FDA工艺验证指南的正式版本

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2019-10-02

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GuidanceforIndustryProcessValidation:GeneralPrinciplesandPracticesU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1GuidanceforIndustryProcessValidation:GeneralPrinciplesandPracticesAdditionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room220110903NewHampshireAve.SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.gov(Tel)800-835-4709or301-827-1800(Tel)240-276-9300 U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1ContainsNonbindingRecommendationsTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................3A.ProcessValidationandDrugQuality..........................................................................................3B.ApproachtoProcessValidation...................................................................................................4III.STATUTORYANDREGULATORYREQUIREMENTSFORPROCESSVALIDATION...................................................................................................................5IV.RECOMMENDATIONS..................................................................................................7A.GeneralConsiderationsforProcessValidation..........................................................................7B.Stage1―ProcessDesign..............................................................................................................81.BuildingandCapturingProcessKnowledgeandUnderstanding...................................................82.EstablishingaStrategyforProcessControl....................................................................................9C.Stage2―ProcessQualification.................................................................................................101.DesignofaFacilityandQualificationofUtilitiesandEquipment...............................................102.ProcessPerformanceQualification...............................................................................................113.PPQProtocol.................................................................................................................................124.PPQProtocolExecutionandReport.............................................................................................13D.Stage3―ContinuedProcessVerification................................................................................14V.CONCURRENTRELEASEOFPPQBATCHES......................................................16VI.DOCUMENTATION......................................................................................................17VII.ANALYTICALMETHODOLOGY..............................................................................17GLOSSARY.................................................................................................................................18REFERENCES............................................................................................................................19iGuidanceforIndustry1ProcessValidation:GeneralPrinciplesandPracticesThisguidancerepresentstheFoodandDrugAdministration’s(FDA’s)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.I.INTRODUCTIONThisguidanceoutlinesthegeneralprinciplesandapproachesthatFDAconsidersappropriateelementsofprocessvalidationforthemanufactureofhumanandanimaldrugandbiologicalproducts,includingactivepharmaceuticalingredients(APIsordrugsubstances),collectivelyreferredtointhisguidanceasdrugsorproducts.Thisguidanceincorporatesprinciplesandapproachesthatallmanufacturerscanusetovalida