ujuiiu.55top+(orTL德信誠(chéng)培訓(xùn)網(wǎng)出好好學(xué)習(xí)天天向上德信誠(chéng)培訓(xùn)網(wǎng)藥品質(zhì)量風(fēng)險(xiǎn)管理程序.目的Objective建立質(zhì)量風(fēng)險(xiǎn)管理程序，對(duì)可能影響到最終產(chǎn)品質(zhì)量的風(fēng)險(xiǎn)因素進(jìn)行確定，評(píng)估和控制，保證最終的產(chǎn)品質(zhì)量。指導(dǎo)公司規(guī)避質(zhì)量事故或藥害事件的發(fā)生，保護(hù)患者的切身利益。TheQualityRiskManagementProcedureisestablishedtodefine,evaluateandcontrolpotentialriskstoproductquality,andtohelptoavoidadversequalityissuesoraccidentssoastoassurepatientbenefit..范圍Scope適用于公司質(zhì)量體系內(nèi)的質(zhì)量風(fēng)險(xiǎn)管理。ThisprocedureappliestoqualityriskmanagementofGosunqualitysystem..責(zé)任Responsibilities所有人員職責(zé)：按本規(guī)程執(zhí)行質(zhì)量風(fēng)險(xiǎn)評(píng)估，準(zhǔn)備文件。ItistheresponsibilityofallpersonnelconductingQualityRiskAssessmentandpreparingthedocumentstoadheretothisprocedure.質(zhì)量風(fēng)險(xiǎn)管理組長(zhǎng)Teamleaderofqualityriskmanagement負(fù)責(zé)協(xié)調(diào)跨職能和部門(mén)的質(zhì)量風(fēng)險(xiǎn)管理。Takeresponsibilityforcoordinatingqualityriskmanagementacrossvariousfunctionsanddepartmentsoftheorganization.確保質(zhì)量風(fēng)險(xiǎn)管理程序按本SOP規(guī)定執(zhí)行，并且有充足的資源可用。AssurethatthequalityriskmanagementprocessasdefinedinthisSOPisfollowedandthatadequateresourcesareavailable.質(zhì)量受權(quán)人：負(fù)責(zé)批準(zhǔn)《質(zhì)量風(fēng)險(xiǎn)評(píng)估表》及關(guān)閉風(fēng)險(xiǎn)管理程序。好好學(xué)習(xí)社區(qū)更多免費(fèi)資料下載請(qǐng)進(jìn)：

