性能确认PQ中英文

1、YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 1 OF 22第1页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：EXECUTION APPROVAL SIGNATURES批准执行签名The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for

2、 execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendment which must be approved prior to execution.下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标 准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。Department &

3、 Site 单位部门Signature & Date签名与日期Issued by起草Reviewed by审核Authorized by批准YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 2 OF 22第2页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：Contents目录1.0SCOPE 范围32.0PURPOSE 目的33.0BACKGROUND 背景34.0INTRODUCTION 介

4、绍35.0REFERENCES 参考书目46.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES责任方及其责任 47.0SYSTEM DESCRIPTION 系统说明6GENERAL DESCRIPTION 总说明 6PRETREATMENT UNIT 预处理单元 6REVERSE OSMOSIS (RO) SYSTEM 反渗透(RO)系统7M IXED BED SYSTEM 混床系统8M ONITOR AND CONTROL SYSTEM 监视和控制系统 98.0TESTING PROCEDURES检验程序 99.0ACCEPTANCE CRITERIA验收

5、标准10ATTACHMENT 1 - VALIDATION TEST EQUIPMENT and materials 附件 1 验证测试设备和材料 11ATTACHMENT 2 PW SYSTEM 30 DAY SAMPLING pLAN DATA SHEET 附件 2 纯化水系统 30 天取样计划数据表.12 ATTACHMENT 3 2ND PHASE PW SYSTEM SAMPLING PLAN DATA SHEET 附件 3 纯化水系统第二阶段取样计划数 据表15ATTACHMENT 4 - PW sample test RESULT FORM 附件 4 - PW样品测试结果表 18

6、ATTACHMENT5-signature verification list 附件 5-签名确认清单 19ATTACHMENT6-PROTOCOL DEVIATION LOG 附件 6 -文件偏差日志 20ATTACHMENT7-PROTOCOL DEVIATION RECORD 附件 7 -文件偏差记录 21ATTACHMENT8-PROTOCOL EXECUTION APPROVAL SIGNATURES DATA SHEET 附件 8 -文件执行批准签名数据表 .22YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：P

7、age: 3 OF 22第3页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：1.0 SCOPE范围This Performance Qualification (PQ) study will be performed on the Purified Water (PW) System, located in YUNG SHIN PHARM.IND.(KS)CO.,LTD. The scope of this protocol will be for the initial 30

8、days of aggressive sampling. An additional eleven months of sampling will be performed per a YUNG SHIN PHARM.IND.(KS)CO.,LTD. SOP to establish an entire year of sample results.本性能确认(PQ)文件应用于位于永信药品工业(昆山)有限公司的纯化水( PW)系统。本文件 的范围将涵盖初始30天的取样。再附上 11个月的取样情况，得到整一年的取样结果，取样方法标准为永信药品工业(昆山)有限公司SOP。This protocol

9、 describes the equipment, test procedures, specifications, documents, and references used to establish that the PW System performs in accordance with the manufacturer ' design specifications, and those of YUNG SHIN PHARM.IND.(KS)CO.,LTD.本文件内容涉及设备、测试步骤、规格、文档和参考书目，这些是用来确保纯化水系统的性能符合 生产商设计规范和永信药品工业(

10、昆山)有限公司要求。Shanghai Baoju personnel, have prepared this documentation package. This document will providefor the delineation of responsibilities of Shanghai Baoju and YUNG SHIN PHARM. IND. (KS) CO.,LTD. appropriate approval signatures, support documentation, and other factors that are normally includ

11、ed in a protocol package. All supporting data and documentation will be attached to this validation protocol when completed.本文件包由纳盛机电准备。本文件将确定纳盛机电和永信药品工业(昆山)有限公司的责任、相关 的批准签名、支持文件和其他一般文件包中都有的因素。完成本验证文件后附上所有的支持数据和 文件。2.0 PURPOSE目的The execution of this protocol will demonstrate and document that the PW

