浅析制药设备验证中的设计确认  

Analysis of Design Approval in Validation of Pharmaceutical Equipment

作　　者：曹元[1] 梁毅[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京210009

出　　处：《医药工程设计》2009年第2期31-35,共5页Pharmaceutical Engineering Design

摘　　要：目的:提出制药企业正确开展设备设计确认工作的对策。方法:通过阐述设备设计确认的重要性、分析企业现行的设计确认工作存在问题,从而提出设计确认如何开展的对策。结果与结论:良好的设备设计确认是制药企业完整并完善设备验证的关键,因此设计确认必须得到制药企业足够的重视。Objective： TTo put forward some measures on how to correctly carry out design qualification of equipment validation in pharmaceutical enterprises. Method： On the basis of the explanation of the importance of design qualification and the analysis of the existed problems in the current design qualification process, the measures to improve design qualification were, then, presented. Results and conclusion： A good design qualification is critical to complete and perfect equipment validation. Thus, more consideration for design qualification should be taken in pharmaceutical enterprises.

关 键 词：设计确认 设备验证 用户需求标准GMP 

分 类 号：TQ460.5[化学工程—制药化工]