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Performance Qualification Protocol
性能确认方案
Purified Water produce and skid 纯化水制备、储存与分配系统
User 用户： Department 部门： Location 位置： Hangzhou ****** Pharmaceutical CO., LTD. 杭州******制药有限公司 Workshop 205 205车间 PW Station 纯化水站 Document NO. 文件编号： ****** Revision 版本号： 00 1文档收集于互联网，如有不妥请联系删除.
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Review and Approval
审核和批准
Name Written by 名字 Company 公司 Function 职务 Signature 签名 Date 日期 编写 Reviewed by 年 月 日 审核 Reviewed by 年 月 日 审核 Reviewed by 年 月 日 审核 Reviewed by 年 月 日 审核 Reviewed by 年 月 日 审核 Approved by 年 月 日 批准 年 月 日 Revision History 版本历史
Revision 版本 Issued date 颁布日期 INDEX目录
1.
Introduction介绍 .................................................................................................................. 错误!未定义书签。 1.1 Purpose目的 ...................................................................................................................... 错误!未定义书签。 1.2 Scope范围 ......................................................................................................................... 错误!未定义书签。 1.3 Responsibility职责 ............................................................................................................ 错误!未定义书签。 1.4 System Description 系统描述 ........................................................................................... 错误!未定义书签。 1.5 PQ execution three stages PQ执行的三个阶段 ............................................................ 错误!未定义书签。 1.6 Documentation Control Specification文件管理规范........................................................ 错误!未定义书签。
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Name of Author(s) 编写人 Reason for new issue 颁布原因 文档来源为:从网络收集整理.word版本可编辑.欢迎下载支持.
1.7 List of Reference Document 参考文件清单 .................................................................. 错误!未定义书签。 2. Test Description and Acceptance Criteria 测试描述和可接受标准 ..................................... 错误!未定义书签。
2.1 Prerequisites先决条件 ...................................................................................................... 错误!未定义书签。 2.2 Validation Instruments Calibration验证仪器校准 ............................................................ 错误!未定义书签。 2.3 SOP Check SOP检查 .......................................................................................................... 错误!未定义书签。 2.4 Sterilization Verification 消毒确认 ................................................................................... 错误!未定义书签。 2.5 Operating Parameter Verification在线测量参数确认 ...................................................... 错误!未定义书签。 2.6 First phase: Intensive Sampling Test第一阶段：密集取样测试 ...................................... 错误!未定义书签。 2.7 Second phase: Intensive Sampling Test第二阶段：密集取样测试 ................................. 错误!未定义书签。 2.8 Third phase: Routine Sampling Test第三阶段：常规取样测试 ....................................... 错误!未定义书签。 3. Personal Identification人员的鉴别 ...................................................................................... 错误!未定义书签。 4. Deviation Report偏差报告 ................................................................................................... 错误!未定义书签。 5. Comment Section注释 .......................................................................................................... 错误!未定义书签。 6. List of Deviation 偏差清单 .................................................................................................... 错误!未定义书签。 7. List of Attachment附件清单 ................................................................................................. 错误!未定义书签。 8. Execution Review and Approval 回顾和批准 ....................................................................... 错误!未定义书签。 9. Modification & Change Control 改造和更改控制 ................................................................ 错误!未定义书签。 10. Index of Test Report 测试报告目录 ..................................................................................... 错误!未定义书签。
Test Report 测试报告1 Prerequisites先决条件 .................................................................... 错误!未定义书签。 Test Report 测试报告2 Validation Instruments Calibration 验证仪器校准 ......................... 错误!未定义书签。 Test Report 测试报告3 SOP Check SOP检查 ........................................................................ 错误!未定义书签。 Test Report 测试报告4 Sterilization Verification 消毒确认 ................................................. 错误!未定义书签。 Test Report 测试报告5 Operational Parameter Verification 在线操作参数确认 ................ 错误!未定义书签。 Test Report 测试报告6 First phase: Intensive Sampling Test第一阶段：密集取样测试 .... 错误!未定义书签。 Test Report 测试报告7 Second phase: Intensive Sampling Test第二阶段：密集取样测试错误!未定义书签。 Test Report 测试报告8 Third phase: Routine Sampling Test第三阶段：常规取样测试 ..... 错误!未定义书签。 Test Report 测试报告9 Personnel Identification人员的鉴别 .............................................. 错误!未定义书签。 Test Report 测试报告10 Deviation Report偏差报告 ........................................................... 错误!未定义书签。 Test Report 测试报告11 Addendum Form注释表 ................................................................ 错误!未定义书签。 Test Report 测试报告12 List of Deviations偏差清单 ........................................................... 错误!未定义书签。 Test Report 测试报告13 List of Attachment附件清单 ......................................................... 错误!未定义书签。 Test Report 测试报告14 Execution Review and Approval 执行的审核和批准 ................... 错误!未定义书签。
1. Introduction介绍
1.1 Purpose目的
The performance qualification protocol is to define the content of performance qualification protocol (PQ) of purified water produce and skid of Hangzhou ****** Pharmaceutical CO., LTD..
