安装确认IQ(中英文)

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 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。

Contents
目录
1.0 SCOPE 范围 (4)
2.0PURPOSE 目的 (4)
3.0BACKGROUND- 背景 (4)
4.0INTRODUCTION 介绍 (4)
5.0REFERENCES 参考书目 (5)
6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任 (6)
7.0SYSTEM DESCRIPTION 系统说明 (7)
G ENERAL D ESCRIPTION 总说明 (7)
P RETREATMENT U NIT 预处理单元 (8)
R EVERSE O SMOSIS (RO)S YSTEM 反渗透(RO)系统 (9)
M IXED B ED S YSTEM 混床系统 (9)
M ONITOR AND C ONTROL S YSTEM 监视和控制系统 (10)
8.0TESTING PROCEDURES 检验程序 (10)
9.0ACCEPTANCE CRITERIA 验收标准 (12)
A TTACHMENT 1-V ALIDATION T EST E QUIPMENT AND M ATERIALS 附件1—验证测试设备和材料 (13)
A TTACHMENT 2-S PECIFICATION AND P URCHASE O RDER V ERIFICATION 附件2—规范和采购单确认 (14)
A TTACHMENT 3-E NGINEERING D RAWING L IST 附件３—工程图纸清单 (15)
A TTACHMENT 4-S TANDARD O PERATING P ROCEDURES L IST 附件4—标准操作程序清单 (16)
A TTACHMENT 5-O PERATION AND M AINTENANCE M ANUAL L IST 附件5—操作和维护手册清单 (17)
A TTACHMENT 6-M AJOR C OMPONENT L ABELING L IST 附件6—主要部件标签清单 (18)
A TTACHMENT 7-C RITICAL I NSTRUMENT L IST 附件7—关键仪器清单 (19)
A TTACHMENT 8-N ON-C RITICAL I NSTRUMENT L IST 附件8—非关键仪器清单 (20)
A TTACHMENT 9-S PARE P ARTS L IST 附件9—备件清单 (21)
A TTACHMENT 10-I NSTALLATION P ROCEDURES V ERIFICATION D ATA S HEET 附件10—安装程序确认数据表 (22)
A TTACHMENT 11-U TILITY D ATA S HEET:E LECTRICAL 附件11—公用工程数据表：电 (23)
A TTACHMENT 12--U TILITY D ATA S HEET:C OMPRESSED A IR 附件12—公用工程数据表：压缩空气 (24)
A TTACHMENT 13--U TILITY D ATA S HEET:C ITY W ATER 附件13—公用工程数据表：自来水 (25)
A TTACHMENT 14--U TILITY D ATA S HEET:W ASTE/D RAIN 附件14—公用工程数据表：废水/排水 (26)
A TTACHMENT 15--PW D ISTRIBUTION L OOP D ATA S HEET 附件15—纯化水循环回路数据表 (27)
A TTACHMENT 16–C HEMICAL T ANK AND D OSING P UMP D ATA S HEET 附件16—化学罐和计量泵数据表 (28)
A TTACHMENT 17–S AND F ILTER D ATA S HEET 附件17—砂滤过滤器表 (29)
A TTACHMENT 18--H EAT E XCHANGER D ATA S HEET (P RETREATMENT)附件18—热交换器数据表（预处理） (30)
A TTACHMENT 19--A CTIVATED C ARBON F ILTER D ATA S HEET 附件19—活性炭过滤器数据表 (31)
