ECA Group Update January through April 2024
Find out what the ECA Foundation Interest and Working Groups were working on and accomplished in the first four months of 2024.
GMP Auditor Association
This new Association was founded in January 2024 – with the goal to represent the interests of GMP auditors in the pharmaceutical and biopharmaceutical industry. It also aims to offer GMP auditors a forum that provides standards and assistance in conducting GMP audits.
Board Developments
Dr Ingrid Walther joined the Board of the European GMP-Auditor Association. Ingrid is an independent consultant and has more than 25 years of professional experience, including in the areas of R&D, QA/QC, auditing and management of strategic projects. She leads the project of creating/ finalising the ECA GMP Auditors Reference Handbook.
A first face-to-face Board Meeting is scheduled end of June in Barcelona at the group’s first GMP Auditor Forum. The Forum was also set up to allow GMP-Auditors to discuss current topics and exchange opinions and experiences with other auditors in moderated session. The presentations will address specific topics deemed important for GMP-Auditors.
Two WebEx Meetings were held for further development of the association and the handbook.
Guideline Developments
A first draft of the GMP-Auditor Handbook was created and four chapters were published on the website. Ingrid Walther started to revise the draft to create Version 2.0 for publication.
Surveys
China has revised its counterespionage law. Compared to the previous version, the new version expands the government's powers to combat espionage and emphasises the role of the public in this task. In theory, activities carried out as part of an audit or inspection can now also be punishable by law. The GMP Auditor Association considers these risks on audits and inspections potentially impactful on auditors. With a survey the association wanted to
get insights into awareness, understanding and implication.
For further information, please see the GMP Auditor Association website.
Take a look at the current GMP Auditor courses & conferences programme.
Analytical Quality Control Group
Board Developments
An Online Board Meeting (via Webex) took place end of February 2024. Several decisions were made concerning the work programme for the coming months.
A face-to-face Board Meeting is planned for end of November 2024 at PharmaLab in Düsseldorf/Neuss, Germany. Further meetings will take place as needed.
Guideline Developments
As already reported, the Group has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV).
The Group organized a Live Online Training “Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation” end of April 2024. During the training, Dr Christopher Burgess and Dr Bob McDowall provided an insight into the new Guide and the rationale for the lifecycle approach. The training included a USP speaker update on the Analytical Procedure Lifecycle by Dr Amanda Guiraldelli-Mahr (Scientific Affairs Manager at USP).
In the Q&A session after the presentations, many interesting aspects were discussed. Selected questions raised during the meeting with the teaching team's answers will be published in the next two Newsletters.
Surveys
A survey is running in connection with the new Guide. Comments and recommendations can be submitted until 30 June 2024.
Miscellaneous
One of the concrete goals mentioned in the Activity Plan is to send regular newsletters to the members of the group, approx. once a quarter. Newsletters were sent out in January and April 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.
Data Integrity & IT Compliance Group
Events
A new ECA Live Online Training on Artificial Intelligence was developed in cooperation with the visual inspection group and will take place end of October 2024.
For further information, please see the DI & IT Compliance Group website.
Take a look at the current Data Integrity & IT Complaince courses & conferences.
Visual Inspection Group
Board Developments
There are no changes planned within the board. The Board meeting is scheduled for early November in Vienna.
Guideline Developments
The new version 4.0 of the ECA Visual Inspection Guide was published in April 2024.
The group is discussing an update of the CCIT position paper as well.
Events
A new online conference specifically on the use of AI in automated visual inspection was developed and will take place end of October.
For further information, please see the Visual Inspection Group website.
Take a look at the current Visual Inspection courses & conferences.
European GDP Association
Board Developments
The next board meeting is scheduled in June 2024 (online Meeting via Webex).
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.
Events
A date for the next GMP & GDP Forum 2025 has been set. The group started to work on the programme.
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. There is a new member in the group.
Guideline Developments
The GPG Integrated Qualification and Validation is being continuously developed:
- Finalisation of the open chapters “Categorization” (with feedback from a 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 with the new title Good Practice Guide Qualification and Validation 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
EQPA Engagement Board
During the QP Forum 2023 a new initiative was made public to establish a new platform to selected EQPA members. Volunteers who want to engage on a regular basis in the new EQPA Engagement Board were looked for. The group was successfully kicked off and met three times since December 2023 – TCs are foreseen every six weeks. A first target is to learn to know each other, build trust and experience how to best work together in this setup which is new for all involved. The first impressions are very positive.
Surveys
Survey on EMA Q&A on remote certification / confirmation
In July 2023 the EMA published three Q&As to clarify expectations on remote certification by QPs across Europe. The Q&As were provided in response to discussions held during the yearly joint meeting in early 2023 between the EU GMP and GDP Inspectors Working Group (IWG) and interested parties including ECA/EQPA. In preparation for the 2024 joint IWG –Interested Parties meeting the IWG requested feedback as to whether the Q&As had been useful to QPs. EQPA set up a membership survey to collect feedback on the usefulness of these Q&As. The results of this survey were discussed with IWG on March 7th, 2024 during the joint IWG Interested Parties meeting. A total number of 120 responses with 103 coming from EU member states were considered in this survey allowing some interesting insights and conclusions. The non-EU responses were in some cases used as reference sample.