好好學(xué)習(xí)社區(qū)Iuuw 51o好好學(xué)習(xí)天天在上Iuuw 51o好好學(xué)習(xí)天天在上德信誠(chéng)培訓(xùn)網(wǎng)TheQualifiedPerson:approve<Qualityriskassessmentsheet>andclosingofariskmanagementprocess.QA辦：負(fù)責(zé)審核在產(chǎn)品生命周期內(nèi)對(duì)其質(zhì)量風(fēng)險(xiǎn)進(jìn)行評(píng)估、控制、信息交流和回顧評(píng)審的系統(tǒng)化過(guò)程。QAOffice:reviewthesystematicprocessofevaluation,control,communicationandreviewofqualityrisksduringthelifecircleofproducts..引用標(biāo)準(zhǔn)及文件References《藥品生產(chǎn)質(zhì)量管理規(guī)范（現(xiàn)行版）》<ChinaGoodManufacturePractice>(current)EUGMP指南Volume4<EUGuidelinestoGoodManufacturingPracticeMedicinalProductsforHumanandVeterinaryUse(Volume4)>ICHQ9.內(nèi)容Contents定義Definition可測(cè)定性：發(fā)現(xiàn)或測(cè)定危險(xiǎn)源存在的能力Detectability-theabilitytodiscoverordeterminetheexistence,presence,orfactofahazard.危害：對(duì)健康的傷害，包括產(chǎn)品質(zhì)量缺陷或可獲得性造成的傷害Harm-damagetohealth,includingthedamagethatcanoccurfromlossofproductqualityoravailability.危險(xiǎn)源：潛在的危害來(lái)源。Hazard-thepotentialsourceofharm.質(zhì)量風(fēng)險(xiǎn)管理：一套系統(tǒng)的程序，用于藥物產(chǎn)品生命周期中的風(fēng)險(xiǎn)評(píng)估、控制、信息交流以及回顧。好好學(xué)習(xí)社區(qū)更多免費(fèi)資料下載請(qǐng)進(jìn)：好好學(xué)習(xí)社區(qū){ ? __ujwLU*55t;op.ton\出好好學(xué)習(xí)天天向上德信誠(chéng)培訓(xùn)網(wǎng)Qualityriskmanagement-asystematicprocessfortheassessment,control,communicationandreviewofriskstothequalityofthedrug(medicinal)productacrosstheproductlifecycle.可能性：有害事件發(fā)生的頻率或可能性。Likelihood-frequencyorprobabilityoftheadverseeventoccurring.嚴(yán)重性：對(duì)危險(xiǎn)源可能造成的后果的衡量Severity-Ameasureofthepossibleconsequencesofahazard.風(fēng)險(xiǎn)評(píng)估：對(duì)可能造成系統(tǒng)故障的原因進(jìn)行仔細(xì)檢查，以便做出合理可行的決策，減少或者預(yù)防故障的發(fā)生。RiskAssessment-Acarefulexaminationofwhatcouldcausefailureofthesystemsothatdecisionscanbemadeaboutwhatisreasonablypracticabletoreduceorpreventmalfunctions.質(zhì)量風(fēng)險(xiǎn)管理程序的適用范圍包括并不局限于以下情況：Thisqualityriskmanagementprocedureappliesbutnotlimitedtothefollowingissues:確定潔凈房間和潔凈空氣設(shè)施的監(jiān)控位置。DefiningenvironmentalmonitoringpositionsofcleanroomandHVACsystems;設(shè)定生產(chǎn)的標(biāo)準(zhǔn)和工藝參數(shù)。Establishinglimitsandparametersofmanufacturingprocess;評(píng)估變更影響。Evaluatingeffectofchanges;確定偏差調(diào)查和糾正措施的程度。Determininglevelsofdeviationinvestigationsandcorrectionactions;評(píng)估工藝的薄弱和高風(fēng)險(xiǎn)區(qū)。Evaluatinganddefiningweaknessandhigh-riskissuesofmanufacturingprocess.好好學(xué)習(xí)社區(qū)更多免費(fèi)資料下載請(qǐng)進(jìn)：

好好學(xué)習(xí)社區(qū)Iuuww*55bo好好學(xué)習(xí)天天在上德信誠(chéng)培訓(xùn)網(wǎng)5.3質(zhì)量風(fēng)險(xiǎn)管理流程QualityRiskManagementProcess質(zhì)量風(fēng)險(xiǎn)管理流程圖QualityRiskManagementFlowChart風(fēng)險(xiǎn)管理小組RiskManagementGroup建立風(fēng)險(xiǎn)管理小組EstablishRMgroup. 確定風(fēng)險(xiǎn)項(xiàng)目，收集背景資料或數(shù)據(jù)Defineriskquestion,collectbackground啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理

程序InitiateQRM

procedure,,"QP審批ReviewedandApprovedbyQP根據(jù)風(fēng)險(xiǎn)控制方式的實(shí)施結(jié)果，起草風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估Prepareriskreassessmentafterperformingriskcontrolasperresultacquiredfromtherisk_control根據(jù)風(fēng)險(xiǎn)評(píng)估結(jié)果制定風(fēng)險(xiǎn)控制方式及實(shí)施計(jì)劃DefineriskcontrolmethodsandexecutetheplanasperRA風(fēng)險(xiǎn)消除或降低Iuuww*55bo好好學(xué)習(xí)天天在上德信誠(chéng)培訓(xùn)網(wǎng)5.3質(zhì)量風(fēng)險(xiǎn)管理流程QualityRiskManagementProcess質(zhì)量風(fēng)險(xiǎn)管理流程圖QualityRiskManagementFlowChart風(fēng)險(xiǎn)管理小組RiskManagementGroup建立風(fēng)險(xiǎn)管理小組EstablishRMgroup. 確定風(fēng)險(xiǎn)項(xiàng)目，收集背景資料或數(shù)據(jù)Defineriskquestion,collectbackground啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理

