2021 023Vc L60L OQ Ok

OPERATIONAL QUALIFICATION
运行确认
CUSTOMER NAME/客户名称:
Vacsera
SUPPLIER NAME/供应商:
Tofflon Science and Technology NO./编号：
Group Co., Ltd. 2021-023Vc

东富龙科技集团股份有限公司
MODEL/型号:
TIVS-L60L (HVLD)
OPERATIONAL QUALIFICATION FOR

INTELLIGENT VISION AND
LEAK INTEGRATED SYSTEM
灯检检漏一体机运行确认
EXPERTISE IN PHARMACEUTICAL INDUSTRY
ADD: 139, DUHUI RD., SHANGHAI -201109 CHINA

TEL: +86 21 64909996
FAX: +86 2154469978
www.tofflon.com
Doc. No. 2021-023Vc-OQ
文件编号
OQ
Model TIVS-L60L(HVLD)
型号
Operational Qualification for Version
Tofflon Science V 1.0
Intelligent Vision and 版本号
and Technology Group Co., Ltd. Leak Integrated System
东富龙科技集团股份有限公司 Page
灯检检漏一体机运行确认 1 of 47
页码
Operational Qualification for Operational Qualification for

Intelligent Vision and Leak Integrated System
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，并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 Xu Chai

Prepared by 起草
质保部柴旭
Quality Assurance Department Morris Meng

Reviewed by 审核
质保部孟伟
Design Department Billy Qiu

Approved by 批准
设计部邱贞桂
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

专业技术服务于制药工业
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Version History 版本历史
Version 版本 Issued date 颁布日期 Reason for issue 颁布原因

V 1.0 Initial issue 首次发布

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Index 目录
1. Purpose 目的.........................................................................................................................................1
2. Scope 范围.............................................................................................................................................1
3. Abbreviations 缩略语............................................................................................................................1
4. Responsibilities 职责.............................................................................................................................1
5. References 参考文件.............................................................................................................................1
6. System Description 系统描述...............................................................................................................1
7. Good Documentation Practice 文件管理规范......................................................................................1
8. Test List 测试列表................................................................................................................................1
9. Personnel Identification 人员确认........................................................................................................1
10. Test Procedure 测试程序......................................................................................................................1
10.1 Prerequisites 先决条件..........................................................................................................................1

10.2 IQ Punch List Closeout Verification IQ 遗留清单关闭确认................................................................1
10.3 Test Leveraging 测试引用....................................................................................................................1
10.4 System Access 系统访问......................................................................................................................1
10.5 Power Failure Test 断电恢复测试........................................................................................................1
10.6 Alarm Test 报警测试............................................................................................................................1
10.7 Production Batch Report &Printing Verification 生产报表&打印确认...............................................1
10.8 Recipe Development & Maintenance Verification 配方开发和维护确认...........................................1
10.9 Speed and Complete Cycle Testing 速度和整个循环测试...................................................................1
11. Deviation Handling 偏差处理...............................................................................................................1
12. Change Handling 变更处理..................................................................................................................1
13. Punch List 遗留清单.............................................................................................................................1
14. Attachment List 附件清单.....................................................................................................................1
15. OQ Summary OQ 总结.........................................................................................................................1
15.1. Test Result Summary 测试结果汇总....................................................................................................1
15.2. OQ Conclusion OQ 结论.......................................................................................................................1
1. Purpose 目的
The purpose of Operational Qualification (OQ) is to establish, through documented testing, that all critical
components are capable of operating within established limits and tolerances. It is the process of testing to
ensure that individual components and systems operate as specified, and how that information is recorded.
OQ is an activity that is regulated by the Current Good Manufacturing Practice, and is a part of final
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qualification activities before Process Validation begins.

