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附：HPLC确认方案/报告（IQ+OQ+PQ）之IQ范文展示：
Installation Qualification Protocol
安装确认（IQ）方案
INDEX目录
1. Purpose目的
2. Scope范围
3. Responsibility职责
4. Regulation and Guidance 法规和指南
5. Terms and Abbreviations术语及缩写
6. System Description 系统描述
7. Documentation Control Specification 文件管理规范
8. Test List测试项目列表
9. Test Description and Acceptance Criteria 测试描述和可接受标准
9.1 Personal Qualification人员的确认
9.2 Prerequisites先决条件
9.3 Module Qualification模块确认
9.4 Module Accessories Qualification模块附件确认
9.5 Module Installation Qualification模块安装确认
9.6 Software Version Controlling软件版本控制
10. Deviation Report偏差报告
11. List of Deviation 偏差清单
12. List of Attachment附件清单
13. Change Control变更控制
14. Execution Review and Approval执行的审核和批准
15. Index of Test Report 测试报告目录
Test Report 测试报告1 Personnel Qualification人员的确认
Test Report 测试报告2 Prerequisites 先决条件
Test Report 测试报告3 Module Qualification模块确认
Test Report 测试报告4 Module Accessories Qualification模块附件确认
Test Report 测试报告5 Module Installation Qualification模块安装确认
Test Report 测试报告6 Software Version Controlling软件版本控制
Test Report 测试报告7 List of Deviations偏差清单
Test Report 测试报告8 List of Attachment附件清单
Test Report 测试报告9 Execution Review and Approval执行的审核和报告的批准
1. Purpose目的
The Installation Qualification (IQ) is to define the test procedures and acceptance criteria of the Axxxx 1200 HPLC of QC of XXX Pharmaceutical Co., Ltd.
本安装确认是为了确认XXX质量控制部Axxxx1200高效液相色谱仪的安装符合相关的测试步骤和验收标准。
The Installation Qualification (IQ) would ensure that the key components that can directly affect the system are correctly installed and conform to the requirements of the design documents, that the supporting documents and quality documents are present at the site. The test and inspection results are to be recorded according to the validation scheme.
安装确认将确定直接影响系统的关键部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。测试和检查的结果将按照该验证方案进行记录。
2. Scope范围
The application scope of this Performance Qualification includes the Agilent 1200 HPLC （Equipment ID:zgb012）in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM-QC-01-HPLC-01
本性能确认的范围为XXX质量控制部的Axxxxt高效液相色谱仪（设备编号：xxxx），系统编号为：SYM-QC-01-HPLC-xx。
3. Responsibility职责
XXX responsibility XXX的职责
ü IQ Protocol Writing
编制IQ方案
XXX responsibilityxxxxx的职责
ü Review and approve this protocol before execution
执行前审核和批准本方案
ü Provide personnel, when necessary, to assist in the operation of equipment and system
在需要的时候，提供必要的人员协助进行系统和设备的运行
ü Provide personnel, when necessary, to calibrate critical and non-critical measuring, recording, and/or controlling instrumentation
在需要的时候，提供必要的人员进行校准关键和非关键的测量、记录和控制仪表
ü Provide calibration certificate of any instruments utilised during the execution of this Protocol
提供在方案执行中所需仪器的校准证书
ü Protocol execution and data collection
方案的实施，数据的收集
ü Define solution for non conformity
针对不一致项界定解决方法
ü Deviation report compilation
偏差报告的编写
ü Final report compilation
最终报告的编写
ü Review and approve the protocol and test reports after successful execution
审核和批准本方案和测试报告
4. Regulation and Guidance 法规和指南
To write this protocol have been used the following reference documents:
为了编写本方案，参考了以下文件：
ü (SFDA) GMP (2010 Revision)
(SFDA) GMP(2010年修订版)
ü CP2015
中国药典2015
5. Terms and Abbreviations术语及缩写
Terms and Abbreviations术语及缩写
Definition定义
IQ
Installation Qualification 安装确认
OQ
Operation Qualification 运行确认
PQ
Performance Qualification性能确认
GMP
Good Manufacturing Practice 药品生产质量管理规范
HPLC
High-Performance Liquid Chromatography 高效液相色谱仪
SOP
Standard Operation Procedure标准操作程序
6. System Description 系统描述
The Axxxx HPLC （Equipment ID:xxxx）in the QC of XXX Pharmaceutical Co., Ltd. System No.: SYM-QC-01-HPLC-xx.
