New: Coordination of GMP Inspections for Centrally Authorised Products

In the 'Compilation of Union Procedures on Inspections and Exchange of Information', the document on the coordination of GMP inspections for centrally authorised products (CAPs) has been updated and came into force on 10 September.

No major changes have been made; apart from a few editorial changes, minor amendments have been made regarding the conduct of inspections without a 'Supporting Authority'. Such an authority is usually one of the other authorities involved in inspections of the products manufactured at the site. The designation of a 'Leading' or 'Supervisory Authority' and a Supporting Authority is intended to ensure that the workload is distributed appropriately amongst the Member States (i.e. Supervisory Authorities) and that a certain degree of consistency and continuity is ensured.

However, for certain sites, it may not be necessary to designate a Supporting Authority (e.g. some quality control labs, very small manufacturing sites, sites with only one Supervisory Authority for CAPs, etc.). In such cases, the inspection may be carried out by a single authority, which acts as both the Leading and Supporting Authority and thus also bears the associated costs of the inspection.