and Controls - Analytical at GSK, was invited to join the Board and accepted his nomination.
The Board met in person end of November 2023 at PharmaLab in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.
The group has agreed, among other things, to include the following elements in the work program for the next two years:
- Review and updating of existing Guidelines, in particular
- OOS Guideline 2013 following FDA September 2022 update
- OOE/OOT Guideline 2016 updated for <1220> Stage 3
- APLM Guideline July 2018 updated for <1220> & Q2(R2) & Q14 - Expanding the AQCG links with authorities and other organzisations
Guideline Developments
The Group has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV). Version 1 of the new document was adopted at the Board Meeting in November in Düsseldorf/Neuss.
The document was written by Dr Christopher Burgess (Chairman of the AQCG Board) and Dr Bob McDowall (Members of the ECA Analytical Quality Control Group Advisory Board and Member of the ECA IT Compliance Interest Group).
The ECA has decided to publish the Guide widely by allowing to download the document free of charge. Die PDF file is available in the AQCG website members' area in January 2024.
Surveys
A survey is planned in connection with the new Guide. Comments and recommendations can be submitted until 30 June 2024.
Miscellaneous
- A newsletter was sent to the members of the group in November. It is planned to send out regular newsletters in the future.
- Several Board members were part of the speakers’ team at PharmaLab 2023.
- It is planned to discuss selected aspects related to the new AIQSV Guide at PharmaLab 2024
For further information, please see the Analytical Quality Control Group website.
Take a look at the current courses & conferences programme in analytical quality control.
European GDP Association
Board Developments
Dr Martin Egger was appointed as CEO at Infrareal Holding and Pharmaserv. Due to the heavy workload he decided to step down from his position as Advisory Board Member. We thank Dr Martin Egger for his strong support for the Association and wish him every success in his new function.
An online Board Meeting (second Board Meeting 2023) took place mid of November 2023. Concrete goals for 2024 were set. The next board meeting is scheduled to take place in June 2024.
Guideline Developments
A review and update of the existing ECA/PQG GDP monograph is planned. The GDPA will support the project. Several Board Members will be involved in the review process.
Surveys
A survey is planned for 2024.
Please also see the European GDP Association website for more information.
Get an overview of the current GDP events.
Validation Group
Board Developments
The Board is still unchanged. There was an online meeting of the Qualification/Validation Task Force mid of November 2023.
Guideline Developments
The Good Practice Guide Integrated Qualification and Validation is still under development:
- Finalisation of the open chapters “Categorization” (with feedback from an regulator) and “CARA”
- Collection of more practical examples to bring into the appendices (more content). Can later be transferred 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
- The launch of version 3.0 is planned at the forum in November 2024
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 QP Association (EQPA)
Board Developments
A Board Meeting was held mid of October face to face in Vienna, where the following topics were discussed:
- Open tasks from last Board Meeting
- Feedback for QP Forum 2023 and ideas for QP Forum 2024
- New „Engagement Board“
- New pharmaceutical legislation - sharing views
- Interaction with IWG - prioritisation and alignment of topics, follow-up actions for IWG meeting
- Update on improvements to the Discussion Forum
- Activities for the board in 2024
EQPA Engagement Board
As decided at the Board Meeting in Vienna, EQPA set up the European QP Association Engagement Board. A charter was defined to describe purpose and targets. The idea was introduced in the opening presentation of the QP Forum. Some members showing interest in supporting such a group were later invited to join it. Two video-conferences were held to discuss the Charta and first activities.
Surveys
Survey on the position of the QP within the organization of the manufacturing authorization holder
With this survey, EQPA wanted to know to what extent the role and function of the QP has evolved, in response to the changes and evolution of the pharmaceutical companies that are manufacturing authorization holders, like the position of QPs within the organisation and among other fellow QPs, differences between QPs responsible for commercial or investigational medicinal products and how the manufacturing authorization holder enables the QPs to carry out their duties. Also Heads of QA/Quality Unit/Heads of Quality Control and Production were invited to participate.
Miscellaneous
EMA Meeting with Interested Parties
The group of Interested Parties sent a letter to EMA’s GMDP IWG with current pharmaceutical priority topics. The Interested Parties are asking GMDP IWG to bring up topics in advance where the inspectors would like to have feedback from the industry and where inspectors think the industry can improve. Furthermore, by this letter the group would like to engage in targeted discussions on specific topics.
This letter was coordinated among all associations (including ECA and EQPA) to prepare for the EMA meeting. EMA will review the proposals and assess what information will be provided at the meeting in spring 2024.
Publications
EQPA Newsletter
The December issue of the EQPA Newsletter was uploaded on the download section of the members’ area with articles on Quality Oversight and Pharmaceutical Contracts.
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.
Visual Inspection Group
Board Developments
Board meetings took place end of September in Vienna and mid of November online.
Christof Langer will become member of the ECA VIS Board.
Surveys
An online survey has been carried out within the preparation of the annual conference.
Guideline Developments
The group is working on an updated Version (4.0) of the ECA Visual Inspection Guideline, which is planned to be finished in the 1st quarter of 2024.
Miscellaneous
The annual meeting is scheduled in early Nov 2024 in Berlin.
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.
ATMP Group
Board Developments
An on-site Board Meeting (second Board Meeting 2023) took place end of 20 November 2023 at PharmaLab. Concrete goals for 2024 were set.
The next board meeting is scheduled in March 2024 at the GMP PharmaCongress.
Guideline Developments
The development on a position paper on cell-banks for allogeneic cell therapy products started.
Find out more on the ATMP Group website.
Please also take a look at the events programme concentrating on ATMP topics.