13/14 December 2023
A new PIC/S Guidance on GMP Inspection Reliance was developed to help Competent Authorities (CA) prioritising resources for GMP inspections for human and veterinary medicines. This Guidance is based on a draft by the International Coalition of Medicines Regulatory Authorities (ICMRA)* GMP Inspection Reliance Framework.
According the recent PIC/S Newsletter, the need for inspections at pharmaceutical manufacturing facilities "far exceeds what any one CA can accomplish and this framework will assist regulators in managing product quality risks posed by the increasingly complex pharmaceuticals global supply chain".
Currently many initiatives are discussing the possibility of using inspection reports of other CAs to plan inspections based on risk evaluation. The main feature now of this document is to give guidance on what to do with the information. It introduces a process for desk-top assessments of GMP compliance of facilities in other countries. If an "acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs", an additional on-site inspection will not be needed.
The guidance document is a non-binding high-level guidance for ICMRA and PIC/S participating authorities, but the process can also serve as a model for the pharmaceutical industry for their risk based supplier qualification and auditing activities:
* ICMRA: International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities.