5/6 October 2022
The PIC/S (Pharmaceutical Inspection Co-operation Scheme) already published a new version of its GMP Guide PE016 in February. This is due to the revision of EU Regulation No. 536/2014 on clinical trials. Annex 13 of the PIC/S document has now also been adapted to this. This is in line with the cooperation agreement between PIC/S and EMA, which stipulates that the PIC/S and EU GMP Guides should be aligned.
Annex 16 of the PIC/S Guide is new. It describes the certification by the Qualified Person and batch release. The analogous Annex 16 of the EU GMP Guide was not included in the PIC/S document in 2016 because the PIC/S felt that Annex 16 was too EU-specific, especially since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution. However, following a consultation with participating PIC/S authorities in 2017, it was agreed to attempt to implement EU Annex 16. The PIC/S also agreed that the item in Annex 16 related to imported medicinal products is voluntary and depends on national law.
The revised GMP Guide (PE 009-16) with the revised Annex 13 and the new Annex 16 are now in force and available on the PIC/S site.