ATMP Group

Board Developments
Dr. Roland Pach joined the Board, bringing extensive expertise in Cell & Gene Therapy from Roche.

Guideline Developments
A position paper on patient-centric specifications for ATMPs is planned to be published in September 2025, addressing challenges with variable starting materials.

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

European QP Association

Board Developments
Discussions in the Engagement Board focused on QP responsibility sharing, which will be featured in a QP Forum session.

Surveys
Conducted on QP roles in drug shortages. Survey results may be shared with inspectors working group.

Regulatory Comments
Submitted feedback on veterinary GMP regulations to the EU Commission.

Miscellaneous
Raised concerns about GMP certificate expirations in 2025; correspondence with EMA is available online.

Involvement in a dedicated stakeholder review for three Q&As related to audits on API manufacturers and how to refer to these audit reports in the QP declaration template. Two of the Q&As have been published as Q&As on GMP and one as Q&A to the QP declaration template for marketed products.

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

Analytical Quality Control Group

Board Developments
Online meetings held in early 2025; in-person meeting planned at PharmaLab 2025.

Guideline Developments
Guideline entitled “Sampling and Sample Management” was finalized at the end of April and scheduled for publication in May.

Miscellaneous
Newsletters issued in January and March; members preparing presentations for PharmaLab 2025.

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

GMP Auditor Association

Board Developments
Held an online meeting to finalize Handbook Version 2 and plan Version 3.

Guideline Developments
Handbook Version 2 updated with new topics (ATMPs, medicinal cannabis), templates, and examples; released in May.

Surveys
Conducted to assess practices on using third-party auditors, in light of new EMA Q&As.

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

Validation Group

Board Developments
No changes; discussed 2025 plans during November 2024 meeting.

Guideline Developments
Collected practical examples for future ECA booklets or videos.

Miscellaneous
New courses on DoE and AI in validation planned for September 2025; expert meetings continued successfully; new members joined the Adhoc group.

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

Visual Inspection Group

Board Developments
Online meetings held regularly, with the next scheduled for June 2025.

Guideline Developments
Ongoing comprehensive revision of the Visual Inspection Guideline

Surveys
Preparing a survey to assess current practices among members.

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

European GDP Association

Surveys
Questionnaire draft under review for a new survey initially planned for late 2024.

Miscellaneous
Monthly newsletters issued; Board members will speak at the June 2025 GMP & GDP Forum in Barcelona.

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

Data Integrity & IT Compliance Group

Guideline Developments
New Best Practice Paper on ‘SOP Audit Trail Review’ published; another on ‘URS’ in progress.

For further details and current events please see the Data Integrity & IT Compliance Group website.