A TTACHMENT 20–S TERILIZATION P UMP D ATA S HEET 附件20—灭菌循环泵数据表 (32)
A TTACHMENT 21--S OFTENER D ATA S HEET 附件21—软化器数据表 (33)
A TTACHMENT 22--P RECISION F ILTER D ATA S HEET 附件22—精密过滤器数据表 (34)
A TTACHMENT 23–B OOSTER P UMPS D ATA S HEET 附件23—增压泵数据表 (35)
A TTACHMENT 24–RO C LEANING T ANK AND P UMP D ATA S HEET 附件24–RO药洗箱和泵数据表 (36)
A TTACHMENT 25--R EVERSE O SMOSIS (RO)S YSTEM D ATA S HEET 附件25--反渗透(RO)系统数据表 (37)
A TTACHMENT 26--I NTERMEDIATE S TORAGE T ANK D ATA S HEET 附件26--中间储罐数据表 (38)
A TTACHMENT 27--M IXED B ED S YSTEM D ATA S HEET 附件27--混床系统数据表 (39)
A TTACHMENT 28–M IXED B ED R EGENERATION T ANKS AND P UMPS D ATA S HEET 附件28–混床再生酸碱箱和泵数据表 (40)
A TTACHMENT 29--M ICRO F ILTER D ATA S HEET 附件29—微滤器数据表 (41)
A TTACHMENT 30--4T D EIONIZED W ATER S TORAGE T ANK D ATA S HEET 附件30–4吨去离子水储罐数据表 (42)
A TTACHMENT 31--1T PW S TORAGE T ANK D ATA S HEET 附件31–1吨纯水储罐数据表 (43)
A TTACHMENT 32-S TORAGE T ANK S PRAY B ALL D ATA S HEET 附件32–储罐喷淋球数据表 (44)
A TTACHMENT 33--UV S ANITIZER U NIT D ATA S HEET 附件33--UV灭菌器数据表 (45)
A TTACHMENT 34–R ESIN T ANK D ATA S HEET 附件34—核子级树脂罐表 (46)
A TTACHMENT 35--2T PW S TORAGE T ANK D ATA S HEET 附件35–2吨纯水储罐数据表 (47)
A TTACHMENT 36--300L PW S TORAGE T ANK D ATA S HEET 附件36–300L纯水储罐数据表 (48)
A TTACHMENT 37--H EAT E XCHANGER L OOP B UFFER T ANK D ATA S HEET 附件37–热交换器循环缓冲罐数据表 (49)
A TTACHMENT 38--V ALVE D ATA S HEET 附件38--阀门数据表 (50)
A TTACHMENT 39-S AMPLE P ORTS D ATA S HEETS 附件39-取样口数据表 (51)
A TTACHMENT 40-S IGNATURE V ERIFICATION L IST 附件40-签名确认清单 (52)
A TTACHMENT 41--P ROTOCOL D EVIATION L OG 附件41--文件偏差日志 (53)
A TTACHMENT 42--P ROTOCOL D EVIATION R ECORD 附件42--文件偏差记录 (54)
A TTACHMENT 43--P ROTOCOL E XECUTION A PPROVAL S IGNATURES D ATA S HEET 附件43--文件执行批准签名数据表 (55)
1.0 SCOPE
范围
This Installation Qualification (IQ) study will be performed on the Purified Water (PW) System located in YUNG SHIN PHARM.IND.(KS)CO.,LTD.
本次安装鉴定 (IQ)将会在位于永信药品工业（昆山）有限公司的纯化水（PW）系统上实施。

