Code of Federal Regulations.docx

Code of Federal Regulations.docx

《Code of Federal Regulations.docx》由会员分享，可在线阅读，更多相关《Code of Federal Regulations.docx（36页珍藏版）》请在冰豆网上搜索。

CodeofFederalRegulations

[CodeofFederalRegulations]

[Title21,Volume4]

[RevisedasofApril1,2004]

[CITE:

21CFR211]

TITLE21--FOODANDDRUGS

SUBCHAPTERC-DRUGS:

GENERAL

PART211

CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS

SubpartA--GeneralProvisions

Sec.211.1Scope.

Linktoanamendmentpublishedat69FR29828,May25,2004.

（a）Theregulationsinthispartcontaintheminimumcurrentgoodmanufacturingpracticeforpreparationofdrugproductsforadministrationtohumansoranimals.

（b）Thecurrentgoodmanufacturingpracticeregulationsinthischapter,astheypertaintodrugproducts,andinparts600through680ofthischapter,astheypertaintobiologicalproductsforhumanuse,shallbeconsideredtosupplement,notsupersede,theregulationsinthispartunlesstheregulationsexplicitlyprovideotherwise.Intheeventitisimpossibletocomplywithapplicableregulationsbothinthispartandinotherpartsofthischapterorinparts600through680ofthischapter,theregulationspecificallyapplicabletothedrugproductinquestionshallsupersedetheregulationinthispart.

（c）Pendingconsiderationofaproposedexemption,publishedintheFederalRegisterofSeptember29,1978,therequirementsinthispartshallnotbeenforcedforOTCdrugproductsiftheproductsandalltheiringredientsareordinarilymarketedandconsumedashumanfoods,andwhichproductsmayalsofallwithinthelegaldefinitionofdrugsbyvirtueoftheirintendeduse.Therefore,untilfurthernotice,regulationsunderpart110ofthischapter,andwhereapplicable,parts113to129ofthischapter,shallbeappliedindeterminingwhethertheseOTCdrugproductsthatarealsofoodsaremanufactured,processed,packed,orheldundercurrentgoodmanufacturingpractice.

[43FR45077,Sept.29,1978,asamendedat62FR66522,Dec.19,1997]

EffectiveDateNote:

At69FR29828,May25,2004,§211.1wasamendedbyrevisingparagraph（b）,effectiveMay25,2005.Fortheconvenienceoftheusertherevisedtextfollows:

Sec.211.3Definitions.

Thedefinitionssetforthin§210.3ofthischapterapplyinthispart.

SubpartB--OrganizationandPersonnel

Sec.211.22Responsibilitiesofqualitycontrolunit.

（a）Thereshallbeaqualitycontrolunitthatshallhavetheresponsibilityandauthoritytoapproveorrejectallcomponents,drugproductcontainers,closures,in-processmaterials,packagingmaterial,labeling,anddrugproducts,andtheauthoritytoreviewproductionrecordstoassurethatnoerrorshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallberesponsibleforapprovingorrejectingdrugproductsmanufactured,processed,packed,orheldundercontractbyanothercompany.

（b）Adequatelaboratoryfacilitiesforthetestingandapproval（orrejection）ofcomponents,drugproductcontainers,closures,packagingmaterials,in-processmaterials,anddrugproductsshallbeavailabletothequalitycontrolunit.

（c）Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,andpurityofthedrugproduct.

（d）Theresponsibilitiesandproceduresapplicabletothequalitycontrolunitshallbeinwriting;suchwrittenproceduresshallbefollowed.

Sec.211.25Personnelqualifications.

（a）Eachpersonengagedinthemanufacture,processing,packing,orholdingofadrugproductshallhaveeducation,training,andexperience,oranycombinationthereof,toenablethatpersontoperformtheassignedfunctions.Trainingshallbeintheparticularoperationsthattheemployeeperformsandincurrentgoodmanufacturingpractice（includingthecurrentgoodmanufacturingpracticeregulationsinthischapterandwrittenproceduresrequiredbytheseregulations）astheyrelatetotheemployee`sfunctions.TrainingincurrentgoodmanufacturingpracticeshallbeconductedbyqualifiedindividualsonacontinuingbasisandwithsufficientfrequencytoassurethatemployeesremainfamiliarwithCGMPrequirementsapplicabletothem.

（b）Eachpersonresponsibleforsupervisingthemanufacture,processing,packing,orholdingofadrugproductshallhavetheeducation,training,andexperience,oranycombinationthereof,toperformassignedfunctionsinsuchamannerastoprovideassurancethatthedrugproducthasthesafety,identity,strength,quality,andpuritythatitpurportsorisrepresentedtopossess.

（c）Thereshallbeanadequatenumberofqualifiedpersonneltoperformandsupervisethemanufacture,processing,packing,orholdingofeachdrugproduct.

Sec.211.28Personnelresponsibilities.

（a）Personnelengagedinthemanufacture,processing,packing,orholdingofadrugproductshallwearcleanclothingappropriateforthedutiestheyperform.Protectiveapparel,suchashead,face,hand,andarmcoverings,shallbewornasnecessarytoprotectdrugproductsfromcontamination.

