Annex 15 is next to change. Are active substance manufacturers ready for it?
EMA Concept Paper on the Revision of GMP Annex 15 (Qualification & Validation)
Published: 19 January 2026
Public consultation: 9 February – 9 April 2026
The EMA’s GMP/GDP Inspectors Working Group and PIC/S have issued a concept paper proposing a targeted revision of Annex 15 (Qualification and Validation) of EudraLex Volume 4. The revision aims to address gaps highlighted by the nitrosamine contamination cases in sartan medicines and to align Annex 15 with the principles of ICH Q9(R1) Quality Risk Management.
By extending Qualification & Validation expectations to active substance manufacturers, regulators are clearly reinforcing the need for deeper process knowledge, stronger validation strategies, and risk‑driven decision‑making across the API lifecycle.
At Eurofins, we believe the strongest response is an integrated one:
pairing expert consulting with robust GMP testing to give manufacturers not only the right strategy — but the data, evidence, and documentation to demonstrate compliance.
From QRM‑driven URS/FAT/SAT and lifecycle validation, to contamination investigations supported by MALDI‑TOF/sequencing, to transport verification and QC analytics — we help companies transform Annex 15 requirements into a strong, future‑proof validation framework.
Annex 15 is evolving.
We’re here to help you evolve with it.
Contact us: EurofinsBiolab@bpt.eurofinseu.com