中英文纯化水验证方案概要1.doc

Project Name项目名称 Manufacture Name制造商名称 Index目录 1. 5 2. Purpose目的 7 3. Scope范围 8 3.1 Scope范围内 8 3.2 Exclusion of Scope范围外 9 Responsibilities职责 9 4.1 Austar Responsibilities奥星职责 9 4.2 HGPF Responsibilities哈药总厂职责 9 5. 11 6. Regulation and Guidance法规和指南 13 7. References参考文件 14 8. System Description系统/设备描述 19 8.1 System Use系统用途 19 8.2 Operation and Design Features运行和设计特点 22 9. 25 9.1 Performance Qualification Flow性能确认流程 25 9.2 PQ sampling plan性能确认取样计划 25 10. 39 11. Test List测试项目列表 43 12. Performance Qualification Tests性能确认测试 45 12.1 Prerequisites Verification先决条件确认 45 12.2 Personnel Verification人员确认 47 12.3 SOP Verification SOP确认 48 12.4 Training Verification培训确认 51 12.5 Testing Instrument Calibration Verification测试用仪器仪表校准确认 53 12.6 System Operation Parameters Verification系统运行参数确认 55 12.7 Sanitization Verification消毒确认 56 12.8 The Water quality for pre-treatment System Verification预处理水质认 59 12.9 PW Quality Verification纯化水质量确认 61 13. 66 14. Change Handling变更处理 66 15. Summary of PQ性能确认总结 66 16. List of Attachment测试报告附件 68 Test Report 1 测试报告1 70 Test Report 2 测试报告2 74 Test Report 3 测试报告3 76 Test Report 4 测试报告4 79 Test Report 5 测试报告5 81 Test Report 6 测试报告6 83 Test Report 7 测试报告7 86 Test Report 8 测试报告8 88 Test Report 9 测试报告9 91 Introduction介绍 Harbin Pharmaceutical Group General Pharmaceutical Factory (hereinafter called HGPF) is establishing a new production building in accordance with the Chinese GMP and EU GMP requirements. Shanghai Austar is responsible for detailed design and construction of new Purified Water Generation Storage and Distribution System in this plant, and it is used for providing water for production of sterile powder for injection on second floor and QC lab on forth floor. This system is designed for circulating 24hours, and sterilized by pasteurization for one hour each time. It has emptying ability and 33 points of use. A set of 3.5m3/h purified water generator is installed in water generation room, and the generated PW is stored in a 6m