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GMP News

22.04.2026

Use of AI Agents leads to the first FDA Warning Letter relating to AI

The FDA Warning Letter to Purolea Cosmetics Lab dated 2 April 2026 also referred to shortcomings in the use of AI (Artificial Intelligence). What specific issues did the FDA raise regarding the use of AI agents?

22.04.2026

IPEC: Updated Qualification Guide

In April 2026, the IPEC announced the updated Version 3 of the ‘Qualification of Excipients for Use in Pharmaceuticals: Guide & Checklist’ on its website. This guide was first published in 2008 and is currently only available in the IPEC members’ area.

22.04.2026

Roadmap for the Introduction of the Electronic Package Leaflet

The European Medicines Agency (EMA) has published a draft plan for the introduction of electronic product information. The roadmap outlines the stages of ePI implementation from 2026 onwards. It includes technical preparations, a phased roll-out and a central EU portal for displaying the information.

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