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1、AGUIDEFORNEWFACILITIESVOLUME5:COMMISSIONINGANDQUALIFICATIONEXECUTIVESUMMARYJUNE2000ADOCUMENTDEVELOPEDINPARTNERSHIPBY:ISPEBASELINE®GUIDECOMMISSIONINGANDQUALIFICATIONJUNE20002ISPEBASELINE®GUIDECOMMISSIONINGANDQUALIFICATIONJUNE20003ISPEBASELINE®GUIDECOMMISSIONINGANDQUALIFICATIONJUNE2000I
2、SPEPHARMACEUTICALENGINEERINGGUIDECOMMISSIONINGANDQUALIFICATIONFOREWORDAsnotedintheBaseline®Guides,Volume1,thepharmaceuticalindustryhasexperiencedaratchetingeffectinthecostofnewfacilities.Thisincreaseincosthasbeendriveninpartbyuncertaintyabouttherequirementsforregulatorycompliance.Some
3、significantareasofconcernarevalidation,particularlyrelatedtoautomationsystems,andthetrendtovalidatebacktosourceutilities,architecturalandHVAC.Theabsenceofaconsistentandwidelyacceptedinterpretationofregulatoryrequirementshasledtoone-upmanship.Thispracticeofbuildingincreasinglytechnical
4、lyadvancedfacilitieshasledtoincreasedcost,longerleadtimesand,insomecases,delaysinbringingnewproductstomarket.InMay1994,engineeringrepresentativesfromthepharmaceuticalindustryengagedinadiscussionwiththeInternationalSocietyforPharmaceuticalEngineering(ISPE)andtheFoodandDrugAdministratio
5、n(FDA).Thatfirstdiscussionallowedforthecreationof10facilityengineeringguides,nowknownastheBaseline®PharmaceuticalEngineeringGuides.Theseguidesareintendedtoassistpharmaceuticalmanufacturersinthedesign,constructionandcommissioningoffacilitiesthatcomplywiththerequirementsoftheFDA.Volume1
6、,coveringBulkPharmaceuticalChemicals(BPC),waspublishedinJuneof1996.ThisGuide,forCommissioningandQualification,isthefifthvolumeintheseries.AswiththeBPCGuide,theCommissioningandQualificationGuide,hasbeensponsoredbyISPE’sPharmaceuticalAdvisoryCouncil,madeupofseniorpharmaceuticalengineeri
7、ngexecutivesfromownercompanies,theFDAandISPEseniormanagement.Overallplanning,directionandtechnicalguidanceinthepreparationoftheCommissioningandQualificationGuidewasprovidedbyaSteeringCommitteemostofwhomwereinvolvedintheBPCGuide.TheCommissioningandQualificationGuideitselfwasproducedbya
8、taskf
