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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: 24 August 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.

Submit feedback

 

PQS Announcements

PQS Dossier Review Schedules: All manufacturers who seek prequalification are required to submit a product dossier to the PQS Secretariat with all the required information and samples (where required) that are listed in the relevant PQS performance specification. The PQS Secretariat will screen the dossier for completeness before it is evaluated. Complete product dossiers are evaluated by a team of evaluators, and assessments are done on a monthly basis (scheduled on the 4th Tuesday of every month). Manufacturers are requested to submit complete product dossiers by the 1st Tuesday of every month if their applications are to be evaluated that same month. Product dossiers that are submitted past this date will be evaluated the following month. Applicants are strongly encouraged to contact the PQS Secretariat (gobinai@who.int) before submitting their product dossiers.

Performance specifications and verification protocols in the PQS pipeline:
• Large walk-in cold room specifications
• Solar power specifications for walk-in cold rooms
• Three-phase voltage stabilizer performance specification and testing protocol
• Threshold indicators verification protocol
• Phase-change material performance specifications and verification protocol
• Energy Harvest Control field testing protocol

Documents currently being reviewed by manufacturers:
• Vaccine cold box with freeze prevention technology (performance specifications, and verification protocol)
• Transportable, powered vaccine storage appliances (performance specifications)
• Integrated and programmable remote temperature and event monitoring systems integrated within monitored equipment (performance specifications)

Documents ready for industry review:
• Single-phase voltage stabilizers performance specifications and verification protocol
• Threshold indicators performance specifications
• Refrigerated vehicles performance specifications and verification protocol
• Refrigerator or combined refrigerator and water-pack freezer: absorption cycle performance specifications and verification protocol

 

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.