Inspection Services consists of a team of expert inspectors and a secretariat support group who contribute to the Prequalification process and compliment the work of all Product Streams by organizing, coordinating and conducting inspections in order to assess and verify compliance of a manufacturer/CRO/laboratory with relevant international standards and norms in connection with a Prequalification application
Prequalification inspections are a cross-cutting activity since the same general principles are applied irrespective of the product for which prequalification inspection is being conducted.
In general, inspections are carried out in connection with a prequalification application (e.g. product dossier, laboratory information file). Inspection Services closely collaborates with Product Streams to prioritize and organize inspections. Before prequalification of any product is granted, it is necessary that Inspection Services confirms compliance of the manufacturer with relevant good practices and international standards and adherence to dossier information. This may be by an initial on-site inspection, or by leveraging the outputs of inspections conducted by national regulatory authorities operating to equivalent standards and stringency to those of WHO. In addition, Inspection Services may conduct subsequent inspections to verify that a product-related site continues to be compliant with the required norms and standards.
The following categories of inspections in accordance with Product Streams are conducted:
- Immunization Devices: immunization device manufacturing sites and product testing laboratories
- In Vitro Diagnostics: in vitro diagnostic & male circumcision device manufacturing sites
- Medicines: active pharmaceutical ingredient (API) manufacturing sites, finished pharmaceutical product (FPP) manufacturing sites, contract research organizations (CRO) and quality control laboratories (QCL)
- Vaccines: vaccine manufacturing sites
- Vector Control Products: vector control product manufacturing sites
Finally, Inspection Services actively participates in international fora and promotes collaboration with and among national regulatory agencies (NRA), partner organizations and inspectorates in order to apply unified standards and norms for relevant product regulation, improve national regulatory capacity, reduce regulatory burden for manufacturers and improve access to medicines, vaccines and other health products.