ECA Group Update May until August 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

Board Developments
The first face-to-face meeting of the Board was held on 24 June 2024 in Barcelona. One of the main tasks was the further development of the GMP-Auditor’s Handbook and the action plan for 2024/2025.

Guideline Developments
GMP-Auditor Handbook
In the course of the first GMP-Auditor Forum, the “ECA Good Practice Guide – GMP Auditors Reference Handbook” (Version 2.0 June 2024) was published in the download area of the Association’s website and in the Download for the delegates of the conference. Previous version and chapters published before were replaced.

A project plan was developed by the chair for further improvements and amendments.

Surveys
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. Espionage suspects may be prevented from leaving China by order of the national security authorities at provincial level or higher. This provision also applies to foreigners.

For that reason the EQPA as well as the GMP Auditor Association asked for feedback with regard to their members’ awareness, understanding and implication of the Chinese revised counterespionage law. Results can be found in the survey section of the members’ area.

Events
GMP-Auditor Forum
The first GMP Auditor Forum of the Association was held on 25/26 June 2024 in Barcelona. More than 60 experienced GMP-Auditors discussed current topics and exchanged opinions and experiences with other auditors in moderated sessions, during presentations and networking breaks.

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
A face-to-face Board Meeting is planned for 24 November 2024 at PharmaLab in Düsseldorf/Neuss, Germany. Further meetings will take place as needed.

Guideline Developments
Selected questions raised during the Live Online Training “Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation” on 29 April 2024 with the teaching team's answers were published in the AQCG newsletters.

Miscellaneous
The PharmaLab Congress will take place from 25-27 November 2024 in Düsseldorf/Neuss. This year, the program includes a new track on Analytical Instrument Qualification and System Validation, where several Board members of the ECA Analytical Quality Control Group (AQCG) will be part of the speaker team.

For further information, please see the Analytical Quality Control Group website.

Take a look at the current courses & conferences programme in analytical quality control.

Visual Inspection Group

Board Developments
There are no changes planned within the board. The board meeting is scheduled for November in Berlin.

Guideline Developments
The group is discussing an update of the CCIT position paper.

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 for fall 2024 (online Meeting via Webex).

It is planned to hold a face-to-face board meeting during the GMP & GDP Forum in June 2025 in Barcelona.

Guideline Developments
A review and update of the existing ECA/PQG GDP monograph is planned. Comments from the GDPA perspectice were provided to PQG.

Surveys
A survey is planned for fall/winter 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 next meeting is scheduled for 4 November 2024 on site before the Equipment Qualification Forum.

Guideline Developments
The Good Practice Guide (GPG) on Integrated Qualification and Validation is in the final phase of development.

For 2024 the launch of version 3.0 with a slightly changed name Good Practice Guide Qualification and Validation (subtitle will be unchanged) is planned at the Equipment Qualification Forum 05/06 November 2024 on-site in Heidelberg.

Surveys
Surveys on AI in qualification projects and regarding DoE are planned.

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
Updated Job Description Template
In EQPA’s efforts to hold contents and materials provided to members up to date, EQPA’s job description template was modernized. The members of the recently created Engagement Board worked out version 2 of the EQPA job description template providing concise and easy to use guidance to the subject. It is now available to all EQPA members on the webpage.

Surveys
Survey on Chinese Counterespionage Law

China has revised its counterespionage law (see also GMP Auditor Association). 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. Espionage suspects may be prevented from leaving China by order of the national security authorities at provincial level or higher. This provision also applies to foreigners.

For that reason the EQPA as well as the GMP Auditor Association asked for feedback with regard to their members’ awareness, understanding and implication of the Chinese revised counterespionage law.

Survey results on the QP’s position within the MIAH organization
The survey results summary report on the QP’s position within the MIAH organization have been published.

Survey of the IMP Working Group on the CTR
The EU Clinical Trial Regulation (536/2014) (CTR) is mandatory for all new Clinical Trial Applications (CTA) in the European Economic Area (EEA) to be submitted under the CTR. Initial submissions under the Clinical Trial Directive (2001/20/EC) (CTD) are no longer possible. The European QP Association (EQPA) would like to know, via a short survey, how the new regulation, and related guidelines, have affected IMP QPs in the relevant aspects of clinical trials. The results of this survey will be shared and discussed at the IMP Pre-conference of the Qualified Person Forum on 27 Nov 2024 in Amsterdam and will also be published on the EQPA website.

You will find detailed reports on the survey results in the survey section of the EQPA Website members' area.

Publications
A new issue of the EQPA Newsletter was published including articles on the results of the surveys on the position of the QP in the MIAH organization, Remote Certification and QPShare. The new edition is also available in the members’ area.

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.

Publications
A new issue of the EQPA Newsletter was published including articles on the results of the surveys on the position of the QP in the MIAH organization, Remote Certification and QPShare. The new edition is also available in the members’ area.

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
Gert Viville (Janssen Pharmaceutica NV) will step down from this team. The next board meeting should take place in Nov 2024 (online Meeting via Webex).

Guideline Developments
It is planned to write a position paper on ICH Q6. A draft version has already been written and shared with the members for comments. The comments will be discussed in Nov during the meeting.

Events
Five new training courses were discussed, designed and planned in collaboration with the ATMP Board. Many of these training courses have speakers from the 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
Due to her involvement in the EMC and her comments on the PharmEur NGS chapter, Anna Liznar from Pathoquest will be invited to the next Board meeting – which is planned on 25 November on-site in Neuss, Germany. The chairs of the ATMP Groupe are expected to be present at times to coordinate joint activities.

Guideline Developments
The NGS Task Force, which was founded last year, collected comments on the new NGS chapter in PharmEur in June and submitted them on time.

Find out more on the Pharmaceutical Microbiology Group website.

Please also take a look at the events programme concentrating on microbiology topics.

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