9/23付のECA/GMP Newsが「USP revises Storage and Transport Chapters」と題する記事を掲載しています。
USPにおける医薬品の保管と輸送の各条およびStimuli Article改訂等に関する内容です。
lGeneral Chapters
・[1079] Good Storage and Distribution Practices for Drug Products
・[1079.2] Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
・[659] Packaging and Storage Requirements
lStimuli Article
・The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions for Controlled Cold Temperature Drugs: Proper and Improper Application
・The Use of Simulated Transport in the Evaluation of Risks to the Product Quality from the Distribution Process
関係者及び興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.org/gmp-news/usp-revises-storage-and-transport-chapters
USPにおける医薬品の保管と輸送の各条およびStimuli Article改訂等に関する内容です。
lGeneral Chapters
・[1079] Good Storage and Distribution Practices for Drug Products
・[1079.2] Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
・[659] Packaging and Storage Requirements
lStimuli Article
・The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions for Controlled Cold Temperature Drugs: Proper and Improper Application
・The Use of Simulated Transport in the Evaluation of Risks to the Product Quality from the Distribution Process
関係者及び興味のある方は、下記URLのニュース記事をご参照く
https://www.gmp-compliance.
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