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2022.01.18

<WHO発行>医薬品の保管と輸送に関する参考文書②「Introduction to the Technical Supplement」

前回のブログでは、WHOのテクニカルレポートシリーズ(WHO Technical Report Series)961「WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS」内の、Annex 9 「Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products」についてご紹介しました。

このAnnex 9に関して、それぞれの項目ごとに詳細内容(どうすれば実現できるか)を解説した参考文書が、WHOから発行されています。今回は、それらの文書を一覧にした「Introduction to the Technical Supplement」をご紹介します。

同文書に記載されている各タイトルは以下のとおりです。

1. Selecting sites for storage facilities
2. Design of storage facilities
3. Estimating the capacity of storage facilities
4. Security and fire protection in storage facilities
5. Maintenance of storage facilities
6. Temperature monitoring of storage areas
7. Qualification of temperature-controlled storage areas
8. Temperature mapping of storage areas
9. Refrigeration equipment maintenance
10. Checking the accuracy of temperature control and monitoring devices
11. Qualification of refrigerated road vehicles
12. Temperature-controlled transport operations by road and by air
13. Qualification of shipping containers
14. Transport route profiling qualification
15. Temperature and humidity monitoring systems for transport operations
16. Environmental management of refrigerant gases and refrigeration equipment

次回以降、これらのなかから輸送・物流への関わりが深い文書をいくつかご紹介していきます。

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