STP03-TY001-I纯化水系统验证方案.docVIP

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