运行确认的目的是通过测试证明所有关键部件能够在已制定的界限及承受能力下运行。这是一个测
试的过程，来确保独立部件和系统能够按照规定运行，并记录信息。运行确认是 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 This document is applicable to Intelligent Vision and Leak Integrated System, model TIVS-L60L.
本文件适用于 TIVS-L60L 灯检检漏一体机。
3. Abbreviations 缩略语
Abbreviations Definition
缩略语定义
Current Good Manufacturing Practice
cGMP
现行药品生产质量管理规范
NMPA
National Medical Products Administration
国家药品监督管理局
Design Qualification
DQ
设计确认
Good Automated Manufacturing Practice
GAMP
良好自动化生产实践指南
Good Manufacturing Practice
GMP
药品生产质量管理规范
International Society For Pharmaceutical Engineering
ISPE
国际制药工程协会
Pipes & Instruments Drawing
P&ID
管道与仪表流程图
Tofflon Intelligent Vision System
TIVS
东富龙智能灯检系统
Tofflon Science and Technology Group Co., Ltd
Tofflon
东富龙科技集团股份有限公司
User Requirements specifications
URS
用户需求说明
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 DQ protocol;

OQ 方案的起草、审核及预批准；
- Execution of OQ;
OQ 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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- Record and handling deviation/change which occurred during OQ;

记录及处理 OQ 过程中发生的偏差/变更；
- Submit the OQ documentation for customer to review and approve.

提交 OQ 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 OQ protocol;

OQ 方案审核及批准；
- Assistant to record and handle the deviation/change occurred during OQ;

协同记录和处理 OQ 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
- (NMPA) Good Manufacturing Practice (2010)
(NMPA)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 部分，成品药生产质量管理规范

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6. System Description 系统描述

Our company's intelligent vision system adopts advanced European design and production technology,
with the characteristics of high quality, high precision and high flexibility; the special bottomless claw
design breaks through the traditional detection method and ensures that every tested product is detected
100%. The advanced touch screen computer operating system makes the testing process visual and
conforms to the American FDA 21 CFR Part11 standard.
我公司的智能灯检机采用了欧洲先进的设计和生产技术，具备高品质，高精度及高灵活性等特点；
特殊的无底座式的夹爪设计，突破了传统的检测方式，保证了每个被检测品 100%被检测到，先进
的触摸屏电脑操作系统，使得检测过程可视化，符合美国 FDA 21 CFR Part11 规范。
The speed of TIVS- L60L (HVLD) intelligent vision system can reach 450 bottles per minute (take 2R vial
as an example). There are four lamp inspection stations, including one Cap detection station and two
independently controlled foreign body detection stations (including liquid level detection), one cosmetic
inspection station. There are 22 cameras in total, The camera resolution is around 2 million. It can
effectively detect foreign particles larger than 40 microns (adjustable) to meet the needs of customers. Add
four HVLD (high-voltage leak detection) One detection is at the head of liquid vial bottle, one detection is
at the bottom of liquid vial bottle, it can effectively detect cracks and micropores larger than 3 um
(adjustable).
TIVS-L60L 型灯检机的速度可达 450 瓶/分钟（以 2R 水针西林瓶为例），共有四个灯检工位，其中

一个 Cap 检测站位，两个独立控制的异物检测站位(包括液位检测)，一个外观检测站位。一共有 22
个摄像头，相机分辨率在 200 万左右。能有效的检测大于 40 微米（可调）的异物粒子，满足客户
的需求。增加四个 HVLD（高压检漏），一个检测在液体瓶的顶部，一个检测在液体瓶的底部，可
有效检测大于 3 um（可调）的裂缝和微孔。
The intelligent vision system is equipped with two collection trays of non-conforming products, which can
be classified and removed after intelligent testing of the machine, or the defective products of different
nature can be classified and output according to the needs of customers. so that regulators can get reliable
data analysis of production status in the first time, find out the possible sources of different foreign bodies,
in order to formulate rectification measures to achieve normal production status.
灯检机配备了两个不合格品收集托盘，机器智能检测后，可以把异物不合格品分类剔除；或根据客
户需求，将不同性质的不良品进行分类输出，从而使监管人员能在第一时间内得到可靠的生产状况
的数据分析，找出不同异物可能产生的源头，以制定整改措施，达到正常的生产状态。
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
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- 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
- 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

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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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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
IQ Punch List Closeout Verification
10.2
IQ 遗留清单关闭确认
Test Leveraging
10.3
测试引用
System Access
10.4
系统访问
Power Failure Test
10.5
断电恢复测试
Alarm Test
10.6
报警测试
Production Batch Report &Printing Verification
10.7
生产报表&打印确认
Recipe Development & Maintenance Verification
10.8
配方开发和维护确认
Speed and Complete Cycle Testing
10.9
速度和整个循环测试
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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 OQ.
Personal must be trained to ensure that competent operational qualification work.
在 OQ 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 OQ 工作。
Name Signature Company Title Date
姓名签名公司职务日期

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10. Test Procedure 测试程序

10.1 Prerequisites 先决条件
Purpose 目的
All prerequisites necessary to the OQ execution have been satisfied.

所有进行 OQ 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 the prerequisites must be satisfied before the beginning of the execution of OQ.
开始执行 OQ 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 OQ protocol has been approved.

