The document provides guidelines for manufacturers on the pre-qualification of cold chain-related products under the PQS (Performance, Quality, Safety) system, specifically focusing on insulated containers and coolant packs type water-packs.
The introduction emphasizes the importance of the PQS system in ensuring the quality and reliability of cold chain-related products for procurement by United Nations (UN) agencies. The products covered include insulated containers and coolant packs used as ice-packs, cool-packs, or warm-packs. The document outlines the various categories of equipment that can be offered for pre-qualification, including cold rooms, refrigerators, freezers, insulated containers, and more.
The background section highlights the role of the QSS group within WHO's Department of Immunization, Vaccines, and Biologicals in providing technical advice and support for a high-quality cold chain. The document underscores the importance of the insulated container industry in providing reliable and high-quality products tailored to the needs of the developing world.
The procedural guide section delves into the specifics of the PQS system, explaining its evolution from the PIS system. It details the process of pre-qualification, from the initial application to the submission of a product dossier, evaluation fees, and the dossier evaluation process. The guide also outlines the verification process, results, and approval process, emphasizing the importance of maintaining pre-qualified status and the potential reasons for losing it.
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