IQPColdroom0202.docx

1、IQPColdroom0202Installation Qualification Protocol安装确认方案ForCold room (S-A-J-2007-148)冷库（S-A-J-2007-148）Retrospective/回顾确认 Prospective/预确认 Re-qualification/再确认Production facility: Tianyuan D/T/aP/Men./Ty facility生产设施： 天元生物D/T/aP/Men./Ty车间Building: main facility Linping Room: C212建筑物： 临平主建筑 房间： C212By

2、 signing of the responsible persons (or deputy) the IQP will be accepted and the application of the planned qualification work and measurements are released. The persons, who have signed, confirm the control of all checklists and the completeness of all tests and the correctness of the acceptance cr

3、iteria.安装确认计划经相关责任人员签署后即可生效。这些责任人员对文件的完整性及正确性负责。Drafter/起草者:Name/姓名: Validation Engineer(KCS)/验证工程师（KCS）Date/日期Check/复核者:Name/姓名: Validation consultant(KCS)/验证顾问（KCS）Date/日期Name/姓名: Production Manager(TY)/生产经理（天元生物）Date/日期Name/姓名: Project Manager(TY)/项目经理（天元生物）Date/日期Released/批准者:Name/姓名: Manager QA

4、(TY)/质量管理部经理（天元生物）Date/日期1. Content/目录1. Content/目录 22. Concept of Cold room qualification/冷库确认概述 33. Applicable documentation/适用文件 34. Description of the Cold room/冷库描述 34.1 General description/概述 34.2 Identification系统鉴别 35. IQ Examination/安装检查 46. List of Deviation偏差列表 57. Change Control变更控制 68. L

5、ist of signatures/签名列表 79. Examination Summary/检查总结 810. Appendices Index/附件索引 911. IQ-Certificate/安装确认证明 102. Concept of Cold room qualification/冷库确认概述In this qualification plan all the required installation qualification tests are described, the acceptance criteria are mentioned and the test resul

6、ts are documented.在此确认计划中，所有需要安装确认的测试项目和接受标准都将被述及，所有的测试结果都将被归档。The installation can be qualified, if all test results are within the specified acceptance criteria or shortness/gaps with an explanation are accepted. 当所有的测试结果符合接受标准，所有的细小偏差都有可接受说明时，安装确认得以完成。The shortness/gaps have to be explained / tra

7、ced. Changes of the tests have to be released by the qualification team.所有的细小偏差都应该有解释以便追溯，测试的变更必须经过确认小组的批准。3. Applicable documentation/适用文件VMP (Validation Master Plan Phase II): VMP.06 II/ VMP(验证主计划 阶段II)：VMP.06IISOP (Q/ZTY.SOP.5608-01) Processing DQ, IQ and OQ/：设计、安装、运行确认的处理4. Description of the Co

8、ld room/冷库描述4.1 General description/概述There are totally 5 cold rooms be installed in 3 workshops to provide defined cold room environment. 在三个车间里总共有5个冷库房间，其目的是提供指定的冷库环境。This volume of cold room IQ applies to cold room C212.本部分冷库安装确认计划适用于C212房间。4.2 Identification系统鉴别System Name 系统名称Cold room（S-A-J-20

9、07-148） 冷库（S-A-J-2007-148）Type/Model型号/模式Manufacturer/Constructor制造商/建造商System Number系统编号N/AInstallation place/Area安装地点C212C212房间5. IQ Examination/安装检查The following examinations are to be performed on Coldroom(S-A-J-2007-148):冷库（S-A-J-2007-148）将执行下列的检查No.编号Object of Inspection检查内容Appendix No.附件编号1Te

10、chnical Documentation Verification有关技术文档的确认A2Part List/maintenance部件列表/维护B3System Installation Verification系统安装确认C4Electrical Installation 电气安装D5Energy and Utility Supply 能量提供E6Cleaning Before Start Up试车前清洗FAll the documents relevant and used for IQ are attached to the Appendix and with the correct

11、cross identifications of the documents.所有和安装确认有关的文件都将见诸附件，所有的交叉引用都应该正确注明。6. List of Deviation偏差列表If there are deviations in the examination, they should be documented following SOP with formal deviation report form. A deviation list will be included into final report and below information should be

12、included.检查过程中如有偏差，应根据操作规程记录于正式的偏差报告表中。最终报告应包括偏差列表和以下信息。No.编号Deviation No.偏差编号Object of Inspection检查项目Expected Result标准值Measured Result实测值Make a copy of each deviation report and attach it to the final report.复制每份偏差报告并附在最后的报告中。7. Change Control变更控制Change Control is the formal system used to judge an

13、d record the proposed changes. The purpose is to renew or keep the qualified validation status. SOP should be followed for the proposed changes.变更控制是用于判断和记录提出变更的正式系统。目的是更新和保持验证的状态。提出的变更应遵循标准操作规程要求。A change control list will be included into final report and below information should be included.最终报告应

14、包括变更控制列表和以下信息。No.编号Opening Date开始日期Change Control No.变更控制编号Content of Change Control变更控制内容Closing Date结束日期Make a copy of each change control form and attach it to the final report.复制每份变更控制表并附在最后的报告中。8. List of signatures/签名列表No.编号Name姓名Function职位Signature签名Initials缩写1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 9. Examination Summary/检查总结Of the mentioned examination, which are required for the qualification of the system, are all overviewed. The results of the examinations are summarized.所有与系统确认相关的检查都已经完成，以下是检查结果的总结。Appendix No.附件