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The WHO Performance, Quality and Safety (PQS) process prequalifies products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs. The PQS process also encourages a wide range of manufacturers to apply for prequalification so that a competitive marketplace develops.

The PQS website provides relevant documents, procedures, and data sheets for all currently prequalified products in the following equipment categories:

 

WHO PQS Devices Catalogue

The WHO PQS Devices Catalogue includes details of all immunization- related products currently pre-qualifies by WHO for procurement by United Nations agencies, in addition to comprehensive guidance notes to help purchasers make informed choices. The catalogue is updated whenever a change occurs with regards to a product, a manufacturer or a laboratory. For assistance with the WHO PQS Devices Catalogue, please contact the PQS Secretariat (gobinai@who.int).

WHO PQS Devices Catalogue (PDF, version: 14 June 2017)

 

Feedback

User feedback on the performance of individual products is actively sought and users are encouraged to use the Feedback form to report product defects affecting any products selected from the WHO PQS devices catalogue or website.

 

PQS Announcements

  • The next product dossier review meeting will be held on July 25th, 2017. Manufacturers are requested to send in all required documents by July 11th, 2017 if they wish to be considered for the July review round.
  • Performance specifications for vaccine carriers with freeze-prevention technology [E004/VC02.1] can be downloaded here.
  • The type-testing protocol for vaccine carriers with freeze-prevention technology [E004/VC02-VP.1] can be downloaded here.
  • Performance specifications for Solar Direct Drive Surplus Energy Harvest Control [E007/EHC01.1] can be downloaded here.

 

About PQS

The WHO PQS approach to equipment and device prequalification is based on three key criteria: a selected product must have performance characteristics that meet the relevant specification standards; quality and reliability characteristics that are appropriate for field conditions, and cradle-to-grave safety characteristics that ensure that no harm is caused to users, patients, or to the environment over the course of the product's life cycle. The PQS team aims to bring the WHO and UNICEF into a more productive relationship with end users, key partners and industry. We have created a three-step innovation, product development and improvement cycle:

  • Wherever possible we adopt international standards as a basis for the design, development and production of each product type. Otherwise we work with industry and partners to define appropriate design criteria.
  • For each product type we develop and maintain technical specifications and related test procedures that adequately reflect programmatic and operational needs.
  • We monitor each product in the market in order to assess performance, quality and safety characteristics over its life cycle from the perspective of the user, and we monitor its suitability for programmatic and operational needs. In order to support this step, there is a user feedback link on the PQS Catalogue page.  All products are subject to a formal annual review process which takes place in April each year.

All PQS operations are implemented in accordance with published Standard Operating Procedures.