20150610 ECA新闻：WHO公布新的药品贮运指南 （转载）

20150610 ECA新闻：WHO公布新的药品贮运指南 （转载）

2015-06-10 23:58:41

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ECA新闻

GMP News
10/06/2015

WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products

WHO公布新的药品贮运指南

During The 137th World Health Organisation (WHO) Executive Board (EB) meeting, the Report of the 49th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations was presented. With this report, a set of new guidances was adopted and recommended for use, in addition to certain monographs and general texts for inclusion in The International Pharmacopoeia. The report is now available in the WHO Technical Report Series as No. 992.

第137届WHO执行董事(EB)会议中对WHO专家委员会制剂标准的第49号会议报告进行了公布。该报告中，一套新的指南被采纳和推荐使用，有一些包括在国际药典中的特定各论和通用章节除外。该报告现在可以在WHO官网下载。

For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products.

对于工作在优良销售规范(GDP)领域的人，可能会对以下文件感兴趣：时间温度敏感药品的贮运指南技术补充。

This series of technical supplements intends to give further guidance and more details to the recommendations given in theModel guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011, Annex 9).This document focuses on principal requirements for the safe storage and distribution of time- and temperature sensitive pharmaceutical products (TTSPPs).

这一系列的技术补充意在对时间温度敏感药品的贮运指南（WHO技术报告系列第961号，2011）给出进一步更详细的指导。本文聚焦在安全存贮和销售时间温度敏感药品（TTSPP）的基本要求。

The additional material provided in these supplements links back to a specific clause or clauses in the parent document mentioned above. All of the 16 single documents contain a reference section with hyperlinks to relevant supporting materials. This gives a great overview on what is the current state of the scientific and technical knowledge in this area.

在这些补充文件中增加的材料链接回到上述母文件的具体条款或多个条款。所有16个单独的文件包括了一个参考文献部分，均有超链接导向支持性材料。这可以让读者对该领域的科学技术知识目前的状态有一个概览。

Supplement 1.	Selecting sites for storage facilities	选择存贮设施
Supplement 2.	Design and procurement of storage facilities	存贮设施的设计和采购
Supplement 3.	Estimating the capacity of storage facilities	存贮设施能力估计
Supplement 4.	Building security and fire protection	建筑安保和防火
Supplement 5.	Maintenance of storage facilities	存贮设施的维护
Supplement 6.	Temperature and humidity monitoring systems for fixed storage areas	固体存贮区域的温湿度监测系统
Supplement 7.	Qualification of temperature-controlled storage areas	温控存贮区域的确认
Supplement 8.	Temperature mapping of storage areas	存贮区域的温度分布
Supplement 9.	Maintenance of refrigeration equipment	冷冻设备的维护
Supplement 10.	Checking the accuracy of temperature control and monitoring devices	温度监控装置的准确度检查
Supplement 11.	Qualification of refrigerated road vehicles	冷冻厢车的确认
Supplement 12.	Temperature-controlled transport operations by road and by air	公路和空运温控运输操作
Supplement 13.	Qualification of shipping containers	海运集装箱的确认
Supplement 14.	Transport route profiling qualification	运输路线概况确认
Supplement 15.	Temperature and humidity monitoring systems for transport operations	运输操作的温湿度监测系统
Supplement 16.	Environmental management of refrigeration equipment	冷冻设备的环境管理

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