STP03-ZJ001-I注射用水系统验证报告.docVIP

注射用水（含纯蒸汽）系统 STP04-ZJ001-Ⅰ 验 证 报 告 辽宁诺康生物制药有限责任公司质量管理部 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 验证下组成员及职责···························································3 4.3验证时间······································································3 4.4验证人员培训··································································4 4.5文件检查······································································4 4.6仪器、仪表的检查·······························································4 4.7注射用水水质的预先测试分析·····················································4 4.8性能确认······································································4 4.9异常情况处理··································································5 4.10注射用水日常监控·····························································5 4.11 再验证周期···································································5 4.12 4.12 漏项及偏差处理··························································6 4.13 验证最终结论·································································6 5 附录············································································6 1 目的 为了证明注射用水系统（含纯蒸汽）设施安装后，能够始终生产出符合产品工艺要求和药品GMP 规范要求的注射用水及能够进行灭菌用纯蒸汽，按照本系统验证方案进行了性能确认，并将验证数据和验证结果进行汇总，形成验证结论，特编制本验证报告。 2范围 本报告适用于注射用水系统（含纯蒸汽）验证过程中数据的汇总和总结，验证结果的评价。 3 职责 质量管理部负责本报告的编制。 4 内容 4.1 概述 本公司注射用水系统及纯蒸汽系统于2007年6月完成了安装确认、运行确认、性能确认等系统验证，已经证明此系统可以始终如一的生产出符合《中国药典》（现行版）标准的注射用水。本次注射用水系统及纯蒸汽系统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