中国GMP英文版.docx

中国GMP英文版.docx

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中国GMP英文版

GoodManufacturingPracticeforPharmaceuticalProducts

（Amendedin1998）SDAOrder#9

Chapter1:

GeneralProvisions

@@Article1:

ThisRegulationisenactedinaccordancewiththe"DrugAdministrationLawofThePeople'sRepublicofChina".

@@Article2:

ThisRegulationispromulgatedasthebasicguidelineformanufacturingandqualitycontrolofpharmaceuticalproducts.ThisRegulationshallbeapplicabletoallthemanufacturingprocessesofdrugpreparationsandtothekeymanufacturingprocessesofrawmaterialswhichmaycausevariationinthequalityoffinishedproducts.

Chapter2:

OrganizationandPersonnel

@@Article3:

Apharmaceuticalenterpriseshallestablishproductionandqualitycontroldepartments.Theresponsibilitiesofdepartmentsatalllevelsandpersonnelshallbeclarified,andeachdepartmentshallbestaffedbyanappropriatenumberofmanagementandtechnicalpersonnelwithexpertknowledge,manufacturingexperienceandorganizationability.

@@Article4:

Theenterprisepersonnelresponsibleforsupervisionofmanufactureandqualitycontrolshall,ataminimum,haveabachelor'sdegreeinmedicine,pharmaceuticals,orrelatedsciences,andhaveappropriateexperienceindrugmanufacturingandqualitycontrol.TheyshallberesponsiblefortheimplementationoftheGMPregulationsandthequalityofproducts.

@@Article5:

Theresponsiblepersonofthemanufactureandqualitycontroldepartmentsshall,ataminimum,haveacollegedegreeofmedicine,pharmaceuticalsorrelatedsciences,haveactualmanagementexperienceinproductionandqualitycontrol,andhavetheabilitytocorrectlydecideandhandlepracticalproblemsinproductionandqualitycontrol.

Themanagersofproductionandqualitycontroldepartmentsshallbeindependentofeachother.

@@Article6:

Allpersonnelengagedindrugmanufactureandqualitycontrolshallhavebeenprofessionallyandtechnicallytrainedsoastoacquirethebasictheoryandpracticaltechnicalskills.

Personnelengagedintheproductionandqualitycontrolofproductswithhighorganicactivity,hightoxicity,strongcontamination,highsensitivityandothersubstanceswithspecialrequirementsshallhavereceivedcorrespondingprofessionaltechnicaltraining.

@@Article7:

PersonnelatalllevelswhoareengagedindrugmanufacturingshallbetrainedandpassexaminationsinaccordancewiththerequirementsofthisRegulation.

Chapter3:

BuildingandFacilities

@@Article8:

Apharmaceuticalenterpriseshallbelocatedinacleanenvironment.Thesurfaceofthegroundandroadsandtransportationoftheplantareashallnotbeasourceofcontaminationofdrugproducts.Thegenerallay-outoftheproduction,administration,livingandancillaryareasshallbeappropriatelyarrangedandnotinterferewitheachother.

@@Article9:

Buildingsshallbeappropriatelylocatedinaccordancewiththetechnologicalprocessandrequisitecleannesslevels.Themanufacturingoperationsundertakeninthesameandnearbyareasshallnotinterferewitheachother.

@@Article10:

Buildingsshallhavethefacilitiestoprotectagainsttheentranceofverminandotheranimals.

@@Article11:

Theeaseandconveniencetoconductcleaningshallbeconsideredinthedesignandconstructionofbuildings.Theinteriorsurfacesofthecleanroom（area）shallbesmooth,withoutcracks,withairtightjunctionpoints.Theinteriorsurfacesshallnotshedanyparticulategranulesandshallwithstandwashinganddisinfecting.Thejointsbetweenwallsandfloorsarepreferablyconstructedwithroundcornersorbyothermeanssoastoreducethecollectionofdustandforeaseofcleaning.

@@Article12:

Inproductionandstorageareas,thereshallbeadequatefloorandairspacefortheorderlyplacementofequipmentandmaterialssoastofacilitateproduction,operations,storageofmaterials,in-processproducts,finishedproductsandthoseunderquarantine,andtothegreatestdegreepossibleminimizeerrorsandcross-contamination.

@@Article13:

Thevariouspipes,lightfixtures,ventilationpointsandotherpublicfacilitiesinthecleanroom（area）shallbedesignedandinstalledsoastoavoidareasbeingdifficulttoclean.

@@Article14:

Thecleanroom（area）shallbeprovidedwithsufficientlightingaccordingtotheproductionrequirements.Illuminationformainproductionroomsshallbe300Lux.Forproductionareaswithspecialrequirements,appropriatelightingshallbeinstalled.Emergencylightingshallbeprovidedinthefacilities.

@@Article15:

Airsuppliedintothecleanroom（area）mustbepurifiedandthecleanleveloftheareashallbeclassifiedinaccordancewiththerequirementsoftheproductionprocess.Thenumberofmicroorganismsandparticulatesintheairofthecleanroom（area）shallbetestedperiodicallyandtheresultsshallbefiled.

