医药STPYZ01000动物房净化空调系统验证方案.docVIP

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2018-08-16 发布于贵州
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医药STPYZ01000动物房净化空调系统验证方案.doc

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医药STPYZ01000动物房净化空调系统验证方案

PAGE 大连昆阳制药有限公司 STP/YZ006 第 PAGE １页共 NUMPAGES 40页动物房净化空调系统验证方案起草人：审核人：批准人：起草部门：起草日期：审核日期：批准日期：执行日期：验证小组会签部门岗位签名签名日期颁发部门： [质量部] Copy №： [ ] 行政部[ ] 物供部[ ] 质量部QA[ ] 质量部QC[ ] 研发部[ ] 生技部[ ] 疫苗车间[ ] 分包装车间[ ] 工程部[ ] 保安部[ ] 营销部[ ] 财务部[ ] 变更记载：修订号批准日期执行日期 00 变更原因及目的：建立验证文件，并通过验证证明所验证对象有效、稳定、可靠。目录验证方案······································································································································3 1 概述···································································································································3 2 目的···································································································································3 3 职责···································································································································3 4 验证方案及记录···············································································································4 4.1 安装确认···················································································································4 4.1.1 设备预确认·······································································································4 4.1.2 文件资料的确认······························································································· 4.1.3 主要设备安装确认··························································································· 4.1.4 通风管道系统的安装确认··············································································· 4.1.5 公用工程安装确认··························································································· 4.1.6 仪器仪表的校正确认······················································································· 4.1.7 高效过滤器的安装检漏确认···········································································5 4.2 运行确认···················································································································5 4.2.1