Overview

Licensure of medicines, biologics, vaccines and devices in as many countries as possible simultaneously provides the greatest potential for equitable access. Many regulators require facility inspections as part of the licensure process. Hosting facility inspections requires significant resources and expert attention by manufacturers, which can prevent them from focusing on production of the vaccines needed to prevent disease.

Joint Inspections

Joint inspections can help reduce disruptions to manufacturers, especially during a public health emergency. Hosting all regulators simultaneously would not be feasible due to space and capacity limitations, but a reference authority could lead the inspection process with a limited number of WHO Listed Authorities, National Regulatory Authorities (NRAs) and PIC/S members, or regional representatives present as observers either in person or virtually.  The outcome of the inspection could be shared with other regulators who are not participating to facilitate recognition or reliance on the joint inspection. 

Platforms

When Designated or Established Platforms are used for manufacture, it may be possible to reference a previous inspection, which could lead to significant acceleration of availability of medicines, biologics, vaccines and devices.

GMP Certificates

Developers may use GMP clearance or GMP certificates to support use of manufacturing facilities or coordinate joint inspections by reference authorities, representative PIC/S member health authorities and WHO. Note that not all NRAs, for example, US FDA, provide GMP certificates, so inclusion of NRAs who do provide GMP certificates in the joint inspection will be important.