International – PIC/S updates GMPs for ATMPs, biological substances

Revisions to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide addressing the manufacturing of advanced therapy medicinal products (ATMPs) as well as biological medicinal substances and products are set to go into effect 1 May.
 
PIC/S published the final Annex 2A and Annex 2B on 23 April after a consultation that began in September 2019. (RELATED: PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances, Regulatory Focus, 14 October 2019)
 
Annex 2A covers PIC/S GMP requirements for ATMPs, which cover cell and gene therapy products. The annex is divided into two parts: Part A covers control over seed lots and cell banks through to finishing activities and testing, while Part B contains more specific guidance on selected product types, such as animal sourced products and gene therapy products.
 
Annex 2A “is not a standalone document but it enables reasonable harmonization with the standalone ATMP guidelines published by the European Commission,” according to a PIC/S statement.
 
The annex covers GMP principles governing a firm’s pharmaceutical quality system, personnel, premises and equipment, documentation, production and handling ATMPs…