This protocol describes the equipment, test procedures, specifications, documents, and references used to establish that the manufacturing facility Purified Water (PW) System has been installed and operates in accordance with the manufacturer’s design specifications, and those of YUNG SHIN PHARM.IND.(KS)CO.,LTD. Company LTD. The facility shall be referred to as YUNG SHIN PHARM.IND.(KS)CO.,LTD.throughout the remainder of this document. The unit will be referred to as the “PW system” throughout this document.
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(PW)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。

本文件下文中工厂指的是永信药品工业（昆山）有限公司，单元指的是“纯化水系统”。

This documentation package has been prepared by Shanghai Baoju personnel. 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 be attached to this validation protocol when completed.
本文件包由纳盛机电准备。

本文件将定义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 system has been installed and operates 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已经按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 manufacturing facility PW system is designed to provide PW grade water for manufacturing use in YUNG SHIN PHARM.IND.(KS)CO.,LTD. This water will be for general manufacturing and formulation use.
生产设备纯化水系统为永信药品工业（昆山）有限公司提供纯化水级别的生产用水。

这些水将用于一般生产和配制使用。

4.0 INTRODUCTION
介绍
This Installation Qualification (IQ) protocol is specific for the manufacturing facility PW system located in YUNG SHIN PHARM.IND.(KS)CO.,LTD.
本安装确认文件（IQ）文件专用于位于永信药品工业（昆山）有限公司的生产用纯化水系统。

Installation checks will be performed to verify and document that the equipment is installed with the proper supporting utilities, services, and components. All instrument calibration, standardization, 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 not exist.
进行安装检查，以确认和记录设备已经与相关的公用工程、服务和部件连接。

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。

Documentation associated with the system, such as operator’s or owner’s manuals, system drawings, purchase specifications, cut sheets, component specification sheets, materials listings, installation diagrams, component plans, and other data, etc., will be reviewed in this report.Copies of these will be included in this report or the storage location of the documentation will be recorded.
在本报告中审核与系统有关的文件，如操作者或所有者手册、系统图纸、采购要求、部件规范表、材料清单、安装图纸、平面布局图和其他的数据，等等。

该报告包括有他们的复印件，或记录了文档储存地点。

Any deviations from the protocol 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, along 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 the 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 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 Pharmaceuticals
21 CFR 第 210和211部分：联邦条例法典，成品药cGMP
•USP 28 - United States Pharmacopeia,
USP 28 –美国药典
•NIST - National Institute of Standards and Technology
NIST –美国国家标准技术研究所
•Draft SOP of the PW System
纯化水系统的SOP
6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES
责任方及其责任
Shanghai Baoju Fluid Equipment Engineering Co., Ltd.
纳盛机电流体设备工程有限公司：.
•Writing, of this protocol.
编写本文件
•Review and approval of the original protocol.
审核和批准原始文件
•Review and approval of the completed protocol package
审核和批准完成的文件包
Engineering / Maintenance Responsibilities:
工程/维护责任：
•Execution of Qualification packages.
执行确认文件包
•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, manuals, 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
•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需要的支持
•Review and approval of the original protocol.
审核和批准原始文件
•Review and approval of the completed protocol package
审核和批准完成的文件
7.0 SYSTEM 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准：
PW quality standards as defined in USP 28 Water for Pharmaceutical Purposes
USP 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 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 distributes 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
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, 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 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℃ 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, 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 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。

1) Booster Pump 增压泵
A 4KW pumps are used to pressurize the RO system.
用一个4kW 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 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 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微粒，
核子级树脂交换系统
Resin Exchange System
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 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。

本系统流程图如下:
8.0
TESTING PROCEDURES 检验程序
The Installation qualification will be performed using the protocol attachments listed in Section 10. 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 the
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.
借助第10部分中列出的文件附件进行安装确认。

把所有有关信息记录在这些表格中。

必要时也可复印表格。

执行文件的同时记录结果和数据。

未使用的地方用单线划去，签名，并注明日期。

用不适用（N/A）标明不适用系统的地方，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 this protocol must be fully investigated and documented. This IQ 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. 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IQ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 equipment used during protocol execution must be documented. If the test equipment is not calibrated, a reason must be recorded and justified.
验证设备和材料- 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。

•Drawings and P&IDs - All drawing must be current
图纸和P&ID图—所有的图纸必须都是最新的图纸
•Utility Verification - All utilities must be verified to meet the manufacturer's specifications.
公用工程验证–必须确认所有的公用工程都达到厂商的规范。

•Materials in Product Contact - Materials in product contact must be as designed and/or appropriate for the process and product. Any deviation in materials must be justified.
与产品接触的材料- 与产品接触的材料必须符合设计要求和/或适合于工艺和产品。

材料有任何偏
差都必须调整。

•Standard Operational Procedures – All Standard Operational Procedures will be in draft format.
标准操作程序–所有的标准操作程序都有草案。

