PIC/S Adopts New Guidelines on Shared Facilities, Revisions to GMP Guide
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good manufacturing practices (GMP) guide.Both the guidelines and the revisions are intended to further regulatory harmonization between PIC/S and EU recommendations. They are also both set to enter into force on 1 July 2018.
The new PIC/S Aide-Memoire and PIC/S guidelines cover a formalized risk-based GMP assessment on excipients of medicinal products, health-based exposure limits to aid GMP inspectors in identifying risk when manufacturing different products in shared facilities, and principles for good distribution practice.
Revisions to chapters 3, 5, 8 and annex 17 of the GMP guide apply to premises and equipment, production, complaints and product recall, and real time release testing and parametric release.
In addition, the PIC/S GMP inspection guidance developed based on an International Coalition of Medicines Regulatory Authorities framework came into force earlier this month.
This guidance—adopted in early May—is aimed at aiding competent authorities in make the most efficient use of resources for the inspection of overseas facilities by establishing “an acceptable level of GMP compliance,” according to PIC/S.