冻干机安装确认单

Freeze Dryer Extension Project
WUXI INSTALLATION QUALIFICATION
PROTOCOL
Freeze Dryer No.1
(GLZ-12)
Author: ……………………………………Xin Juxiang, Validation Leader
Reviewed by: ……………………………………Bertil Boman/Lu Xiaoan, Project Managers Approved by: ……………………………………Chen Yueyun, Production Manager
Approved by: ……………………………………Ma Tao, QA Manager
List of Contents Page
1Introduction (3)
2Background (3)
3Scope (3)
4Identification of Personnel Performing IQ IQ的实施人员 (4)
5Installation Qualification 安装确认 (5)
5.1Check of the P&ID Drawing图纸审核 (5)
5.2Instrument Calibration Check 仪表校验的检查 (7)
5.3Utilities 公用介质检查 (9)
5.4Documentation文件的检查 (10)
6Punch and Deviation List (11)
7Appendix (12)
1Introduction
Installation Qualification (IQ) is to verify that all key aspects of the installation have met the design specification and user requirements, including in respect of GMP.
This IQ follows validation plan 402-VP-P1.
Punches and deviations that may occur during the validation must be documented and logged, so that it is clear to verify what test it belongs to and what test has gone wrong. Comments and immediate corretive actions, if any, must be signed, see section 6.
If it is not possible to perform a test as detailed in a validation protocol the tester may adjust the test in order to make it work and perform the revised test. This must be documented and logged and eventually be reported, as described above. Major changes to a test should be reported to the Validation Team leader for approval before execution.
This protocol details the IQ of freeze drying machine. This machine is used to manufacture lyophilized product of Soluvit N.
IQ即确认设备的安装符合设计要求、本公司要求和有关的GMP要求。

本IQ与验证计划402-VP-P1一致。

2Background
See the description of the system in validation plan 402 -VP-P1.
系统的描述详见验证计划402-VP-P1。

3Scope
These IQ tests will provide documented evidence that the equipment was installed to meet all cGMP, safety requirements and technical specification. The IQ protocol was supplied and executed in local factory by vender, and most of key installation for freeze dryer listed in a FAT document have been executed by vender together with technical engineers of SSPC before the machine delivery. (the FAT document, see Binder 283)
主要检查和确认设备安装符合合同所规定及有关GMP方面的要求。

要说明的是安装确认文件及实施由该设备制造商在设备出厂前进行。

另外还有一个FAT文件，该文件中主要的安装情况及检查已制造商和华瑞公司技术人员进行了核查（见文件夹283 FAT文件）。

在华瑞公司现场对该设备的安装确认主要是增加几个项目的检查，如供应介质、竣工图、仪表的校正及文件检查。

4Identification of Personnel Performing IQ 实施人员
In case both Chinese and English are used when signing, then both must be entered. Fill in the missing information in the table below.
5Installation Qualification 安装确认
5.1Check of the P&ID Drawing图纸审核
Purpose 目的:
To clarify that the equipment, pipe-work, connections, valves, instruments etc. have been installed in compliance with the as built drawing” and undamaged.
检查设备、管道、连接、阀门、仪表等物的安装与竣工图一致，并且未被损伤。

Pre Requisite 准备:
Copies of the following as built drawings and item lists must be present:
需准备以下竣工图以及设备清单
Test Method: 方法
Drawings should be checked in order to verify: 1) that installed and “as built” is what is actually described by the drawing, 2) is actually delivered and 3) is consistent with the specification and all relevant documentation, 4) has correct slope, drainage, sanitary connections and no dead-legs allowing standing water, 5) check the sealing to adjacent higher environment hygiene class.
Check for overall impression such as undamaged, connection and pipe work, make and model number, dimensions and size, material etc. All drawings should have a unique reference number, be approved, signed and listed.
Start with the general drawing. Inspect the installed equipment and pipe-work against the drawing and mark with a green ink pen each detail on the drawings and item lists when it has been verified as present and correct. Also check satisfactory tagging and identity numbers. If any correction to the drawings or item lists are required, these should be made on the drawing with a red ink pen. If it is not possible to verify a detail, the reason should be written on the drawing beside the item in red ink.
Any punch or deviation has to be uniquely referenced, and be added to the Punch and Deviation List, see section6. Any comment added to the drawings after the validation must be signed and dated by the person who adds the comment.
Once the drawing has been fully marked-up the person performing the check should label the drawing with “IQ DRAWING CHECK”, then sign and date the drawin gs and item lists and append them to this protocol. Finally, fill in the missing information above in the table of Pre Requisite.
图纸审核的目的是证实：所安装并竣工的设备与图纸的一致；与有关指标和文件相符；
检查总体印象：是否完好无损、接头和管路、型号、尺寸、材质等。