确认本方案已得到批准。
There should be a documented training for all people involved in the tests before initiation of OQ.
在 OQ 开始前，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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Prerequisites
先决条件
Prerequisites Yes/No
先决条件是否符合要求
OQ for Intelligent Vision and Leak Integrated System
OQ has been approved. Document No.文件号：
Yes ( ) No ( )
OQ 已经得到批准。
Version No.版本号：
All people involved in the tests has 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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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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10.2 IQ Punch List Closeout Verification IQ 遗留清单关闭确认
Purpose 目的
Verify the issue which were documented during the IQ, and required to be verified during OQ had
been addressed.
确认执行 IQ 过程中记录的需要遗留到 OQ 阶段进行确认的遗留项目及其他事项已经得到解决。
The issues identified during IQ and which should be verified during OQ had been appropriately
addressed as per the resolution listed next to each issue.
在 IQ 活动中确定的需要在 OQ 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 IQ.
取得 IQ 测试的遗留清单的复印件。
Review and remark each item which shall be verified during OQ and verify it had been appropriately
“closed” as per the resolution listed in Punch List.
在 OQ 期间逐一审核，确认每一项遗留到 OQ 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 PQ, shall be not as
the veto items for this test and they shall be documented in the Punch List of OQ and verified in
following work.
某些遗留项目需要遗留到后续的工作，例如 PQ 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 OQ 的遗留清单中，然后在后续的工作中进行确认。
And some issues which are required to be closed upon successful test execution as part of OQ. 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 OQ 的某些测试之后才能被关闭，必须等待这些测试完成之后
再关闭该遗留项目。
Attach the copy of IQ punch list to this test.

附上此项测试的 IQ 遗留清单复印件。

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IQ Punch List Closeout Verification

Description Yes/No
描述是否符合要求
The issues identified during IQ and which should be verified during OQ had been
appropriately addressed as per the resolution listed next to each issue. Yes ( ) No ( )
在 IQ 活动中确定的需要在 OQ 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 IQ Punch List.

附上 IQ 遗留清单复印件。
Att. ID 附件编号：

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Conclusion/Remarks 结论/备注
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

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10.3 Test Leveraging 测试引用
Purpose 目的
Summary the leveraging test items that are required in OQ document, but had been performed in
FAT, SAT and IQ, and verify these test items had been released.
汇总需要在 OQ 阶段执行，但实际已经在 FAT、SAT 及 IQ 执行过的测试项目，确认这些项目
已经成功执行。
All the leveraging test items had been executed in FAT, SAT or IQ successfully, and the test
condition can present the final condition of equipment delivery. And the copy of test documents and
records 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、SAT 或 IQ 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 OQ document and review the test items required by OQ, and verify
whether them had been performed in FAT, SAT or IQ.
根据已批准的 OQ 文件中执行的测试项目，确认其是否在 FAT、SAT 或 IQ 中已经被执行过。
If a test item had been executed in FAT, SAT or IQ successfully, and this test item had been defined
in this protocol also, review the test condition of FAT, SAT and IQ, to verify whether are same or
similar with the test requirements described in this protocol and can present the final delivery
condition of equipment:
如果某个测试项目在 FAT、SAT 或 IQ 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、SAT 或 IQ 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 obtain
a copy of the test section and test documents of FAT, SAT or IQ 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、SAT 或 IQ 所对应的该章节及测试记录复印，附到本方案后，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

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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
Conclusion
结论

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Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

