The WHO Performance, Quality and Safety (PQS) process
The vaccine supply chain involves not only manufacturing the vaccine contents, but also using temperature-controlled storage to help maintain vaccine quality from production to patient.
To engender confidence in their choice of products for use in immunization programs, UN member states and purchasing agencies may rely on the WHO Performance, Quality and Safety (PQS) process. PQS prequalifies devices for use based on performance relative to applicable standards, quality and reliability characteristics needed for use in challenging environments and safety characteristics that protect people and the environment throughout the course of the product's life cycle.
Products that have been tested and found to meet the applicable specification standards are listed in the WHO PQS Devices Catalogue, which includes information aimed at helping purchasers make informed choices.
UL offers PQS testing for vaccine storage refrigeration products
UL’s laboratories in Italy and India have received WHO accreditation as designated third-party testing laboratories for refrigeration equipment, including refrigerators and freezers, used for the storage of vaccines.
The accreditation is part of WHO’s Performance, Quality and Safety (PQS) process and allows UL to carry out full quality assurance testing – on-site installation and commissioning – of cold room, freezer room, and related equipment and coolants.
The quality of medical-related products is important in the prevention and treatment of diseases. The level of control of the products is not the same for each country
UL received the PQS accreditation for refrigeration equipment and devices after demonstrating to WHO officials the UL Refrigeration Laboratory’s conformity capabilities to appropriate internationally or nationally accepted standards or codes of practice.
Our services help manufacturers to:
- Understand the PQS process
- Get qualifying products or devices added to the PQS database
- Control product quality
- Build trust between manufacturers and target countries markets
- Differentiate their products in a competitive marketplace
Testing refrigeration equipment used for the storage of vaccines
The PQS process prequalifies vaccine storage devices and their suitability for use in immunization programs.
Before a product or device can be added to the PQS database, it must be tested to establish whether a product satisfies the requirements of relevant PQS performance specification. Testing includes:
- Cold rooms
- Freezer rooms
- Solar-powered refrigeration and freezers equipment
- Coolant-packs and related equipment
Solar-powered refrigeration equipment is seen as critical for vaccine effectiveness in developing countries without a reliable electricity grid.
Our global facilities and technical experts help ensure that refrigerated medical devices are packaged, stored and safe when put into use.
Manufacturers of vaccine storage refrigeration equipment can rely on UL for WHO PQS testing and other critical services. Our product safety and performance testing offerings can help mitigate risk and accelerate the process of getting refrigerated medical and vaccine solutions to market.
We can also help you solve some of your most complex business challenges with services such as process auditing, performance material validation, chain of custody, chain of condition, cybersecurity, sanitation, electromagnetic compatibility (EMC) and wireless services.