Revision of the PIC/S GMP Guide

The PIC/S (Pharmaceutical Inspection Co-operation Scheme) published a new version of its GMP Guide PE016 in February. 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.

The new revision is in fact due to the revision of the EU regulation on clinical trials (EU Regulation No. 536/2014) and Annex 13 of the PIC/S document has now also been adapted. There is also a new annex on certification by a Qualified Person and batch release. 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.