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型号
页码
10.4 System Access 系统访问
Purpose 目的
Verify that the access to the control system is only allowed with pre-defined access password.
确认只有输入预先授权的口令才可以进入控制系统相应的界面。
The use of correct password must allow the access to each specified functions.
使用正确的密码能有权使用所指定的功能。
Verify that the access to the control system need electronic signature.
确认进入控制系统相应的界面需要电子签名
Access to the control system is allowed only after entering the relevant correct access key (password).
The access is automatically denied if a wrong password is entered.
只有在输入相应正确的口令可以进入控制系统，错误的口令将自动拒绝。
The use of correct password must allow the access to each specified functions.
使用正确的密码能有权使用所指定的功能。
Execute the corresponding functions are required to electronic sign as following table.
如下表，执行对应功能时需要电子签名。
Procedure 程序
For each human interface to the control system and for each access level enter the corresponding
password and verify the allowed control system functions, repeat the procedure entering a wrong
password, verify the denied access.
对每个控制系统的人机界面和进入等级，输入相应的口令，确认允许进入控制系统的相应功能，
使用相同步骤输入错误的口令，确认拒绝进入。

文件编号
OQ
型号
页码
System Access Test

系统访问测试
Yes/No
Description Visitor Operator Technician Administrator
是否符合
说明访客组操作员组工艺员组系统管理员组
要求
User ID
N/A
用户 ID
Right password(only for test)
N/A
正确密码（仅限测试用）
Wrong password(only for test)
N/A
错误密码（仅限测试用）
Switch Over Different Station Yes ( )
Yes 是 Yes 是 Yes 是 Yes 是
不同检测工位图像切换 No ( )
Machine Parameter Yes ( )
No 否 No 否 Yes 是 No 否
机械参数 No ( )
Download Recipe Yes ( )
No 否 Yes 是 Yes 是 No 否
下载配方 No ( )
New Recipe/Delete Recipe Yes ( )
新建配方/删除配方 No ( )
Enable/Disable The Belt Yes ( )
开启/关闭网带 No ( )
Set User ID/ Password Yes ( )
No 否 No 否 No 否 Yes 是
设置用户账号/密码 No ( )
Batches Yes ( )
批次 No ( )
Inspection Parameter Yes ( )
检测参数 No ( )
Query log report Yes ( )
查询日志报表 No ( )
Audit trail view Yes ( )
审计追踪查看 No ( )
Start Inspection/Stop Inspection Yes ( )
开始检测/停止检测 No ( )
Exit Yes ( )
No 否 No 否 No 否 Yes 是
退出检测 No ( )

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：

文件编号
OQ
型号
页码
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

文件编号
OQ
型号
页码
10.5 Power Failure Test 断电恢复测试
Purpose 目的
Verify the equipment will halt when the power is cut off during the normal operation.
确认设备正常运行时如果断电设备将停止运行。
Verify the equipment can work normally when the power is restored after power down.
确认设备断电再送电后设备可以正常工作。
Verify there is no data loss.

确认设备没有数据丢失。
If the power supply is cut when the equipment is in normal operation, all the programs that are running
before the power supply is cut would stop and there are no abnormal responses from the equipment
and the operating parameters have not changed.
设备在正常工作时如果断电后再重新给设备供电，设备将停止断电前运行的程序，设备存储数
据不会丢失。
Procedure 程序
Turn on the equipment and run the machine.

首先启动设备，运行设备。
When the program is running, cut off the power supply.

在程序运行过程时，切断设备电源，使设备断电。
Cut the power supply and then restore the power supply 2 minutes later.
断电时间超过两分钟后，再重新给设备上电。
Visually check the operation of the equipment.

目测设备运行情况。

文件编号
OQ
型号
页码
Power failure test

断电恢复测试
Step Acceptance Criteria Result Yes/No
步骤接受标准实际结果是否符合要求
The system is running

Turn on the machine
normally Yes ( ) No ( )
启动设备
系统运转正常
The running procedure

Cut off the main power supply. stop.
断开主电源运行的程序停止。
Power off time: The machine is halt Yes ( ) No ( )

断电时间： and the program runs
normally.
：～：；设备停止运行，程序
正常运行。
The system resume

operation Yes ( ) No ( )
Restore the power 系统恢复运行。
恢复电源 The saved data is not
lost. Yes ( ) No ( )
保存的数据不会丢失