本性能确认（PQ）方案描述了位于杭州******制药有限公司内新建的纯化水制备、储存与分配的性能确认方案的内容。
The purpose of this protocol is to demonstrate that the purified water produce and distribution system consistently produces water that meets the requirements for Purified Water specified in the Chinese Pharmacopoeia 2010 edition, the European Pharmacopoeia (EP) 6th Edition and United States
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Pharmacopoeia 33 Edition. This qualification includes verification that all relevant Standard Operating Procedures used for this performance qualification are accurate and that all necessary instrumentation have been calibrated. And monitor the quality of purified water through continuous sampling.
该方案用于证明该纯化水制备、储存和分配系统能持续产出符合中国药典CP 2010版、欧洲药典第六版和美国药典33版的相关规定和要求的纯化水。该确认包括确认所有用于该性能确认的相关SOP的准确性和确保所有关键设备都是经过校验的，并通过连续取样来监测纯化水的质量。
1.2 Scope范围
The application scope of this PQ includes the purified water produce, storage and skid system, not include loop of use points.
本性能确认的范围为新建的纯化水制备、储存与分配系统,，不包括使用点分配管路。
1.3 Responsibility职责
On the following are defined the responsibilities relevant to PQ writing and execution. 下面描述了有关PQ的编写和执行的职责。 Austar responsibility******的职责：
? Protocol compilation方案的编写
? Supply of all procedures, data, manuals, drawings and documentation necessary for the
generation and execution of this protocol and the completion of the final report
提供为方案编写、方案执行和报告编写所需要的所有的规程、数据、手册、图纸和文件
******.responsibility******的职责
? Review and approve this protocol before execution.
执行前审核和批准本方案。
? Provide personnel, when necessary, to assist in the operation of equipment of equipment and
system.
如果需要时，提供必要的人员协助进行系统或设备的运行。
? Provide personnel, when necessary, to calibrate critical and non-critical measuring, recording,
and/or controlling instrumentation.
如果需要时，提供必要的人员进行校准关键和非关键的测量、记录和/或控制仪表。 ? Define solution for non conformity.
针对不一致项界定解决方法。 ? Protocol execution, data collection
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方案的实施，数据的收集
? Review and approve the protocol and test reports after successful execution.
审核和批准本方案和测试报告。
1.4 System Description 系统描述
The OSMOSTAR 15000C PWG is supplied by Shanghai Austar。 该OSMOSTAR 15000C型纯化水机是由******提供。
The Purified Water Generator consists of pretreatment, reverse osmosis units, EDI unit, with drinking water as raw water.
该纯化水机由预处理装置、反渗透装置、EDI装置组成，采用饮用水作为源水.
The purified water is stored in a 20000L storage tank. The purified water is drawn from the tank by the recycling pump, then flows to the various user points through loop and finally back to the top of the storage tank after passing through a main heat exchanger.
纯化水贮存在一个20000L容量的储罐内，循环泵从储罐中取水，通过分配管路去往各个使用点，最后再通过一个主换热器回到储罐的顶部。
There are fourteen loops in the distribution system.The PW quality and operation mode can be supervised by differential pressure transmitter , temperature thermometer, flowrate sensor, conductivity sensor, PH tester and TOC tester etc.
该分配系统一共有14个循环回路，每个回路上均安装有压力表，流量计，电导率仪，温度传感器和公用的PH计和TOC仪。
One dual function heat exchanger are installed at the return line of distribution nearby the storage tank for cooling and heating.
一个双管板热交换器安装在分配系统的总回路上，并靠近储罐，用于冷却和加热。
Storage and distribution system can be sanitized, via an automatic cycle, where purified water itself is the sanitizing fluid, being heated-up to 121 °C through the exchangers, which be fed by plant steam. The installation has to guarantee system drain ability.
储存与分配系统可以通过一个自动控制的程序进行消毒，纯化水通过热交换器(通工业蒸汽)加热至121 °C。整个系统的安装被保证具有排水能力。
The purified water shall conform to the requirements specified in the ChP 2005, USP 33,EP 6.1. If there are any discrepancies between different standards, the strictest standard shall be adopted. 纯化水应符合中国药典2010、美国药典33版、欧盟药典6.1版，如果有不同的标准，则选用最严格的标准。
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纯化水制备、贮存和分配系统性能确认方案.doc
