Broader Acceptance of GMP Inspection Reports from PIC/S Countries

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

Within PIC/ there is a so-called "Access Consortium" consisting of representatives of regulatory authorities from Australia (Therapeutic Goods Administration), Canada (Health Canada), Singapore (Health Sciences Authority), Switzerland (Swissmedic) and recently also from the UK (Medicines and Healthcare Products Regulatory Agency, MHRA). The aim of this consortium is to promote international cooperation, reduce duplication of work and increase the capacities of the individual authorities.

Now, the heads of the agencies represented in this consortium have published an "Access Consortium Good Manufacturing Practice (GMP) Statement", in which it was affirmed that the members of the consortium want to rely more on inspections of the other members of the consortium and mutually accept the results of GMP inspections. The reliability of inspection results will be based on the review of inspection reports or other evidence carried out by Access Consortium members in their territory. This is to avoid additional GMP inspections.

The statement reflects the intention of the Access Consortium members. It is not intended to create legal obligations. It is not intended to diminish or affect the authority of the members to carry out their responsibilities. Consortium members may continue to conduct inspections themselves if deemed necessary.

Source: Notice from the MHRA