G04.016質(zhì)量風(fēng)險(xiǎn)管理規(guī)程-110726

1、標(biāo)題：藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure起草人WrittenBy年月日審核人ReviewedBy年月日編號(hào)Documentnumber：Q/GSG04.016-11ZG年月日版本：第一版頁(yè)號(hào)：01/13Version：01Page:批準(zhǔn)人Approvedby年月曰制訂部門(mén)：質(zhì)量管理部生效日期：年月曰Writtendepartment:QualityManagementEffectivedate：Department分發(fā)部門(mén)：QA辦、QC辦、粉針車(chē)間、合成車(chē)間、設(shè)備辦、物控辦、人力資源部、行政辦、研發(fā)部、銷(xiāo)售部Distributionto

2、:R&D,QA,QC,APIWorkshop,PowderforinjectionWorkshop,Logistics,Engineering,HR,Administration、SalesDepartment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,an

3、dtohelptoavoidadversequalityissuesoraccidentssoastoassurepatientbenefit.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。ItistheresponsibilityofallpersonnelconductingQualityRiskAssessmentandpreparingthedocumentstoadhe

4、retothisprocedure.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.3.2.2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。標(biāo)題：藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure版本：第一版頁(yè)號(hào)：02/13Version01Page:編號(hào)

5、Documentnumber：Q/GSG04.016-11ZGAssurethatthequalityriskmanagementprocessasdefinedinthisSOPisfollowedandthatadequateresourcesareavailable.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。TheQualifiedPerson:approveandclosingofariskmanagementprocess.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:reviewthesystematicp

6、rocessofevaluation,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)(current)EUGMP指南Volume4ICHQ9內(nèi)容Contents5.1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

7、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。Qualityriskmanagement-asystematicprocessfortheassessment,control,communicationandreviewofriskstothequalityofthedrug(

8、medicinal)productacrosstheproductlifecycle.可能性：有害事件發(fā)生的頻率或可能性。標(biāo)題：藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure版本：第一版頁(yè)號(hào)：03/13Version01Page:編號(hào)Documentnumber：Q/GSG04.016-11ZGLikelihood-frequencyorprobabilityoftheadverseeventoccurring.嚴(yán)重性：對(duì)危險(xiǎn)源可能造成的后果的衡量Severity-Ameasureofthepossibleconsequencesofahazard

9、.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.5.2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：Thisqualityriskmanagementprocedureappliesbutnotlimitedtothefollowingi

10、ssues: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)。Evaluatinganddefin

11、ingweaknessandhigh-riskissuesofmanufacturingprocess.5.3質(zhì)量風(fēng)險(xiǎn)管理流程QualityRiskManagementProcess標(biāo)題:版本:第一版頁(yè)號(hào):04/13藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Version01PageTitle:QualityRiskManagementProcedure編號(hào)Documentnumber：Q/GSG04.016-11ZG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

12、資料或數(shù)據(jù)Defineriskquestion,collectbackgroundinfo.Or.data啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理程序InitiateQRMprocedure”執(zhí)行正式風(fēng)險(xiǎn)評(píng)估Executeformalriskassessment-批準(zhǔn)ApproveQAQP審批ReviewedandApprovedbyQP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DefineriskcontrolmethodsandexecutetheplanasperRAresu.lf不批準(zhǔn)NotapproveQP審批ReviewedandApprovedbyQP執(zhí)行風(fēng)險(xiǎn)控制方式實(shí)施計(jì)劃Executeplanof.

