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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 at: gobinai@who.int

WHO PQS Devices Catalogue (PDF, version: 05 July 2018)

Feedback

User feedback supplies valuable information on equipment performance under field conditions. It also facilitates identification of emerging vaccine transport delivery or storage needs that are not yet (fully) met by existing products or devices. The PQS Secretariat monitors and collates product performance data from all sources. This data is then used to inform revisions to existing PQS standards as well as prompt creation of new Target Product Profiles (TPPs).
 
The PQS Secretariat and the PQS Working Group collaborate with UNICEF and WHO country and regional offices, as well as with product manufacturers, to obtain comprehensive field performance data. PQS actively encourages product users to provide feedback on product performance or any defects, as well as evolving operational needs. Positive feedback is also welcomed. Please use this
Feedback Form to provide us with your inputs or send an email to
pqsinfo@who.int

Submit feedback

Making an Application for Prequalification

·      The “Prequalification of immunization-related products and devices” pre-submission form should be filled out and submitted for new products seeking PQS prequalification. Product information provided by the manufacturer in this form helps the PQS Secretariat to determine whether a product is eligible for WHO prequalification assessment and, if so, the type of assessment that the product will undergo. It is therefore crucial that the form is both complete and accurate. Please kindly send a completed form to gobinai@who.int, with pqsinfo@who.int in copy.

 

     PQS Announcements

PQS Dossier Review Schedules: All manufacturers who seek prequalification are required to submit a pre-submission form. Once the product has been deemed eligible for WHO prequalification, a separate prequalification dossier must be submitted 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.

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.

Standard Operating Procedures

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