Author日期:Date部门主管审查::DateQA批准:ApprovedbyQA日期:Date分发:Distribution:QA、QC、工程QA,QC,Engineering目的:制订纯化水系统的日常质量监测及偏差处理规程,确保纯化水的质量符合要求。PURPOSE::适用于公司内纯化水系统(包括纯化水制备系统、纯化水使用点及取样点)的日常质量监测。在非日常监测(如验证、再验证以及要求的研究)期间,根据具体的监测方案进行;在此期间相关的日常监测暂停。SCOPE:ThisSOPisapplicabletotheroutinemonitoringonpurifiedwatersystem(includingpurifiedwatergeneratorsystem,usepointsandsamplingpoints)Duringthenon-routinemonitoringperiod(suchasvalidation,re-validationandspecialstudies),-:REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE记录/附件/题目FORMS/ATTACHMENTS/TITLE1-3002偏差调查附件1:纯化水系统中的使用点和取样点DeviationInvestigationsAttachment1:Point-of-useandsamplingpointlocationsinthepurifiedwatersystemF-02-014纯化水系统取样记录Purifiedwatersystemsamplinglogbook定义:N/ADEFINITIONS:规程:PROCEDURE::Purifiedwatersystemconsistsof2portions::包括相应的设备单元和管路。Generatorsystem::纯化水的循环分配管路。Pipeloop:,见附件1。Thepoint-of-
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