EMA and PIC/S revision of GMP Annex 15 on Validation
- Date
- February 9, 2026
- Category
EU Regulations
- Description
The EMA and PIC/S have jointly published a Concept Paper proposing to update GMP Annex 15 on Qualification and Validation. The consultation commenced on 9 February and lasts until 9 April.
The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH guideline Q9 (R1) on quality risk management.