13、controlling_therisk批準(zhǔn)ApproveQA督促計(jì)劃實(shí)施QAsupervisestheexecution風(fēng)險(xiǎn)消除或降低Riskeliminatedormitigated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Prepareriskreassessmentafterperformingriskcontrolasperresultacquired.fromtheriskcontrol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)RiskacceptedQP關(guān)閉QPclosetheRMproce

14、ss5.4啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理程序深圳九新藥業(yè)有限公司GosunPharmaceuticalCo.,Ltd.標(biāo)題：版本：第一版頁(yè)號(hào)： /13Version01Page:藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure編號(hào)Documentnumber：Q/GSG04.016-11ZGInitiatingaQualityRiskManagementProcess.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:5.4.1.2確定風(fēng)險(xiǎn)項(xiàng)目Defin

15、etheriskquestion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.5.4.1.3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

16、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,andpersonnelengagedinthedepartmentwhichpossessestheproblemorriskqu

17、estionQApersonnelshouldbeinvolvedinthequalityriskmanagementteamatleast.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/ordatao

18、nthepotentialhazard,harmorhumanhealthimpactrelevanttotheriskassessmentandexplainstheprogramtoteammemberstohelpthemgettoknowthisprogram.風(fēng)險(xiǎn)管理小組成員依據(jù)自己的專(zhuān)業(yè)，使用5.6中介紹的質(zhì)量風(fēng)險(xiǎn)管理方法，找到該項(xiàng)目中可能存在的影響到產(chǎn)品質(zhì)量的危險(xiǎn)源，并對(duì)這些危險(xiǎn)源進(jìn)行分析討論，確認(rèn)各類(lèi)危險(xiǎn)源對(duì)最終產(chǎn)品質(zhì)量影響的嚴(yán)重性，風(fēng)險(xiǎn)管理小組組長(zhǎng)根據(jù)最后的風(fēng)險(xiǎn)分析的結(jié)果，起草質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016-R）第一部分內(nèi)容,質(zhì)量風(fēng)險(xiǎn)評(píng)估表第一部分的內(nèi)容應(yīng)包括但不限于：

19、風(fēng)險(xiǎn)項(xiàng)目名稱(chēng)、存在的危險(xiǎn)源、風(fēng)險(xiǎn)發(fā)生后的危害、目前的控制方式等。Accordingtotheirexpertise,qualityriskmanagementteammembersemploythequalityriskmanagementtoolslistedinarticle5.6toidentifyandanalyzepotentialrisksourcesthatmayaffectproductqualityanddefinetheseverity;theteamleaderpreparethefirstpartofQualityRiskassessmentSheet(No.:G04.

20、016-R1)basedontheconclusionofriskanalysis.ThecontentofQualityRiskassessmentSheetincludesbutisnotlimitedtonameoftheriskquestion,existinghazardresources,possibleconsequencesandcurrentcontrols,etc.明確風(fēng)險(xiǎn)評(píng)估的計(jì)劃開(kāi)始時(shí)間和完成時(shí)間Specifythetimelineofriskmanagementprocess.5.4.2質(zhì)量風(fēng)險(xiǎn)分析報(bào)告交相關(guān)部門(mén)會(huì)審，QP批準(zhǔn)質(zhì)量風(fēng)險(xiǎn)評(píng)估的啟動(dòng)。Afterbeingf

21、inished,thequalityanalysisreportisreviewedbyrelevantdepartmentsandapprovedbyQualifiedPersonbeforethequalityriskassessmentprogramisinitiated.5.4.3從質(zhì)量管理部文件QA處取得質(zhì)量風(fēng)險(xiǎn)評(píng)估編號(hào)，按以下方式編號(hào)：QRAyy-mm-dd，yy為兩位年號(hào)，mm為兩位月號(hào),dd為兩位月度流水號(hào)。文件QA發(fā)放編號(hào)的同時(shí)登記質(zhì)量風(fēng)險(xiǎn)管理臺(tái)帳(編號(hào):G04.016-R3)。TheQApersonnelinchargeofdocumentationassignsanumb

22、ertoqualityriskassessmentintheformof“QRAyy-mm-dd”,where“yy”isthelasttwofiguresoftheyear,“mm”isthetwofiguresindicatingthemonth,and“dd”isthetwosequentialnumberswhicharerenewedmonthly.TheassignednumberisrecordedinQualityRiskManagementLog(No.:G04.016-R3)bytheQApersonnelinchargeofdocumentation.5.5執(zhí)行正式風(fēng)險(xiǎn)評(píng)

