Pharmaceutical Microbiology Group

Board Developments
The next meeting is scheduled for 24 November 2025 in Neuss, Germany.

Guidelines Developments
“Q&A Bioburden” Version 2 finalized for ECA Board review.

Events
The European Microbiology Conference took place in Vienna (20–22 May 2025) with ~130 participants and contributions from major pharmacopeias (Ph. Eur., USP, JP, ChP).

Miscellaneous
The next annual conference (2026) will be part of the 20th PharmaCongress anniversary.

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

European QP Association

Board Developments
A project was launched to review and improve the QPSHARE database and related Q&As.

Surveys
The IMP Working Group’s survey on the EU Clinical Trial Regulation (CTR 536/2014) was completed and published in the EQPA News (Issue 21, July 2025). It summarized challenges and implementation strategies across organizations.

Publications
The latest EQPA Newsletter was issued.

Miscellaneous
EQPA is cooperating with Prof. Debbie Cenzipe (ProPublica / Northwestern University) and her students on an article about improving the quality of imported generic medicines in the U.S., including the EU QP’s role.

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

European GDP Association

Board Developments
In-person meeting held on 25 June 2025 in Barcelona (during ECA GMP & GDP Forum); next virtual meeting planned for 2026.

Guidelines Developments
Decision to review existing GDP-related documents.

Surveys
Conducted on the implementation of GDP requirements in the pharmaceutical supply chain; summary published in the newsletter, full report available to members.

Miscellaneous
GDP Forum (Bacelona, June 2025) covered current supply chain challenges. Board members acted as speakers/moderators.

Regular monthly GDP newsletters continued and article “GDP Update 2024/2025” was published in the GMP Journal.

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

Visual Inspection Group

Board Developments
Online board meetings on 3 July, 22 July, and 13 August; more planned for autumn.

Guidelines Developments
Major revision of the Visual Inspection Guideline and update of the CCIT Position Paper underway.

Surveys
Launched in August to assess technology status for 100% visual inspection.

Miscellaneous
Annual board meeting to be held in November in Vienna during the “Visual Inspection of Parenterals” conference.

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

ATMP Group

Board Developments
Stable multidisciplinary team (industry, academia, regulators, consultants); next online meeting in November 2025.

Guidelines Developments
Reviewed the EMA Concept Paper (May 2025) on revising EudraLex Vol. 4 Part IV; submitted formal comments on Annex 1 integration.

Contributed to other consultations (e.g., Ph. Eur. Chapter 5.34 on gene therapy).

Miscellaneous
Successful “ATMP – short & simple” and “ATMP meets Development” trainings. New event concepts on ATMP/SoHO supply chains launched. Collaboration with the Pharmaceutical Microbiology Group for PharmaLab 2025 (mRNA/LNP QC pre-conference).

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

Analytical Quality Control Group

Board Devlopments
Dr Amanda Guiraldelli Mahr joined in June 2025.

Online meeting held on 17 July; next in-person meeting scheduled during PharmaLab 2025 (24 November, Düsseldorf/Neuss).

Guideline Developments
Webinar on new Sampling and Sample Management Guidance (June 2025); recording and Q&A (39 questions) available to members.

Revisions ongoing for older guidelines (OOS 2013, OOE/OOT 2016, APLM 2018, AIQ&SV 2023).

Miscellaneous
Newsletters sent in May and July 2025.

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

GMP Auditor Association

Guidelines Developments
Work started on Version 3 of the GMP-Auditor Handbook; collecting ideas for improvements.

Surveys
On use of contracted third-party auditors for API supplier qualification—81 respondents, high compliance with EMA Q&A expectations (96% found EMA guidance useful, 74% compliant).

Publications
Presented the updated handbook at the ECA GMP/GDP Conference (June 2025, Barcelona).

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