合规性评价 29 EMEA(CPMP) NOTE FOR GUIDANCE ON QUALITY OF WATER FOR PHARMACEUTICAL USE 制药用水质量指南 wr（无不符合）.docxVIP

文档名称：质量管理法律法规和其他要求管理制度文档编号：QA-M5.4.4-001版本号：A\03起草人：倪静发布日期：2012-7-2文件状态：发布的;待创建新版[第PAGE4页\共1页]

质量管理法律法规和其他要求文件合规性评价表(部门自评)

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文件名称：NOTEFORGUIDANCEONQUALITYOFWATERFOR

PHARMACEUTICALUSE

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4.1

PotableWaterisnotcoveredbyapharmacopoeialmonographbutmustcomplywiththeregulationsonwaterlaiddownbythecompetentauthority.Testingshouldbecarriedoutatthemanufacturingsitetoconfirmthequalityofthewater.Potablewatermaybeusedinchemicalsynthesisandintheearlystagesofcleaningpharmaceuticalmanufacturingequipmentunlesstherearespecifictechnicalorqualityrequirementsforhighergradesofwater.Itistheprescribedsourcefeedwaterfortheproductionofpharmacopoeialgrade

waters.

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无

4.2

ControlofthechemicalpurityofWFIpresentsfewmajorproblems.Thecriticalissueisthatofensuringconsistentmicrobiologicalqualitywithrespecttoremovalofbacteriaandbacterialendotoxins.Distillationhasalonghistoryofreliableperformanceandcanbe

validatedasaunitoperation,henceitcurrentlyremainstheonlyofficialmethodforWFI.

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WFIinbulkisobtainedfromwaterthatcomplieswiththeregulationonwaterintendedforhumanconsumptionlaiddownbythecompetentauthority,orfrompurifiedwater,by

distillationinanapparatusofwhichthepartsincontactwiththewaterareofneutralglass,quartzorsuitablemetalandwhichisfittedwithaneffectivedevicetopre