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GMP News

Revised Annex 19 on Reference and Retention Samples

The European Commission has published a revised version of Annex 19 of EudraLex Volume 4, allowing photographic or digital records as an alternative to physical retention samples for parallel traded products. The new version is applicable from 24 September 2026.

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How to (not) use AI for GxP Inspection Responses

In a recent blog post, the U.K. MHRA has outlined examples of responses to inspection reports that were generated by artificial intelligence (AI), which, in some cases, contain alarming errors.

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Q&As on "GMP meets AI - How to Use Artificial Intelligence in Quality Assurance and Quality Control"

In February, more than 80 people participated in the Live Online Training organized by the ECA on the Use of Artificial Intelligence in Quality Assurance and Quality Control. During the Q&A sessions, numerous interesting questions were asked, which were answered by the presenters. We have compiled a selection of these questions and answers for you.

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