•Critical and Non Critical Equipment Lists - All critical instruments must be currently in calibration.
关键和非关键设备清单- 所有的关键仪器都必须处于最近的校验有效期中。

•Spare Parts -A spare parts list must be available for the system and its associated pieces of equipment.
备件–系统及设备的相关零件必须有备件清单。

•Components Labeling - All instruments and critical components must be identified.
部件标签–所有仪器和关键部件都已经识别。

•Installation/Startup Procedures - All system installation and startup procedures must have been properly executed and documented.
安装/启动程序–准确的执行和记录所有的系统安装和启动程序
•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 criteria specified on the data sheets must be met.
符合数据表中指定的所有标准。

•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 - Validation 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
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:
Attachment 2 - Specification and Purchase Order Verification
附件2—规范和采购单确认
List the specifications and purchase orders associated with the equipment and/or system being qualified.
列出与需要确认的设备和/或系统有关的规格和采购单
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
Acceptance Criteria:All associated purchase orders with this equipment will be attached.
验收标准：所有与该设备有关的采购单都附在文件之后。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 3 - Engineering Drawing List
附件３—工程图纸清单
Copies of the latest revisions are attached to the Protocol
最新的修改版本附在文件后。

Signature of Shanghai Baoju or YSP KS personnel confirms that drawing has been finalized
由纳盛机电或昆山永信公司人员签名，确认图纸完成。

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
Acceptance Criteria:All drawing must be current.
验收标准：所有图纸都是最新的。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 4 - Standard Operating Procedures List
附件4—标准操作程序清单
Identify operational procedures for the system and/or equipment and list below.
确认系统和/或设备的操作程序，在下面列出。

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
Acceptance Criteria:All Standard Operational Procedures will be in a draft format.
验收标准：所有的标准操作程序都已有草案。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 5 - Operation and Maintenance Manual List
附件5—操作和维护手册清单
Equipment manuals may include installation, start-up, operation, and troubleshooting procedures. List manuals below and note the location where they are kept.
设备手册包括安装、启动、操作和故障处理程序。

在下面列出手册，注明其存放地点。

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
Acceptance Criteria:List all Operational and Maintenance Manuals associated to this equipment.
验收标准：列出与该设备有关的所有操作和维护手册。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 6 - Major Component Labeling List
附件6 —主要部件标签清单
All major components, sensors, transmitters, gauges, valves and controlled devices must be listed.
列出所有的主要部件、传感器、变送器、仪表、阀门和控制设备。

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
Acceptance Criteria:All major components must be identified.
验收标准：所有主要的部件都已经识别。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 7 - Critical Instrument List
附件7—关键仪器清单
Instruments are classified as "critical" or "non-critical". Critical instruments are defined as those whose performance directly affects the quality of the process utility or product produced by the system. An instrument must be defined critical if it provides data that is recorded in a manufacturing record, provides a reading by which product quality decisions are made, or provides data by which product specifications are developed. Non-critical instruments are those provided for information or convenience only. All instruments will be calibrated before the execution of the OQ protocol.
仪器分为“关键”和“非关键”两种。

关键仪器指的是其性能直接影响工艺效果或系统产品质量的仪器。

一个仪器，如果它提供的数据被记录在生产记录中，或者它显示的读数是产品质量的决定因素，或者它提供的数据是起草产品规范的依据，那么它就应该属于关键仪器。

非关键仪器只提供信息或只是为了便利。

执行OQ前所有的仪器必须已校验。

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
Acceptance Criteria:All critical instruments must be currently in calibration.
验收标准：所有的关键仪器都必须处于最近的校验有效期中。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 8 - Non-Critical Instrument List
附件8—非关键仪器清单
Instruments are classified as "critical" or "non-critical". Critical instruments are defined as those whose performance directly affects the quality of the process utility or product produced by the system. An instrument must be defined critical if it provides data that is recorded in a manufacturing record, provides a reading by which product quality decisions are made, or provides data by which product specifications are developed. Non-critical instruments are those provided for information or convenience only. All instruments will be calibrated before the execution of the OQ protocol.
仪器分为“关键”和“非关键”两种。

