Data Integrity and Compliance With CGMP美国FDA发布数据完整性指导原则草案Word下载.docx
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Data Integrity and Compliance With CGMP美国FDA发布数据完整性指导原则草案Word下载.docx
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CenterforDrugEvaluationandResearch(CDER)
CenterforBiologicsEvaluationandResearch(CBER)
CenterforVeterinaryMedicine(CVM)
April2016
PharmaceuticalQuality/ManufacturingStandards(CGMP)
Additionalcopiesareavailablefrom:
OfficeofCommunications,DivisionofDrugInformation
CenterforDrugEvaluationandResearch
FoodandDrugAdministration
th
10001NewHampshireAve.,HillandaleBldg.,4Floor
SilverSpring,MD20993-0002
Phone:
855-543-3784or301-796-3400;
Fax:
301-431-6353
Email:
druginfo@fda.hhs.gov
http:
//www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
OfficeofCommunication,OutreachandDevelopment
CenterforBiologicsEvaluationandResearch
10903NewHampshireAve.,Bldg.71,Room3128
800-835-4709or240-402-8010
ocod@fda.hhs.gov
//www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
PolicyandRegulationsStaff,HFV-6
CenterforVeterinaryMedicine
7519StandishPlace,Rockville,MD20855
ContainsNonbindingRecommendations
Draft—NotforImplementation
TABLEOFCONTENTS
I.
INTRODUCTION.............................................................................................................1
BACKGROUND...............................................................................................................1
QUESTIONSANDANSWERS.......................................................................................2
PleaseclarifythefollowingtermsastheyrelatetoCGMPrecords:
.........................................2
II.
III.
1.
a.Whatis“dataintegrity”?
................................................................................................................2
b.Whatis“metadata”?
.......................................................................................................................3
c.Whatisan“audittrail”?
.................................................................................................................3
d.HowdoesFDAusetheterms“static”and“dynamic”astheyrelatetorecordformats?
.............3
e.HowdoesFDAusetheterm“backup”in§
211.68(b)?
..................................................................4
f.Whatarethe“systems”in“computerorrelatedsystems”in§
211.68?
........................................4
2.
3.
4.
5.
6.
7.
8.
9.
WhenisitpermissibletoexcludeCGMPdatafromdecisionmaking?
....................................4
Doeseachworkflowonourcomputersystemneedtobevalidated?
........................................4
HowshouldaccesstoCGMPcomputersystemsberestricted?
................................................5
WhyisFDAconcernedwiththeuseofsharedloginaccountsforcomputersystems?
...........6
Howshouldblankformsbecontrolled?
......................................................................................6
Howoftenshouldaudittrailsbereviewed?
.................................................................................6
Whoshouldreviewaudittrails?
...................................................................................................6
Canelectroniccopiesbeusedasaccuratereproductionsofpaperorelectronicrecords?
.....7
10.Isitacceptabletoretainpaperprintoutsorstaticrecordsinsteadoforiginalelectronic
recordsfromstand-alonecomputerizedlaboratoryinstruments,suchasanFT-IRinstrument?
.7
11.Canelectronicsignaturesbeusedinsteadofhandwrittensignaturesformasterproduction
andcontrolrecords?
...............................................................................................................................8
12.WhendoeselectronicdatabecomeaCGMPrecord?
................................................................8
13.WhyhastheFDAciteduseofactualsamplesduring“systemsuitability”ortest,prep,or
equilibrationrunsinwarningletters?
..................................................................................................9
14.Isitacceptabletoonlysavethefinalresultsfromreprocessedlaboratory
chromatography?
...................................................................................................................................9
15.Cananinternaltipregardingaqualityissue,suchaspotentialdatafalsification,behandled
informallyoutsideofthedocumentedCGMPqualitysystem?
..........................................................9
16.ShouldpersonnelbetrainedindetectingdataintegrityissuesaspartofaroutineCGMP
trainingprogram?
................................................................................................................................10
17.IstheFDAinvestigatorallowedtolookatmyelectronicrecords?
.........................................10
18.HowdoesFDArecommenddataintegrityproblemsidentifiedduringinspections,in
warningletters,orinotherregulatoryactionsbeaddressed?
.........................................................10
Draft—NotforImplementation
1
DataIntegrityandComplianceWithCGMP
GuidanceforIndustry1
2
3
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Thisdraftguidance,whenfinalized,willrepresentthecurrentthinkingoftheFoodandDrug
Administration(FDAorAgency)onthistopic.Itdoesnotestablishanyrightsforanypersonandisnot
bindingonFDAorthepublic.Youcanuseanalternativeapproachifitsatisfiestherequirementsofthe
applicablestatutesandregulations.Todiscussanalternativeapproach,contacttheFDAstaffresponsible
forthisguidanceaslistedonthetitlepage.
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INTRODUCTION
Thepurposeofthisguidanceistoclarifytheroleofdataintegrityincurrentgoodmanufacturing
practice(CGMP)fordrugs,asrequiredin21CFRparts210,211,and212.Part210covers
CurrentGoodManufacturingPracticeinManufacturing,Processing,Packing,orHoldingof
Drugs;
General;
part211coversCurrentGoodManufacturingPracticeforFinished
20Pharmaceuticals;
andpart212coversCurrentGoodManufacturingPracticeforPositron
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EmissionTomographyDrugs.ThisguidanceprovidestheAgency’scurrentthinkingonthe
creationandhandlingofdatainaccordancewithCGMPrequirements.
FDAexpectsthatdatabereliableandaccurate(seethe“Background”section).CGMP
regulationsandguidanceallowforflexibleandrisk-basedstrategiestopreventanddetectdata
integrityissues.Firmsshouldimplementmeaningfulandeffectivestrategiestomanagetheirdata
integrityrisksbasedupontheirprocessunderstandingandknowledgemanagementof
technologiesandbusinessmodels.
Ingeneral,FDA’sguidancedocumentsdonotestablishlegallyenforceableresponsibilities.
Instead,guidancesdescribetheAgency’scurrentthinkingonatopicandshouldbeviewedonly
asrecommendations,unlessspecificregulatoryorstatutoryrequirementsarecited.Theuseof
thewordshouldinAgencyguidancesmeansthatsomethingissuggestedorrecommended,but
34notrequired.
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BACKGROUND
Inrecentyears,FDAhasincreasinglyobservedCGMPviolationsinvolvingdataintegrityduring
CGMPinspections.Thisistroublingbecauseensuringdataintegrityisanimportantcomponent
ofindustry’sresponsibilitytoensurethesafety,efficacy,andqualityofdrugs,andofFDA’s
41abilitytoprotectthepublichealth.Thesedataintegrity-relatedCGMPviolationshaveledto
ThisguidancehasbeenpreparedbytheOfficeofPharmaceuticalQualityandtheOfficeofComplianceinthe
CenterforDrugEvaluationandResearchincooperationwiththeCenterforBiologicsEvaluationandResearch,the
CenterforVeterinaryMedicine,andtheOfficeofRegulatoryAffairsattheFoodandDrugAdministration.
1
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numerousregulatoryactions,includingwarningletters,importalerts,andconsentdecrees.The
underlyingpremisein§
§
210.1and212.2isthatCGMPsetsforthminimumrequirementsto
44assurethatdrugsmeetthestandardsoftheFederalFood,Drug,andCosmeticAct(FD&
C
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