12、 System performs according to the manufacturer's specifications and YUNG SHIN PHARM. IND. (KS) CO., LTD.requirements.本文件的执行将记录和证明纯化水系统的性能符合生产商规范和永信药品工业(昆山)有限公司要 求安装和操作。3.0 BACKGROUND背景The PW System is a new system purchased specifically for use at YUNG SHIN PHARM. IND. (KS)CO., LTD纯化水系统是为永信药品工业(

13、昆山)有限公司使用而特别采购的一套新设备。4.0 INTRODUCTION介绍YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 4 OF 22第4页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：All instrument calibration, standardization, or adjustment will be performed and documented for the measu

14、ring equipment used during the execution of this protocol. Standards used will be traceable to the National Institute of Standards and Technology (NIST). Other accepted standards will be used where applicable if NIST standards do not exist.在文件执行过程中，作为测量工具，所有的仪器校验、标准化或调整都将进行，且记录下来。所使 用的标准都可追溯到美国国家标准和

15、技术研究院(NIST)。如果NIST不涉及的地方也可使用其他的验收标准。Performance checks will be performed to verify and document that the system is producing the quality of water required to meet USP guidelines.进行性能确认，确认和记录系统生产的水的质量符合USP规范。Any deviations from the protocol or from specifications or any exceptional conditions encount

16、eredwill be documented and identified for review on the Protocol Deviation Report Form. The deviations and exceptional conditions noted will be investigated and appropriate actions determined and implemented. The investigations, along with the corrective actions and their justifications, will be doc

17、umented on the Protocol Deviation Report Form.任何与文件或规范的偏差或遇到任何例外的情况都要记录下来，加以鉴别，以供文件偏差报告表的 审查。记录的偏差和例外情况要进行调查，而且决定并采取相应的措施。文件偏差报告表中需记录 有调查、纠正性措施及其理由。Final protocol package approval will be by the same personnel who initially approved the protocol, by their designee, or by another person holding an eq

18、uivalent level of authority.最终文件包的批准人必须是文件最初批准人、其指定人、或其他的有同等权力的人员。5.0 REFERENCES参考书目This protocol conforms to the applicable guidelines of the publications listed below. Each publication shall be the latest revision with all addenda in effect on the date of approval of the protocol, unless otherwise

19、 noted.该文件符合下列出版物中的规范。除非另外注明，否则每个出版物都指的是截止批准之日的最新的 版本，其附录也有效。 21 CFR Part 211: Code of Federal Regulations; Current Good Manufacturing Practice for Finished Pharmaceuticals21 CFR第210和211部分：联邦条例法典，成品药 cGMP USP 32 - United States PharmacopeiaUSP 32 水国药典 NIST - National Institute of Standards and Techn

20、ologyNIST Tt国国家标准技术研究所6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES责任方及其责任YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 5 OF 22第5页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：Shanghai Baoju Fluid Equipment Engineering Co., Ltd.纳盛机电流体设备工程有限公司. Wri

21、ting, of this protocol.编写本文件 Generation of Final Report.编写最终报告 Review and approval of the original protocol.审核和批准原始文件 Review and approval of the completed protocol package and the final report.审核和批准完成的文件包和最终报告QA Responsibilities:QA责任 Execution of this protocol.执行本文件 Supply support and technical expe

22、rtise needed in the preparation and execution of the protocol.准备和执行文件时提供支持和技术意见 Supply all documents, data, procedures, manuals, and drawings needed to generate and execute the protocol and complete the final report.提供编写和执行本文件时所需要的所有文件、数据、程序、手册和图纸，完成最终报告Engineering/Manufacturing Responsibilities:工程牛

23、正责任 Supply all procedures, data, manuals, drawings, and documentation needed to generate and execute the protocol and complete the final report.提供文件编写和执行时所需的所有程序、数据、手册、图纸和文件，完成最终报告YUNG SHIN PHARM.IND.(KS)CO.,LTD :永信药品工业(昆山)有限公司： Oversee the validation process.监督验证程序 Supply support needed in the prep

