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Welcome to the PQS Catalogue

The WHO Department of Essential Medicines and Health Products (EMP), Prequalification Team (PQT) is responsible for prequalifying vaccines. It also prequalifies a comprehensive range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery.

The PQS (Performance, Quality and Safety) website provides data sheets for all currently prequalified products. Users may also download a device catalogue that includes a complete range of currently prequalified products and comprehensive guidance notes to help purchasers make informed choices. This catalogue is updated whenever a change occurs with regards to a product, a manufacture or a laboratory.

 

Prequalification of immunization related equipment and devices

pdf catalogue download: Catalogue - last version 03 August 2016

Feedback form: Feedback

E003 database in documentation guidelines: E003 database version 27 June 2016

E003 pdf Catalogue 28 June 2016

Announcement:

Due to technical problems with our database, the latest version of the catalogue is not available on our website and some links are broken. We are trying to resolve these problems as soon as possible. Please kindly email: gobinai@who.int if you need any assistance with the catalogue

The latest Sure chill Vaccine Refrigerators are now manufactured by Godrei Appliances and Zero Appliances

New: prequalification of a Vaccine Cold Box Long Term Storage Device ARTEK model YBC-5 manufactured by AUCMA in China. Note that this device is subjected to a field evaluation for full validation of its prequalification status.

Newly published:

New draft version 2: cold box with freeze prevention feature CB05.2 and CB-VP.2

Generic Guide for Field Evaluation of New Technologies; WHO/PQS/GENERIC/GUIDE1.1

Introducing solar-powered vaccine refrigerator and freezer systems, a guide for managers in national immunization programmes

Solar power system for compression-cycle vaccine refrigerator or combined refrigerator-icepack freezer: PQS performance specification WHO/PQS/E003/PV01.3

Freeze-protection testing protocol: FREEZE TESTING_PQS E003 RF05-RF06_20151116.pdf and FREEZE TESTING_PQS E003 RF03_20150916.pdf (Latest version)Programmable remote temperature and event monitoring systems: PQS performance specification, WHO/PQS/E006/TR03.2

Programmable remote temperature and event monitoring systems: PQS independent type-testing protocol, WHO/PQS/E006/TR03-VP.2

Programmable remote temperature and event monitoring systems: PQS protocol tool, WHO/PQS/E006/TR03-VPT.2

The PQS team also accredits the independent testing laboratories.  These organizations undertake the product inspection and testing which is part of the prequalification process for devices. 

The 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 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:

Step 1: 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.

Step 2: For each product type we develop and maintain technical specifications and related test procedures that adequately reflect programmatic and operational needs.

Step 3: 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 that can be found at:

Other links

 

Prequalification of vaccines

WHO provides a pre-qualification service for UNICEF and other UN agencies that purchase vaccines.  The pre-qualification process determines the acceptability, in principle, of the vaccines supplied to these agencies.  The following links describe the procedures in more detail.

         A system for the prequalification of vaccines for UN supply

         Issues relating to prequalified vaccines

         Revision of the WHO vaccines prequalification procedure.

         Assessing the programmatic suitability of vaccines candidates for WHO prequalification.