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

文件编号
OQ
型号
页码
10.6 Alarm Test 报警测试
Purpose 目的
Verify that key alarm will be activated properly and can be reset properly.
确认关键报警能被正确触发和复位。
Alarm is correctly generated, expected results and action due to alarm triggering is in accordance
with alarm list.
报警正确的产生预计的结果和行动，与报警清单一致。
Procedure 程序
The alarm list will be used as test scheme. The alarm tests are performed in operational mode.
将报警清单作为测试方案。报警测试要在正常操作模式下进行。
For key alarm, generate an alarm condition using one of the following methods:
对关键报警，使用下面所列的方法之一来产生报警：
 Modify the alarm threshold.
改变报警限。
 Use a proper signal generator.
使用适当的信号发生器。
 Disconnecting the device (sensor, photocell, instruments).
断开设备（传感器、光电管、仪器仪表）。
 Disconnecting or shorting the signal cable (only applicable for digital signals).
断开或短接信号线（仅对数字信号）。
 Simulating ‘real condition’ (e.g.: putting the element in the warm bath to simulate the high
temperature).
模拟“真实的条件”（例如将元件放入水浴中模拟高温）。
Make sure that all the alarm work properly.

确认报警功能正常。
Note: No alarm shall be triggered in a way that could damage the unit.
注：不能以有可能损坏系统的方式触发报警。
Print alarm record.

打印报警记录。
Attach the checked alarm record and alarm list to this test.
此项测试附上检查的报警记录及报警清单。

文件编号
OQ
型号
页码
Alarm Test
报警测试
Document Name Document No. Version/Date
文件名称文件编号版本/日期
No. Alarm Test Yes/No

序号报警测试是否符合要求
Alarm is correctly generated, expected results and action due to alarm

1. triggering is in accordance with alarm list. Yes ( ) No ( )
报警正确的产生预计的结果和行动，与报警清单一致。
Verify the alarm record can be exported to local address for subsequent
printing.
2. 确认报警记录能导出到本地进行后续打印操作。 Yes ( ) No ( )
Check the information of the exported alarm record and confirm its format and
content are correct.
检查导出的报警记录的信息，确认其格式和内容无误。
The alarm record is based on a non-editable format.

3. Yes ( ) No ( )
报警记录是基于不可修改的电子文档格式。
Att. ID 附件编号：_____________________________________________________________________

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

文件编号
OQ
型号
页码
10.7 Production Batch Report &Printing Verification 生产报表&打印确认
Purpose 目的
Check and verify a production batch report can be generated by machine system automatically after
production.
确认灯检机运行结束后输出的生产报表符合用户期望。
A production batch report confirming to user requirements can be generated automatically by machine
system and the format of this report is un-modifiable and can printed.
灯检机运行结束后能自动生成一份符合用户期望的生产报表，生产报表的格式为不可修改的格
式，可以被正确地打印输出。
Procedure 程序
After a production batch, check the electrical batch report generated by the system and records the file
format in following form and filed address.
在生产结束后，检查系统生成的电子报表，记录报表的电子文档格式和保存地址。
Connect a printer with machine and print the batch report generated.
连接打印机与灯检机控制系统，将电子报表打印输出。
Check the paper report and the format, and verify data integration.
检查打印输出的报表的信息及格式，确认数据信息是否完整。
Use a red pen to identify nonconformities on the printed report.

用红色的笔在打印的报表上标识出不符合项。
Attach this paper report to the following form.

将该报表附到下表中。

文件编号
OQ
型号
页码
Production Batch Report &Printing Verification

Item Result Yes/No
项目结果是否符合要求
A production batch report confirming to
user requirements can be generated
automatically by machine system Yes ( ) No ( )
灯检机运行结束后能自动生成一份符合
用户期望的生产报表
Electrical report format Yes ( ) No ( )

电子报表的格式
Filed Address Yes ( ) No ( )

保存位置
Check the paper report and the format, and

verify data integration. Yes ( ) No ( )
检查打印输出的报表的信息及格式，确 Attachment ID
认数据信息是否完整。附件编号：；

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

文件编号
OQ
型号
页码
10.8 Recipe Development & Maintenance Verification 配方开发和维护确认
Purpose 目的
To confirm the validity and accuracy of the formulation and maintenance of the formulation;
确认提供的配方建立和维护的程序有效且准确；
Able to establish and maintain the equipment formulation (mobile, copy, delete, storage, etc.) based on
the system file.
能够依据系统文件建立和维护设备配方（移动、复制、删除和存储等）。
Provide the formulation and maintenance of the program to effectively and accurately;
提供的配方建立和维护的程序有效且准确；
Able to establish and maintain the equipment formulation (mobile, copy, delete, storage, etc.) based on
the system file.
能够依据系统文件建立和维护设备配方（移动、复制、删除和存储等）。
Procedure 程序
Start the intelligent vision system and perform the operation according to the following table.
启动灯检机，按照下表执行操作。

