纯化水性能确认
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文件名称
Document Number
文件编号
InstallationQualificationReport
安装确认报告
P&I Drawing of generation system
制水系统管线图
P&I Drawing of distribution system
P&ID图和分配系统图
Isometric drawingof distribution system
呼吸器：提供0.2µ筒式除菌过滤器
口服固体制剂车间
Floor楼层
Room name and number
房间名称和编号
This protocol should be generated to qualify the initial installation of the System. In case of further modification or relocation, some part of the same protocol can be used or separate protocol or addendum can be generated.
取样点分布图和取样操作规程
5.0
5.1
The purified water system is used for the generation of purified water; from treated water which comes from the purified water room and distribute the purified water to the production plants for the following pharmaceutical use
经过签名，确保测试参与人员了解测试中应遵守的程序和相关文件的完成程序。
Name
姓名
Company / Department / Function
公司/部门/职位
Signature
签名
Training Record Location
培训记录存放位置
2.0
The purpose of carrying outPQis to establish documented evidence that the system operation is in accordance with the requirements of design documentsand URS.
Final rinsing of equipment used in OSD.
As process raw material in manufacturing of OSD (tablet).
clean requirement
纯化水系统用来自纯水车间的水作为原水制备纯化水，输送至生产车间，用途如下：
分配系统的等比例图
SOP for operation of purified water generation, storage and distribution system
纯水系统制水储存和分配系统操作标准操作规程
SOP for cleaning and sanitization of water generation, storage and distribution system
水系统是将企业预处理水作为原水制成纯化水。
The process is handled in two stages, EDI and UF.
工艺经过二个阶段, EDI和超滤。
Purified water distribute through out the production plant by a continuous recirculation loop。
在项目经理的授权下，本文件由XXX制药有限公司项目组为口服固体制剂厂房项目编写的，所以在文件生效前应由XXX制药有限公司质量保证部批准，并由适当的项目授权人授权。
Prepared by起草人
Name/Department姓名/部门
Signature签名
Date日期
Reviewed by审核人
Name/Department姓名/部门
纯化水储罐和分配系统应考虑下列GMP设计特征
Tank储罐
Vertical (For better drainage through bottom discharge)
直立（为了储罐更好的排水）
MOC: SS316L.
Vent: Provided with hydrophobic 0.2µ cartridge filter.
GMP requirements of storage tanks and distribution pipeline for purified water:
纯化水储罐和分配管道的GMP要求
Following GMP design features are considered in storage and distribution system:
水系统设计成一个整体，采用控制面板操作，以获得操作参数的数据收集
Storage tank, components and pipeline are of sanitary construction and made of SS316L.
储罐、部件和管道都是卫生级设计，材质为316L.
Producted purified water quality must Pof 31thversion and EP of 5thversion.
a） 固体制剂车间设备的最终洗涤
b） 固体制剂生产中作为原料
5.2
2000Liters per hour.2000升／小时
5.3
Water system is designed to produce purified water from feed purified water ofpretreatments.
制水，储存和分配系统的清洁灭菌标准操作规程
SOP formaintenanceof purified water generation, storage and distribution system
纯水系统制水储存和分配系统维护标准操作规程
SOPand sampling mapfor water sampling
产水水质符合CP2010 .USP31和EP5.0的要求。主要指标如下表：
Figure 01: The purified water generation process steps
表1：制水工艺
Figure to be attached here.
RO water tank EDI UF Tank PUO Ozone
本方案是为确认设备的首次安装编写的，如果设备变更或移位，本方案的部分内容可以使用或生成独立的方案或附录。
4.0
Following documents are referred during preparation of the protocol
在方案编制过程中，以下文件可以参考
Document Name
修订原因
00
00
TABLE OF CONTENT
目录
1.0Pre Approval3
2.0Objective目标4
3.0Scope范围4
4.0Reference Document参考文件5
5.0Equipment description5
5.1Use ofsystem:用途5
5.2Capacity产能5
实施PW性能确认是为建立文件化的证据证明设备运行符合设计文件标准及URS要求.
