Prequalification of cold chain-related products under the PQS system - A guideline for manufacturers of solar power systems. E003/ GUIDE 2.3

The guide provides a comprehensive framework for the pre-qualification of cold chain-related products, specifically focusing on solar power systems for vaccine storage. The document is part of the World Health Organization's (WHO) initiative to ensure the quality and reliability of cold chain equipment for immunization programs worldwide.

The guide begins by explaining the PQS (Performance, Quality, Safety) system, which has evolved from the earlier Product Information Sheets (PIS) system. The PQS system is designed to evaluate and list products that conform to WHO's performance specifications. The document emphasizes that only products from the legal manufacturer or licensed re-seller will be considered for pre-qualification.

The procedural guide section outlines the steps manufacturers need to follow for pre-qualification. It details the application process, the preparation of a product dossier, associated fees, and the evaluation process. The guide also explains the verification process, where products are assessed against specific protocols to ensure they meet the required standards.

Maintaining pre-qualified status is crucial, and the guide describes both the annual review process and the extra-ordinary review process. The former is a standard yearly review, while the latter can be triggered by any serious issues with the product or the manufacturer.

In essence, the guide serves as a roadmap for manufacturers, ensuring that the solar power systems used in the cold chain for immunization programs are of the highest quality and reliability.