Data-Integrity-and-Compliance-With-CGMP(美国FDA发布数据完

DataIntegrityandComplianceWithCGMPGuidanceforIndustryDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocument,contact(CDER)KarenTakahashi301-796-3191;(CBER)OfficeofCommunication,OutreachandDevelopment,800-835-4709or240-402-8010;or(CVM)JonathanBray240-402-5623.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)April2016PharmaceuticalQuality/ManufacturingStandards(CGMP)DataIntegrityandComplianceWithCGMPGuidanceforIndustryAdditionalcopiesareavailablefrom:OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministrationth10001NewHampshireAve.,HillandaleBldg.,4FloorSilverSpring,MD20993-0002Phone:[phone]or301-796-3400;Fax:[phone]Email:[e-mail]:800-835-4709or240-402-8010Email:[e-mail](CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)April2016PharmaceuticalQuality/ManufacturingStandards(CGMP)ContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1BACKGROUND...............................................................................................................1QUESTIONSANDANSWERS.......................................................................................2PleaseclarifythefollowingtermsastheyrelatetoCGMPrecords:.........................................2II.III.1.a.Whatis“dataintegrity”?................................................................................................................2b.Whatis“metadata”?.......................................................................................................................3c.Whatisan“audittrail”?.................................................................................................................3d.HowdoesFDAusetheterms“static”and“dynamic”astheyrelatetorecordformats?.............3e.HowdoesFDAusetheterm“backup”in§211.68(b)?..................................................................4f.Whatarethe“systems”in“computerorrelatedsystems”in§211.68?........................................42.3.4.5.6.7.8.9.WhenisitpermissibletoexcludeCGMPdatafromdecisionmaking?....................................4Doeseachworkflowonourcomputersystemneedtobevalidated?........................................4HowshouldaccesstoCGMPcomputersystemsberestricted?................................................5WhyisFDAconcernedwiththeuseofsharedloginaccountsforcomputersystems?...........6Howshouldblankformsbecontrolled?......................................................................................6Howoftenshouldaudittrailsbereviewed?.................................................................................6Whoshouldreviewaudittrails?...................................................................................................6Canelectroniccopiesbeusedasaccuratereproductionsofpaperorelectronicrecords?.....710.Isitacceptabletoretainpaperprintoutsorstaticrecordsinsteadoforiginalelectronicrecordsfromstand-alonecomputerizedlaboratoryinstruments,suchasanFT-IRinstrument?.711.Canelectronicsignaturesbeusedinsteadofhandwrittensignaturesformasterproductionandcontrolrecords?...............................................................................................................................812.WhendoeselectronicdatabecomeaCGMPrecord?................................................................813.WhyhastheFDAciteduseofactualsamplesduring“systemsuitability”ortest,prep,orequilibrationrunsinwarningletters?..................................................................................................914.Isitacceptabletoonlysavethefinalresultsfromreprocessedlaboratorychromatography?.....