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1/10NewChinese,EUandUSGMPscomparativeoverview中国新版，欧盟和美国GMP比较概要Date:24–February–2011日期：2011年2月24日Authors作者：:VíctorSamitier(TDV)/OctaviColomina(TDV)2/101.QualityManagement质量管理SIMILARITIES相似点:EUandnewChineseGMPssetforththerequirementofestablishaqualitysystem,withtheirownqualityobjectives,applyingallofrequirementsonsafety,efficacyandqualitycontrolrelatedwithdrugregistrationtothewholeprocessofdrugproduction.EUandnewChineseGMPsintroducetheconceptsofQualityAssuranceinthesameway.USGMPsdoesnotestablishtherequirementofhavingaqualitysystem,butitcanbeunderstoodwiththewholereadingof21CFRParts210&211.欧盟和新版中国GMP都建立了质量系统要求，包括了确立相应质量目标，应用从药品注册到整个药品生产工艺的安全，成效和质量控制。欧盟和新版中国GMP引入了相同的质量保证概念。美国GMP并没有建立质量系统的需求，但是通过对21CFRParts210和211的解读能够体现质量系统概念。AgainEUandnewChineseGMPsintroduceclearlytheRiskManagementApproachaccordingtoICHQ9concepts.Conversely,21CFRdoesnotmentiontheseconceptswhicharemuchnewerthanlastrevisionofUSGMPs.欧盟和中国新版GMP又再次重申了了由ICHQ9引出的质量管理方法。相对陈旧的美国GMP21CFR没有涉及到这些最新概念。DIFFERENCES差异点:NewChineseGMPsidentifiestheresponsibilityoftopmanagementpersonnelfortheimplementationofqualityobjectives(ICHQ10concept).新版中国GMP确立了实施质量目标最高管理层人员的责任，这一点来源于ICHQ10概念。2.Organizationandpersonnel组织机构和人员SIMILARITIES相似点:PeopleshouldbetrainedintheirdutiesandincGMPs,previouslytoperformtheirdutiesandcontinuously,byqualifiedpersonnel.Atrainingprogrammeshouldbeinplacetoassuretrainingisperformedperiodically,althoughUSGMPdoesnotspecifyit.人员需要根据其GMP中的职责，上岗前进行培训，培训需要有连续性，并且由具有资质的人员实施。培训计划应到位以保证培训能够定期进行，但美国GMP没有涉及培训计划。DIFFERENCES差异点:MainresponsibilitiesofHeadofProduction,QualityUnitandQualifiedpersonaredescribedinEUandnewChineseGMPs.Nevertheless,newChineseGMPsalsoidentifytheminimumtrainingofthepersoninchargeofproduction(degreeinpharmacy),qualityunit(degreeinpharmacyorrelated),andqualifiedperson(Bachelordegreeinpharmacyorrelated).USGMPdoesnotincludeanyconsiderationaboutit.在欧盟和中国新版GMP中明确了生产，质量主管和质量授权人的主要责任。然而，新版中国GMP同时明确了人员的最低资质要求：生产负责人（药学或相关专业），质量单元（药学或相关专业）和质量授权人（药学或相关专业本科学位）。美国GMP没有上述要求。EUGMPsandnewChineseGMPsaremuchmorespecificwithPersonnelhygienic,requiringanspecifictrainingprogramme.Theyalsorequestperiodicalmedicalchecktoemployeesindirectcontactwiththeproduct(atleastoneperyearinnewChineseGMPs)欧盟GMPs和中国新版GMP都特别关注了人员卫生，需要特别的培训内容。都要求进行直接接触产品的员工进行周期性体检（在中国新版GMP中规定至少每年1次）3/10Finally,USGMPistheonlyonerequiringconsultants’qualification.Theirqualificationrecords(curriculums)shouldberetained.只有美国GMP需要对咨询师的资质有要求。资质记录（简历）需要保留。