INSTALLATION QUALIFICATION

安装确认

CUSTOMER NAME/客户名称:

PROFAM

SUPPLIER NAME/供应商:

Shanghai Tofflon Science & NO./编号:

Technology Co., Ltd. 2020-001TFc

上海东富龙科技股份有限公司

MODEL/型号:

TF400

INSTALLATION QUALIFICATION FOR

BLISTER MACHINE
泡罩机安装确认

EXPERTISE IN PHARMACEUTICAL INDUSTRY

ADD: 1509, DUHUI RD., SHANGHAI -201108 CHINA

TEL: +86 21 64906201
FAX: +86 21 64906202
www.tofflon.com

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专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Installation Qualification for Version
Shanghai Tofflon Science & V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Installation Qualification for Blister Machine

泡罩机安装确认
The signatures below 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.
下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。
Document Approval 文件批准

Department Name Signature Date

部门 姓名 签名 日期

Quality Assurance Department

Prepared by 起草 冉婷婷
质保部

Quality Assurance Department

Reviewed by 审核 孟伟
质保部

Design Department
Approved by 批准 熊长春
设计部

Document Approval (Customer)文件批准(客户)

Department Signature Date

部门 签名 日期

Reviewed by 审核

Reviewed by 审核

Reviewed by 审核

Reviewed by 审核

Approved by 批准

Version History 版本历史

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Installation Qualification for Version
Shanghai Tofflon Science & V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Version 版本 Issued date 颁布日期 Reason for change 颁布原因

V 1.0 Initial issue 首次发布

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Index 目 录
1. Purpose 目的....................................................................................................................................................4
2. Scope 范围.......................................................................................................................................................4
3. Abbreviations 缩略语.......................................................................................................................................4
4. Responsibilities 职责........................................................................................................................................4
5. References 参考文件........................................................................................................................................5
6. System Description 系统描述..........................................................................................................................5
7. Good Documentation Practice 文件管理规范..................................................................................................6
8. Test List 测试列表...........................................................................................................................................8
9. Personnel Identification 人员确认...................................................................................................................9
10. Test Procedure 测试程序..............................................................................................................................10
10.1 Prerequisites 先决条件.........................................................................................................................10
10.2 Test Instruments Calibration Verification 测试用仪器仪表校准确认................................................13
10.3 SAT Punch List Closeout Verification SAT 遗留清单关闭确认........................................................16
10.4 Test Leveraging 测试引用...................................................................................................................19
10.5 Documentation Qualification 文件确认...............................................................................................22
10.6 Main Component Check 主要部件检查...............................................................................................25
10.7 Installation Qualification 安装检查......................................................................................................28
10.8 Spare Parts Inspection 备品备件检查..................................................................................................31
10.9 Utilities Check 公用工程检查..............................................................................................................34
10.10 Control System Software Qualification 控制系统软件确认..............................................................37
11. Deviation Handling 偏差处理......................................................................................................................40
12. Change Handling 变更处理..........................................................................................................................42
13. Punch List 遗留清单....................................................................................................................................44
14. Attachment List 附件清单............................................................................................................................46
15. IQ Summary IQ 总结....................................................................................................................................48
15.1. Test Result Summary 测试结果汇总..................................................................................................48
15.2. IQ Conclusion IQ 结论........................................................................................................................49

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 4 of 49
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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
in place and of suitable quality. IQ is an activity that is regulated by the Current Good Manufaceutical
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
确认活动的一系统。
2. Scope 范围
This document is applicable to Blister Machine, No.: 2020-001TFc, model TF400 for PROFAM.
本文件适用于 PROFAM 编号 2020-001TFc，型号为 TF400 的泡罩机。

3. Abbreviations 缩略语
Abbreviations Definition
缩写 定义
China Food and Drug Administration
CFDA
国家食品药品监督管理总局
Good Manufacturing Practice
GMP
药品生产质量管理规范
Installation Qualification
IQ
安装确认
International Society For Pharmaceutical Engineering
ISPE
国际制药工程协会
Operational qualification
OQ
运行确认
Piping and Instruments Diagram
P&ID
管道仪表图
Standard Operation Procedure
SOP
标准操作规程
Shanghai Tofflon Science & Technology Co.,Ltd
Tofflon
上海东富龙科技股份有限公司
User Requirements Specifications
URS
用户需求说明
Not Applicable
N/A
不适用
4. Responsibilities 职责
The Responsibilities of Shanghai Tofflon include but not limited to
Tofflon 的职责包括但不仅限于
- Prepare, review and pre-approval of IQ protocol;
IQ 方案的编制、审核及预批准；
- Execution of IQ;
IQ 执行；
- Gather raw data and fill in the test form;
收集原始数据并填写在测试表格中；

