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.
The production section addresses cross contamination, control of starting and raw materials, handling human tissues and cells as starting materials, handling complaint and product recalls, and the batch release process in case of decentralized point of care manufacturing.
Minor revisions for annex 2B
Annex 2B has “very minor revisions” from the former version and that the guide is harmonized with the EU’s GMP Annex 2 on human use biological medicinal substances and products, according to PIC/S.
This annex provides guidance on the full range of GMPs for active substances and medicinal products defined as biologicals, except ATMPs.
The annex is divided into two parts: Part A contains supplementary guidance on the manufacture of biological active substances and medicinal products from control over seed lots and cell banks through to finishing activities and testing.
Part A covers GMP principles governing the personnel involved with biological active substance and product manufacturing, principles for premises and equipment, the use of animals, documentation and production, and controlling starting and raw materials. Part B addresses specific types of biological active substances and medicinal products, including animal-sourced products, allergen product, vaccines and recombinant products.
Both annexes will enter into force on 1 May. PIC/S invites all non-EEA participating authorities and applicants to transpose the revised chapters of the PIC/S guide into their own GMP guides.
PIC/S is a non-binding, informal cooperative group of regulators that seeks to develop common GMP standards. The group comprises 54 participating authorities worldwide.
PIC/S Annex 2A Guide Revisions, PIC/S Annex 2B Guide Revisions
