纯化水制备、贮存和分配系统性能确认方案.doc

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Purified Water produce and skid
纯化水制备、储存与分配系统
Performance Qualification
性能确认
g Test第三阶段：常规取样测试 16
3. Personal Identification人员的鉴别 17
4. Deviation Report偏差报告 17
5. Comment Section注释 17
6. List of Deviation 偏差清单 18
7. List of Attachment附件清单 18
8. Execution Review and Approval 回顾和批准 18
9. Modification & Change Control 改造和更改控制 18
10. Index of Test Report 测试报告目录 18
Test Report 测试报告1 Prerequisites先决条件 20
Test Report 测试报告2 Validation Instruments Calibration 验证仪器校准 21
Test Report 测试报告3 SOP Check SOP检查 22
Test Report 测试报告4 Sterilization Verification 消毒确认 23
Test Report 测试报告5 Operational Parameter Verification 在线操作参数确认 24
Test Report 测试报告6 First phase: Intensive Sampling Test第一阶段：密集取样测试 25
Test Report 测试报告7 Second phase: Intensive Sampling Test第二阶段：密集取样测试 33
Test Report 测试报告8 Third phase: Routine Sampling Test第三阶段：常规取样测试 41
Test Report 测试报告9 Personnel Identification人员的鉴别 52
Test Report 测试报告10 Deviation Report偏差报告 53
Test Report 测试报告11 Addendum Form注释表 55
Test Report 测试报告12 List of Deviations偏差清单 56
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Purified Water produce and skid
纯化水制备、储存与分配系统
Performance Qualification
性能确认
Test Report 测试报告13 List of Attachment附件清单 57
Test Report 测试报告14 Execution Review and Approval 执行的审核和批准 58
Introduction介绍
Purpose目的
The performance qualification protocol is to define the content of performance qualification protocol (PQ) of purified water produce and skid of Hangzhou ****** Pharmaceutical CO., LTD..
本性能确认（PQ）方案描述了位于杭州******制药有限公司内新建的纯化水制备、储存与分配的性能确认方案的内容。
The purpose of this protocol is to demonstrate that the purified water produce and distribution system consistently produces water that meets the requirements for Purified Water specified in the Chinese Pharmacopoeia 2010 edition, the European Pharmacopoeia (EP) 6th Edition and United States Pharmacopoeia 33 Edition. This qualification includes verification that all relevant Standard Operating Procedures used fo