Analytical Quality Group Developments May through August 2026

Board Developments

• There have been no changes to the composition of the Board.

Board Meetings

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

Guideline Developments

• The Board continues to work on the revision and update of the Group’s existing guidelines:
  - OOS Guideline from 2013;
  - OOE/OOT Guideline from 2016;
  - APLM Guideline from 2018;
  - AIQ & SV Guideline from 2023.

Surveys

• As already reported, the Group collected input via a survey to support the revision and update of its guidance on Out-of-Specification (OOS) investigations. Following the publication of a short summary in May, a detailed report was prepared. It presents the individual results graphically and is supplemented by free-text comments from the respondents. The report was made available in the Members’ Area in August. In addition, a short recorded discussion between Dr Markus Funk (Administration Manager of the AQCG) and Ms Margarita Sabater, a Board Member of the ECA AQCG who was closely involved in planning and evaluating the survey, was published.

Miscellaneous

• Newsletters were sent to the Group’s members in May and August.
• The Group will participate in PharmaLab 2026 with:
  - a one-day track on “Analytical Procedure Lifecycle Management (APLM)”; and
  - a pre-conference session entitled “Data Quality Management of Aberrant Results – Handling Out-of-Specification (OOS) and Out-of-Trend (OOT) Results".
  The planning has been finalized, and the programme has been published.