Survey on Chinese Counterespionage Law
China has revised its counterespionage law. Compared to the previous version, the new version expands the government's powers to combat espionage and emphasises the role of the public in this task. In theory, activities carried out as part of an audit or inspection can now also be punishable by law. The European QP Association considers these risks on audits and inspections potentially impactful on QPs’ responsibilities. With a survey EQPA wanted to get insights into awareness, understanding and implication. QPs perform audits, sign QP declarations referring to audits and certify batches received from appropriately inspected authorized manufacturers. Any limitation to audit or inspection execution will immediately impact QPs.
Survey on the use of QPSHARE
A short survey was created to get valuable insights into its usage, awareness, and areas for improvement. Responses have been collected from 170 survey participants. Only 22 (13%) were aware of the QPSHARE database before receiving the survey. Overall, it can be said that the database and, in particular, the possibility of carrying out joint activities such as joint audits or sharing audit reports is not used very often. This may be mainly due to a lack of knowledge
of the database. The EQPA can only encourage its members to utilise the database and the opportunities it offers to save resources.
You will find detailed reports on the survey results in the survey section of the EQPA Website members' area.
Miscellaneous
EMA Meeting with Interested Parties on 07 March
The meeting of the GMDP Inspectors Working Group (IWG) with Interested Parties took place on 07 March 2024. EMA provided an update on the activities of the IWG in 2023, with focus on the regulatory flexibilities in light of the COVID-19 pandemic, the progress on IWG Drafting groups on guidelines and Q&As, developments concerning Mutual Recognition Agreements as well the outlook for 2024 with areas of focus for the GMDP IWG.
ECA/EQPA provided feedback on the general process of revision of the GMP guidelines, and proposed areas for consideration for improvement of this process to maintain the consistency and integrity of the overall guidelines. The GMP IWG recognised the need to maintain the consistency and integrity of the GMP guidelines, and ensured that when a guideline is being drafted or revised, consideration on impact to other sections is given.
EQPA provided detailed feedback on the results of an EQPA survey on the published Q&A on remote certification. The overall feedback was that the guidance is considered useful, and more QPs are considering remote certification following the clarifications. The survey also identified that a more standardised approach between the MSs is still an area for improvement.
The IWG acknowledged the survey results and supported the interested parties to continue monitoring the implementation and report any further updates.
Following the meeting, the Interested Parties sent a letter to provide feedback to the attention of the GMDP IWG. IPs greatly appreciate the interaction and feedback during that meeting and want to build on that experience and point out opportunities for improvement, especially with respect to the communication in both directions by discussing details on topics of mutual interest.
Meeting with EDQM
The EDQM wants to foster regular exchange with industry associations and has contacted EQPA. A first meeting was held on 11 March 2024 for a further introduction and sharing ideas. The EDQM will organise a meeting in the second half of this year to discuss current issues and collaborative measures for 2025. In general, measures would be supported by both sides to raise awareness about the European Pharmacopoeia and other activities of the EDQM.
Events
The EQPA Board has decided to offer this year's QP Forum (28/29 November 2024, Amsterdam) as on-site only Conference. A lot of hot topics for QPs have been identified and will be discussed in the various presentations. After a Key Note by the Executive Director of the European Medicines Agency, Emer Cooke, a lot of hot topics for QPs will be discussed in the various presentations and interactive sessions. Preceding the Forum, three parallel Pre-Conference Sessions on specific topics will run on 27 November: Investigational Medicinal Products, Quality Oversight for MAHs and one on Liability.
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.
ATMP Group
Board Developments
Julie Van Kerschaver decided to step down as member of the Board. Her colleague Gert Viville (Janssen Pharmaceutica NV) was nominated to take her place.
The next board meeting is scheduled in Nov 2024 (online Meeting via Webex).
Surveys
A survey was started on quarantine shipment of ATMP manufacturers. For the analysis an extra working group was set up that will present the results to the Board in November.
Events
Two new ECA Trainings on ATMPs and on Tissue were developed and will take place on 02/03 July 2024 and 19 September 2024 with many speakers of the ECA ATMP Board.
Find out more on the ATMP Group website.
Please also take a look at the events programme concentrating on ATMP topics.
Pharmaceutical Microbiology Group
Board Developments
Prof Isabelle Bekeredjian-Ding is now Head of the Institute of Medical Microbiology and Hospital Hygiene at the University of Marburg. She remains on the Board as a representative of the academic perspective.
Dr Oleg Krut has joined the Board as a representative of the Paul Ehrlich Institute. He has already been Chair of the ECA MAT Drafting Group and is currently Chair of the ECA NGS Task Force.
Miscellaneous
The Group is commenting on the new draft of the EDQM 2.6.41. HIGH-THROUGHPUT SEQUENCING FOR THE DETECTION OF VIRAL EXTRANEOUS AGENTS.
Find out more on the Pharmaceutical Microbiology Group website.
Please also take a look at the events programme concentrating on microbiology topics.