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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- Record and handling deviation/change which occurred during IQ;

记录及处理 IQ 过程中发生的偏差/变更；
- Submit the IQ documentation for customer to review and approve.
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；
- Assistant to record and handle the deviation/change occurred during IQ;
协同记录和处理 IQ 过程中发生的偏差/变更；
- Assistant to collect raw data and fill in relevant check table;
协同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
- 21CFR Part 211, Current Good Manufacturing Practice For Finished Pharmaceuticals
21CFR 第 211 系统，成品药生产质量管理规范
- ISPE Baseline Guide Volume 5: Commissioning and Qualification
ISPE 基准指南第 5 卷：调试和确认
6. System Description 系统描述
Blister machineTF-400 is composed of film rolling system, heating unit, punching facility, traction drive,
testing device, loading unit, blanking unit, transfer unit and waste film recycling unit.Its characteristics are
as follows:
泡罩机 TF400 由卷膜系统、加热装置、冲孔装置、牵引驱动、检测装置、上料装置、下料装置、传
送装置和废膜回收装置组成,其特点有：
– applicable to vial and ampoule horizontal packaging
适用于瓶装和安瓶水平包装
– simple structure
结构简单
– high productivity
高工作效率
- Process control is stable, in line with the requirements of GAMP5, 21CFR Part11.
过程控制稳定，符合 GAMP5、21CFR Part11 的要求。

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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7. Good Documentation Practice 文件管理规范

Recording Pens 记录用笔：
- Choose nonfading ink pens or marker pens. Blue pens are recommended.
使用不消褪的墨水笔或记号笔，推荐使用蓝色笔记录
Signature 签名：
- Only authorized persons can sign on any documents.
被授权的人员才能签署文件
- Unless otherwise specified, the full name shall be used as the signature.
应签全名，除非文件另有规定
- The signature shall be legible
签名应该是可辨认的
- The signatures shall be consistent
签名应始终一致
Column Filling 填写栏目：
- All the columns shall be filled.
所有栏目必须填写
- The full text shall be filled if it is the same as that in the field above.
填写内容与上面栏目相同应重新填写
- If there is nothing to be filled in to an individual field, N/A (abbreviation for not applicable)
shall be written in this field.
若有单个栏目不需要填入内容，则在空白处填写英文字母“不适用”的简写“N/A”，以
表示无此项内容。
- If there is nothing to be filled in more than one neighboring fields, such fields shall be crossed
with a diagonal line, with “N/A” noted above the line and the signature and the date noted
below the line. The signature and the date shall be written along the line on the same side as
much as possible.
填写记录时，若有多个栏目不需要填入内容，应用斜线划掉，斜线上方填写“N/A”，下
方签名和注明日期。签名及日期应尽量沿斜线同侧填写

N/A

签名 日期 Signature date

Correction of Mistakes 更改错误：

- When any mistakes are to be corrected immediately after the document has been complete, the
correct record shall be entered and signed and dated. The original information shall be left
clearly readable.
文件刚完成，立即更改的在错误处划线，填入正确的，签名和注明更改日期，确保原先
信息仍清晰可识别
- For example: January 1, 2016, signature and date
如：2016.01.01 ，签字并日期

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 7 of 49
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- When any mistakes are to be corrected afterwards, besides conforming to the above
requirements, the reasons for the correction must be noted indicating the possible influences.
The same shall also be assessed and noted with signature and current date.
事后更改的，除非立即更改的要求外，还应注明更改的原因，检查和注释可能的影响，
并签上名字和注明日期
Date Recording Format 记录日期：
- Four digits shall be used for the indication of the year, two digits for the month and another two
for the date.
年用 4 位数表示，日和月用 2 位数表示
- For example: 2016.01.01
如：2016.01.01
Use of Abbreviations 使用缩略语：
- An abbreviation shall be noted in brackets immediately after the full name before it can be used
in the rest of the document.
在术语全称后的括号内注明缩写，然后才可以使用缩写。
Written Words and Names 书面语及名称：
- Standard written words and names shall be used.
使用规范的书面语及名称
- The names shall be consistent all through the document.
文件前后名称要一致

