PIC/S revises GMP guide to reflect EU Clinical Trials Regulation

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its good manufacturing practice (GMP) guide (PE 009-16, Annexes) to reflect the EU Clinical Trials Regulation 536/2014 (CTR), which came into application on 31 January 2022. In particular, Annex 13 of the PIC/S GMP guide, which relates to the manufacture of investigational medical products (IMPs), has been revised based on the EU GMP Annex 13, in line with the Co-operation Agreement between EMA (European Medicines Agency) and PIC/S. 

Revised PIC/S Annex 13: Manufacture of IMPs

In 2017, the European Commission released the “Detailed Commission Guideline on GMP for IMPs” (in Annex 13 of the EU GMP Guide) that became applicable together with the CTR on 31 January 2022. According to the PIC/s, the aim is to keep GMP standards equivalent in order to facilitate the exchange and use of information regarding the manufacture of medicinal products. The new EU GMP Annex 13, for example, has implications for the labeling of IMPs and the handling of complaints and recalls.

New PIC/S Annex 16: Certification by the Authorized Person and Batch Release

The PIC/S also introduced a new Annex 16 on the certification by the Authorized Person and batch release. The EU GMP Guide Annex 16 (“Certification by a Qualified Person and Batch Release”) had not been adapted so far to the PIC/S GMP guide as it was considered “to be EU-specific and difficult to transpose“, “in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution“. Based on a consultation in 2017, it was agreed to transpose Annex 16 of the EU GMP Guide, considering that adaptation could offer added benefit regarding expectations associated with product release. However, elements related to imported medicinal products would be voluntary, dependent on national law.

Both Annexes were approved by the PIC/S Committee and the revised PIC/S GMP Guide (PE 009-16), with the revised Annex 13 and the new Annex 16, entered into force on 1 February 2022. All non-EEA (non-European Economic Area) participating authorities of PIC/S and applicants are invited to transpose the Annexes 13 & 16 of the PIC/S GMP Guide into their own GMP Guides.

More information is available at the PIC/S News website in Revision of PIC/S GMP Guide (PE 009-16).