仪器设备流程..docx

SOP审核和批准 SOP Review and Approval职责Responsibility签名Signature日期Date打印名Printed Name职位Title起草人Created by 分析主任Analytical Director复核Reviewed by分析副主任Analytical Associate Director 批准人Approved by 副总经理Vice President批准人Approved byQA经理QA Manager目的Purpose该规程用于系统性地管理分析实验室内的分析仪器，确保仪器性能满足规定要求。This document is used to systematically manage analytical instrument/equipment within ARD laboratory to ensure equipment performance meet the specified requirement. 范围Scope本程序适用于XXX有限公司分析实验室所有分析仪器。.职责Responsibility操作人 Operator负责按照SOP和操作手册正确操作仪器。Be responsible for operating the instrument/equipment correctly in accordance with SOP and operation manual for each instrument/equipment.负责根据良好文件规范GDP要求，填写仪器记录。Be responsible for maintaining record in accordance with good documentation practices.仪器管理员 Instrument Equipment Administrator负责该规程的起草、修订。Be responsible for drafting and revising this SOP.负责按照文件要求对仪器进行管理。Be responsible for instrument/equipment management in accordance with this SOP.质量管理专员 QA负责文件执行符合性检查。Be responsible for compliance inspection.简写和定义Abbreviations Definitions序号S. No.简写ABBREVIATIONS定义DEFINITIONS4.1AIQ 分析仪器确认Analytical Instrument Qualification 4.2DQ设计确认（DQ）是以文本记录的活动汇总，基于仪器预定用途，规定了仪器的功能与操作标准和提供商的选取标准。Design qualification (DQ) is the documented collection of activities that define the functional and operational specifications of the instrument and criteria for the selection of the vendor, based on the intended purpose of the instrument.4.3IQ安装确认（IQ）是以文本记录的必要的活动汇总，确认仪器按照设计和规定进行交付，并正确安装在所选的适合的环境中。Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument.4.4OQ运行确认是以文本记录的必要的活动汇总，证明仪器设备能够根据操作标准在所选环境中正常运行。Operational qualification (OQ) is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the