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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8. Test List 测试列表

The tests need to be performed in this protocol are listed in the following form.
在下面的表格列出了本方案将要执行的测试。
Test No. Test Name
测试编号 测试名称
Prerequisites
10.1
先决条件
Test Instruments Calibration Verification
10.2
测试用仪器仪表校准确认
SAT Punch List Closeout Verification
10.3
SAT 遗留清单关闭确认
Test Leveraging
10.4
测试引用
Documentation Qualification
10.5
文件确认
Main Component Check
10.6
主要部件检查
Installation Check
10.7
安装检查
Spare Parts Inspection
10.8
备品备件检查
Utilities Check
10.9
公用工程检查
Control System Software Qualification
10.10
控制系统软件确认

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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9. Personnel Identification 人员确认

All the personnel involved in the protocol must sign in the following form before the initiation of IQ.
Personal must be trained to ensure that competent installation qualification work.
在 IQ 开始前，本方案涉及的所有人员必须在下表签字。参加确认的人员必须经过培训，以保证胜
任 IQ 工作。

Name Signature Company Title Date

姓名 签名 公司 职务 日期

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10. Test Procedure 测试程序

10.1 Prerequisites 先决条件
Purpose 目的
Verify all prerequisites for this protocol execution have been satisfied.
确认所有进行本方案的先决条件已经得到满足。
To ensure that the personnel involved in the protocol are all trained.
确认参与此方案的人员都已经过培训。
Acceptance Criteria 可接受标准
All prerequisites must be satisfied before this protocol execution.
开始执行本方案之前，所有的先决条件必须得到满足。
All persons involved in this protocol must be trained.
参与此方案的人员都必需经过培训。
Procedure 程序
Verify that IQ protocol has been approved.
确认本方案已得到批准。
There should be a documented training for all persons involved in the tests before the initiation of
this protocol.
在本方案执行前，对所有参与测试的人员进行培训，培训应该有记录。
Note: if there is any additional person, the additional person shall be provided with supplementary
training. The training record shall be attached to this test item, and the executive and the auditor shall
add signature and date.
注：后续若出现新增人员，则对新增人员进行补充培训，培训记录作为附件附在本测试项后，
需对执行人和审核人进行补充签名及日期。

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Prerequisites
先决条件

Prerequisites Yes/No
先决条件 是否符合要求

The protocol for Blister Machine:

The protocol has been
泡罩机方案：
approved.
Yes ( ) No ( )
本方案已经得到批 Document No.文件号：___________________________
准。
Version No.版本号：

All persons involved in the tests have been trained and recorded.
所有参与测试的人员已经过培训并有记录。 Yes ( ) No ( )
Att. ID 附件编号：

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion & Remarks 结论和备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10.2 Test Instruments Calibration Verification 测试用仪器仪表校准确认

Purpose 目的
Verify that each test instruments that will be used during the execution of the protocol has been
calibrated.
确认执行本方案需使用的所有仪器仪表都经过校准。
Acceptance Criteria 可接受标准
The testing instruments for this protocol have been calibrated and are within the calibration due date.
本方案测试使用的仪器仪表均经过校准，且在有效期内。
Measurement standard for calibration can be traced back to China National Standards of
Measurement.
用于校准的计量标准应该能够追溯到中国国家计量基准。
Procedure 程序
Record the name, serial number, model, the calibration certificate number, calibration dates, and the
next calibration dates of instruments used for the protocol test, and attach copy of calibration
certificate. Check whether it can be traced back to National Standards of Measurement.
记录本方案测试用仪器仪表名称、序列号、型号、校准证书编号、校准日期以及有效期至，
并附上仪器校准证明复印件。检查是否能够追溯到国家计量基准。

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Test instruments calibration qualification

测试用仪器仪表校准确认

Calibration
Calibration 校准
Instruments Name Manufacture Serial No. Model
Certificate No.
仪器仪表名称 生产厂家 系列号 型号
校准证书编号 Cal. Date Due Date
校准日期 有效期至

Att. ID 附件编号：

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2020-001TFc-IQ
文件编号
IQ
Model
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型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion/Remarks 结论/备注
Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
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型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
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10.3 SAT Punch List Closeout Verification SAT 遗留清单关闭确认

