生物製劑先導工廠潔淨室環境管理之研究

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Title:	生物製劑先導工廠潔淨室環境管理之研究
Authors:	蕭炎泉 Shiau, Yan-Chyuan
Contributors:	營建管理學系 Construction Management
Keywords:	生物製劑工廠;潔淨室 Biological Products Factory;Clean Room
Date:	2009
Issue Date:	2014-06-26 20:30:44 (UTC+8)
Abstract:	建造生物製劑先導工廠，必須符合衛生署最新公布之各項相關法令，包含藥物製造工廠設廠標準，藥品優良製造規範、藥品優良製造確效作業基準及生物安全第三等級實驗室品質管制規範等，同時必須參照美國及歐盟有關cGMP 之相關規定辦理，且須能通過確效及檢查。生物醫學科技產業雖具備高投資、高風險的特質，但也是目前全球先進國家科技發展極富競爭力重點之一，許多國家也陸續設立了相應政策機構及建設。本文將探討生物製劑先導工廠潔淨室環境管理作業機制作，同時蒐集相關文獻資料及擷取專家識庫與綜合相關作業人員之經驗，來探討生 Establishing a pilot plant for biological products must comply with all the relevant latest enactments proclaimed by the Department of Health, including Standards for the Establishment of Pharmaceutical Factory, Good Manufacturing Practice (GMP), GMP Vali
Appears in Collections:	[Department of Construction Management] Seminar Papers

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