Transcription of 美國與歐盟對藥品包材可浸出物 (extractables) 與可 …
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美國與歐盟對藥品包材可浸出物 (extractables) 與可 …
RegMed 2015 Vol. 52 1 (extractables) ( leachables ) / 1 GMP DMF ( ) Guidance for industry: container closure systems for packaging human drugs and biologics(1) Guideline on plastic immediate packaging materials(2) (packaging component) (materials of construction) (extractables) ( leachables ) (extraction) (1,2,3) (migration) (2,3) 1 RegMed 2015 Vol.
RegMed 2015 Vol. 52 1 美國與歐盟對藥品包材可浸出物 (extractables) 與可滲出物 (leachables) 之審查考量 張凱琳/張琳巧1 前言 綜觀世界各國對藥品包裝材料之管理規範，從上游GMP 管理、DMF 資料、
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