XXX质量控制部的Axxxt 高效液相色谱仪（设备编号：xxx），系统编号为：SYM-QC-01-HPLC-xx。
The AXXXXX HPLC is composed of degasser, transfer pump, column heater, auto-sampler, detector and system software. It is used for assay test, identification and impurity analysis.
该Axxxx高效液相色谱仪由脱气机，输液泵，柱温箱，自动进样器，检测器及系统软件组成。主要用来进行含量测定、鉴别、及杂质分析。
7. Documentation Control Specification 文件管理规范
ü Recording pens 记录用笔：
- Archive proof ink pens or marker pens shall be used. Blue pens are recommended.使用不消退的墨水笔和记号笔，推荐使用蓝色笔记录
ü 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 readable.签名应该是可辨认的
- The signatures shall be consistent.签名应始终一致
ü 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
ü 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.
- For example: January 1, 2010, signature and date
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。
如：2010年01月01日 签字，日期
- When any mistakes are to be corrected afterwards, besides conforming to the above requirements, the reasons for the correction must be noted and the possible influences shall also be assessed and noted.
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。
ü 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: 2010.01.01
如：2010.01.01
ü 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。
ü 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
8. Test List测试项目列表
The test which will 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.
编号
Test Name
名称
9.1
Personal Qualification
人员的确认
9.2
Prerequisites
先决条件
9.3
Module Qualification
模块确认
9.4
Module Accessories Qualification
模块附件确认
9.5
Module Installation Qualification
模块安装确认
9.6
Software Version Controlling
软件版本控制
9. Test Description and Acceptance Criteria 测试描述和可接受标准
9.1 Personal Qualification人员的确认
Purpose 目的
Identify all people involve in protocol execution.
确认所有在执行本方案的人员的资格。
Procedure程序
List and identify all personnel involved in the execution of the present protocol (Name. Signature, Initials and Department/Company).
列出和确认所有在执行本方案的人员（姓名、签名、缩写和部门/公司）。
Acceptance Criteria可接受标准
All the operators are identified by Name, Signature, Initials and Department/Company.
所有在执行本方案的人员（姓名、签名、缩写和部门/公司）已确认。
Test Report测试报告
Fill in Test Report No.1.
填写“测试报告1”。
9.2 Prerequisites先决条件
Purpose 目的
All prerequisites necessary to the PQ execution have been satisfied.
所有进行性能确认的先决条件已经得到满足。
Procedure程序
The installation of the HPLC has been finished.
高效液相色谱仪已完成安装。
Verify that IQ protocol has been approved.
确认本安装确认方案已得到批准。
There should be a documented training for all people involved in the tests before initiation of IQ.
在IQ开始前，对所有参与测试的人员进行方案的培训。培训应该有记录。
Acceptance Criteria可接受标准
All the prerequisites must be satisfied before the beginning of the execution of IQ test.
开始执行本测试之前，所有的先决条件必须得到满足。
Test Report测试报告
Fill in Test Report No.2.
填写“测试报告2”。
9.3 Module Qualification模块确认
Purpose 目的
This test is to verify the consistency between the module list and site module.
该测试用以确认模块清单与现场模块的一致性。
Procedure程序
Refer to the module list to verify the site module and record the type.
根据模块清单，核实现场模块，并记录其型号。
Module list includes quaternary pump module, auto-sampler module, ultraviolet detector module and column heater module.
模块清单内包含：四元泵模块、自动进样器模块、紫外检测器模块、柱温箱模块。
Acceptance Criteria可接受标准
The module list should conform to site module, and record the type.
模块清单应与现场模块一致，型号已记录。
Test Report测试报告
Fill in Test Report No.3.
填写“测试报告3”。
9.4 Module Accessories Qualification模块附件确认
Purpose 目的
This test is to verify the integration of each module accessories and relevant manual.
该测试用以确认各模块附件及其相关手册的完整性。
Procedure程序
Check the integration of each component accessories and relevant manual.
