试验用药品的冷链管理研究

Cold chain management for investigational drugs

试验用药品在规定的温度条件下运输和储存是保证试验用药品质量的前提,是药物临床试验数据和结果真实、可靠的基础。通过查阅《药物临床试验质量管理规范》《药物临床试验数据现场核查要点》《中国药典》《美国药典》和相关国内外文献,结合本机构试验用药物管理模式的特点,探索试验用药品冷链管理的关键环节,实现试验用药品冷链的闭环管理,减少超温事件的发生。介绍本机构试验用药品的冷链管理经验,为药物临床试验机构进行试验用药品的冷链管理提供借鉴和参考。

The transportation and storage of investigational drugs under specified temperature conditions is the premise of ensuring the quality of investigational drugs,and is the basis for the authenticity and reliability of drug clinical trial data and results.By consulting“Good Clinical Practice for Drugs”,“Key Points for On-site Inspection of Drug Clinical Trial Data”,“Chinese Pharmacopoeia”,“US Pharmacopoeia”,and related domestic and foreign documents,combined with the characteristics of investigational drug management model,we explore the key links of cold chain management of investigational drugs,realize closedloop management of cold chain of investigational drugs,and reduce the occurrence of over-temperature events.This article introduces the cold chain management experience of investigational drugs,and provides reference for the cold chain management of investigational drugs in drug clinical trial institutions.