How PQS Certification Impacts the Cold Chain

Acronyms are everywhere in pharmaceutical and food safety. However, some are more important than others.  The World Health Organization’s PQS certification is one that sets the global standard on effective cold chain equipment. Otherwise known as “Performance, Quality, and Safety”, PQS is granted by the WHO for a comprehensive range of cold chain equipment, injection devices and other products needed for safe and effective immunization delivery.

A collaboration between the WHO and UNICEF Supply Division, the PQS system dates back to 1979 and is the principal source of information and advice for those responsible for purchasing products used in immunization programs. And while PQS status does not guarantee purchase, it does indicate to buyers that a product is technically sound and approved for procurement by UN Agencies for its intended purpose (i.e. temperature monitoring).

Last year SmartSense went through the WHO process of becoming PQS certified. The decision makers in the qualification process include a variety of teams within the WHO, including: the WHO Department of Immunization, Vaccines and Biologicals (IVB); the WHO Department of Essential Medicines and Health Products (EMP); and the Quality, Safety, and Standards team (QSS).

To streamline the qualification process, PQS eligible products are divided into the 10 cold chain product categories identified below. They’re tested and measured on their performance against relevant specification standards, their quality and reliability in the field, and their overall safety to ensure no harm is caused to users, patients, or to the environment over the course of the product's life cycle.

E01: Cold rooms, freezer rooms and related equipment

E03: Refrigerators and freezers

E04: Insulated containers

E05: Ice packs and chilled water packs

E06: Temperature monitoring devices

E07: Cold chain accessories

E08: Single-use injection devices

E10: Waste management equipment

E11: Specimen collection equipment

E13: Therapeutic injection devices

To ensure these key criteria are met, the PQS team created a three-step screening process:

Step 1: Wherever possible, adopt international standards as a basis for the design, development and production of each product type.  If this is not possible, the team will work with industry and partners to define appropriate design criteria.

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

Step 3: 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 monitor its suitability for programmatic and operational needs.

While the process is stringent, the benefits are numerous. It takes uncertainty out of the equation for buyers. By selecting from a list of pre-qualified products, UN procurement agencies, Governments, and NGOs purchasing cold chain equipment can ensure they are accessing a reliable stream of safe, affordable, high quality products designed to meet the needs and constraints of the developing world.

The WHO estimates the global vaccine wastage currently amounts to 50% for lyophilize (freeze dry) and 25% for liquid vaccines due to improperly maintained or outdated refrigeration equipment, poor compliance with cold-chain procedures, and inadequate monitoring.  Products with PQS status are helping to reduce those statistics and strengthen the cold chain.

Click here for more information about the WHO and PQS process. To learn how SmartSense is committed to improving cold chain management and vaccine storage in resource-challenged countries, check out our Vaccine Monitoring Initiative here.