發(fā)布時間：2018-07-07 18:01

  本文選題：E驗證標準 + 關(guān)鍵方面風險評估　； 參考：《中國醫(yī)藥工業(yè)雜志》2017年08期

【摘要】：本文目的在于通過對E2500驗證標準的介紹并結(jié)合E2500在藥廠項目中的應(yīng)用,就如何制定基于項目的 E2500實施流程重點展開討論,以科學理論為基礎(chǔ),通過關(guān)鍵方面風險評估(CARA)及關(guān)鍵方面設(shè)計評審(CADR)、供應(yīng)商及主題專家的深度參與等具體方法,實現(xiàn)符合工藝及質(zhì)量要求的系統(tǒng)、設(shè)施和設(shè)備,達到既保證產(chǎn)品質(zhì)量和患者安全,又能快速提高生產(chǎn)能力、降低確認活動成本的目的 ;并為同行或企業(yè)提供具有指導意義的參考依據(jù)。
[Abstract]:Through the introduction of E2500 verification standard and the application of E2500 in pharmaceutical factory project, this paper discusses how to make the implementation process of E2500 based on the project, based on scientific theory. Through specific methods such as critical aspect risk assessment (Cara) and critical aspect design review (CADR), the deep participation of suppliers and subject matter experts, the system, facilities and equipment that meet the requirements of process and quality are realized, and the product quality and patient safety are ensured. It can also increase production capacity, reduce the cost of confirming activities, and provide reference basis for peers or enterprises.
【作者單位】： 西安交通大學藥學院;西安楊森制藥有限公司;
【分類號】：R95
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本文編號：2105785