24、aration and execution of the protocol.准备和执行文件时提供支持 Review and approval of the original protocol.审核和批准原始文件 Review and approval of the completed protocol package and the final report.审核和批准完成的文件包和最终报告YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 6 OF 22第6页共22页Purified Water System Pe

25、rformance QualificationVersion: A版本：纯化水系统性能确认Date:日期：7.0 SYSTEM DESCRIPTION系统说明General Description总说明1) Production Capacity 产育昌Production capacity of the PW system is specified at 1000 liters per hour purified water (PW).纯化水系统的产能定为每小时1000升纯化水(PW)。2) Quality Standard of PW System纯化水系统的质量标准The PW syst

26、em will meet the following criteria:纯化水系统将达到以下标准：PW quality standards as defined in USP 28 Water for Pharmaceutical PurposesUSP 28制药用水定义的纯化水质量标准Meet GMP and FDA requirements and pass appropriate qualification/validation 达到GMP和FDA的要求，通过相关的确认/验证。3) Distribution Loop分配回路The PW system distribution loop

27、will be constructed of 316L stainless steel pipe with orbital welded joints. Complete specifications for the pipe, valves, pumps, and connectors are provided in the Technical Specification of Purified Water System for YUNG SHIN PHARM.IND.(KS)CO.,LTD. Project. The PW System distribution loop distribu

28、tes Purified Water to the use points listed below. 纯化水系统的循环回路由带轨道自动焊接焊点的316L不锈钢管道建造。永信药品工业(昆山)有限公司纯化水系统技术规范中说明了关于管道、阀门、泵和接头的详细规 范。纯化水系统循环回路分配纯化水到下面列出的使用点。4) Purified Water (PW) Loop 纯化水回路一楼软膏调剂室一楼洗涤室一楼混合造粒室一楼洗涤室一楼洗涤室三楼洗盘室三楼洗烘衣 M130三楼洁具三楼洗涤三楼洗涤Pretreatment Unit预处理单元YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品

29、工业(昆山)有恒公司Code: VP402编号：Page: 7 OF 22第7页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：The Pretreatment Unit consists of the following components, listed in the order of process flow:预处理单元包含以下部件，按流程图的顺序列出依次为：1) Chemical Container and Dosing Pump化学容器和计量泵A 80 liter PE

30、 tanks and dosing pumps are used to add flocculating and anti-scaling agents to the raw water.用一个80升的PE箱和计量泵在原水中加入絮凝剂和反垢剂。2) SandFilter 沙滤器The sand filter unit employs quartz sand in a 304 stainless steel housing to remove suspended solids and colloidal materials from the incoming water.沙滤器单元利用304不锈

31、钢罐体中的石英砂来除去进水中的悬浮物质和胶质材料。3) Heat Exchanger (Pretreatment)热交换器(预处理)A heat exchanger is used to maintain water temperature at 25oC for optimum purification performance. And also it is used to maintain water temperature at 80°C when sterilizing the carbonfilter o为了达到最佳净化性能，使用热交换器使水温保持在 25oC o在碳过滤器

32、灭菌时，使用热交换器使水 温保持在80 °C ,达到灭菌效果。4) Activated Carbon Filter活性炭过滤器The activated carbon filter uses activated carbon in a 304 stainless steel housing to remove organic compounds, chlorine, odors, and reduce turbidity from the incoming water.活性炭过滤器在 304不锈钢罐体内使用活性炭来除去进水中的有机化合物、氯、气味和减少浊度。5) Softener 软

33、化器To reduce raw water hardness by softener.用软化器降低原水的硬度。6) Brine Tank 盐水箱The auto control valve on the top of softener periodically adopts brine from the brine tank for the use of softener regeneration.软化器上的自动头定时从盐箱中抽盐水，以再生软化器.7) Precision Filter 精细过滤器The precision filter employs a 5-micron membrane

34、filter to remove any remaining particles to prevent contamination of the Reverse Osmosis (RO) membranes.精细过滤器采用5微米膜过滤来除去任何残留的微粒，以防止对反渗透( RO)膜的污染。Reverse Osmosis (RO) System反渗透(RO)系统The R.O System is supplied from a standard water softener and pre-treatment system.R.O系统的水来自标准水软化器和预处理系统。YUNG SHIN PHAR