3.0
The document includes the Operational Qualification procedure of the following equipment:
包括以下设备的运行确认程序：
In-house name of the equipment
Signature签名
Date日期
Approved by批准人
Name/Department姓名/部门
Signature签名
Date日期
Identification of Signatures / Participants签名确认
In the list below all persons having participated in the execution of thisPQ and having signed on any of the tests are identified with their name, their company / department / function and their signatures.
7.0Responsibility职责8
8.0Test Execution Method测试方法9
9.0Acceptance Criteria接受标准14
10.0Summary Report and Conclusion总结报告和结论14
11.0Abbreviations缩略语17
1.0
This document is prepared by project team ofXXXPharmaceuticals Co. Ltdfor the projectOSDfacilityunder the authority of their Project Manager. Hence this document before being effective shall be approved by the QA team ofXXXPharmaceuticals Co. Ltd, and authorized by the appropriate Project Authority
Performance Qualification Protocol
Purified Water System
SystemID:XXX
纯化水系统性能确认方案
系统编号：XXX
RevisionHistory:
修订历史
Version
版本
RevisionNo.
修订号
RevisionDate源自修订日期Reason for revision
二级反渗透水储罐电渗析EDI超滤UF储罐用水点臭氧
Figure 02: Storage and distribution of purified water
表2：纯水的储藏和分配
Figure to be attached here.
Tank Pump UV Lamp PUO Ozone
储罐泵紫外灯用水点臭氧
下列清单中所有参与实施确认的人员和在任何测试中签名的人员要求确认他们的姓名、公司名称、部门、职位和签名。
With this signature the test participant confirms awareness of the procedures to be followed in qualification tests and completion of associated documentation.
纯化水采用连续循环管路在生产区内循环
The water generation systems designed as an integrated system to be operated with control panel for data acquisition for operating parameters.
设备内部编号
Heating Ventilation and Air Conditioning System
空气净化系统
Equipment identification number
设备编号
Installation location安装位置
Facility车间
OSD Formulations facility
5.3Operation & Design Feature操作设计特征6
6.0Performance Qualification Test Plan运行确认测试计划7
6.1Phase I validation Study:7
6.2Phase II Validation Study第二阶段验证研究8
6.3Phase III Validation Study第三阶段验证8
Document Number
文件编号
InstallationQualificationReport
安装确认报告
P&I Drawing of generation system
制水系统管线图
P&I Drawing of distribution system
P&ID图和分配系统图
Isometric drawingof distribution system
呼吸器：提供0.2µ筒式除菌过滤器
口服固体制剂车间
Floor楼层
Room name and number
房间名称和编号
This protocol should be generated to qualify the initial installation of the System. In case of further modification or relocation, some part of the same protocol can be used or separate protocol or addendum can be generated.
取样点分布图和取样操作规程
5.0
5.1
The purified water system is used for the generation of purified water; from treated water which comes from the purified water room and distribute the purified water to the production plants for the following pharmaceutical use
经过签名，确保测试参与人员了解测试中应遵守的程序和相关文件的完成程序。
Name
姓名
Company / Department / Function
公司/部门/职位
Signature
签名
Training Record Location
培训记录存放位置
2.0
The purpose of carrying outPQis to establish documented evidence that the system operation is in accordance with the requirements of design documentsand URS.
Final rinsing of equipment used in OSD.
As process raw material in manufacturing of OSD (tablet).
clean requirement
纯化水系统用来自纯水车间的水作为原水制备纯化水，输送至生产车间，用途如下：
分配系统的等比例图
SOP for operation of purified water generation, storage and distribution system
纯水系统制水储存和分配系统操作标准操作规程
SOP for cleaning and sanitization of water generation, storage and distribution system
水系统是将企业预处理水作为原水制成纯化水。
The process is handled in two stages, EDI and UF.
工艺经过二个阶段, EDI和超滤。
Purified water distribute through out the production plant by a continuous recirculation loop。
在项目经理的授权下，本文件由XXX制药有限公司项目组为口服固体制剂厂房项目编写的，所以在文件生效前应由XXX制药有限公司质量保证部批准，并由适当的项目授权人授权。
Prepared by起草人
Name/Department姓名/部门
Signature签名
Date日期
Reviewed by审核人
Name/Department姓名/部门
纯化水储罐和分配系统应考虑下列GMP设计特征
Tank储罐
Vertical (For better drainage through bottom discharge)
直立（为了储罐更好的排水）
MOC: SS316L.
