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STP03-TY001-I纯化水系统验证方案
纯化水系统
STP03-TY001-Ⅰ
验 证 方 案
辽宁诺康生物制药有限责任公司设备工程部
目录
1 目的··············································································3
2 范围··············································································3
3 职责··············································································3
4 内容··············································································3
4.1 概述············································································3
4.2 验证领导小组成员及职责··························································3
4.3 验证时间········································································3
4.4 验证人员的培训··································································4
4.5 文件检查········································································4
4.6 仪器、仪表的检查································································4
4.7 纯化水水质的预先测试分析························································4
4.8 性能确认········································································4
4.9 纯化水系统的日常监测····························································5
4.10再验证周期 ····································································5
4.11漏项及偏差处理··································································5
4.12验证结论········································································6
5 附录··············································································6
1目的
为确认纯化水系统按照其使用维护标准操作规程操作,在正常运行时,设备各项性能技术指标符合设计要求,始终能够保证生产出质量稳定、合格的纯化水,特制订本验证方案。本方案提供本系统验证方法和判定标准,验证过程应严格按照本方案规定的内容进行,若因特殊原因确需变更时,应填写验证方案漏项及偏差处理表,报验证领导小组批准。
2 范围
本方案适用于纯化水系统性能确认。
3 职责
验证小组对本方案的实施负责。
4 内容
4.1概述
本公司纯化水系统于2007年06月份完成了安装确认、运行确认、性能确认等系统验证,已经证明该系统可以始终如一的生产出符合《中国药典》(现行版)标准的纯化水。本次纯化水系统验证针对其性能进行检测,因此只做预先测试及性能确认。
4.2验证小组成员及职责
4.2.1 验证小组成员
小组职务 姓名 所在部门 职务 负责人 郁野 副总经理 组长 王弘 设备工程部 经 理 组员 沈文彧 质量管理部 经 理 组员 宋宇春 生产技术部 经 理 组员 徐驰 制水岗位 操作工 4.2.2验证小组成员职责
4.2.2.1验证小组负责人:负责验证方案、验证报告的批准;负责从验证方案的起草、方案的实施 以及验证报告完成全过程的组织工作。
4.2.2.2设备工程部:负责验证方
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