gmp检查之sop纯化水监测

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1、Page:SOP#:Eff.Date:Supersedes:STANDARDOPERATINGPROCEDURE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM起草/修订人：Author日期：Date部门主管审查：Dept.HeadApproval日期：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。PUR

2、POSE:Thisdocumentdefinestheprocedureforroutinequalitymonitoringanddeviationdispositiononpurifiedwatersystemtoensurethepurifiedwaterqualitymeetstherequirement.范围：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:This

3、SOPisapplicabletotheroutinemonitoringonpurifiedwatersystem(includingpurifiedwatergeneratorsystem,usepointsandsamplingpoints)Duringthenon-routinemonitoringperiod(suchasvalidation,re-validationandspecialstudies),themonitoringwillbeconductedinaccordancewiththespecif

4、icprotocol.Theroutinemonitoringcanbepausedduringsuchnon-routinemonitoringperiod.参考文件：REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE记录/附件/题目FORMS/ATTACHMENTS/TITLE定义：N/ADEFINITIONS:规程：PROCEDURE:责任人操作RESPONSIBILITYACTION1.系统描述SYSTEMDESCRIPTION1.1纯化水系统由2部分组成：Purifiedwatersy

5、stemconsistsof2portions:责任人操作RESPONSIBILITYACTIONPage:SOP#:Eff.Date:Supersedes:STANDARDOPERATINGPROCEDURE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM1.1.1制备系统：为设备和必需的管路以制备并贮存纯化水Generatorsystem：Istheequipmentandpipingnecessarytoproduceandstorepurifiedwater.1

6、.1.2循环管路系统：将纯化水送至使用点并将剩余的纯化水返回贮罐的分配管路。Circulatingsystem:Isthedistributionpipingthatdeliversthepurifiedwatertothepoints-of-useandreturnstheexcesstothestoragetank.1.2纯化水系统中的使用点和取样点，见附件1。Thepoint-of-useandsamplingpointlocationsinthepurifiedwatersystempleaseseeAttach

7、ment1.2.日常监测ROUTINEMONITORING2.1监测点及监测频率Monitoringpointsandsamplingfrequency2.1.1循环管路Circulatingpipesystem2.1.1.1对于有4至7天的正常工作周，每周（至少每隔2～3天1次）取样监测2次。如果工作周为3天或更少，则每次取样1次。如果由于停产而不使用水，日常取样可不进行。Collectwatersamplestwiceperweek(atleastonceeverytwoorthreedays)fornormalwo

8、rkweeksoffourtosevendays.Iftheworkweekisthreedaysorless,collectsamplesonceperweek.Ifthewaterisnotbeingusedduetoashutdown,routinesamplingmaynotbeperformed.2.1.1