The document provides guidelines for the performance, quality, and safety (PQS) and procedures for suppliers of cold chain equipmentand temperature monitoring devices to get prequalified. These devices are designed to store vaccines and other temperature-sensitive health commodities in areas where electricity is unreliable or unavailable.
The guide emphasizes the importance of these equipment in ensuring the potency and efficacy of vaccines, especially in remote and off-grid locations. The document outlines the PQS process, which includes a prequalification procedure to ensure that these devices meet the required standards for performance, quality, and safety.
Manufacturers seeking PQS prequalification for their products must undergo a rigorous evaluation process, including laboratory testing and field evaluation. The document also provides guidance on the installation, operation, and maintenance of these devices to ensure their longevity and effectiveness in preserving vaccines.
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