FDA指南 混合均匀性接受标准.pdf

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1、GuidanceforIndustryPowderBlendsandFinishedDosageUnits—StratifiedIn-ProcessDosageUnitSamplingandAssessmentDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin6

2、0daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstoDocketsManagementBranch(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.Allcommentsshouldbeidentifiedwiththedocke

3、tnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.ForquestionsregardingthisdraftdocumentcontactJonE.Clark,301-594-5613orMikeGavini,301-827-9053.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluatio

4、nandResearch(CDER)October2003PharmaceuticalCGMPsG:5831dft.doc10/27/03GuidanceforIndustryPowderBlendsandFinishedDosageUnits—StratifiedIn-ProcessDosageUnitSamplingandAssessmentAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofD

5、rugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573http://www.fda.gov/cder/guidance/index.htmU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEva

6、luationandResearch(CDER)OfficeofPharmaceuticalScience(OPS)OfficeofCompliance(OC)October2003PharmaceuticalCGMPsG:5831dft.doc10/27/03ContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION...............................

7、..................................................................................1II.BACKGROUND...................................................................................................................1III.SCOPE..............................

8、.....................................................................................................2IV.CORRELATIONOFIN-PROCESSSTRATIFIEDSAMPLINGWITHPOWDERMIXANDFINISHEDPRODUCT..................................................................