Installation Qualification for
Pure Steam Distribution System
纯蒸汽分配系统安装确认
The signatures above indicate the approval of this document and it is ready for execution. Any changes or modification of this document requires the approval and generation of an amendment, which must be approved prior to execution.
上面的签名表示批准本文件，且表明已经为执行作好了准备。在批准后，任何对本文件的改变或修正都必须提供补充文件，并在执行以前必须取得批准。
Version History 版本历史
Index 目录
1.PURPOSE 目的 (4)
2.SCOPE 范围 (4)
3.ABBREVIATIONS缩略语 (4)
4.RESPONSIBILITIES职责 (5)
5.REFERENCES参考文件 (5)
6.SYSTEM DESCRIPTION系统描述 (6)
7.GOOD DOCUMENTATION PRACTICE文件管理规范 (6)
8.TEST LIST测试列表 (9)
9.PERSONNEL IDENTIFICATION人员确认 (10)
霸气网络10.TEST PROCEDURE测试程序 (11)
大学生就业难的原因10.1P REREQUISITES先决条件 (11)
10.2T EST I NSTRUMENTS C ALIBRATION V ERIFICATION测试用仪器仪表校准确认 (13)
10.3SAT P UNCH L IST C LOSE OUT V ERIFICATION SAT遗留清单关闭确认 (15)
10.4A S-BUILT D OCUMENT VERIFICATION竣工文件确认 (17)
10.5P&ID&C OMPONENTS V ERIFICATION P&ID&部件确认 (19)
10.6C RITICAL I NSTRUMENTS C ALIBRATION关键仪表校验 (21)
10.7C RITICAL M ATERIAL C ERTIFICATE V ERIFICATION 关键材料材质证明确认 (26)
10.8C RITICAL S URFACE R OUGHNESS V ERIFICATION关键表面粗糙度确认 (29)
10.9S YSTEM W ELDING D OCUMENTS R EVIEW系统焊接文件审查 (32)
10.10S LOPE AND D RAINING P ERFORMANCE I NSPECTION 坡度及排水能力检查 (34)
11.DEVIATION HANDLING偏差处理 (37)
12.CHANGE HANDLING变更处理 (41)
赵本山电影13.ATTACHMENT LIST附件清单 (43)
14.IQ SUMMARY IQ总结 (45)
14.1. TEST RESULT SUMMARY 测试结果汇总 (45)
14.2．IQ CONCLUSION IQ结论 (46)
1.Purpose 目的
The purpose of Installation Qualification (IQ) is to establish that the critical components are installed correctly and in accordance with design documentation requirements. Supporting documentation should be kept of suitable quality. IQ is an activity that is regulated by the Current Good Manufacturing Practice, and is a part of final qualification activities before Process Validation begins.
安装确认的目的是保证关键的部件得到了正确的安装，并符合设计文件的要求。支持文件保存在合适的地方，并符合质量部门的要求。安装确认是cGMP规定进行的活动，它是在工艺验证开始之前确认活动的一部分。
2.Scope 范围
This document is applicable to Pure Steam Distribution System of Process System of XXX Project .
本文件适用于XXX公司XXX项目的工艺系统的纯蒸汽分配系统。
3.Abbreviations缩略语
4.Responsibilities职责
The Responsibilities of XXX include but not limited to
XXX有限公司的职责包括但不仅限于
-Prepare and review of IQ protocol;
IQ方案的编制、审核；
-Execution of IQ;
IQ执行；
-Gather raw data and fill in the test form;
开学第一课2014收集原始数据并填写在测试表格中；
-Record and handling deviation/change which occur during the execution of IQ;
股东权利记录及处理IQ过程中发生的偏差/变更；
-Submit the IQ documentation to customer for review and approval.
提交IQ记录，以供用户进行审核和批准。
Responsibilities of client include but not limited to
客户的职责包括但不仅限于
-The review and approval of IQ protocol;
IQ方案审核及批准；
-Assist XXX in recording and handling the deviation/change occurred during IQ;
协同XXX有限公司记录和处理IQ过程中发生的偏差/变更；
-
Assist XXX in collecting raw data and filling in relevant check table;
协同XXX有限公司收集原始数据并填写相关表格；
-Provide the provision of necessary human resource and equipment;
提供为此次执行本方案所必要的资源（包括人力资源、设备运行资源）；
-Review and approve the final conclusion.
审核和批准最终结论。
5.References参考文件
- (CFDA) Good Manufacturing Practice (2010)
（CFDA）药品生产质量管理规范（2010年）
- EudraLex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
EudraLex 第4卷–欧盟人用药品和兽用药品GMP指南
历史学有哪些专业- EudraLex Volume 4 - Annex 15: Qualification and validation
EudraLex 第4卷附录15：确认和验证
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