Purpose 目的
To verify the issue which were documented during the SAT, and required to be verified during IQ
had been addressed.
确认执行 SAT 过程中记录的需要遗留到 IQ 阶段进行确认的遗留项目及其他事项已经得到解
决。
Acceptance Criteria 可接受标准
The issues identified during SAT and which should be verified during IQ had been appropriately
addressed as per the resolution listed next to each issue.
在 SAT 活动中确定的需要在 IQ 阶段进行确认的遗留项目已经按照每一遗留项目旁边的应对
措施进行了解决。
Procedure 程序
Obtain a copy of Punch List of SAT.
取得 SAT 测试的遗留清单的复印件。
Review and remark each item which shall be verified during IQ and verify it had been appropriately
“closed” as per the resolution listed in Punch List.
在 IQ 期间逐一审核，确认每一项遗留到 IQ 的项目均已得到合适的解决并关闭，并在该遗留
清单中进行标注。
Some issues which are required to be verified in the following work, such as the OQ, shall be not as
the veto items for this test and they shall be documented in the Punch List of SAT and verified in
following work.
某些遗留项目需要遗留到后续的工作，例如 OQ 中进行确认，可以不作为本项测试否决项，
但这些项目将遗留到 IQ 的遗留清单中，然后在后续的工作中进行确认。
And some issues shall be closed upon successful test execution as part of IQ. In that case, the issues
should be closed after these tests are completed.
某些遗留项目需要在成功完成 IQ 的某些测试之后才能被关闭，那么就等这些测试完成之后再
来关闭该遗留项目。
Attach the copy of SAT punch list to this test.
附上此项测试的 SAT 遗留清单复印件。

SAT Punch List Closeout Qualification

SAT 遗留清单关闭确认
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 Doc. No.
2020-001TFc-IQ
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IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Description Yes/No
描述 是否符合要求

The issues identified during SAT and which should be verified during IQ had been
appropriately addressed as per the resolution listed next to each issue.
Yes ( ) No ( )
在 SAT 活动中确定的需要在 IQ 阶段进行确认的遗留项目已经按照每一遗留项
目旁边的应对措施进行了解决。

Attach the copy of SAT Punch List.

附上 SAT 遗留清单复印件。
Att. ID 附件编号：

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion/Remarks 结论/备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10.4 Test Leveraging 测试引用

Purpose 目的
Summary the leveraging test items that are required in IQ document, but had been
performed in FAT and SAT, and verify these test items had been released.
汇总需要在 IQ 阶段执行，但实际已经在 FAT 及 SAT 执行过的测试项目，并确认这
些项目已经成功执行。
Acceptance Criteria 可接受标准
All the leaveraging test items had been executed in FAT or SAT successfully, and the test
condition can present the final condition of equipment delivery. And the copy of test
documents had been attached to this protocol.
所有通过“测试引用”的方式执行的项目的已经在 FAT 或 SAT 阶段成功被执行，
测试通过，且执行条件能够反映设备最终交付的状态，相关的测试文件和记录的复
印件也已经被附到本方案之后。
Procedure 程序
According to the approved IQ document and review the test items required by IQ, and
verify whether them had been performed in SAT or FAT.
根据已批准的 IQ 文件中执行的测试项目，确认他们是否在 FAT 或 SAT 中已经被执
行过。
If a test item had been executed in FAT or SAT successfully, and this test item had been
defined in this protocol also, review the test condition of FAT and SAT, to verify whether
are same or similar with the test requirement descrbed in this protocol and can present the
final delivery condition of equipment:
如果某个测试项目在 FAT 或 SAT 已经被成功执行过，且该项目也被定义到本方案中，
确认在 FAT 或 SAT 阶段执行本项目时的测试条件与本方案描述的测试条件是否相同
或相近，能够代表设备最终的交付状态：
 If yes,handle the test form of this protocol as per the requirements of section 7.0 and
abtain a copy of the test section and test documents of FAT or SAT and attach to this
protocol and note the attachment number, and fill the information in the form of this
section.
如果是，则将本方案中该项目的测试表格按 7.0 中定义的要求划掉。然后将
FAT 或 SAT 所对应的该章节及测试记录复印，附到本方案后，并注明引用的附
件编号，并将相关信息登记在本章节表格中。
 If no, perform this item again as per the procedure defined in this protocol.
如果测试条件不同，则按本方案规定的程序重新进行测试

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Test Leveraging
测试引用

Lev. Item Title Lev. For Lev. From Lev. Reason Attach. ID
引用项目 引用章节 引用自 引用理由 附件编号

