FDA 清洁验证审计指南.doc

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1、__________________________________________________ValidationofCleaningProcesses(7/93)GUIDETOINSPECTIONSVALIDATIONOFCLEANINGPROCESSESNote:ThisdocumentisreferencematerialforinvestigatorsandotherFDApersonnel.ThedocumentdoesnotbindFDA,anddoesnoconferanyrights,privileges,benefits,orimmunitiesfororonanyp

2、erson(s).I.INTRODUCTIONValidationofcleaningprocedureshasgeneratedconsiderablediscussionsinceagencydocuments,includingtheInspectionGuideforBulkPharmaceuticalChemicalsandtheBiotechnologyInspectionGuide,havebrieflyaddressedthisissue.TheseAgencydocumentsclearlyestablishtheexpectationthatcleaningprocedu

3、res(processes)bevalidated.Thisguideisdesignedtoestablishinspectionconsistencyanduniformitybydiscussingpracticesthathavebeenfoundacceptable(orunacceptable).Simultaneously,____________________________________________________________________________________________________onemustrecognizethatforcleani

4、ngvalidation,aswithvalidationofotherprocesses,theremaybemorethanonewaytovalidateaprocess.Intheend,thetestofanyvalidationprocessiswhetherscientificdatashowsthatthesystemconsistentlydoesasexpectedandproducesaresultthatconsistentlymeetspredeterminedspecifications.Thisguideisintendedtocoverequipmentcle

5、aningforchemicalresiduesonly.I.BACKGROUNDForFDAtorequirethatequipmentbecleanpriortouseisnothingnew,the1963GMPRegulations(Part133.4)statedasfollows"Equipment***shallbemaintainedinacleanandorderlymanner***."Averysimilarsectiononequipmentcleaning(211.67)wasincludedinthe1978CGMPregulations.Ofcourse,the

6、mainrationaleforrequiringcleanequipmentistopreventcontaminationoradulterationofdrug____________________________________________________________________________________________________products.Historically,FDAinvestigatorshavelookedforgrossinsanitationduetoinadequatecleaningandmaintenanceofequipment

7、and/orpoordustcontrolsystems.Also,historicallyspeaking,FDAwasmoreconcernedaboutthecontaminationofnonpenicillindrugproductswithpenicillinsorthecross-contaminationofdrugproductswithpotentsteroidsorhormones.An