Analytical Quality Group Developments September through December 2025

Board Developments

• Ms. Silviya Dimitrova (TEVA Pharmaceuticals Industries, Bulgaria) has left the Board. This was decided during the Board Meeting in November. The AQCG would like to thank her for her many years of commitment and valuable contribution. It is planned that she may be considered for rejoining the Board in the future, possibly in 2027/2028.

 Board Meetings

• An in-person Board Meeting was held on 24 November 2025 during PharmaLab 2025 in Düsseldorf/Neuss.
• For 2026, three Board Meetings are planned: March (online), July (online), and November during PharmaLab 2026 in Darmstadt.

Guideline Developments

• The Board is still working on updates and revisions of existing guidelines (OOS Guideline from 2013; OOE/OOT Guideline from 2016; APLM Guideline from 2018; AIQ & SV Guideline from 2023). During the Board Meeting in Düsseldorf/Neuss, the current status was discussed and the timelines were reviewed once again.
• New guideline ideas were also discussed; however, it is planned to first complete the revision of the existing documents.

Miscellaneous

• Newsletters were sent to the members of the Group in September, November, and December.
• As part of PharmaLab 2025, the Group organised a one-day conference track entitled “Analytical Quality and Lifecycle Concepts”. The track was moderated by Dr Christopher Burgess (Chairman) and focused on lifecycle-based approaches to analytical procedures, instruments, and data, reflecting recent developments in ICH guidelines and USP chapters.
• The Group will also participate in PharmaLab 2026. A one-day track as well as a pre-conference workshop are planned. The planning activities for these have already started.