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 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion/Remarks 结论/备注
Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10.5 Documentation Qualification 文件确认

Purpose 目的
Verify all documents which should be supplied to user are applicable and conform to the user
requirements.
确认此项目需要提供给用户的所有文件都可用并符合用户需求。
Acceptance Criteria 可接受标准
All documents have been approved, which include document name, document number, version and
issuing date.
所有的文件都已被批准，同时文件中应有文件名称、文件编号、版本、颁布日期。
Procedure 程序
Check documents one by one, record the document number, version, issuing date and relevant
approval status.
对现有的设计文件进行逐个确认，记录文件编号、版本、颁布日期和相关的批准状态。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Documentation Qualification
文件确认

Document Name Document No. Version Issuing Date Applicable and Approved
文件名称 文件编号 版本 颁布日期 是否适用的和被批准的
Layout Arrangement
Drawing Yes ( ) No ( )
平面布置图
P&ID
Yes ( ) No ( )
工艺流程图

Electrical Drawings
Yes ( ) No ( )
电气图

Installation Manual
Yes ( ) No ( )
安装手册

Operation Manual
Yes ( ) No ( )
操作手册

Maintenance Manual
Yes ( ) No ( )
维护手册

Material of certificate
Yes ( ) No ( )
材质证明

Main Component List

Yes ( ) No ( )
主要部件清单
Main Component
Instruction Yes ( ) No ( )
主要部件说明书
Product quality
certification Yes ( ) No ( )
产品质量证明书
Spare parts list
Yes ( ) No ( )
备品备件清单

Alarm List
Yes ( ) No ( )
报警清单
I/O Test List
Yes ( ) No ( )
I/O 测试清单

Factory Acceptance Test

Yes ( ) No ( )
工厂验收测试

Site Acceptance test

Yes ( ) No ( )
现场验收测试

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion & Remarks 结论和备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期
10.6 Main Component Check 主要部件检查
Purpose 目的
EXPERTISE IN PHARMACEUTICAL INDUSTRY
专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Verify that the critical components of the machine comply with approved main components list。
确认设备的关键部件与已批准的主要部件清单一致。
Acceptance Criteria 可接受标准
The installed components are in accordance with the main components list.
实际安装部件与主要部件清单一致。
Procedure 程序
Obtain the copy of the main components list.
取得主要部件清单复印件。
Compare the main components list against the installation, and fill "OK" in remark of the main
components list when the observed condition matches the main components list. Fill out the actual
result in remark of the main components list when the observed condition doesn’t match the main
components list.
比较主要部件清单和现场安装。如果现场安装与主要部件清单一致，在清单的备注一列中填
“OK”；如果现场安装与主要部件清单不一致, 在清单的备注一列中填写实际结果。
Attach the checked main components list to this test.
此项测试附上检查的主要部件清单。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Main Component Check

主要部件检查

Verified Item and Acceptance Criteria Yes/No

检查项目和可接受标准 是否符合要求

The installed components are in accordance with the main components list.（No
lacking, quantity, brand, model） Yes ( ) No ( )
实际安装部件与主要部件清单一致。(无缺失，数量，品牌，型号)

Att. ID 附件编号：

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion/Remarks 结论/备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10.7 Installation Qualification 安装检查

Purpose 目的
Verify that the installation of the machine conforms to the latest approved drawings.
确认设备的安装与已批准的最新版的图纸相符。
Acceptance Criteria 可接受标准
Detail acceptance criteria refer the following table.
详细接受标准参见下表。
Procedure 程序
Copy the relevant drawings (see the following table), and record the Drawing No. and Version in the
table.
复印相关图纸(参见下表)，在表格中记录图号和修订版本。
Compare the drawing against the installation and highlight the drawing in green when field observed
condition matches drawing.
比较图纸和现场安装。如果现场安装与图纸一致，用绿色荧光笔在图纸上标识。
Compare the drawing against the installation and highlight the drawing in RED when field observed
condition doesn’t match drawing Correction with RED ink.
比较图纸和现场安装。如果现场安装与图纸不一致，用红色荧光笔在图纸上标识，并用红色
水笔纠正。
Attach all the checked drawings to this test
此项测试附上检查的所有图纸。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
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Installation Check
安装检查

Relevant Drawing Information Acceptance Criteria Yes/No

相关图纸信息 接受标准 是否符合要求

No components missing. Yes ( ) No ( )