（b）Personnelshallpracticegoodsanitationandhealthhabits.

（c）Onlypersonnelauthorizedbysupervisorypersonnelshallenterthoseareasofthebuildingsandfacilitiesdesignatedaslimited-accessareas.

（d）Anypersonshownatanytime（eitherbymedicalexaminationorsupervisoryobservation）tohaveanapparentillnessoropenlesionsthatmayadverselyaffectthesafetyorqualityofdrugproductsshallbeexcludedfromdirectcontactwithcomponents,drugproductcontainers,closures,in-processmaterials,anddrugproductsuntiltheconditioniscorrectedordeterminedbycompetentmedicalpersonnelnottojeopardizethesafetyorqualityofdrugproducts.Allpersonnelshallbeinstructedtoreporttosupervisorypersonnelanyhealthconditionsthatmayhaveanadverseeffectondrugproducts.

Sec.211.34Consultants.

Consultantsadvisingonthemanufacture,processing,packing,orholdingofdrugproductsshallhavesufficienteducation,training,andexperience,oranycombinationthereof,toadviseonthesubjectforwhichtheyareretained.Recordsshallbemaintainedstatingthename,address,andqualificationsofanyconsultantsandthetypeofservicetheyprovide.

SubpartC--BuildingsandFacilities

Sec.211.42Designandconstructionfeatures.

（a）Anybuildingorbuildingsusedinthemanufacture,processing,packing,orholdingofadrugproductshallbeofsuitablesize,constructionandlocationtofacilitatecleaning,maintenance,andproperoperations.

（b）Anysuchbuildingshallhaveadequatespacefortheorderlyplacementofequipmentandmaterialstopreventmixupsbetweendifferentcomponents,drugproductcontainers,closures,labeling,in-processmaterials,ordrugproducts,andtopreventcontamination.Theflowofcomponents,drugproductcontainers,closures,labeling,in-processmaterials,anddrugproductsthroughthebuildingorbuildingsshallbedesignedtopreventcontamination.

（c）Operationsshallbeperformedwithinspecificallydefinedareasofadequatesize.Thereshallbeseparateordefinedareasorsuchothercontrolsystemsforthefirm`soperationsasarenecessarytopreventcontaminationormixupsduringthecourseofthefollowingprocedures:

（1）Receipt,identification,storage,andwithholdingfromuseofcomponents,drugproductcontainers,closures,andlabeling,pendingtheappropriatesampling,testing,orexaminationbythequalitycontrolunitbeforereleaseformanufacturingorpackaging;

（2）Holdingrejectedcomponents,drugproductcontainers,closures,andlabelingbeforedisposition;

（3）Storageofreleasedcomponents,drugproductcontainers,closures,andlabeling;

（4）Storageofin-processmaterials;

（5）Manufacturingandprocessingoperations;

（6）Packagingandlabelingoperations;

（7）Quarantinestoragebeforereleaseofdrugproducts;

（8）Storageofdrugproductsafterrelease;

（9）Controlandlaboratoryoperations;

（10）Asepticprocessing,whichincludesasappropriate:

（i）Floors,walls,andceilingsofsmooth,hardsurfacesthatareeasilycleanable;

（ii）Temperatureandhumiditycontrols;

（iii）Anairsupplyfilteredthroughhigh-efficiencyparticulateairfiltersunderpositivepressure,regardlessofwhetherflowislaminarornonlaminar;

（iv）Asystemformonitoringenvironmentalconditions;

（v）Asystemforcleaninganddisinfectingtheroomandequipmenttoproduceasepticconditions;

（vi）Asystemformaintaininganyequipmentusedtocontroltheasepticconditions.

（d）Operationsrelatingtothemanufacture,processing,andpackingofpenicillinshallbeperformedinfacilitiesseparatefromthoseusedforotherdrugproductsforhumanuse.

[43FR45077,Sept.29,1978,asamendedat60FR4091,Jan.20,1995]

Sec.211.44Lighting.

Adequatelightingshallbeprovidedinallareas.

Sec.211.46Ventilation,airfiltration,airheatingandcooling.

（a）Adequateventilationshallbeprovided.

（b）Equipmentforadequatecontroloverairpressure,micro-organisms,dust,humidity,andtemperatureshallbeprovidedwhenappropriateforthemanufacture,processing,packing,orholdingofadrugproduct.

（c）Airfiltrationsystems,includingprefiltersandparticulatematterairfilters,shallbeusedwhenappropriateonairsuppliestoproductionareas.Ifairisrecirculatedtoproductionareas,measuresshallbetakentocontrolrecirculationofdustfromproduction.Inareaswhereaircontaminationoccursduringproduction,thereshallbeadequateexhaustsystemsorothersystemsadequatetocontrolcontaminants.

（d）Air-handlingsystemsforthemanufacture,processing,andpackingofpenicillinshallbecompletelyseparatefromthoseforotherdrugproductsforhumanuse.

Sec.211.48Plumbing.

（a）Potablew