VP纯化水系统验证方案.doc

PAGE 7 Purified Water System Validation Protocol 纯化水系统验证方案 Document No.文件编号 Revision No.版本号 00 Date日期Company Name 公司名称 Page页码 Page PAGE 18 of NUMPAGES 39 Purified Water System Validation Protocol 纯化水系统验证方案 Document No.文件编号 VP- Revision No.版本号 00 Date日期Company Name 公司名称 Page页码 Page PAGE 1 of NUMPAGES 41 Purified Water System Validation Protocol 纯化水系统验证方案 Approval of the Purified Water System Validation Protocol 纯化水系统验证方案的审批 Title 职务 Name 姓名 Signature 签字 Date 日期 Written By 起草人 Reviewed By 复核人 Approved By 批准人  Table of Contents TOC \o 1-2 \h \z \u HYPERLINK \l _Toc244941873 1 Summarize/概述 PAGEREF _Toc244941873 \h 3 HYPERLINK \l _Toc244941874 2 Purpose/验证目的 PAGEREF _Toc244941874 \h 4 HYPERLINK \l _Toc244941875 3Validation Team and Responsibilities/验证人员及职责 PAGEREF _Toc244941875 \h 4 HYPERLINK \l _Toc244941876 3.1Validation Team Member/项目验证小组成员 PAGEREF _Toc244941876 \h 4 HYPERLINK \l _Toc244941877 3.2 Responsibilities/职责 PAGEREF _Toc244941877 \h 4 HYPERLINK \l _Toc244941878 4 Content, Method and Criterion/验证内容、方法及合格标准 PAGEREF _Toc244941878 \h 5 HYPERLINK \l _Toc244941879 4.1Beforehand Qualification/预确认（安装前确认） PAGEREF _Toc244941879 \h 5 HYPERLINK \l _Toc244941880 4.2 Installation qualification/安装确认 PAGEREF _Toc244941880 \h 7 HYPERLINK \l _Toc244941881 4.3 Operation qualification/运行确认 PAGEREF _Toc244941881 \h 11 HYPERLINK \l _Toc244941882 4.4 Performance Qualification/性能确认 PAGEREF _Toc244941882 \h 12 HYPERLINK \l _Toc244941883 5 Deviation and deal with method/验证过程中的偏差及处理 PAGEREF _Toc244941883 \h 14 HYPERLINK \l _Toc244941884 6 Validation Conclusion/验证结果评定与结论 PAGEREF _Toc244941884 \h 14 HYPERLINK \l _Toc244941885 7.Revalidation Periods/再验证周期 PAGEREF _Toc244941885 \h 15 HYPERLINK \l _Toc244941886 8．Validation Schedule/验证时间安排 PAGEREF _Toc244941886 \h 15 HYPERLINK \l _Toc244941887 9.Attachment/ 附件 PAGEREF _Toc244941887 \h 16 1 Summarize/概述 The company commissioned the Jiaxing Jiame Water Treatment Engineering Co., Ltd. f