没有部件缺失。

P&ID The type, installation and specification of

工艺仪表流程图 component are consistent with the P&ID without
apparent damage condition. Yes ( ) No ( )
Drawing No.图号： 部件的类型、安装方式、规格与 P& ID 一致，
无明显的损坏。

Version：版本： The indicator of the machine, parts, instruments

(including the nameplate, ID etc.) are complete
and clear. Yes ( ) No ( )
设备、部件、仪表的标示（铭牌、编号等）完
整、清晰。

The relative position, shape and external

Layout Drawing dimensions are in accordance with those marked
on the approved layout drawing. Yes ( ) No ( )
平面布局图
设备的相对位置、外型和外部尺寸与批准的平
Drawing No.图号： 面布局图上所标注的相符。

Revision：版本： Position and connection of all utility are in

accordance with the approved layout drawing. Yes ( ) No ( )
公用工程的位置和接口与批准的平面布局图相
符。

Wiring Drawing The layout of all the components in the control

cabinet is in accordance with the wiring drawing. Yes ( ) No ( )
电气图
电器柜内所有元器件布置均与电气图纸相一
Drawing No.图号： 致。

The wiring is in accordance with the wiring

Version：版本： drawing. Yes ( ) No ( )
实际接线与电气图线图相符合。

Att. ID 附件编号：

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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Conclusion/Remarks 结论/备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
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10.8 Spare Parts Inspection 备品备件检查

Purpose 目的
Check and verify the spare parts of equipment/system is adequate and in good storage.
检查并确认设备/系统的备品备件充足且保存完好。
Acceptance Criteria 可接受标准
The spare parts for equipment/system is adequate and in good storage, each part has a sole and
identifiable ID.
设备/系统的备品备件充足，且保存完好，每个部件均由唯一、可识别的编号。
Procedure 程序
Obtain the copy spare parts list of equipment/system.
取得一份设备/系统的备品备件清单。
Check the spare parts in storage site, verify whether the quantity, specification, label and storage
environment are meet the requirements of vendor and using.
在备品备件储存的现场检查其数量，规格，标识及存储环境是否符合供应商及使用要求。
If the inspection pass, use a blue pen to highlight, and if fail, use a red pen to highlight on the spare
parts list.
如果符合要求，用蓝色笔在备品备件清单上标出；如果不符合要求，用红色笔标出。
Finally, attach the spare parts list for inspection to this form.
最后将用于检查的备品备件清单作为本表附件。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
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Spare Parts Inspection

备品备件检查
SN Item Yes/No
序号 项目 是否符合要求
Spare parts is adequate
1 Yes ( ) No ( )
数量充足
Specification of each part is correct
2 Yes ( ) No ( )
规格正确

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专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
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Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
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Conclusion & Remarks 结论和备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
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10.9 Utilities Check 公用工程检查

Purpose 目的
Verify the utilities required for operation have been correctly connected.
确认设备运行需要的公用工程已经正确连接。
Verify the utility parameters for operation are conforming to the use requirements.
确认设备运行需要的公用工程参数满足使用要求。
Acceptance Criteria 可接受标准
All the utilities are correctly connected and their operative parameters are in accordance with the
design.
所有的公用工程已经正确连接，公用工程的操作参数符合设计要求。
Procedure 程序
Verify all the utilities necessary to equipment are correctly connected.
确认与设备有关的所有的公用工程已经正确连接。
List all the utilities and fill the following table.
列出所有的公用工程，完成以下表格。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 35 of 49
页码

Utilities Check
公用工程检查

No. Item Requirements Design Yes/No

序号 项目 要求 设计情况 是否符合要求

Electrical
电源
Power Supply
电源类型 3 Phase 5 Wires Yes ( ) No ( )

Voltage [V]
电压 [V] 380 V Yes ( ) No ( )
1
Frequency [Hz]
频率 [Hz] 50 Hz Yes ( ) No ( )

Total Power [kW]

总功率 [kW] 30KW Yes ( ) No ( )

Pneumatic Valve Compressed Air

气动阀压缩空气
Consumption [L/min]
耗量 [L/min] 500 L/Min Yes ( ) No ( )
2
Pressure [bar]
压力 [bar] 5.0-8.0bar Yes ( ) No ( )

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 36 of 49
页码

Conclusion & Remarks 结论和备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 37 of 49
页码