35、M.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 8 OF 22第8页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：1) Booster Pump 增压泵A 4 KW pumps are used to pressurize the RO system.用一个4 kW的泵来给RO系统增压。2) RO Cleaning Tank RO 药洗箱A 120 liter PE tank is used to feed cleaning

36、agents, during period RO membrane cleaning process.在RO膜洁净程序中用一个120升PE箱来补充清洁剂。3) RO Water Storage Tank RO 贮水箱The RO water storage tank will be constructed of 304 stainless steel. The tank capacity shall be 2 tons.RO贮水箱由304不锈钢制造。容量为 2吨。Mixed Bed System混床系统1) Mixed Bed 混床The mixed bed system adopts ani

37、on resin and cation resin to remove the cation and anion in the water and thus to reduce water conductivity.混床系统利用阴阳离子树脂来除去水中的阳离子和阴离子，降低水的电导率.2) Acid Tank and Alkali Tank酸碱水箱The acid and alkali in the acid tank and alkali tank is used to regenerate the anion and cation in the mixed bed.酸碱水箱中的酸和碱用于再生

38、混床中的阴阳离子3) Mixed Bed Regeneration Pump 混床再生泵The system adopts dual 480W regeneration pumps to feed acid and alkali separately into the mixed bed for generation.系统使用两个480W的再生泵分别将酸和碱打入混床进行再生4) Micro Filter 微滤器The precision filter employs a 1-micron membrane filter to remove any remaining particles fol

39、lowing the mixed bed system.精细过滤器在混床后，采用1微米膜过滤来除去任何残留的微粒，核子级树脂交换系统Resin Exchange System1) Feed Water Tank 原水箱The feed water tank is constructed of 316L with a capacity of 1000 liters.给水箱材料为316L,容量为1000升。2) Feed Water Pumps 进料水泵YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 9 OF 22第

40、9页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：One 0.48 kW pumps provide feed water to the system.一个0.48 kW的泵为系统给水。3) Nucleon-class Resin Tank 核子级树脂罐A FRE nucleon-class resin tank with PE liner is adopted for ion exchange.用一个FRE衬PE的核子级树脂罐中的核子级树脂进行离子交换。4) The Preci

41、sion Filter 微滤器The precision filter employs a 0.22-micron membrane filter to remove any remaining particles.精细过滤器采用0.22微米膜过滤来除去任何残留的微粒。4) Ultraviolet Sterilizer紫外线消毒器An ultraviolet sterilizer is installed to eliminate bacteria.安装一个紫外线消毒器来除去细菌。Monitor and Control System监视和控制系统The entire PW/WFI system

42、 shall be automatically monitored and automatically controlled by PLC (Programmable Logic Control).整个PW/WFI系统应该由PLC (可编程逻辑控制)自动监视和自动控制。8.0 TESTING PROCEDURES检验程序The Performance Qualification will be performed using the protocol attachments. All pertinent information will be recorded on these forms.

43、Copies of forms may be obtained from QA.Document results and data concurrently with the execution of this protocol. Mark through any unused spaces with a single line and initial and date. Mark spaces that do not apply to the system being qualified with Not Applicable (N/A) and provide an explanation

44、 where appropriate. Document any deviations or abnormalities observed during the execution of the protocol.进行性能鉴定要用到文件附件。所有相关信息都将会记录在这些表格上。如果需要可以复印这些表 格。记录下执行文件时的结果和数据。表格复印件可向QA索取。在文件执行过程同时记录结果和数据。用单线划过不用的地方，签名且注明日期。用不合适( N/A)标明不适合系统的地方，并且在 合适的地方写明理由。记录下执行文件时发现的任何偏差或不正常的情况。NOTE: Any exceptions to th

