Analytical Quality Group Developments January through April 2026

Board Developments

• No changes to Board composition.

 Board Meetings

• For 2026, three Board meetings were planned: March (online), July (online), and November during PharmaLab 2026 in Darmstadt.
• The first online Board meeting took place on 27 March 2026.

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).
• The current status was discussed during the Board meeting, and the timeline was specified in more detail.

Surveys

• The Group collected input via a short survey to support the revision and update of its guidance on Out-of-Specification (OOS) investigations.
• The survey started in February and closed in mid-April. A total of 169 responses have been received. The responses are currently being evaluated.
• A report is planned to make the results available to everyone in a summarized form.

Miscellaneous

• Newsletters were sent to the members of the Group in February and March.
• The Group will participate in PharmaLab 2026. A one-day track as well as a pre-conference session are planned. Planning activities were discussed during the Board meeting, further developed afterwards, and are now almost complete.