Vent: Provided with hydrophobic 0.2µ cartridge filter.
GMP requirements of storage tanks and distribution pipeline for purified water:
纯化水储罐和分配管道的GMP要求
Following GMP design features are considered in storage and distribution system:
水系统设计成一个整体，采用控制面板操作，以获得操作参数的数据收集
Storage tank, components and pipeline are of sanitary construction and made of SS316L.
储罐、部件和管道都是卫生级设计，材质为316L.
Producted purified water quality must Pof 31thversion and EP of 5thversion.
a） 固体制剂车间设备的最终洗涤
b） 固体制剂生产中作为原料
5.2
2000Liters per hour.2000升／小时
5.3
Water system is designed to produce purified water from feed purified water ofpretreatments.
制水，储存和分配系统的清洁灭菌标准操作规程
SOP formaintenanceof purified water generation, storage and distribution system
纯水系统制水储存和分配系统维护标准操作规程
SOPand sampling mapfor water sampling
产水水质符合CP2010 .USP31和EP5.0的要求。主要指标如下表：
Figure 01: The purified water generation process steps
表1：制水工艺
Figure to be attached here.
RO water tank EDI UF Tank PUO Ozone
本方案是为确认设备的首次安装编写的，如果设备变更或移位，本方案的部分内容可以使用或生成独立的方案或附录。
4.0
Following documents are referred during preparation of the protocol
在方案编制过程中，以下文件可以参考
Document Name
修订原因
00
00
TABLE OF CONTENT
目录
1.0Pre Approval3
2.0Objective目标4
3.0Scope范围4
4.0Reference Document参考文件5
5.0Equipment description5
5.1Use ofsystem:用途5
5.2Capacity产能5
实施PW性能确认是为建立文件化的证据证明设备运行符合设计文件标准及URS要求.
3.0
The document includes the Operational Qualification procedure of the following equipment:
包括以下设备的运行确认程序：
In-house name of the equipment
Signature签名
Date日期
Approved by批准人
Name/Department姓名/部门
Signature签名
Date日期
Identification of Signatures / Participants签名确认
In the list below all persons having participated in the execution of thisPQ and having signed on any of the tests are identified with their name, their company / department / function and their signatures.
7.0Responsibility职责8
8.0Test Execution Method测试方法9
9.0Acceptance Criteria接受标准14
10.0Summary Report and Conclusion总结报告和结论14
11.0Abbreviations缩略语17
1.0
This document is prepared by project team ofXXXPharmaceuticals Co. Ltdfor the projectOSDfacilityunder the authority of their Project Manager. Hence this document before being effective shall be approved by the QA team ofXXXPharmaceuticals Co. Ltd, and authorized by the appropriate Project Authority
Performance Qualification Protocol
Purified Water System
SystemID:XXX
纯化水系统性能确认方案
系统编号：XXX
RevisionHistory:
修订历史
Version
版本
RevisionNo.
修订号
RevisionDate源自修订日期Reason for revision
二级反渗透水储罐电渗析EDI超滤UF储罐用水点臭氧
Figure 02: Storage and distribution of purified water
表2：纯水的储藏和分配
Figure to be attached here.
Tank Pump UV Lamp PUO Ozone
储罐泵紫外灯用水点臭氧
下列清单中所有参与实施确认的人员和在任何测试中签名的人员要求确认他们的姓名、公司名称、部门、职位和签名。
With this signature the test participant confirms awareness of the procedures to be followed in qualification tests and completion of associated documentation.
纯化水采用连续循环管路在生产区内循环
The water generation systems designed as an integrated system to be operated with control panel for data acquisition for operating parameters.
设备内部编号
Heating Ventilation and Air Conditioning System
空气净化系统
Equipment identification number
设备编号
Installation location安装位置
Facility车间
OSD Formulations facility
5.3Operation & Design Feature操作设计特征6
6.0Performance Qualification Test Plan运行确认测试计划7
6.1Phase I validation Study:7
6.2Phase II Validation Study第二阶段验证研究8
6.3Phase III Validation Study第三阶段验证8