10.10 Control System Software Qualification 控制系统软件确认

Purpose 目的
Check that the software version of the system is the same as the design documents.
检查系统软件版本同设计文件相同。
Acceptance Criteria 可接受标准
Detail acceptance criteria refer to the following table.
详细接受标准参见下表。
Procedure 程序
Check the HMI system software, PLC software, record the following information: software name,
software version.
检查 HMI 系统软件、PLC 软件，记录以下信息：软件名称、软件版本。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 38 of 49
页码

Control System Software Qualification

控制系统软件确认

Check Content Acceptance Criteria Actual Result Yes/No

检查内容 可接受标准 实际结果 是否符合要求

HMI software name: HMI software name:

HMI 软件名称： HMI 软件名称：
Check the HMI NetSCADA DevProject Yes ( )
software
HMI software version HMI software version No ( )
检查 HMI 软件
HMI 软件版本： HMI 软件版本
5.2.0.320

PLC software name: PLC software name:

PLC 软件名称： PLC 软件名称：
Check the PLC Simotion Scout Yes ( )
software
PLC software version PLC software version No ( )
检查 PLC 软件
PLC 软件版本： PLC 软件版本
V5.3

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 39 of 49
页码

Conclusion & Remarks 结论和备注

Conclusion
结论
Remark 备注：

Conformity
符合性

Yes 是 ( ) No 否 ( ) Deviation ID 偏差编号_______________

Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 40 of 49
页码

11. Deviation Handling 偏差处理

If the qualification result is not conformity with acceptance criteria, it shall fill in deviation record and
determine the comments. If there are many deviation records, it should mark number in the deviation
forms.
如果确认结果与验收标准不符，应当填写偏差记录，明确处理意见，如果有多份偏差记录，则在
偏差表上必须填好编号。
An independent ID is necessary for each deviation. Numbering for deviation shall be as per: D + section
number-sequence number, such as the D10.1-01, means the first deviation of 10.1 section.
每个偏差需要一个独立的编号。编号原则为：D+章节编号-顺序号，例如 D10.1-01，代表 10.1 章节
的第一个偏差。
Collect all found deviations during the IQ and record.
收集 IQ 中发生的所有偏差并记录。
For all the found deviations during IQ, Tofflon need to provide solutions to close these deviations and the
customer has responsible for reviewing and approving the solutions.
IQ 中发现的偏差，东富龙需提出解决方法，由客户审核、批准解决方案。
Use copy of deviation record if necessary.
如有需要可复印偏差记录。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 41 of 49
页码

Deviation List
偏差清单
(Page of )
Deviation Other
Deviation Description Deviation Correction Attachments Conclusion
ID Description
偏差描述 偏差整改 附件 结论
偏差编号 其他说明
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 42 of 49
页码

12. Change Handling 变更处理

Any change for this protocol, it shall fill in change report and determine the comments.
如果需要对本文件变更，应填写变更报告，明确处理意见。
An independent ID is necessary for each Changing. Numbering for Changing shall be as per: C + section
number-sequence number, such as the C10.1-01, means the first changing of 10.1 section.
每个变更需要一个独立的编号。编号原则为：C+章节编号-顺序号，例如 C10.1-01，代表 10.1 章节
的第一个变更。
Collect all found changes during the IQ and record.
收集 IQ 中发生的所有变更并记录。
For all the found changes during IQ, Tofflon need to provide solutions to close these deviations and the
customer has responsible for reviewing and approving the solutions.
IQ 中发现的变更，东富龙需提出解决方法，由客户审核、批准解决方案。
Use copy of Change report if necessary.
如有需要可复印变更报告。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 43 of 49
页码

Change List
变更清单
(Page of )
Other
Change ID Change Description Change Correction Attachments Conclusion
Description
变更编号 变更描述 变更整改 附件 结论
其他说明
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 44 of 49
页码

13. Punch List 遗留清单

If there are any issues which need to be verified in following work and a punch list shall be drafted as per
the requirements.
如果尚有未决事项需要遗留到后续工作，则需要按照遗留项目要求起草遗留工作清单。
An independent ID is necessary for each Punch. Numbering for Punch shall be as per: P + section number-
sequence number, such as the P10.1-01, means the first punch of 10.1 section.
每个遗留项目需要一个独立的编号。编号原则为：P+章节编号-顺序号，例如 P10.1-01，代表 10.1
章节的第一个遗留项目。
Collect all found punch during the IQ and record.
收集 IQ 中发生的所有遗留项并记录。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 45 of 49
页码

