4/9付のECA/GMP Newsが「USP Published New Drafts for General Chapters on Plastic Materials」と題する記事を掲載しています。
Pharmacopeial Forum（PF）45（2）の最新号（2019年3月 ～4月）で、以下の各条に対するコメント募集として再発行されたとのことです。
■<661> Plastic Packaging Systems and Their Materials of Construction,
■<661.1> Plastic Materials Of Construction,
■<661.2> Plastic Packaging Systems for Pharmaceutical Use,
■<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact,
■<665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products,
■<1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
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-published-new-drafts-for-general-chapters-on-plastic-materials
Pharmacopeial Forum（PF）45（2）の最新号（2019年3月 ～4月）で、
■<661> Plastic Packaging Systems and Their Materials of Construction,
■<661.1> Plastic Materials Of Construction,
■<661.2> Plastic Packaging Systems for Pharmaceutical Use,
■<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact,
■<665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products,
■<1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
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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