Did you know that EudraLex Volume 4. “Good Manufacturing Practices for medicinal products for human and veterinary Annex 15 Qualification and Validation”, will soon become mandatory for API manufacturers?
Significant changes are coming to Qualification and Validation in the Pharma industry. While EU Annex 15 has traditionally been considered optional for active substance manufacturers, its principles have long been broadly acknowledged and applied across the sector. Now, the European Medicines Agency (EMA), together with PIC/S, has proposed a specific revision of the EU GMP Annex 15, moving from an optional guideline to a mandatory requirement for manufacturers of active substances.
With implementation planned for December 2026, the transition period has already begun, and this is the moment for API manufacturers to start preparing.