News about GMP/cGMP


PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S: Adoption of EU GMP Annex 16 on QPs and Batch Release

PIC/S has started the consultation process for the adoption of Annex 16 of the EU GMP Guide. It is a very important step towards international harmonisation of GMP requirements.

Following the revision of EU Annex 16 Certification by a Qualified Person and Batch Release in 2016, PIC/S decided to transpose Annex 16 in order to harmonise internationally requirements regarding product release.

The PIC/S Committee had internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16. The PIC/S document was written with a view to applicability across the members worldwide. Therefore, it focusses especially on important technical elements of QP release decisions.

The Committee recently agreed to proceed to Step 2 of the PIC/S consultation process. Step 2 of the PIC/S adoption process enables an opportunity for PIC/S Participating Authorities to consult with stakeholders.

This consultation was launched on 15 June 2021 for a period of 3 months. The consultation will focus on national stakeholders of non-EU/EEA Members of PIC/S, considering that EU/EEA Members of PIC/S already apply EU Annex 16.


PIC/S: News