Information for Manufacturers on the Inspection of Manufacturing Site(s). (Assessment of the Quality Management System) - WHO Prequalification of In Vitro Diagnostics
(2017; 32 pages)


The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) is coordinated through the department of Essential Medicines and Health Products. Focus is placed on in vitro diagnostics for priority diseases and their suitability for use in resource-limited settings.

WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining whether the product meets WHO prequalification requirements.

The full prequalification assessment process includes the following components:

- review of a product dossier;

- performance evaluation including operational characteristics;

- inspection of manufacturing site(s); and

- labelling review.

The abridged prequalification assessment includes the following components:

- performance evaluation including operational characteristics;

- abridged inspection of manufacturing site(s); and

- labelling review.

Products submitted for prequalification assessment that meet, as determined by WHO, the WHO prequalification requirements are included in the WHO list of prequalified IVDs. The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, including:

- prequalification commitments;

- annual reporting;

- reporting of changes;

- post-market surveillance obligations;

- re-inspection; and

- on-going compliance with WHO prequalification technical specifications.

The findings of the WHO Prequalification of IVDs are used to assess the safety, quality and performance of commercially available in vitro diagnostics for the purpose of providing guidance to interested United Nations (UN) agencies and WHO Member States in their procurement decisions.

This document has been prepared to provide manufacturers with information on the inspection of manufacturing site(s) of product(s) undergoing WHO prequalification assessment, including the assessment of their quality management system. In addition, this document is issued to inspection team members.

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