STPYZ007-00真空系统验证方案.docVIP

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2017-07-05 发布于江西
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STPYZ007-00真空系统验证方案.doc

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STPYZ007-00真空系统验证方案

大连昆阳制药有限公司 STP/YZ007-00 第 PAGE ８页共 NUMPAGES 8页 PAGE 大连昆阳制药有限公司 STP/YZ007-00 第 PAGE １页共9页真空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 文件资料的确认·······························································································4 4.1.2 主要设备安装确认·····························································································4 4.1.3 管路分配系统的安装确认···············································································4 4.1.4 公用工程安装确认···························································································4 4.1.5 仪器仪表的校正确认·······················································································5 4.2 运行确认···················································································································5 5 日常监控和周期验证·······················································································