Welcome to the PQS web main page.
The WHO Department of Essential Medicines and Health Products (EMP), Quality, Safety and Standards (QSS) Unit 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.
Prequalification of immunization related equipment and devices
pdf catalogue download: Catalogue - last version 7 June 2013
Feedback form: Feedback
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.
ZLF100DC Solar Direct Drive "Sure Chill" Technology by Zero Applliances (E003/037)
20-day shipping indicator TIC20 from Logtag (E006/021)
AD Jet Injector Stratis from Pharmajet (E008/050)
First "Central Temperature Monitoring System" (E006/019) and Fridge-Tag 2 (E006/020)
First combined refrigerator-freezer solar direct drive, Dometic TCW2000SDD (E003/035)
New specification: Vaccine cold box – long-term storage - 10 days
Two new specifications: Large capacity vaccine cold box and Vaccine cold box – long-term storage - 35 days
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:
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.