75%乙醇、0.1%新洁尔灭消毒效果验证方案.pdfVIP

苏州万庆药业有限公司QC-VAL-535-01

75%乙醇、0.1%新洁尔灭

消毒效果验证方案

验证编号：QC-VAL-535-01

苏州万庆药业有限公司

2010年11月

苏州万庆药业有限公司QC-VAL-535-01

验证方案确定

报告确定部门姓名签名日期

起草QC

复核QC

QC

审核

QA

批准QualityDirector

苏州万庆药业有限公司QC-VAL-535-01

目录

1.验证方案介绍、目的、范围、相关文件·····························································1·

2.验证准备.····································································································1·

3.验证内容·····································································································3·

4.变更与偏差··································································································7·

5.验证结论····································································································8·

6.附件··········································································································8·

7.参考文献····································································································8·

苏州万庆药业有限公司QC-VAL-535-01

1.验证方案简介、目的、范围、相关文件

1.1验证方案简介：

本验证共分三部分：

1.1.1第一部分是对验证方案的介绍，包括验证目的、范围以及相关验证、文件的介绍。

1.1.2第二部分是验证的相关内容：75%乙醇及0.1%新洁尔灭的喷洒消毒效果试验。验证在微生

物实验室阳性菌对照室完成。

1.1.3第三部分是验证结论及再验证。

1.2目的

通过喷洒消毒的方法验证75%乙醇及0.1%新洁尔灭在实验室条件下对各种载体上已知菌的消毒效

果，为其正确使用提供保障。

1.3范围