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Overview

Overview

History

The first inspections, conducted by inspectors appointed to represent the WHO Prequalification, took place in the late 1980s in connection with the publication and application of the WHO prequalification requirements for vaccines. Inspection Services was established in 2001 as part of the Prequalification of Medicines Programme, in response to the HIV/AIDS pandemic. In 2010, the first Prequalification inspection of in-vitro diagnostics was conducted. In 2013, the Prequalification of Medicines Programme merged with the WHO programmes for prequalification of diagnostics and vaccines, to create the WHO Prequalification Team. The vector control product stream joined the WHO Prequalification in 2017, and the first vector control manufacturer inspection took place in 2018. During the same year, the first vaccine immunization equipment and device inspection was performed.

Vision and mission

Inspection Services’ vision is aligned and supports WHO Prequalification Unit (PQT) vision to increase access to quality, safe, efficacious medicines, vaccines and health products, for all.

As part of PQT, Inspection Services is committed to contributing towards the achievement of the Universal Health Coverage and facilitating access to affordable medicines, vaccines and other health products.

Inspection Services plays an integral role, supports and complements the prequalification process of priority health products (in vitro diagnostics, medicines, vaccines, active pharmaceutical ingredients, vector control products, immunization equipment and devices and male circumcision devices), ensuring their quality, safety and efficacy/performance by means of initial and repeated inspections, where necessary.

Furthermore, Inspection Services collaborates with national regulatory agencies (NRA) and partner organizations to improve national regulatory capacity, to promote and apply harmonized standards for the manufacture, quality control, regulation and monitoring of medicines, vaccines and other health products.

Strategy

For inspection services to achieve its vision and objectives, the following actions have been established:

  • to conduct initial inspections and subsequent inspections of manufacturers and clinical trial sites to assess compliance with good practices and adherence to information included in the application;
  • to conduct inspections of medicines’ Quality Control Laboratories seeking prequalification, to assess compliance with the relevant standards and the Laboratory Information File; hence improving in-country capacity for regulatory supervision of the quality of medicines;
  • to promote harmonization of quality, safety and efficacy/performance standards and norms by conducting joint or observed inspections with national regulatory agencies;
  • to promote international collaboration on inspections and exchange of information between national regulatory authorities in order to enhance regulatory capacity and improve use of regulatory resources; 
  • to provide hands-on training to NRA inspectors by introducing them to the WHO Prequalification’s Quality Management System and the processes for planning, conducting and closing out inspections and by participating in WHO Prequalification inspections.

Key outputs

The outputs of Inspection Services are the: