What We Do
The WHO Performance, Quality and Safety initiative for immunization devices (WHO PQS) is the group within the WHO prequalification that prequalifies products used to transport, store, monitor, administer and safely dispose of vaccines and is part of the WHO Expanded Programme on Immunization (EPI). Thanks to WHO prequalification Member States and UN procurement agencies can be assured that products have been evaluated and deemed suitable and reliable for immunization programmes. PQS contributes to the broad access agenda of WHO which seeks to strengthen regulation of health products and expand access to quality-assured products in countries that have a heavy disease burden, including vaccine-preventable diseases.
PQS works to ensure that WHO Member States can select products that have the requisite characteristics, that UN procurement and other agencies can procure products that are fit for use, and that manufactures have a fair basis for tendering products and investing in the development of future innovation. It does this by:
- encouraging adherence to and setting standards and norms in the form of product specifications that define the performance, quality and the safety characteristics required for specific operating environments
- defining the product testing and verification protocols for determining whether a product meets the specified criteria
- evaluating whether products meet these performance specifications and are eligible for prequalification for use in immunization programmes
- reviewing product performance to determine whether the prequalified status of a product or device can be maintained or should be withdrawn
- assessing for accreditation the facilities and competencies of laboratories for testing immunization products undergoing evaluation for prequalification
- collecting product performance feedback from WHO Member States and product manufacturers, and gathering information from product end users about their evolving needs to help stimulate innovation.
Our key outputs
The key outputs for WHO immunization devices prequalification are:
- the Catalogue of WHO-prequalified Immunization Devices
- the WHO list of laboratories that are accredited to test for product compliance with prequalification standards
- standards for immunization products
- product verification protocols for the testing and evaluation of products
- target product profiles that define the desirable characteristics for future innovations
- guidance for product manufacturers and research organizations carrying out field evaluations.