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。
| Department & Site 单位部门 | Signature & Date 签名与日期 |
Issued by 起草 | | |
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Reviewed by 审核 | | |
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异日图将好景 | | 由于近义词
Authorized by 批准 | | |
| 消防意识 | 电脑游戏英语 |
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| 快速抑制呕吐感 |
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Contents
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.
孙悟空的精神
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 ud to establish that the manufacturing facility Purified Water (PW) System has been installed and operates in accordance with the manufacturer’s design specifications, and tho 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.
四季感冒片说明书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 u in YUNG SHIN PHARM.IND.(KS)CO.,LTD. This water will be for general manufacturing and formulation u.
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
博鳌玉带滩
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, rvices, and components. All instrument calibration, standardization, or adjustment will be performed and documented for the measuring equipment ud during the execution of this protocol. Standards ud will be traceable to the National Institute of Standards and Technology (NIST). Other accepted standards will be ud 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。