3.Facilityandutilities厂房和设施SIMILARITIES相似点:EU,USandnewChineseGMPsagreethatPremisesandequipmentmustbelocated,designed,constructed,adaptedandmaintainedtosuittheoperationstobecarriedout.Theirlayoutanddesignmustaimtominimizetheriskoferrorsandpermiteffectivecleaningandmaintenanceinordertoavoidcross-contamination,buildupofdustordirtand,ingeneral,anyadverseeffectonthequalityofproducts.Theytotallyagreeintherequirementofstorageareasandauxiliaryareas.欧盟，美国和中国新版GMP都要求厂房和设备的安置，设计，建筑材料，配置和维护需要与相应的操作相符合。布局图和设计必须专注于最小化产生错误风险并易于有效清洁和维护避免交叉污染。积累灰尘或者污物——即避免任何不利于产品质量的有害影响。这也同样适用于存储区域和辅助区域。DIFFERENCES差异点:Althoughtheyagreeinthegeneralterms,somedifferencesbetweenthemcanbefound,asthespecificationofnewChineseGMPontheestablishmentofaminimumof10psiofdifferentialpressurebetweencleanareasandnon-clean,ortherequirementofisolatethedifferentpackaginglinestoavoidmix-ups(EUGMPsspecifies“Differentproductsshouldnotbepackagedincloseproximityunlessthereisphysicalsegregation”andUSGMPs“Preventionofmixupsandcross-contaminationbyphysicalorspatialseparationfromoperationsonotherdrugproducts”).虽然他们在通则方面都相同，但是还是存在一些差异点，例如新版中国GMP在洁净区和非洁净区压差设计要至少保证最小10帕斯卡，对于隔离不同产品线避免混淆的要求也有不同之处，欧盟GMP规定“不同产品间不能靠近包装，除非有物理隔离”同样，美国GMP规定了“通过与其他药品生产操作的物理或者空间隔离预防混淆和交叉污染”FornewChineseGMPsadesignoftheplantinalogicalsequenceofmanufacturingoperationsconnectionsisnotarequirementdespiteitsupposesacross-contaminationrisk.新版中国GMP没有对厂房设计需要按照工艺操作逻辑路线合理安排的要求，尽管这是可能带来交叉污染风险的因素之一。Finally,USGMPsestablishestherequirementofdisposesewage,trash,andotherrefuseinandfromthebuildingandimmediateinasafeandsanitarymanner,aswelloftheexistenceofwrittenproceduresforinstallationsanitization.最后，美国GMP建立了对污水处理，垃圾和其他废物的处理要求。必须立即根据建立的卫生处理规程用安全和清洁的方式进行管理。4.Equipment设备SIMILARITIES相似点:EUGMPs,USGMPsandnewChineseGMPsagreethatManufacturingequipmentshouldbedesigned,locatedandmaintainedtosuititsintendedpurpose,accordingthecriteriatoavoidriskoferrororcontamination,equipmentshouldbecleanedaccordingwrittenproceduresandthatequipmentmaintenanceandrepairshallnotaffecttheproductquality.EquipmentshouldbeusedandcleanedaccordingapprovedSOPs.4/10欧盟GMP，美国GMP和新版中国GMP都要求生产设备需要根据规范按照预期的目的合理设计，安置和维护，以避免错误和污染的风险。设备需要根据建立的规程清洁。设备维护和维修不能影响产品质量，设备需要按照已批准的SOP使用和清洁。DIFFERENCES差异点:NewChineseGMPsaremuchmoreexplicitinsomesections,forexample,detailingSOPdistributionandwithdrawal,theuseoffoodgradelubricantwhenpossible,theexistenceofamaintenanceprogramme,existenceofspecificcleaningmethods,existenceofequipmentstatusidentificationortheexistenceofcalibrationlabels.Moreover,newChineseGMPsincludesrequirementsonthewaterquality(atleastusedrinkingwater).TheseaspectsareallincludedinICHQ7A(EUGMPsP