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WHO prequalification of immunization devices consists of four areas of work:
- setting standards and norms: WHO uses international standards to evaluate immunization products. If no such standards exist for challenging operating environments, WHO works with industry and partners to define appropriate design criteria. These criteria are codified in product specifications which lay out the functional and performance characteristics required of any product or device to be evaluated for WHO prequalification. Specifications are constantly evolving, informed by feedback on product performance in the operating environment.
- evaluating products for prequalification: Every product specification is accompanied by verification protocols that outline precisely how products must be tested for compliance with the performance specifications. Dossier reviews take place once per month during which a team of independent evaluators together with the immunization group of the Prequalification Team assess product dossiers recently submitted by manufacturers. Each dossier must include a product test report from a WHO-accredited laboratory. All prequalified products undergo annual review in April of each year. Subsequent to the review, a product may retain its prequalified status or see it withdrawn if product performance and/or required documentation no longer meet WHO standards or requirements.
- stimulating product innovation: WHO aims to consistently improve the quality and reliability of immunization products. To achieve this, it engages with WHO Member States and manufacturers to understand the evolving needs of product end users and to define desirable future product characteristics that will better satisfy operational and programmatic needs. These characteristics are described in target product profiles. This process also helps to support a healthy and competitive marketplace, as well as stimulate innovation and the development of new technologies for immunization products. WHO also provides guidance for the field-testing of products for which this is a prequalification prerequisite.
- assessing laboratories’ suitability for product testing-accreditation: A WHO-accredited laboratory is an organization that conforms to international standards or codes of practice. It is able to demonstrate to a competent third-party accreditation body that it meets these criteria. Laboratories may be accredited to test one or several categories of immunization products. They must also be able to carry out one or more of the three types of product verification test: type-examination, independent type testing, or full quality assurance.