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fda qc实验室检查指南（英文版）.doc

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fda_qc实验室检查指南（英文版）.docGUIDETOINSPECTIONSOFPHARMACEUTICALQUALITYCONTROLLABORATORIESNote:,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyperson(s).INTRODUCTIONThepharmaceuticalqualitycontrollaboratoryservesoneofthemostimportantfunctionsinpharmaceuticalproductionandcontroLAsignificantportionoftheCGMPregulations(21CFR211)-Thisinspectionguidesupplementsotherinspectionalinformalioncontainedinotheragencyinspectionalguidancedocuments--approvalNDA/DA/-,prehensiveevaluationofthelaboratory"scompliancewithCGMP',--thespecificmethodologywhichwillbeusedtotestanewproduct--acompleteassessmentoflaboratory"sconformancewithGMP's--,plex,highlytechnicalandspecializedtestingequipment,proceduresanddatamanipulations,・Nevertheless,weexpectinvestigators,-,Pre-ApprovalInspections/1nvestigations・RelevantsectionsoftheNDAorANDAshouldbereviewedpriortotheinspection;butiftheapplicationisnotavailablefromanyothersourc

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