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大连昆阳制药有限公司 STP/YZ006-00 第 PAGE 1页共 NUMPAGES 14页
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大连昆阳制药有限公司 STP/YZ009-00 第 PAGE 0页共 NUMPAGES 14页
压缩空气系统验证方案
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···············································································································3
4.1 设备预确认···················································································································3
4.2 安装确认···················································································································4
4.3 运行确认···················································································································5
4.4 性能确认···················································································································5
4.4.1 微生物限度确认···································································································5
4.4.2 尘埃粒子数测定···································································································6
5 常监控和周期验证·········································································································6
附件1：压缩空气系统工艺流程图
附件2：文件资料的确认记录
附件3：主要设备安装确认记录
附件4：终端过滤器起
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