无菌过滤工艺验证方案.pdf

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1、武雍药业（中国）有限公司确认方案页数Page:1/9QualificationProtocol无菌过滤工艺确认起草Preparedby:日期Date:吴广德审核Reviewedby:日期Date:李戴帅批准Approvedby:日期Date:毛明坤发行Releasedby:日期Date:李仲斯更改记录RevisionHistory版本生效日期更改、审核原因VersionEffectivedateReasonforRevision01新建文件。确认方案QualificationProtocol编码Code:页数Page:2/9无菌过滤工艺确认目录Tableofcontent1.目的Objecti

2、ve.....................................................................................................................32.范围Scope..........................................................................................................................33.定义Definition..................................

3、...................................................................................34.描述Description..................................................................................................................35.职责Responsibilities..................................................................

4、..........................................36.确认Qualification.................................................................................................................46.1组件确认....................................................................................................................46.

5、2过滤器完整性测试......................................................................................................56.3最佳过滤速度确认......................................................................................................56.4气密性确认..................................................................

6、..............................................66.5无菌性确认................................................................................................................76.6人员培训确认.............................................................................................................77.偏差/变更Deviat

7、ion/ChangeControl....................................................................................88.参考文件References..................................................................................