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Cold chain: difference between revisions

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Revision 72 — 21:45, 18 Oct 2025
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163The World Health Organization's model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, published as Annex 9 to Technical Report Series 961, performs a similar function internationally and is written to be adoptable by national regulators. It is accompanied by technical supplements addressing individual operations — refrigerated storage, temperature mapping, qualification of shippers, and monitoring — that are the closest thing to a practical manual in the public literature.{{r|whotrs961}}163The World Health Organization's model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, published as Annex 9 to Technical Report Series 961, performs a similar function internationally and is written to be adoptable by national regulators. It is accompanied by technical supplements addressing individual operations — refrigerated storage, temperature mapping, qualification of shippers, and monitoring — that are the closest thing to a practical manual in the public literature.{{r|whotrs961}}
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+165USP <1079> approaches the same ground from the compendial side, describing risks in storage and transport and mitigation strategies, and it is the chapter in which mean kinetic temperature and the treatment of excursions are elaborated for United States practice. USP <1118> covers the monitoring devices themselves.{{r|usp1079,usp1118}}
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165== References ==167== References ==
166{{reflist}}168{{reflist}}