GMP Auditor Association

Board Developments
The Association held a face-to-face Board meeting in Barcelona on 22 June to review completed work, future auditor involvement, progress on the GMP Auditor Guide, and additional support for auditors.

Guideline Developments
Version 4.0 of the GMP Auditors Reference Handbook was introduced with practical examples, templates, revised content, and new chapters on packaging-company audits, closing meetings, and AI in auditing. The handbook is available in the members' area of the website.

Surveys
The Association published the results of its survey on the rights, duties, limitations, and critical situations of GMP auditors and auditees.

Miscellaneous

Event
The GMP-Auditor Forum took place in Barcelona on 23/24 June 2026 and received very positive feedback for its discussions, presentations, and networking opportunities.

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

Analytical Quality Control Group

Board Meetings
The next in-person AQCG Board meeting will take place in November during PharmaLab 2026 in Darmstadt.

Guideline Developments
The AQCG continued revising its OOS, OOE/OOT, APLM, and AIQ & SV guidelines.

Surveys
The AQCG published a detailed report and a recorded discussion on its survey supporting the revision of guidance on Out-of-Specification investigations.

Miscellaneous
The AQCG issued newsletters in May and August and finalised and published its programme for the APLM track and OOS/OOT pre-conference session at PharmaLab 2026.

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

European QP Association

Board Developments
The EQPA held an online board meeting on 6 July covering publications, activity plans, feedback from IWG/IP meetings and workshops, and current EU-GMP and legislative developments.

IMP Working Group Activity Plan
The IMP Working Group submitted its 2026 activity plan, including preparations for the IMP Conference and Qualified Person Forum, establishment of a Product Specification File Taskforce, and review of relevant IMP guidelines.

Surveys
Audit Trail Review Documentation for QPs
An EQPA survey examined how QPs access and use audit-trail review documentation and considered the proposed requirement that batch-release-relevant reviews be available to QPs at release.

Publications
EQPA Membership Newsletter
A new EQPA newsletter was published with articles on audit-trail review documentation, artificial intelligence for QPs, and reflections on the profession. All issues of the newsletter are available in the members' area of the website.

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

Visual Inspection Group

Board Developments
Haluk Dönmez of B. Braun joined the Board, whose annual meeting is scheduled for October in Vienna during the ECA conference on “Visual Inspection of Parenterals”.

Guideline Developments
The Group comprehensively revised and expanded its Q&A document on visual inspection and published it in the members’ area in early September.

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

Validation Group

Guideline Developments
The Validation Group continued the full review of its Good Practice Guide on Qualification and Validation, prepared an AI annex, and advanced the drafting of related ECA booklets.

Surveys
The Group evaluated and published the results of its survey on the use of artificial intelligence in equipment qualification.

Miscellaneous
The Group developed an online course on AI in Qualification and Validation scheduled for 17/18 November 2026.

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

Pharmaceutical Microbiology Group

Board Deevelopments
The next board meeting will be held at PharmaLab 2026 on 23 November 2026 in Darmstadt. Chair and Administration had an online meeting on 19. August to discuss the current board structure, active and less active members etc.

Guideline Developments
The scheduled NGS Paper is nearly finished. It is in the last review of the Authors and will be shared with the board then. Following it will be issued in the ECA Design.

Surveys
A survey on the topic of ‘Single Temperature Incubation’ is currently being finalised and will be sent out to members shortly. The results will be summarized by Isabelle Hoenen (Lilly, Member of the CCS Task Force) and published in the GMP Journal.

Events
The European Microbiology Conference 2027 will be a part of the PharmaCongress again. The call for papers is open.

Miscellaneous
The Group will be represented at the EDQM Meeting on Alternative Methods in October in Straßbourg with speakers as well as with participants.

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

European GDP Association

Board Meetings
The EGDPA Board meeting was postponed to 9 October and is scheduled to take place online via Webex.

Surveys
The evaluation of last year’s survey was completed, and ideas for future surveys were collected for discussion at the October Board meeting.

Miscellaneous
The EGDPA launched the call for presentations for the 2027 GMP & GDP Forum in Berlin, scheduled the programme for publication by December 2026, and continued distributing monthly newsletters.

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