PQS : Performance Quality Safety is a regulatory instrument which has been designed by WHO, the World Health Organization in order to make sure that products which are used in the health system in low and middle income countries (LMICs) are compliant to minimum standards set out in the PQS documentation. They focus on performance, quality and safety of various products and services used in healthcare to ensure that
What products and services are covered by PQS?
WHO has prequalified almost 1,500 products — across in vitro diagnostics (IVDs), male circumcision devices, medicines, vaccines, immunization devices and cold chain equipment, and vector control products.
Who is concerned by PQS?
PQS concerns manufacturers and customers / users equally. On one hand side it regulates the minimum product design, safety and performance and by doing so, it allows on the other hand side the customer and users peace of mind when purchasing a PQS approved product, because they know it complies to the minimum required standards.
Why is PQS important
Without PQS, any product can hit the market and there is no evidence of proper performance. As an example, any refrigerator can keep things cold, but we have to make sure it does not get too cold or too warm inside : PQS laboratory testing exposes the refrigerator to different ambient temperature conditions and measures the achieved temperature profile inside, and is therefore able to document the refrigerator performance as a vaccine refrigerator which has to guarantee inside 2°C to 8°C when the outside temperature can differ between 5°C and 43°C. A household refrigerator would not be able to work under such conditions.
Once a product has obtained PQS, it can be supplied to a large number of countries without any additional certifications, thus creating a huge market potential for any product with PQS
How can PQS be obtained
PQS is a standard set out by the WHO. The basic guidelines and performance requirements can be found on the WHO PQS website. Manufacturers have to make sure to meet those requirements already in the design process of their new product. Internal laboratory testing followed by third party testing will confirm the performance. With all test results a product dossier has to be established and PQS would be granted after successful submission with PQS committee.
How can Global South Health Ventures help?
The GSHV team has had decades of experience working with WHO PQS and successfully applying for PQS of multiple products across different categories.
GSHV is able to provide services to guide manufacturers from the design process until dossier submission in order to make sure the product and the application are successful.
