Q12 Technical and RegulatoryQ12技术与法规 药学思考 产品生命周期管理

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1、Q12TechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagementAnnexThisdraftguidance,whenfinalized,willrepresentthecurrentthinkingoftheFoodandDrugAdministration(FDAorAgency)onthistopic.ItdoesnotestablishanyrightsforanypersonandisnotbindingonFDAorthepublic.Youcanuseanalte

2、rnativeapproachifitsatisfiestherequirementsoftheapplicablestatutesandregulations.Todiscussanalternativeapproach,contacttheFDAstaffresponsibleforthisguidanceaslistedonthetitlepage.Forquestionsregardingthisdraftdocumentcontact(CDER)MaheshRamanadham301-796-3272or(CBER)IngridMarkovic240-402-811

3、5.INTERNATIONALCOUNCILFORHARMONISATIONOFTECHNICALREQUIREMENTSFORPHARMACEUTICALSFORHUMANUSEICHHARMONISEDGUIDELINETechnicalandRegulatoryConsiderationsforPharmaceuticalProductLifecycleManagementAnnexQ12DraftversionEndorsedon16November2017CurrentlyunderpublicconsultationAtStep2oftheICHProcess,a

4、consensusdrafttextorguideline,agreedbytheappropriateICHExpertWorkingGroup,istransmittedbytheICHAssemblytotheregulatoryauthoritiesoftheICHregionsforinternalandexternalconsultation,accordingtonationalorregionalprocedures.TABLEOFCONTENTSANNEXI:ECs–ILLUSTRATIVEEXAMPLES..........................

5、.......................................1AnnexIA:ChemicalProduct......................................................................................2AnnexIB:BiologicalProduct.....................................................................................5ANNEXII:PACMP–ILLUSTRATIVEEXAM

6、PLES.........................................................9AnnexIIA:PACMPExample1..................................................................................9AnnexIIB:PACMPExample2................................................................................12ANNEXIII:PRODUCTLIFE

7、CYCLEMANAGEMENTDOCUMENT–ILLUSTRATIVEEXAMPLE....................................................................................151ANNEXI:ECs–ILLUSTRATIVEEXA/MPLES12IdentificationofEstablishedConditionsfortheManufacturingProcess3Theexamplesprovidedbelowar