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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 15 December 2015

Feedback form: Feedback

E003 database in documentation guidelines: E003 database version 10 November 2015

Events:

· Next PQS Specifications Working Group meeting, 9 – 11 December 2015.

Newly prequalified:

E003/048

Solar direct drive refrigerator/freezer

VC150SDD

Dulas Solar

E003/049

Solar direct drive refrigerator

GVR50DC

Godrej

E003/050

Solar direct drive refrigerator

GVR100DC

Godrej

E003/051

Icelined refrigerator

ZLF30AC

Zero Appliances

E003/052

Solar direct drive refrigerator

ZLF150DC

Zero Appliances

E003/053

Solar direct drive refrigerator

VLS094

Vestfrost Solutions

E003/054

Solar direct drive refrigerator

VLS154

Vestfrost Solutions

E003/055

Solar direct drive refrigerator

ZLF30DC

Zero Appliances

E006/036

RTM System

Ice3-BC140

Beyond Wireless

E006/037

RTM System

Ice3-Extra BC440

Beyond Wireless

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:

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

Suspension notification: following several complaints from countries, PQS has suspended the product E008/028 AD syringe 0.05mL and E008/029 AD syringe 0.1mL until the issue is resolved.

PQS has been informed that the Remote Temperature Monitoring System “Smart View” (code: E006/019) will not be supplied anymore until further notice.

 

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.