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1、标题：药品质风险管理规程Tit1e:Qua1ityRiskManagementProcedure起草人WrittenBy年月日审核人ReviewedBy年月日编号Documentnumber：Q/GSG04.016-11ZG年月日版本：第一版页号：01/17VersionsO1Page：批准人Approvedby年月日制订部门：质量管理部Writtendepartment:Qua1ityManagementDepartment生效日期：年月日Effectivedate：分发部门：QA办、QC办、粉针车间、合成车间、设备办、物控办、人力资源部、行政办、研发部、销售部1 Distributiont
2、o:R&D,QA,QC,APIWorkshop,PowderforinjectionWorkshop,1ogistics,Engineering,HR,Administration.Sa1esDePartmCnt2 .目的ObjeCtiVe建立质量风险管理程序，对可能影响到最终产品质量的风险因素进行确定，评估和控制，保证最终的产品质量。指导公司规避质量事故或药害事件的发生，保护患者的切身利益。TheQua1ityRiskManagementProcedureisestab1ishedtodefine,eva1uateandcontro1potentia1riskstoproductqua1it
3、y,andtohe1ptoavoidadversequa1ityissuesoraccidentssoastoassurepatientbenefit.3 .范围Scope适用于公司质量体系内的质量风险管理。Thisprocedureapp1iestoqua1ityriskmanagementofGosunqua1itysystem.4 .责任Responsibi1ities4.1 所有人员职责：按本规程执行质量风险评估，准备文件。Itistheresponsibi1ityofa11personne1conductingQua1ityRiskAssessmentandpreparingthed
4、ocumentstoadheretothisprocedure.4.2 质量风险管理组长Team1eaderofqua1ityriskmanagement4.2.1 负责协调跨职能和部门的质量风险管理。Takeresponsibi1ityforcoordinatingqua1ityriskmanagementacrossvariousfunctionsanddepartmentsoftheorganization.4.2.2 确保质量风险管理程序按本SOP规定执行，并且有充足的资源可用。Assurethatthequa1ityriskmanagementprocessasdefinedinth
5、isSOPisfo11owedandthatadequateresourcesareavai1ab1e.4.3 质量受权人：负责批准质量风险评估表及关闭风险管理程序。TheQua1ifiedPerson:approveandc1osingofariskmanagementprocess.4.4 QA办：负责审核在产品生命周期内对其质量风险进行评估、控制、信息交流和回顾评审的系统化过程。QAOffice:reviewthesystematicprocessofeva1uation,contro1,communicationandreviewofqua1ityrisksduringthe1ifec
6、irc1eofproducts.5 .引用标准及文件References药品生产质量管理规范(现行版)(current)EUGMP指南Vo1ume4ICHQ96 .内容Contents6.1 定义Definition6.1.1 可测定性：发现或测定危险源存在的能力Detectabi1ity-theabi1itytodiscoverordeterminetheexistence,presence,orfactofahazard.6.1.2 危害：对健康的伤害，包括产品质量缺陷或可获得性造成的伤害Harm-damagetohea1th,inc1udingthedamagethatcanoccurf
7、rom1ossofproductqua1ityoravai1abi1ity.6.1.3 危险源：潜在的危害来源。Hazard-thepotentia1sourceofharm.6.1.4 质量风险管理：一套系统的程序，用于药物产品生命周期中的风险评估、控制、信息交流以及回顾。Qua1ityriskmanagement-asystematicprocessfortheassessment,contro1,communicationandreviewofriskstothequa1ityofthedrug(medicina1)productacrosstheproduct1ifecyc1e.6.1
8、.5 可能性：有害事件发生的频率或可能性。1ike1ihood-frequencyorprobabi1ityoftheadverseeventoccurring.6.1.6 严重性：对危险源可能造成的后果的衡量Severity-Ameasureofthepossib1econsequencesofahazard.6.1.7 风险评估：对可能造成系统故障的原因进行仔细检查，以便做出合理可行的决策，减少或者预防故障的发生。RiskAssessment-Acarefu1examinationofwhatcou1dcausefai1ureofthesystemsothatdecisionscanbem
9、adeaboutwhatisreasonab1ypracticab1etoreduceorpreventma1functions.6.2 质量风险管理程序的适用范围包括并不局限于以下情况:Thisqua1ityriskmanagementprocedureapp1iesbutnot1imitedtothefo11owingissues:6.2.1 确定洁净房间和洁净空气设施的监控位置。Definingenvironmenta1monitoringpositionsofc1eanroomandHVACsystems;6.2.2 设定生产的标准和工艺参数。Estab1ishing1imitsand
10、parametersofmanufacturingprocess;6.2.3 评估变更影响。Eva1uatingeffectofchanges;6.2.4 确定偏差调查和纠正措施的程度。Determining1eve1sofdeviationinvestigationsandcorrectionactions;6.2.5 评估工艺的薄弱和高风险区。Eva1uatinganddefiningweaknessandhigh-riskissuesofmanufacturingprocess.6.3 质量风险管理流程Qua1ityRiskManagementProcess质量风险管理流程图QUaIiI
11、yRiSkManagementF1owChart风险管理小组RiSkManagementGroupQAEss1ab1ishRMgroup的定风的项I1,收肥rt侬“我能留DofifM)rifikQiMfition.o1Icctbackgroundinfo.Ordotn启动旗量收除管理程序QP审批ReviewedandApprovedbyQPTni1iateQRMprocedure批准APProVe执行正式风险印估Executeforma1riskassessmentIUitt应依W好MM1M定K.fcv刎!MnorS9kcontro1oCIhOdXCDdexecutethp1anasperRA
12、IaeMi11eQP审批Reviewedandapprove.1ApprovedbyQP执行风0控削大灾总计JExocutop1anofcontro1Hnfitherisk/71tRM呻tw根贴以险冲划方式的*他f现.热点MKHW执行完率后的阿峻3N的Proper4*rixkrw-aaasajifmaforpcrforinriskcontro1aperrcicu1tQCqUiredfrwIhrikC4x1ro1QA精促计划实施QAsupervisesthexecution风险未消除或降低Risknot.e1imintedorInitigCIGd风险消除或降低Riske1iminatedormi
13、tigated不接受风险Riskrejected接受风险RiskacceptedQP关闭QPc1osetheRMprocess6.4 启动质量风险管理程序InitiatingaQua1ityRiskManagementProcess.6.4.1 执行以下步骤，启动并计划质量风险管理程序。Aqua1ityriskmanagementprocessisp1annedandinitiatedasfo11ows:1.1.1.2 确定风险项目Definetheriskquestion确定难题或风险问题，包括对相关潜在风险的设想。质量风险评估从一个定义明确的难题或风险疑问开始。Definetheprob1
14、emand/orriskquestion,inc1udingpertinentassumptionsidentifyingthepotentia1forrisk.Qua1ityriskassessmentsbeginwithawe11-definedprob1emdescriptionorriskquestion.1.1.1.3 组建质量风险管理小组OrganiZeaqua1ityriskmanagementteam由难题或风险问题部门负责人或其指定的人员担任组长，风险管理小组的成员应该至少包括该难题或风险问题部门的成员及QA人员。同时根据需要，也可以邀请其他相关部门的专业成员参加。Thepe
15、rsoninchargeoforthepersondesignatedbythepersoninchargeofthedepartmentwhichpossessestheprob1emorriskquestionisdesignatedasthe1eaderofqua1ityriskmanagementteam,andpersonne1engagedinthedepartmentwhichpossessestheprob1emorriskquestionQApersonne1shou1dbeinvo1vedinthequa1ityriskmanagementteamat1east.Expertsofotherre1evantdepa
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