Updated PIC/S GMP guide for ATMPs and biological substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published revisions to its good manufacturing practice (GMP) guide for advanced therapy medicinal products (ATMPs) and biological medicinal substances.

Annex 2A of the guide is new and relates to ATMPs. Designed not as a standalone document but to work in harmony with the European Commission’s GMP guidelines, this annex covers a manufacturer’s pharmaceutical quality system, personnel, premises and equipment, documentation, production and ATMP handling.

Annex 2B covers biological medicinal substances and is intended to harmonise with Annex 2 for human use biological medicinal substances and products of the European Union’s GMP guide. Annex 2B has only had some very minor revisions.

Following a consultation which began in September 2019, the final Annexes were published in April 2021 and came into force on 01 May 2021.

The full guide can be found here.