气相色谱验证报告.doc

目录
确认目的························································2
确认范围························································2
方案说明························································2
验证职责························································2
仪器概述························································2
确认步骤·······················································2
7. 偏差处理·······················································7
8. 风险评估·······················································7
9. 确认总结·······················································7
·······················································8
·······················································9
一、确认目的
此验证是为确认气相色谱仪的运行和各种性能指标是否满足规定要求。
二、确认范围
证明并保证本仪器确认后,经本仪器检验的数据真实可靠。
三、方案说明
。用墨水笔填写。完成表格的人员应签上姓名和日期。如果由一个以上的人填写,那么每一个人都应签上姓名和日期。
。一旦这种情况发生,应将一份“异常情况报告”送交验证领导小组进行处理。
验证小组最终做出验证报告,该报告由公司验证负责人批准。
四、验证职责

负责验证工作的组织和协调。负责验证数据及结果的审批。负责验证报告的审批。
2. 质量部
负责验证的检验工作。负责保管验证文件。
五、设备概述
1、设备概述:本仪器由安捷伦科技有限公司生产,主要用于实验的检测,存放于气液相室。该仪器更快的柱箱降温速率和更强的反吹功能,使您的分析时间更短,样品的分析成本更低。第五代电子气路控制(EPC)和数字电路为压力设定和保留时间锁定(RTL)的精度()设置了新的标准,使安捷伦GC7820A具有前所未有的可靠性。
2、设备名称:气相色谱仪
3、设备型号:GC7820A
4、制造商:安捷伦仪器有限公司
六、确认步骤
1、人员培训确认
进行测试的人员必须接受足够的培训并将培训计划和考核结果存档(培训是现行GMP所要求的),熟悉检验仪器的操作原则,理解人员安全要求,全面理解仪器及检验的标准操作规程。
确认:
。
是: 否:
。