文件编号
OQ
型号
页码
Recipe Development & Maintenance Verification

Item Yes/No
项目是否符合要求
Create new recipe Yes ( ) No ( )
新建配方
Save the new recipe Yes ( ) No ( )
保存配方
Download recipe Yes ( ) No ( )
下载配方
Modify recipe Yes ( ) No ( )
修改配方

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期

文件编号
OQ
型号
页码
10.9 Speed and Complete Cycle Testing 速度和整个循环测试
Purpose 目的
To test and verify the Intelligent Vision and Leakage Integrated System running speed,
infeed ,outfeed, and the complete cycle running stability, the equipment inspect accuracy. Customer
supplys samples, and inspect with customer-specified product types.
测试并验证灯检检漏一体机的运行速度，以及进料、出料整个循环运行的稳定性,机器检测的
准确率。由客户提供样品, 使用客户指定瓶型来进行测试。
The complete cycle is running smoothly.

整个测试过程中运行平稳。
Procedure 程序
Load the appropriate size product and run the Intelligent Vision and Leakage Integrated System.
The system can run smoothly for a period of time.
装载相应规格的产品并运行灯检检漏一体机，灯检检漏一体机平稳运行。

文件编号
OQ
型号
页码
Speed and Complete Cycle Testing

速度和整个循环
Actual Running
Spec. Downtime and The Cause Expected Result Yes/No
Speed Time
是否符合
实际运行要求
规格速度停机时间及原因预期结果
运行时间
The complete cycle Yes ( )

runs smoothly
整个循环运行正常 No ( )

runs smoothly

runs smoothly

runs smoothly

文件编号
OQ
型号
页码
Conclusion
结论
Remark 备注：
Conformity
符合性
Executed by / Date:
执行人/日期
Reviewed by/ Date:
审核人/日期
11. Deviation Handling 偏差处理

文件编号
OQ
型号
页码
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 OQ and record.

收集 OQ 中发生的所有偏差并记录。
For all the found deviations during OQ, Tofflon need to provide solutions to close these deviations and
the customer has responsible for reviewing and approving the solutions.
OQ 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。

文件编号
OQ
型号
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. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

文件编号
OQ
型号
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 OQ and record.

收集 OQ 中发生的所有变更并记录。
For all the found changes during OQ, Tofflon need to provide solutions to close these deviations and the
customer has responsible for reviewing and approving the solutions.
OQ 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。

文件编号
OQ
型号
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. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

文件编号
OQ
型号
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 pending item. Numbering for pending item shall be as per: P +
section number-sequence number, such as the P10.1-01, means the first pending item 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 pending item during the OQ and record.

收集 OQ 中发生的所有遗留项并记录。

文件编号
OQ
型号
页码
Punch List
遗留清单
(Page of )
Punch List Other
ID Pending Item Description Pending Item Correction Attachments Conclusion
Description
遗留清单遗留项目描述遗留项目整改附件结论
其他说明
编号
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
N/A ( ) Yes ( )
Att. ID: ________ No ( )
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

文件编号
OQ
型号
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。

文件编号
OQ
型号
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

文件编号
OQ
型号
页码
15. OQ Summary OQ 总结
15.1.Test Result Summary 测试结果汇总
Test No. Test Name Conclusion Deviation ID Punch List ID
测试编号测试名称结论偏差编号遗留清单编号
Prerequisites N/A ( ) N/A ( )
10.1 Yes ( ) No ( )
先决条件 Dev. ID: ________ PL. ID: ______
IQ Punch List Closeout
N/A ( ) N/A ( )
10.2 Verification Yes ( ) No ( )
Dev. ID: ________ PL. ID: ______
Test Leveraging N/A ( ) N/A ( )
10.3 Yes ( ) No ( )
测试引用 Dev. ID: ________ PL. ID: ______
System Access N/A ( ) N/A ( )
10.4 Yes ( ) No ( )
系统访问 Dev. ID: ________ PL. ID: ______
Power Failure Test N/A ( ) N/A ( )
10.5 Yes ( ) No ( )
断电恢复测试 Dev. ID: ________ PL. ID: ______
Alarm Test N/A ( ) N/A ( )
10.6 Yes ( ) No ( )
报警测试 Dev. ID: ________ PL. ID: ______
Production Batch Report
N/A ( ) N/A ( )
10.7 &Printing Verification Yes ( ) No ( )
Dev. ID: ________ PL. ID: ______
Recipe Development & N/A ( ) N/A ( )
10.8 Maintenance Verification Yes ( ) No ( )
Dev. ID: ________ PL. ID: ______
Speed and Complete Cycle N/A ( ) N/A ( )
10.9 Testing Yes ( ) No ( )
Dev. ID: ________ PL. ID: ______
速度和整个循环测试
Executed by /Date
执行人/日期
Reviewed by /Date
审核人/日期

