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GMP News

27.04.2026

ECA Validation Group comments on Concept Paper regarding the Revision of Annex 15

In February 2026, the EMA published a concept paper announcing a further revision of Annex 15 to the EU GMP Guidelines. This concept paper was open for comments until 9 April 2026. The ECA Validation Group took advantage of this opportunity. What comments were made?

27.04.2026

IPEC: Updated Stability Guide for Excipients

At the end of March 2026, the IPEC announced the updated Version 3 of its 'Excipient Stability Guide for Pharmaceutical Excipients' in a notice on its website. This was first published in 2010 and is currently only available and viewable in the IPEC members' area. Following a three-month period (expected to end on 30 June 2026), the updated guide is to be published in full.

27.04.2026

Statistical Methods from the Perspective of ICH Q9 Quality Risk Management

In a previous news, we discussed the updates to the ICH Q9 training package. Among other things, the slides illustrating how statistical methods can support quality risk management have also been updated. What does this set of slides contain?

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