医药STPYZ01000动物房净化空调系统验证方案.doc
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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
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