Punch List
遗留清单
(Page of )
Punch ID
Punch Description Punch Correction Other Description Attachments Conclusion
遗留项目
遗留问题描述 遗留问题整改 其他说明 附件 结论
编号
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
N/A ( ) Yes ( )
Att. No.______ No ( )
Executed by /Date
执行人/日期

Reviewed by /Date
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 46 of 49
页码

14. Attachment List 附件清单

Record all the documents attached to this report and record.
记录所有附在本报告中的文件并记录。
An independent ID is necessary for each attachment. Numbering for attachment shall be as per: A +
section number-sequence number, such as the A10.1-01, means the first attachment of 10.1 section.
每个附件需要一个独立的编号。编号原则为：A+章节编号-顺序号，例如 A10.1-01，代表 10.1 章节
的第一个附件。
The executor shall sign name and date on the first page and the last page, and indicate the page number on
each page as per X/X, such as the 1/10, means the first page of a ten page attachment.
执行人员应在附件的首末页签字，并在每页上注明页码：X/X，例如：1/10，代表一个共有 10 页
的附件的第一页。

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 47 of 49
页码

Attachments List
附件清单
(Page of )
Attachment ID Attachment Description Pages
附件编号 附件描述 页数

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 48 of 49
页码

15. IQ Summary IQ 总结
15.1. Test Result Summary 测试结果汇总

Test No.
Test Name Conclusion Deviation ID Punch ID
测试编
测试名称 结论 偏差编号 遗留项目编号
号

Prerequisites N/A ( ) N/A ( )

10.1 Yes ( ) No ( )
先决条件 Dev.No._____ PL. No.______
Test Instruments Calibration Verification N/A ( ) N/A ( )
10.2 Yes ( ) No ( )
测试用仪器仪表校准确认 Dev.No._____ PL. No.______
SAT Punch List Closeout Verification N/A ( ) N/A ( )
10.3 Yes ( ) No ( )
SAT 遗留清单关闭确认 Dev.No._____ PL. No.______
Test Leveraging N/A ( ) N/A ( )
10.4 Yes ( ) No ( )
测试引用 Dev.No._____ PL. No.______
Documentation Qualification N/A ( ) N/A ( )
10.5 Yes ( ) No ( )
文件确认 Dev.No._____ PL. No.______
Main Component Check N/A ( ) N/A ( )
10.6 Yes ( ) No ( )
主要部件检查 Dev.No._____ PL. No.______
Installation Check N/A ( ) N/A ( )
10.7 Yes ( ) No ( )
安装检查 Dev.No._____ PL. No.______
Spare Parts Inspection N/A ( ) N/A ( )
10.8 Yes ( ) No ( )
备品备件检查 Dev.No._____ PL. No.______
Utilities Check N/A ( ) N/A ( )
10.9 Yes ( ) No ( )
公用工程检查 Dev.No._____ PL. No.______
Control System Software Qualification N/A ( ) N/A ( )
10.10 Yes ( ) No ( )
控制系统软件确认 Dev.No._____ PL. No.______
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业
 Doc. No.
2020-001TFc-IQ
文件编号
IQ
Model
TF400
型号
Version
Shanghai Tofflon Science & Installation Qualification for V 1.0
版本号
Technology Co., Ltd. Blister Machine
Page
上海东富龙科技股份有限公司 泡罩机安装确认 49 of 49
页码

15.2. IQ Conclusion IQ 结论
Review the test result and data, and give a final conclusion for IQ of Blister Machine
对测试结果和数据进行审核，得出泡罩机安装确认的最终结论。

IQ Review and Approval

IQ 审核与批准

Department or Company Result Signature/Date

部门或公司 结果 签名/日期

CHECKED BY:
(by Supplier) Yes ( ) No ( )
核查（供应商）
REVIEWED BY:
(by Customer) Yes ( ) No ( )
审核（用户）
REVIEWED BY:
(by Customer) Yes ( ) No ( )
审核（用户）
REVIEWED BY:
(by Customer) Yes ( ) No ( )
审核（用户）
REVIEWED BY:
(by Customer) Yes ( ) No ( )
审核（用户）
APPROVED BY:
(by Customer) Yes ( ) No ( )
批准（用户）

EXPERTISE IN PHARMACEUTICAL INDUSTRY

专业技术服务于制药工业