关键仪器指的是其性能直接影响工艺效果或系统产品质量的仪器。

一个仪器，如果它提供的数据被记录在生产记录中，或者它显示的读数是产品质量的决定因素，或者它提供的数据是起草产品规范的依据，那么它就应该属于关键仪器。

非关键仪器只提供信息或只是为了便利。

执行OQ前所有的仪器必须已校验。

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
Acceptance Criteria: All non-critical instruments have been listed in the above table.
验收标准：所有非关键仪器都已经在上表列出。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 9 - Spare Parts List
附件9—备件清单
Generate or attach an itemized list of the manufacturer recommended spare parts. Attachments may be copies of spare parts lists provided in individual equipment operation or maintenance manuals. Spare parts are items used to replace worn-out or broken items.
在备件清单中逐项列出生产商推荐的备件。

可以用单个设备的操作或维护手册上的备件清单的复印件作为附件。

备件指的是用来代替磨损或破坏部件的部件。

If a manufacturer recommended spare parts listing is available it may be attached to this datasheet.
如果有生产商推荐的备件清单，可以附上。

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
Acceptance Criteria:A spare parts list must be available for the system and its associated pieces of equipment.
验收标准：系统和设备都有备件清单。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 10 - Installation Procedures Verification Data Sheet
附件10—安装程序确认数据表
Acceptance Criteria:All system installation and startup procedures must have been properly executed and documented.
验收标准：所有的系统安装和启动程序都已经正确执行和记录。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 11 - Utility Data Sheet: Electrical
附件11—公用工程数据表：电
Field Notes:现场注释：
Acceptance Criteria:All utilities must be verified to meet the manufacturer's specifications.
验收标准：审核所有的公用工程，确认符合生产商规范。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Compiled By编辑: _______________________________________ Date日期: _____________________
Attachment 12 -- Utility Data Sheet: Compressed Air
附件12—公用工程数据表：压缩空气
Field Notes:现场注释
Acceptance Criteria All blanks must be completed and all yes/no questions must be answered with “yes” or explained.
验收标准所有的空格都填好，所有的是/否问题的回答均为“是”，答“否”的问题都给出了解释。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 13 -- Utility Data Sheet: City Water
附件13—公用工程数据表：自来水
Field Notes:现场注释:
Acceptance Criteria: 验收标准:
All blanks must be completed and all yes/no questions must be answered with “yes” or explained.所有的空格都填好，所有的是/否问题的回答均为“是”，答“否”的问题都给出了解释。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 14 -- Utility Data Sheet: Waste/Drain
附件14—公用工程数据表：废水/排水
Field Notes: 现场注释:
Acceptance Criteria: 验收标准:
All blanks must be completed and all yes/no questions must be answered with “yes” or explained.所有的空格都填好，所有的是/否问题的回答均为“是”，答“否”的问题都给出了解释。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 15 -- PW Distribution Loop Data Sheet
附件15—纯化水循环回路数据表
Acceptance Criteria: 验收标准:
All blanks must be completed and all yes/no questions must be answered with “yes” or explained. Copies of all weld certifications will be attached.
所有的空格都填好，所有的是/否问题的回答均为“是”，答“否”的问题都给出了解释。

附上所有的焊接证书。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:
Attachment 16– Chemical Tank and Dosing Pump Data Sheet
附件16—化学罐和计量泵数据表
Page _____ of _____第 _____页共_____ 页
Field Notes: 现场注释:
Acceptance Criteria: 验收标准:
All blanks must be completed and all yes/no questions must be answered with “yes” or explained.所有的空格都填好，所有的是/否问题的回答均为“是”，答“否”的问题都给出了解释。

Meets Acceptance Criteria符合验收标准: Yes 是( ) No否 ( )
Verified by校验人: Date日期:。