News about GMP/cGMP


PIC/S: Revision of GMP Guide Annex 13 and new Annex 16

PIC/S: Revision of GMP Guide Annex 13 and new Annex 16

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products to include

  • the revised Annex 13 on the Manufacture of Investigational Medicinal Products and
  • the new Annex 16 on the Certification by the Authorised Person and Batch Release.

What’s new?

PIC/S Annex 13 (Manufacture of Investigational Medicinal Products) has been revised based on EC Regulation No. 536/2014 on Clinical Trials, which finally entered into force on 31 January 2022. Article 63(1) of the regulation necessitated a revision of Annex 13.

PIC/S Annex 16 (Authorised Person and Batch Release) is new to the PIC/S GMP Guide, as PIC/S did not adopt it parallel to the EU GMP Guide back in the year 2016. At that time, PIC/S considered the document to be EU-specific and difficult to transpose for PIC/S purposes. Under the aspect of international harmonisation of GMP standards, PIC/S now adapted EU Annex 16 to its purposes. For example, PIC/S agreed that elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.

The Annexes entered into force on 1 February 2022.

The revised GMP Guide (PE 009-16) can be downloaded here.


PIC/S: News