程序InitiateQRM

procedure,,"QP審批ReviewedandApprovedbyQP根據(jù)風(fēng)險(xiǎn)控制方式的實(shí)施結(jié)果，起草風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估Prepareriskreassessmentafterperformingriskcontrolasperresultacquiredfromtherisk_control根據(jù)風(fēng)險(xiǎn)評(píng)估結(jié)果制定風(fēng)險(xiǎn)控制方式及實(shí)施計(jì)劃DefineriskcontrolmethodsandexecutetheplanasperRA風(fēng)險(xiǎn)消除或降低Riskeliminatedormitigated執(zhí)行正式風(fēng)險(xiǎn)評(píng)估ExecuteformalQA督促計(jì)劃實(shí)施QAsupervisestheexecutionQP審批ReviewedandApprovedbyQP執(zhí)行風(fēng)險(xiǎn)控制方式實(shí)施計(jì)劃Executeplanof.controlling仲erisk風(fēng)險(xiǎn)未消除或降低Risknoteliminatedormitigated不接受風(fēng)險(xiǎn)Riskrejected接受風(fēng)險(xiǎn)RiskacceptedQPclosetheRM

process好好學(xué)習(xí)社區(qū)更多免費(fèi)資料下載請(qǐng)進(jìn)：

好好學(xué)習(xí)社區(qū)德信誠(chéng)培訓(xùn)網(wǎng)5.4啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理程序InitiatingaQualityRiskManagementProcess.執(zhí)行以下步驟，啟動(dòng)并計(jì)劃質(zhì)量風(fēng)險(xiǎn)管理程序。Aqualityriskmanagementprocessisplannedandinitiatedasfollows:確定風(fēng)險(xiǎn)項(xiàng)目Definetheriskquestion確定難題或風(fēng)險(xiǎn)問(wèn)題，包括對(duì)相關(guān)潛在風(fēng)險(xiǎn)的設(shè)想。質(zhì)量風(fēng)險(xiǎn)評(píng)估從一個(gè)定義明確的難題或風(fēng)險(xiǎn)疑問(wèn)開(kāi)始。Definetheproblemand/orriskquestion,includingpertinentassumptionsidentifyingthepotentialforrisk.Qualityriskassessmentsbeginwithawell-definedproblemdescriptionorriskquestion.組建質(zhì)量風(fēng)險(xiǎn)管理小組Organizeaqualityriskmanagementteam由難題或風(fēng)險(xiǎn)問(wèn)題部門(mén)負(fù)責(zé)人或其指定的人員擔(dān)任組長(zhǎng)，風(fēng)險(xiǎn)管理小組的成員應(yīng)該至少包括該難題或風(fēng)險(xiǎn)問(wèn)題部門(mén)的成員及QA人員。同時(shí)根據(jù)需要，也可以邀請(qǐng)其他相關(guān)部門(mén)的專(zhuān)業(yè)成員參加。Thepersoninchargeoforthepersondesignatedbythepersoninchargeofthedepartmentwhichpossessestheproblemorriskquestionisdesignatedastheleaderofqualityriskmanagementteam,andpersonnelengagedinthedepartmentwhichpossessestheproblemorriskquestionQApersonnelshouldbeinvolvedinthequalityriskmanagementteamatleast.Expertsofotherrelevantdepartmentmightbeinvolvedintheteam,wherenecessary.風(fēng)險(xiǎn)管理小組組長(zhǎng)，搜集潛在危險(xiǎn)源、危害或風(fēng)險(xiǎn)評(píng)估相關(guān)的人員健康影響的背景資料或數(shù)據(jù)，并向風(fēng)險(xiǎn)管理小組的成員講解整個(gè)項(xiàng)目的情況，幫助風(fēng)險(xiǎn)管理小組成員了解整個(gè)項(xiàng)目。Theleaderofqualityriskmanagementteamassemblesbackgroundinformationand/ordataonthepotentialhazard,harmor