GB/T 46204-2025
ActiveRequirement for traceability management in medicinal product cold chain logistics
药品冷链物流追溯管理要求
Application Summary AI generated
This standard specifies the traceability management requirements for the entire cold chain logistics process of medicinal products, including temperature monitoring, data recording, and information sharing. It is applied by pharmaceutical manufacturers, logistics providers, and healthcare institutions in China to ensure the integrity of temperature-sensitive drugs, such as vaccines and biologics, during transportation and storage. The standard supports compliance with regulatory audits and facilitates rapid recall or investigation in case of temperature excursions.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.