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ID:12993174
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页数:8页
时间:2018-07-20
《gmp检查之sop纯化水监测》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
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
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