WHO prequalification ensures the availability of quality, reliable products that help safeguard vaccine potency as well as expand and extend their availability.

Laboratories that test products contribute to this mission by verifying that products submitted for prequalification meet stringent requirements and quality standards. WHO accredits only those laboratories that can demonstrate they conform to international standards or codes of practice.

Why participate?

Participating in the WHO prequalification of immunization products initiative delivers benefits for testing laboratories:

• increased capacity and skills through application of stringent product examination and testing protocols, in order to meet  accreditation requirements
• increased market access
• opportunity to become market-leaders in testing products for challenging operating environments
• improved image or brand through status associated with testing quality-assured products and association with the WHO, UNICEF and national Expanded Programme on Immunizations programmes.

Product testing laboratories that are interested in becoming accredited will find the following information useful:

• Benefits of WHO immunization devices prequalification ― what WHO immunization devices prequalification brings to its different stakeholders
• Laboratory accreditation ― the procedure through which laboratories become accredited to test products submitted for prequalification.
• Laboratory re-accreditation ― how to retain WHO accreditation to test products
• Product testing support for laboratories ― information about the circumstances in which field-testing may be required for prequalification
• IMD-PQS verification protocols ― access to all IMD-PQS verification protocols
• Guidance documents ― the principle types of guidance documents for laboratories pursuing accreditation
• IMD-PQS ePQS Learning materials for Laboratory accreditation - comprehensive training deck for applicants for the WHO's online e-Prequalification system (mandatory for all applications from January 2025)
• Types of product testing ― the three different ways in which products are tested for prequalification, and the role of laboratories in these tests
• Accredited laboratories ― listing of currently-accredited laboratories and their testing competencies
• Key contacts ― the key persons who can be contacted regarding different aspects of prequalification of immunization devices.