核实各组件附件及其手册的完整性。
Pump：Operating Manual, Power Cord, LAN cable
泵：操作手册，电源线，Lan电缆
Auto-sampler：Operating Manual, Power Cord, LAN cable, 100ml Rhoedyne ,Package 200×2ml Vials
自动进样器：操作手册，电源线，Lan电缆 ，100ml定量环，一盒200×2ml进样瓶
Column heater：Operating Manual, Power Cord, LAN cable
柱温箱：操作手册，电源线，Lan电缆
Detector：Operating Manual, Power Cord, LAN cable, UV Lamp
检测器：操作手册，电源线，Lan电缆，紫外灯
Acceptance Criteria可接受标准
Each module accessories and relevant files are integral.
各模块附件及其相关文件应完整。
Test Report测试报告
Fill in Test Report No.4.
填写“测试报告4”。
9.5 Module Installation Qualification模块安装确认
Purpose 目的
This test is to verify the module has been installed normally.
该测试用以确认模块已经正常安装。
Procedure程序
The width and depth of each module is suitable to complete the installation properly.
各模块的宽度与深度合适，可以正确安装。
Detector flow cell and UV lamp are easy to dismount.
检测器流通池和紫外灯应易拆卸。
Pump, auto-sampler, column heater and detector unit are started normally, and the power button will indicate open status. The corresponding part on software controlling interface will show be usable.
泵、自动进样器、柱温箱、检测器单元可正常启动，电源键应显示开启状态，软件控制界面相应单元部分显示可用。
Acceptance Criteria可接受标准
Each module has been installed properly and is usable.
各模块已经正确安装，并且可用。
Test Report测试报告
Fill in Test Report No.5.
填写“测试报告5”。
9.6 Software Version Controlling软件版本控制
Purpose 目的
This test is to verify the operating software version.
该测试用以确认操作软件的版本。
Procedure程序
Record the current software version and verify the installation CD is readable.
记录当前软件版本并确认安装光盘可读。
Acceptance Criteria可接受标准
Software version has been recorded, and the installation CD is readable and preserved properly.
软件版本已记录，安装光盘可打开并已经妥善保存。
Test Report测试报告
Fill in Test Report No.6.
填写“测试报告6”。
10. Deviation Report偏差报告
Any deviations found during execution of this protocol will be handled according to the SOP for Deviation Management of XXX. Each deviation will be given a unique number and recorded in the deviation report. The deviations will be summarized in the deviation list.
测试过程中发生的任何偏差都将依据xxxx的偏差管理SOP处理。每个偏差都要给予一个唯一的编号并记录在偏差报告里。在偏差清单中，汇总所有的偏差。
Use copies of the deviation report if necessary.
如有需要可复印偏差报告。
11. List of Deviation 偏差清单
Record in the test report 7 all deviations found during PQ activities and indicate solution date.
在测试报告7中记录所有的在执行PQ活动中发生的偏差，并注明解决日期。
Use additional pages as required, Number the pages used.
如果需要可以加页，需对使用的页进行编号。
12. List of Attachment附件清单
Record in the test report 8 all documents attached to this protocol indicating the number and the title of relevant test report.
在测试报告8中记录所有附在本方案中的文件，注明页数和相关的测试报告。
Use additional pages as required, Number the pages used.
如果需要可以加页，需对使用的页进行编号。
13. Change Control变更控制
Any changed of the system will be submitted to a Change Control Procedure, in accordance with according to the SOP for Change Control of XXX. All Change Control Forms for the system will be filed.
系统任何的变更应按照石家庄四药的变更控制SOP 处理，所有变更控制表将被收集。
14. Execution Review and Approval执行的审核和批准
To conclude the performance of PQ and approval of the report.
对性能确认的执行过程进行总结并对报告进行审批。
Record in the test report 9.
填写测试报告9。
15. Index of Test Report 测试报告目录
Index
目录
Description
描述
Test Report测试报告1
Personnel Qualification
人员的确认
Test Report测试报告2
Prerequisites
先决条件
Test Report测试报告3
Module Qualification
模块确认
Test Report测试报告4
Module Accessories Qualification
模块附件确认
Test Report测试报告5
Module Installation Qualification
模块安装确认
Test Report测试报告6
Software Version Controlling
软件版本控制
Test Report测试报告7
List of Deviations
偏差清单
Test Report测试报告8
List of Attachment
附件清单
Test Report测试报告9
Execution Review and Approval
执行的审核和报告的批准
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