GMP Auditor Association

Board Developments
An online meeting on 6 February reviewed the status and further development of the GMP-Auditor Handbook, including three new chapters, and defined next steps.

Guideline Developments
Version 4.0 of the GMP Auditors Reference Handbook, including revisions and new chapters on auditing a packaging company, conducting a closing meeting, and using AI in auditing, has been published in the members’ area.

Surveys
A survey on the impact of AI on GMP auditing with 137 respondents has been completed, and a report summarising key insights and trends is available on the Association’s website.

Miscellaneous

Publication
David Abraham published an article on the utilisation of AI in auditing in ECA’s GMP Journal, (Issue 46 2026).

Event
Registration is open for the GMP-Auditor Forum, which will be held on 23–24 June 2026 in Barcelona as an experience-exchange conference for GMP auditors.

For further details and current events please see the GMP Auditor Association website.

Analytical Quality Control Group

Board Developments
There were no changes in the Board composition.

Board Meetings
Three Board meetings were scheduled for 2026 (March and July online, November at PharmaLab in Darmstadt), with the first held on 27 March 2026.

Guideline Developments
The Board is revising several existing guidelines (OOS, OOE/OOT, APLM, AIQ & SV), and the current status and timelines were refined during the Board meeting.

Surveys
An OOS survey run from February to mid-April received 169 responses, which are now being evaluated, with a summary report planned.

Miscellaneous
Newsletters were sent to Group members in February and March, and planning for a one-day track and a pre-conference session at PharmaLab 2026 is almost complete.

For further details and current events please see the Analytical Quality Control Group website.

European QP Association

Board Developments
The Board met online on 25 February to discuss Good Practice Guide updates, plan the 2026 QP Forum, and strengthen collaboration within the quality community.

New Task Force
The IMP Working Group created a PSF Taskforce and, via a call for participants, recruited suitable QPs from various areas to interpret survey results and address key challenges.

Miscellaneous
The QP Forum 2026 will take place on 26/27 November in Barcelona as an on-site-only conference, preceded on 25 November by three parallel pre-conference sessions on IMPs, data quality/data management, and training for new QPs.

For further details and current events please see the European QP Association website.

Visual Inspection Group

Board Developments
The annual Board meeting will be held during the conference “Visual Inspection of Parenterals” in early October, with additional ad hoc online meetings possible during the Q&A revision.

Guideline Developments
The Group is revising the Q&As on Visual Inspection, and updated versions of the Visual Inspection Guideline and CCIT Position Paper (revised in Q4 2025) are available in the members’ area.

Surveys
The results of the survey on the “Current state of technology with regard to 100% visual inspection” were published in December 2025.

For further details and current events please see the Visual Inspection Group website.

Validation Group

Guideline Developments
Based on feedback from the 2025 Equipment Qualification Forum, the Group is revising the Good Practice Guide on Qualification and Validation, preparing a second draft of an ECA booklet, and has formed a new AI in Qualification subgroup.

Surveys
A survey on the use of AI in equipment qualification has been drafted for distribution via the ECA newsletter in May/June, and results of an SPC survey have been published in ECA News and in the members’ area.

Miscellaneous
The Group submitted comments on the Concept Paper for the revision of Annex 15, with the full comment list available in the ECA Foundation news section.

For further details and current events please see the Validation Group website.

Pharmaceutical Microbiology Group

Events
The Group celebrated its 20 Years Jubilee Conference at PharmaCongress & PharmaTechnica Expo 2026 and is planning a short webinar series with around 30 topics and potential speakers identified.

Miscellaneous
The Group (via Dr Deutschmann) is cooperating with the ATMP Group, EQPA, and the ECA Board on comments for a new chapter on phages.

For further details and current events please see the Pharmaceutical Microbiology Group website.

European GDP Association

Surveys
Further analysis of last year’s survey is ongoing, and an additional article focusing on one specific aspect is planned.

Miscellaneous
Around 120 participants attended the “GDP Update 2026” webinar in March, and the speaker’s written replies to questions are being published stepwise in newsletters, which are issued monthly to Group members.

For further details and current events please see the European GDP Association website.