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Analytical Quality Group Developments January through April 2025
Recommendation
9-11 June 2026
Development, Validation & Control
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Board Development and Resolutions
It was agreed to hold online Board Meetings as needed in Q1/Q2 2025. The next in-person meeting will be held during PharmaLab 2025.
Guideline Developments
The Group has developed a new Guideline titled "Sampling and Sample Management", authored by Dr Christopher Burgess. Several group members contributed to the internal review process, while the external technical review was conducted by M.L. Jane Weitzel. The guideline was finalized at the end of April and has now been published in the members' area. A recodring of a webinar on the new Guideline is also available there.
Miscellaneous
Newsletters were sent to the members of the Group in January and March. To receive these newsletters, please see the ECA Academy website (please see under "You can also sign up for special Newsletters on the following topics:" and mark "Newsletter Analytical Quality Control").
Several Board Members are set to contribute as speakers at PharmaLab 2025, with preliminary preparations for their presentations already underway.
Related GMP News
03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem
28.05.2026WHO Working Document on Bioequivalence open for Public Consultation
21.05.2026LCGC Article on Analytical Procedure Lifecycle Approaches