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1、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 execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendm
2、ent 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 & Site单位部门Signature & Date签名与日期Issued by起草Reviewed by审核Authorized by批准 Contents目录1.0SCOPE 范围22.0PURPOSE 目的23.0BACKGROUND 背景24.0INTRODUCTION 介绍25.0REFERENCES 参考书目
3、26.0RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任27.0SYSTEM DESCRIPTION 系统说明2General Description 总说明2Pretreatment Unit 预处理单元2Reverse Osmosis (RO) System 反渗透 (RO) 系统2Mixed Bed System 混床系统2Monitor and Control System 监视和控制系统28.0TESTING PROCEDURES 检验程序29.0 ACCEPTANCE CRITERIA 验收标准2Attachment 1 - Vali
4、dation Test Equipment and Materials 附件1验证测试设备和材料2Attachment 2 - Sand Filter Data Sheet 附件2 砂滤器数据表2Attachment 3 - Carbon Filter Data Sheet 附件3 - 碳滤器数据表2Attachment 4 - Softener Data Sheet 附件4 软化器数据表2Attachment 5 - 5.0 m Micron Filter Data Sheet 附件5 - 5.0微米过滤器数据表2Attachment 6 - Reverse Osmosis Unit Dat
5、a Sheet 附件6 - 反渗透单元数据表2Attachment 7 Mixed Bed Unit Data Sheet 附件7 混床单元数据表2Attachment 8 - PW Circulation Pump Data Sheet 附件8 纯化水循环泵数据表2Attachment 9 - UV Unit Data Sheet 附件9 - UV 单元数据表2Attachment 10 - PW Unit Manual Start-UP Data Sheet 附件10 - PW 单元手动启动数据表2Attachment 11 - PW Unit Automatic Start-UP Dat
6、a Sheet 附件11 纯化水单元自动启动数据表2Attachment 12 - Purified Water System Data Sheet 附件12 - 纯化水系统数据表2Attachment 13 - PW Sanitation Cycle Verification 附件13 纯化水系统卫生循环验证2Attachment 14 - Purified Water Sample Test Result Form 附件14 - 纯化水样品检验结果表2Attachment 15 4T PW Storage Tank Level Control 附件15 4T 纯化水储罐液位控制2Attac
7、hment 16 - System Monitors 附件16 - 系统监视器2Attachment 17 - System Printers 附件17 - 系统打印机2Attachment 18 - Signature Verification List 附件18 - 签名确认清单2Attachment 19 Protocol Deviation Log 附件19 - 文件偏差日志2Attachment 20 - Protocol Deviation Record 附件20 - 文件偏差记录2Attachment 21 - Protocol Execution Approval Signat
8、ures Data Sheet 附件21 -文件执行批准签名数据表21.0SCOPE范围This Operational Qualification (OQ) study will be performed on the Purified Water (PW) System, located in YUNG SHIN PHARM.IND.(KS)CO.,LTD.本操作确认（OQ）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。This protocol describes the equipment, test procedures, specifications, docum
9、ents, and references used to establish that the PW System operates in accordance with the manufacturers 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已经按生产商设计规范和永信药品工业（昆山）有限公司要求安装和操作。Shanghai Baoju personnel, has prepared this documentation
10、 package. This document will provide for 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 included in a protocol package. All supporting data and documentation will
11、be attached to this validation protocol when completed. 本文件包由上海宝钜准备。本文件将确定上海宝钜和永信药品工业（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。2.0PURPOSE目的The execution of this protocol will demonstrate and document that the PW System performs according to the manufacturers specifications and YUNG
12、 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。3.0BACKGROUND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（昆山）有限公司使用而特别采购的一套新设备。4.0INTRODUCTION介绍All instrument calibration, standardi
13、zation, or adjustment will be performed and documented for the measuring 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 no
14、t 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 pr
15、otocol or from specifications or any exceptional conditions encountered will 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, alo
16、ng with the corrective actions and their justifications, will be documented 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 t
17、he protocol, by their designee, or by another person holding an equivalent 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
18、in effect on the date of approval of the protocol, unless otherwise 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 Pharm
19、acopeiaUSP 32 美国药典 NIST - National Institute of Standards and TechnologyNIST 美国国家标准技术研究所 Draft SOP of the PW System纯化水系统的SOP草案6.0RESPONSIBLE PARTIES AND RESPONSIBILITIES责任方及其责任Shanghai Baoju Fluid Equipment Engineering Co., Ltd.上海宝钜流体设备工程有限公司. Writing, of this protocol.编写本文件 Review and approval of t
20、he original protocol.审核和批准原始文件 Review and approval of the completed protocol package审核和批准完成的文件包Engineering / Maintenance Responsibilities:工程/维护责任 Supply support and technical expertise 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, m
