ECA Groups report on their Activities between September and December 2025
The ECA Foundation Interest and Working Groups continuously work on various projects - what this comprised and what they accomplished between September and December 2025 you can read in their reports.
Visual Inspection Group
Board Developments
The annual board meeting took place in October during the ECA Visual Inspection conference in Vienna.
Guidelines Developments
Version 5.0 of the Visual Inspection Guideline and a revised CCIT Position Paper were published and made available to members.
Surveys
A survey on the state of technology for 100% visual inspection was conducted and evaluated. Results will be published in early 2026.
For further details and current events please see the Visual Inspection Group website.
GMP Auditor Association
Board Developments
The Board met online to review progress on the GMP Auditor Handbook update, with completion targeted for early 2026.
Guideline Developments
Work began on Version 3.0 of the Handbook, including new chapters on packaging audits, closing meetings, and AI in auditing.
Surveys
A survey was conducted to assess how GMP auditors use and evaluate AI tools. Results will be published on the association’s website.
Events
The programme for the GMP Auditor Forum 2026 in Barcelona was finalised and published.
For further details and current events please see the GMP Auditor Association website.
Validation Group
Board Devlopments
The Board composition remained unchanged. Topics and activities for 2026 were discussed during an online board meeting.
Guideline Developments
Feedback from the Equipment Qualification Forum was collected to improve qualification and validation guidance, with a focus on case studies, equipment-specific details, and templates. New booklet topics, including AI in qualification, are planned.
Surveys
A survey on the use of Statistical Process Control in continued process verification and other applications will be launched in early 2026.
Miscellaneous
A new on-site Quality Statistics course is scheduled for May 2026.
Expert meetings will continue throughout the year.
For further details and current events please see the Validation Group website.
Pharmaceutical Microbiology Group
Board Developments
Guidelines Developments
Events
Miscellaneous
For further details and current events please see the Pharmaceutical Microbiology Group website.
European QP Association
Board Developments
The EQPA Board met in November to discuss board changes, open actions, new governance principles, and feedback for latest and ideas for future QP Forums.
After eight years of service, Georg Göstl stepped down from the Board. He was succeeded by Patryk Jegorow, who already supports EQPA through working group activities and speaking engagements.
The IMP Working Group announced the creation of a PSF Taskforce for early 2026 to evaluate survey results and address key challenges, supported by a call for participants.
Surveys
Audit Trails
A survey was conducted to gather QP experience and interpretation of the proposed Annex 11 (draft 2025) requirements on audit trail availability. Results are expected in early 2026.
Product Specification File (PSF)
The IMP QP Working Group surveyed current PSF practices across companies. The results will be published on the IMP QP website.
Publications
A special EQPA newsletter edition on the evolution of the QP role was published and made available in the members’ area.
Miscellaneous
EQPA discontinued physical membership cards to reduce postal mail and improve sustainability, while maintaining full access to member services online.
Events
The QP Forum combined anniversary celebrations with expert presentations, interactive sessions, and pre-conference workshops, focusing on current regulatory and practical QP topics.
For further details and current events please see the European QP Association website.
Analytical Quality Control Group
Board Devlopments
One board member stepped down, with the possibility of rejoining in future years.
An in-person board meeting was held during PharmaLab 2025, and three board meetings are planned for 2026.
Guideline Developments
The Board continued revising existing analytical guidelines and reviewed timelines. New guideline ideas were discussed but postponed until revisions are completed.
Miscellaneous
Regular newsletters were distributed.
The group organised a dedicated conference track at PharmaLab 2025 and has started planning a similar track and a pre-conference workshop for PharmaLab 2026.
For further details and current events please see the Analytical Quality Control Group website.
European GDP Association
Surveys
The group completed and published a survey on GDP implementation in the pharmaceutical supply chain. Selected findings are being further analysed through targeted news articles.
Miscellaneous
Monthly newsletters were issued, including a Q&A series on transport and vehicle qualification.
Physical membership cards were discontinued to improve sustainability and reduce returned mail.
For further details and current events please see the European GDP Association website.
ATMP Group
Board Developments
Guidelines Developments
Miscellaneous
For further details and current events please see the ATMP Group website.