每件图纸应有唯一的号码。

按照图纸核对已安装的所有组件标识排和编号，如果确认实际安装的情况与图纸及相关文件符合，则在图纸和设备清单上用绿色记号笔标出。

如图纸与实际安装情况或设备清单不符合，则用红色记号笔标示，并应在图纸相应的设备旁用写明原因。

任何偏差和漏项都应记录，并给出唯一的编号，安装本方案第6部分的要求处理。

图纸审核完后，审核人应在图纸上标明图纸已审核，在图纸和设备清单上签名、日期，并附在本方案后。

Acceptance Criteria合格标准:
All components and piping are correct according to the drawings and item lists, undamaged and tagged.
所有安装的组件和管路均与图纸和设备清单一致，完好无损并有正确标记。

Comments 注:
Results 结果:
The results comply with the Acceptance Criteria: ___________________
(write P as in passed or F as in failed) P/F, Signed by and date
Note: If not fill in data in the Punch and Deviation List.
Review 审核:
The test has been carried out according to this test
description and the results comply with acceptance ___________________
criteria: (write P as in passed or F as in failed) P/F, Signed by and date
5.2Instrument Calibration Check 仪表校验的检查
Purpose 目的:
To check that the critical instruments and their calibration records are accurate and available, and when critical integrated into the calibration system.
检查重要仪表的精确度和校验记录，并纳入计量体系。

Pre Requisite 准备:
Instruction manual is present.
Each instrument must be uniquely identified and tagged accordingly.
有使用说明书。

每个仪表应有唯一的标识。

Test Method 方法:
All the instruments will be registered in SSPC.
Each the critical instrument has certificate by manufactory before it was sale. Some of them have been calibrated and some of haven't yet. They must be calibrated before are used on the machine, including the recorder, pressure transmitter, temperature transmitter, pressure meter. Calibration method should refer to the temperature and pressure procedure of the Instruction Metrological Assurance System.
Check the calibration certificates for at least all critical instrumentation from supplier or any internal made calibrations. Also check for presence of calibration sticker indicating “ calibrated” and the next time for re calibration.
Each calibration certificate should detailed limits, results, reference number of the object calibrated, reference to the used reference standard, applied test method, signature and date as well as last date for re calibration.
所有的仪表都应按类别登记在计量仪器登记册中。

所有的关键仪表在投入使用前必须进行校正并出具校正证书。

校正方法应按照计量手册中温度、压力校正方法进行。

检查供应商提供的或内部校验的校验证书。

检查校验标签，查看下次校验时间。

校验证书上应有详细的限度、结果、被校验仪表的编号、所用的参考标准、所用的试验方法号、签名
和日期、末次再校验日期。

Acceptance Criteria 合格标准:
All critical instruments and their calibration certificates are accurate and part of the calibration system.
所有的关键仪表及其校验证书精确度正确，并且已纳入计量体系。

Results 结果:
The results comply with the Acceptance Criteria: ___________________ (write P as in passed or F as in failed) P/F, Signed by and date
Note: If not fill in data in the Punch and Deviation List.
Review 审核:
The test has been carried out according to this test
description and the results comply with acceptance ___________________
criteria: (write P as in passed or F as in failed) P/F, Signed by and date
5.3Utilities 公用介质检查
Purpose目的:
To verify that the utilities are installed correctly and meet the requirements specified by the supplier documentation.
验明公用介质已被正确连接，并符合供应商文件中的有关要求。