21、anuals, and drawings needed to generate and execute the protocol 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Manufacturing Responsibilities:生产责任 Execution of Qualification packages执行确认文件包 Supply all procedures, data, manuals, drawings, and documentation needed to generate and execute the protocol提供文件编写和执行时所需的所有程
22、序、数据、手册、图纸和文件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 preparation 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.审核和批
23、准完成的文件包7.0SYSTEM DESCRIPTION系统说明General Description总说明1) Production Capacity 产能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 system will meet the following criteria:纯化水系统将达到以下标
24、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 will be constructed of 316L stainless steel pip
25、e 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 distributes Purified Water to the use points listed bel
26、ow. 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M110色水罐三楼洗手三楼手消三楼洗手Pretreatment Unit预处理单元The Pretreatment Unit consists of the following components, lis
27、ted 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 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 i
28、n 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 i
29、s used to maintain water temperature at 80 when sterilizing the carbon filter。为了达到最佳净化性能，使用热交换器使水温保持在25oC 。在碳过滤器灭菌时，使用热交换器使水温保持在80，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, a
30、nd 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 regeneratio
31、n. 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 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
32、 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。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 agents, during period RO membrane cleaning process.在
33、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 anion resin and cation resin to remove the cation and a
34、nion 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混床中的阴阳离子.3）Mixed Bed Regeneration Pump混床再生泵The system
35、 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 following 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
36、微粒， 核子级树脂交换系统1) 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
37、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 Precision 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
38、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 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 operational qualification will be performed using the protocol a
39、ttachments. All pertinent information will be recorded on these forms. Copies of the forms may be made as necessary. 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 th
40、e system being qualified with Not Applicable (N/A) and provide an explanation where appropriate. Document any deviations or abnormalities observed during the execution of the protocol.进行操作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。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
41、行文件时发现的任何偏差或不正常的情况。NOTE:Any exceptions to this protocol must be fully investigated and documented. This OQ 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
42、 not invalidate the protocol studies. Quality 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OQ才可以接受，QA有权决定是否接受例外数据。9.0 ACCEPTANCE CRITERIA验收标准 Test Equipment and Materials - All test equipme
43、nt used during protocol execution must be documented. If the test equipment is not calibrated, a reason must be recorded and justified.检验设备和材料- 文件执行过程中的所有检验设备都必须有记录。如果检验设备没有校验，必须写明并说明理由。 All data forms required for execution of the protocol must be completely, accurately, and properly filled out. 执行
44、文件时所有必需的数据表都必须完整、准确，且正确填写。 All criteria specified on the data sheets must be met.符合数据表中指定的所有标准。 All validation tests outlined in the protocol attachments must be successfully executed with the results noted on the appropriate pages. All verifications must be answered “yes” or a protocol deviation mu
45、st be documented. Re-testing must be described and justified.文件附件指定的所有验证测试都必须成功的进行，并在相关页面上记录结果。所有的审核都必须回答“是”，否则记录为文件偏差。进行重新测试时必须进行记录，证明其合理性。 All deviations must have been corrected or an action plan for correction of the deviation(s) must have been developed所有的偏差必须纠正，或提出一个纠偏计划。Attachment 1 - Validat
46、ion Test Equipment and Materials附件1验证测试设备和材料List the instruments/equipment/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。Note: This sheet may be copied, if necessary.注：如果需要，该表可以复印。Page _ of _第_页 共_页Description说明Calibrated(Y/N)已校验（是/否）ID No./Serial No. .ID号系列号Calibration Date校验日期CalibrationDue Date校验到期日Copies of the most recent calibration reports fo
