QILU PHARMACEUTICAL 基因工程车间纯化水系统验证方案 页次：Pag e 1 o f 72 文件号：V-U-2800076 替代文件: 无 题 目: 纯化水系统验证方案 文 件 号： V-U-2800076 替代文件: 无 总 页 数: 50页 生效日期: 年 月 日 批准： 部门 职务 签名 日期 起 草 人 年 月 日 车间审核人 年 月 日 QA审核人 年 月 日 批准人 年 月 日 QILU PHARMACEUTICAL 基因工程车间纯化水系统验证方案 页次：Page 2 of 72 文件号：V-U-2800076 替代文件: 无 目 录 一、概述 ·················································································································································· 3 二、原水(饮用水)、纯化水、水质量标准、设备一览表 ···························································· 13 三、纯化水系统的安装确认 ··············································································································· 15 四、纯化水系统的运行确认 ··············································································································· 26 五、性能确认 ········································································································································ 42 六、偏差分析 ·················································································································...