45、is protocol must be fully investigated and documented. This PQ can be considered acceptable with exceptional data only if the cause of the exception has been determined or an assignable cause can be attributed to it and it can be proven that such data will not invalidate the protocol studies. Qualit

46、y Assurance is responsible for determining the acceptability of any exceptional data备注：对本文件中的任何例外进行完全调查和记录。只有当例外的原因已经确定，或可以归结为特定的原因，且能证明该数据不会使文件无效时，这个有例外数据的PQ才可以接受，QA有权决定是否接受例外数据。YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 10 OF 22 第10页共22页Purified Water System Performance Quali

47、ficationVersion: A版本：纯化水系统性能确认Date:日期：9.0 ACCEPTANCE CRITERIA验收标准 All data forms required for execution of the protocol must be completely, accurately, and properly filled out.执行文件时所有必需的数据表都必须完整、准确，且正确填写。 All of the above sample points will be collected as defined in the table and test results will

48、be recorded on the PW System Sample Result Datasheets.以上所有的取样点都收集在表中，在纯化水系统取样结果数据表中记录结果。 All required data will be collected and recorded and all samples will meet test requirements.所有需要的数据都已经收集并记录，所有的样品都符合测试要求。 All deviations must have been corrected or an action plan for correction of the deviatio

49、n(s) must have been developed所有的偏差必须纠正，或提出一个纠偏计划。YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 11 OF 22 第11页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：Attachment 1 - Validation Test Equipment and Materials附件1 -验证测试设备和材料List the instruments/equ

50、ipment/materials not installed on or part of the equipment and/or system being qualified that are used for the installation qualification.在下表中列出安装确认中要使用，但未安装的仪器/设备/材料，或需鉴定的设备和 /或系统的一部分。Page of 第 页共 页Description说明Calibrated （Y/N） 已校验 （是/否）ID No./ Serial No.ID号系歹0号Calibration Date校验日期Calibration Due D

51、ate 校验到期日Copies of the most recent calibration reports for applicable instruments are: 仪器的最近校验报告复印件在（）Attached 附件中Comments:注释：Acceptance Criteria: All test equipment used during protocol execution must be documented. If the test equipment is not calibrated, a reason must be recorded and justified.验收

52、标准：记录下文件执行过程中所有的检测设备。如果检测设备没有校验，则记录原因，说明理由。Meets Acceptance Criteria 符合验收标准：Yes 是（） No 否（）Compiled By 编辑： Date 日期： YUNG SHIN PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 12 OF 22 第12页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：Attachment 2- PW System 30

53、 Day Sampling Plan Data Sheet附件2 -纯化水系统30天取样计划数据表Test Method: Obtain at least one water sample from the PW Storage Tank and all points of use for thirty consecutive business days (Monday thru Friday), obtain at least one sample for each point of use per week. Record the results on the PW System Samp

54、le From. '测试方法：连续30个工作日(星期一到星期五)从纯化水贮水箱或所有使用点取至少一个水样，每个使用点 每周必须取样一次.在纯化水系统样品表中记录结果。Page 1 of 3 第1页共3页Week of 6 第 周共6周Purified Water Thirty Day Sampling Plan纯化水30天取样计划PW SamplePoint纯化水取样点编号Room Name房间名Monday星期一Tuesday星期二Wednesday星期三Thursday星期四Friday星期五A一楼软膏调剂室B一楼洗涤室AC一楼洗涤室BD一楼洗涤室CE一楼混合造粒室YUNG SHI

55、N PHARM.IND.(KS)CO.,LTD永信药品工业(昆山)有恒公司Code: VP402编号：Page: 13 OF 22 第13页共22页Purified Water System Performance QualificationVersion: A版本：纯化水系统性能确认Date:日期：Attachment 2 PW System 30 Day Sampling Plan Data Sheet (cont ' d)附件2 -纯化水系统30天取样计划数据表(接上表)Page 2 of 3 第2页共3页Week of 6 第 周共6周Purified Water Thirty Day Sampling Plan纯化水30天取样计划PW SamplePoint纯化水取样点编号Room Name房间名Monday星期