作者：徐恒金
单位：正大天晴药业集团股份有限公司，江苏连云港  222006
中图分类号：TP277        
文献标识码：A        
文章编号：1006-883X(2018)08-0015-03
收稿日期：2018-07-06

摘要：2013年以前，中国《药品经营质量管理规范》对药品温湿度记录有要求，但未做详细规定，2013年国家食品药品监督管理总局发布《药品经营质量管理规范》冷藏、冷冻药品的储存与运输管理等5个附录的公告，其中附录3主要针对药品储存与运输过程中的温湿度自动监测系统。本文简要分析相关的文件要求，介绍了温湿度监控系统及其实施过程，针对几个比较关键节点给出了具体方案。
关键词：《药品经营质量管理规范》；温湿度；监控

New GSP Temperature and Humidity Monitoring System
XU Heng-jin
Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Lianyungang 222006, China
Abstract: Good Supply Practice (GSP) of China before 2013 has requirements on the storage temperature and humidity of drugs, but no detailed regulations have been made. In 2013, the State Food and Drug Administration issued five appendices of GSP on storage and transportation management of  refrigerated and frozen drugs, among which appendix 3 is mainly for automatic temperature and humid-ity monitoring system used in the process of storage and transportation of drugs. The related  requirements are analyzed in briefly in this paper. The temperature and humidity monitoring system and the implementation process are introduced, and specific solutions for several key nodes are given.
Key words: Good Supply Practice (GSP); temperature and humidity; monitoring

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备注：2018年 第24卷 第08期