纯化水性能确认.docVIP

Performance Qualification Protocol Purified Water System System ID: XXX 纯化水系统性能确认方案 系统编号： Revision History: 修订历史 Version 版本 Revision No. 修订号 Revision Date 修订日期 Reason for revision 修订原因 00 00 TABLE OF CONTENT 目 录 1.0 Pre Approval 3 2.0 Objective 目标 4 3.0 Scope 范围 4 4.0 Reference Document 参考文件 5 5.0 Equipment description 5 5.1 Use of system:用途 5 5.2 Capacity 产能 5 5.3 Operation Design Feature操作设计特征 6 6.0 Performance Qualification Test Plan 运行确认测试计划 7 6.1 Phase I validation Study: 7 6.2 Phase II Validation Study 第二阶段验证研究 8 6.3 Phase III Validation Study 第三阶段验证 8 7.0 Responsibility 职责 8 8.0 Test Execution Method 测试方法 9 9.0 Acceptance Criteria接受标准 14 10.0 Summary Report and Conclusion 总结报告和结论 14 11.0 Abbreviations 缩略语 17 Pre Approval This document is prepared by project team of XXX Pharmaceuticals Co. Ltd for the project OSD facility under the authority of their Project Manager. Hence this document before being effective shall be approved by the QA team of XXX Pharmaceuticals Co. Ltd, and authorized by the appropriate Project Authority 在项目经理的授权下，本文件由XXX制药有限公司项目组为口服固体制剂厂房项目编写的，所以在文件生效前应由有限公司质量保证批准，并由适当的项目授权人授权。 Prepared by起草人 Name/Department姓名/部门 Signature签名 Date日期 Reviewed by 审核人 Name/Department姓名/部门 Signature签名 Date日期 Approved by批准人 Name/Department姓名/部门 Signature签名 Date日期 Identification of Signatures / Participants签名确认 In the list below all persons having participated in the execution of this PQ and having signed on any of the tests are identified with their name, their company / department / function and their signatures. 下列清单中所有参与实施确认的人员和在任何测试中签名的人员要求确认他们的姓名、公司名称、部门、职位和签名。 With this signature the test participant confirms awareness of the procedures to be followed in qualification tests and completion of associated documentation. 经过签名，确保测试参与人员了解测试中应遵守的程序和相关文件的完成程序。 Name 姓名 Company / Department / Function 公司/部门/职位 Signature 签名 Training Record Location 培训记录存放位置 Objective 目标 PQ is to establish