E2500验证标准在药厂项目中的探讨与应用

发布时间：2018-07-07 18:01

  本文选题：E验证标准 + 关键方面风险评估　； 参考：《中国医药工业杂志》2017年08期

【摘要】：本文目的在于通过对E2500验证标准的介绍并结合E2500在药厂项目中的应用,就如何制定基于项目的 E2500实施流程重点展开讨论,以科学理论为基础,通过关键方面风险评估(CARA)及关键方面设计评审(CADR)、供应商及主题专家的深度参与等具体方法,实现符合工艺及质量要求的系统、设施和设备,达到既保证产品质量和患者安全,又能快速提高生产能力、降低确认活动成本的目的 ;并为同行或企业提供具有指导意义的参考依据。
[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.
【作者单位】： 西安交通大学药学院;西安杨森制药有限公司;
【分类号】：R95
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本文编号：2105785