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1、GUIDETOINSPECTIONSOFSTERILEDRUGSUBSTANCEMANUFACTURERSFDA无菌原料药检查指南Note:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).注：本文件是FDA现场检查官和其他FDA人员的参考资料。本文件并不束缚FDA，也不赋予任何人任何权利、特
2、权、好处以便获得赦免。Oneofthemoredifficultprocessestoinspectandonewhichhaspresentedconsiderableproblemsovertheyearsisthatofthemanufactureofsterilebulkdrugsubstances.Withinthepastseveralyears,therehavebeenanumberofbatchesofsterilebulkdrugsubstancesfromdifferentmanufacturerswhichexhibitedmicrobiologicalc
3、ontamination.Onemanufacturerhadapproximately100batchescontaminatedina6monthtimeperiod.Anotherhadapproximately25batchescontaminatedinasimilarperiod.Othermanufacturershavehadrecallsduetothelackofassuranceofsterility.AlthoughtheInspectionGuideforBulkDrugSubstancesprovidessomedirectionfortheinspe
4、ctionofthesterilebulkdrugsubstance,itdoesnotprovidethedetaileddirectionneeded.在过去多年中，现场检查最难的，也是出现问题最多的领域就是无菌原料药的制造。在过去几年中，有数批来自不同制造商的无菌原料药出现了微生物污染。一个制造商在6个月中有100批产品有污染。另一个在相同的时间内出现了25批污染。其它一些供应商由于缺少无菌保证而召回了产品。虽然大宗原料药的现场检查指南在对无菌原料药的检查上提供了一些指导，但它未能提供所需要的详细指导。I.INTRODUCTION简介Inthemanufactureofth
5、esterilebulkpowders,itisimportanttorecognizethatthereisnofurtherprocessingofthefinishedsterilebulkpowdertoremovecontaminantsorimpuritiessuchasparticulates,endotoxinsanddegradants.在大宗无菌粉的制造中，认识到下面一点很重要，即最终无菌粉生产出来之后，再也没有别的程序来去除微粒、内毒素和降解物。Aswithotherinspections,anyrejectedbatches,alongwiththevar
6、iousreasonsforrejection,shouldbeidentifiedearlyintheinspectiontoprovidedirectionfortheinvestigator.Forexample,listsofbatchesrejectedand/orretestedoveraperiodoftimeshouldbeobtainedfromthemanufacturertoprovidedirectionforcoveragetobegiventospecificprocessesorsystems.Becausesomeoftheactualsteril
7、ebulkoperationsmaynotbeseen,andbecauseofthecomplexityoftheprocess,itisparticularlyimportanttoreviewreportsandsummaries,suchasvalidationstudies,rejectlists,EnvironmentalMonitoringSummaryReports,QAInvestigationLogs,etc.Thesesystemsandothersared