@@Article16:

Thewindows,ceilings,enteringpipes,ventilation,lightfixturesandjointsbetweenwallsandceilingsincleanroom（area）shallbeairtight.Thestaticpressuredifferencebetweenareasofdifferentcleanlinessclassshallbemaintainedmorethan5Pa,thestaticpressuredifferencebetweencleanrooms（area）andtheatmosphereoutsideshallbemaintainedatmorethan10Paanddevicesforindicatingpressuredifferenceshallbeinstalled.

@@Article17:

Thetemperatureandrelativehumidityinthecleanrooms（areas）shallcomplywiththerequirementsoftheproductionprocess.Whentherearenospecialrequirements,thetemperatureandrelativehumiditymaybecontrolledat18-26¡æand45-65%,respectively.

@@Article18:

Sinksanddrainsincleanrooms（areas）shallbeinstalledsothatdrugswillnotbecontaminated.

@@Article19:

Measuresshallbetakentoprotectagainstcrosscontaminationofpersonnelandmaterialsenteringorleavingcleanrooms（areas）ofdifferentcleanlinessclass.

@@Article20:

Separatesbuildingsandfacilitiesmustbeusedintheproductionofhighlysensitivedrugs,suchaspenicillin.Infillingroomsofthesedrugsanegativepressureshallbemaintainedrelativetootherrooms.Beforebeingdischargedoutsidetheroom,theusedsteam（orair）shallbecleanedsoastocomplywiththerequirements.Theopeningforthedischargeofusedsteamshallbefarawayfromtheairintakeorotheraircleaningsystems.DrugswiththestructureofB-lactammusthavespecializedequipmentandaseparateaircleaningsystemandtheproductionareamustbestrictlyseparatedfromotherproductionareas.

@@Article21:

Buildingsforproductionofcontraceptivesshallbeseparatedfromthoseofotherdrugs.Anindependentdedicatedaircleaningsystemshallbeinstalled.Chemicaldrugssuchashormonesandanti-tumorpharmaceuticalsshallnotusethesameequipmentorair-cleaningsystemwithotherdrugs;however,ifsuchusecannotbeavoided,effectiveprecautionsmustbetakenandnecessaryvalidationsobtained.

Dedicatedandsafeequipmentshallbeusedintheprocessing,packagingandstorageofradioactivedrugs.Airdischargedfromtheproductionareashallnotbecirculatedforuse.Dischargedairshallnotcontainradioactivep@@Articlesandtherequirementsandregulationsregardingradiationprotectionshallbecompliedwith.

@@Article22:

Theprocessingorfillingof:

bacterialandviralstrainsusedforproductionornon-production,cellsusedforproductionornon-production,wildandattenuatedstrains,deadandlivestrains,pre-detoxifiedandpost-detoxifiedproducts,liveorinactivatedvaccines,humanbloodproductsandpreventiveproducts;shallnotbeconductedinthesamebuilding,andtheirstorageshallbestrictlyseparatedfromeachother.Treatmentandfillingofdifferenttypesoflivevaccinesshallbeseparatedfromeachother.Theproductionareaforwildmicroorganismsandspore-formingmicroorganismspreparationsshallbeundernegativepressurerelativetoneighboringareasandshallhaveanindependentaircleaningsystem.

@@Article23:

Thepretreatment,extraction,concentration（evaporation）ofTCMandthewashingandtreatmentareasofanimalorgansandtissuesshallbestrictlyseparatedfromtheproductionareasofotherpreparations.

Thesteaming,stir-frying,roastingandbakingprocessesforpreparingChinesecrudedrugsshallbecarriedoutinareasequippedwithventilation,de-fuming,dustextraction,andcoolingfacilities.Theprocessofselection,slicing,andmashingshallbecarriedoutinareasequippedwitheffectivedust-catchingandventilationfacilities.

@@Article24:

Thebuildingsshallbeprovidedwithdustprotectiondevicesanddust-catchingdevicesifnecessary.

@@Article25:

Airdirectlyincontactwithproductswhichhasbeendried,compressedormadeinertshallbecleanedandshallcomplywiththerequirementsofproduction.

@@Article26:

Storageareasshallbekeptcleananddry.Thefacilitiesoflighting,ventilation,etc.aswellastemperaturecontrolandhumidityshallcomplywiththestoragerequirementsandshallbeperiodicallytested.

Storageareasmaybeequippedwithsamplingroom（s）forrawmaterialsprovidedtheaircleanlinessclassisthesameasthatofproductionrequirements.Ifsamplingisnotconductedinasamplingroom,measurestopreventcontaminationandcross-contaminationshallbeadopted.

@@Article27:

Inaccordancewithrequirementsoftheproductionprocess,theaircleanlinessclassoftheweighingroomandmaterialpreparation（togetmaterialreadyforproduction）roominthecleanroom（area）shallbethesameastheproductionrequirementsandshallbeprovidedwithfacilitiestocatchdustandtoprotectagainstcrosscontamination.

@@Article28:

Roomsfortesting,Chinesecrudedrugspecimens,sampleretentionandothersimilarlaboratoriesasdeterminedbythequalitycontroldepartmentshallbes