Concept paper on the revision of EU-PIC/S GMP Annex 15 (Qualification and validation) - Corrigendum

22nd July 2026

Summary: The joint EMA and PIC/S drafting group has issued a corrigendum to the concept paper outlining the proposed revision of Annex 15 (Qualification and validation) of the EU-PIC/S Good Manufacturing Practice (GMP) Guide. The revision aims to extend the scope of Annex 15 to include active substance manufacturers and to align with the revised ICH Q9(R1) Guideline on Quality Risk Management. Following a joint public consultation, which closed on 9 April 2026, the implementation timetable has been updated, while the remainder of the concept paper remains unchanged. The revised concept paper is available on both the PIC/S and EMA websites.

Link: https://picscheme.org/en/news?tri=all#newsitem_299

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