Pre Requisite准备:
If measurements are carried out, relevant calibration certificates must be appended for the instruments used.
如需进行度量，度量的仪器需有有关校验证书。

Test Method 验证方法:
Check the connections and verify correct utility as specified by the supplier documentation.
When judged relevant, measure or estimate actual values and fill in missing data.
检查连接处，并确认所供应的介质是供应商文件中所规定的。

度量或估算实际值，并填写下表。

Acceptance Criteria 合格标准:
All the media meet the design requirement.
准备运行所需的所有介质安装符合设计要求。

Results 结果:
The results comply with the Acceptance Criteria: ___________________
(write P as in passed or F as in failed) P/F, Signed by and date
Note: If not fill in data in the Punch and Deviation List.
Review 复核:
The test has been carried out according to this test
description and the results comply with acceptance ___________________
criteria: (write P as in passed or F as in failed)P/F, Signed by and date
5.4Documentation文件的检查
Purpose目的:
To check presence and accuracy of the system documentation. Correct numbers of each documentation set or consistency between them is not covered.
检查系统的文件是否都在，并且正确，文件代码没有重复情况。

Pre Requisite准备:
The purchase contract, specifying the supplier documentation.
采购合同及供应商有关文件。

Test Method方法:
Verify that should have four sets of the documentation binder for each freeze dryer, and one set documentation includes 3 sets document binders.
Check of the each document binder included documents is in compliance with its content.
Fill in the missing information in the table below and refer to the location of it, finally sign and date.
确认冷冻干燥机应有的文件；确认每个文件夹中所包括的文件与目录一致。

把检查的情况填入下表：
Acceptance Criteria 合格标准:
That the documents as specified in the table and the list of content of this system exist, are sufficient and current. 上表中的文件充分而正确，系统文件夹中的目录和内容是最新版本。

Results 结果:
The results comply with the Acceptance Criteria: ___________________
(write P as in passed or F as in failed) P/F, Signed by and date
Note: If not fill in data in the Punch and Deviation List.
Review 复核:
The test has been carried out according to this test
description and the results comply with acceptance ___________________
criteria: (write P as in passed or F as in failed)P/F, Signed by and date
6Punch and Deviation List 漏项及偏差
Any punch (e. g. it is not possible to perform the test) or deviation (e. g. slight modification of test method in order to make the test work) must be recorded in a Punch and Deviation List as described by the VMP (appendix 4.4).
Enter data so that it is clear to: what protocol it belongs to, what testing that went wrong, comments and performed corrective actions if any, and be signed. Finally attach it to the section of appendix.
If it is not possible to perform a test as detailed in a validation protocol the tester may adjust the test in order to make it work and perform the revised test. This too must be documented and logged as described above. Major changes to a test should be reported to the Validation Team leader for approval before execution.
Fill in the data for each punch/deviation and if possible make a quick assessment whether the impact is 1= critical, 2= must be adjusted, 3= to be checked and evaluated.
在验证过程中可能会出现的失误与偏差必须记录存档，以明确属于哪一个方案，是何种偏差。

任何改正的建议和实施都要有记录并签名，并在验证会议上汇报，见验证总规划附录4.4失误与偏差清单。

如果不能实施验证方案中的有关试验，试验者可自行调整以到达实施，但应有所记录，并应在验证会议上汇报。

试验中的关键部分的修改应在实施前向验证队负责人报告并获得批准。

将偏差按照关键偏差（1）、调整偏差（2）和一般偏差（3）三个等级分别处理，并填入偏差表中。

关键偏差是指对系统的运行有影响或关键参数方面的设定等；调整偏差是指如果系统运行良好，此偏差必须进行解决或调整。

评估偏差是指不对系统有任何影响，如文件的签字，修改等。

如不对系统运行有影响，可以采取检查和评估的方法处理。

7Appendix 附件
Fill in the missing information in the table below, and attach these appendices on the protocol. 将所有附件的代号、名称等填入下表中。