文件编号
OQ
型号
页码
15.2. OQ Conclusion OQ 结论
Review the test result and data, and give a final conclusion for OQ of Intelligent Vision and
Leak Integrated System.
对测试结果和数据进行审核，得出灯检检漏一体机运行确认的最终结论。
OQ Review and Approval

OQ 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:
审核（用户）
REVIEWED BY:
审核（用户）
REVIEWED BY:
审核（用户）
APPROVED BY:
批准（用户）


2021 023Vc L60L OQ Ok

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2021 023Vc L60L OQ Ok

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OPERATIONAL QUALIFICATION

Group Co., Ltd. 2021-023Vc

OPERATIONAL QUALIFICATION FOR

EXPERTISE IN PHARMACEUTICAL INDUSTRY

ADD: 139, DUHUI RD., SHANGHAI -201109 CHINA

Operational Qualification for Operational Qualification for

Document Approval 文件批准

Department Name Signature Date

Quality Assurance Department Xu Chai

Quality Assurance Department Morris Meng

Design Department Billy Qiu

Department Signature Date

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Version History 版本历史

Version 版本 Issued date 颁布日期 Reason for issue 颁布原因

EXPERTISE IN PHARMACEUTICAL INDUSTRY

6. System Description 系统描述...............................................................................................................1

7. Good Documentation Practice 文件管理规范......................................................................................1

8. Test List 测试列表................................................................................................................................1

9. Personnel Identification 人员确认........................................................................................................1

10. Test Procedure 测试程序......................................................................................................................1

10.1 Prerequisites 先决条件..........................................................................................................................1

12. Change Handling 变更处理..................................................................................................................1

13. Punch List 遗留清单.............................................................................................................................1

14. Attachment List 附件清单.....................................................................................................................1

15. OQ Summary OQ 总结.........................................................................................................................1

15.1. Test Result Summary 测试结果汇总....................................................................................................1

15.2. OQ Conclusion OQ 结论.......................................................................................................................1

qualification activities before Process Validation begins.

- Prepare, review and pre-approval of DQ protocol;

- Gather raw data and fill in the test form;

EXPERTISE IN PHARMACEUTICAL INDUSTRY

- Record and handling deviation/change which occurred during OQ;

- Submit the OQ documentation for customer to review and approve.

Responsibilities of client include but not limited to

- The review and approval of OQ protocol;

- Assistant to record and handle the deviation/change occurred during OQ;

- Assistant to collect raw data and fill in relevant check table;

- Provide the provision of necessary human resource and equipment;

- Review and approve the final conclusion.

EXPERTISE IN PHARMACEUTICAL INDUSTRY

6. System Description 系统描述

TIVS-L60L 型灯检机的速度可达 450 瓶/分钟（以 2R 水针西林瓶为例），共有四个灯检工位，其中

7. Good Documentation Practice 文件管理规范

- Only authorized persons can sign on any documents.

- The signature shall be legible

- The signatures shall be consistent

Column Filling 填写栏目：

- All the columns shall be filled.

Correction of Mistakes 更改错误：

- For example: January 1, 2016, signature and date

Date Recording Format 记录日期：

- For example: 2016.01.01

EXPERTISE IN PHARMACEUTICAL INDUSTRY

Use of Abbreviations 使用缩略语：

Written Words and Names 书面语及名称：

- Standard written words and names shall be used.

- The names shall be consistent all through the document.

EXPERTISE IN PHARMACEUTICAL INDUSTRY

8. Test List 测试列表

9. Personnel Identification 人员确认

EXPERTISE IN PHARMACEUTICAL INDUSTRY