23、估Deployariskassessment按以下步驟執(zhí)行風(fēng)險(xiǎn)評(píng)估Theriskassessmentisdeployedasfollows:質(zhì)量風(fēng)險(xiǎn)評(píng)估啟動(dòng)后，由風(fēng)險(xiǎn)管理小組組長(zhǎng)組織小組成員，或邀請(qǐng)其它相關(guān)部門(mén)的專(zhuān)業(yè)成員，填寫(xiě)質(zhì)量風(fēng)險(xiǎn)評(píng)估表(編號(hào)：G04.016-叫)第二部分內(nèi)容一執(zhí)行正式風(fēng)險(xiǎn)評(píng)估，第二部分的內(nèi)容應(yīng)包括但不限于：數(shù)據(jù)評(píng)估(總結(jié)數(shù)據(jù)的充分性，有效性及其他相關(guān)方面)、風(fēng)險(xiǎn)識(shí)別、風(fēng)險(xiǎn)分析及評(píng)估、擬定采用的控制方式，風(fēng)險(xiǎn)控制實(shí)施的標(biāo)準(zhǔn)等。Afterariskassessmentisinitiated,membersofthequalityriskmanagementteamand/or

24、expertsofrelevantdepartments,organizedbytheteamleader,filloutthesecondpartofQualityRiskassessmentSheet(No.:G04.016-R1)with(includingbutnotlimitedto)dataassessment(adequacy,effectivenessandotherrelatedaspectsofthedata),riskidentification,riskanalysisandevaluation,proposedriskcontrolmethods,acceptance

25、criteriaofexecutionofriskcontrol,etc.由風(fēng)險(xiǎn)管理小組組長(zhǎng)組織小組成員，或邀請(qǐng)其它相關(guān)部門(mén)的專(zhuān)業(yè)成員，收集相關(guān)數(shù)據(jù)（歷史數(shù)據(jù)、理論分析、已知的見(jiàn)解或相關(guān)利益者的關(guān)注點(diǎn)），并總結(jié)數(shù)據(jù)的充分性、有效性及其他相關(guān)方面。填入質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016-R）的“數(shù)據(jù)評(píng)估”中。Membersofthequalityriskmanagementteamand/orexpertsofrelevantdepartments,organizedbytheteamleader,assemblerelevantdata（historicaldata,theoreticala

26、nalysis,informedopinionsorconcernsofstakeholders）,summarizeadequacy,effectivenessandotherrelevantaspectsandfilloutthe“DataEvaluation”itemoftheQualityRiskassessmentSheet（No.:G04.016-R1）.5.5.1.1.2風(fēng)險(xiǎn)管理小組成員依據(jù)自己的專(zhuān)業(yè)，根據(jù)風(fēng)險(xiǎn)提問(wèn)（什么可能出錯(cuò)？）和問(wèn)題描述，系統(tǒng)地利用“數(shù)據(jù)評(píng)估”中的信息來(lái)確定該項(xiàng)目中可能存在的影響到產(chǎn)品質(zhì)量的危險(xiǎn)源，并填入質(zhì)量風(fēng)險(xiǎn)評(píng)估表（編號(hào)：G04.016-R1）的“風(fēng)險(xiǎn)識(shí)

27、別”中。Accordingtotheirexpertise,qualityriskmanagementteammembersusefundamentalquestion“whatmightgowrong”andinformationlistedin“DataEvaluation”mentionedabovetoidentifyhazardsreferringtotheriskquestionorproblemdescriptionandfilloutthe“RiskIdentification”itemoftheQualityRiskassessmentSheet（No.:G04.016-R1

28、）.5.5.1.1.3風(fēng)險(xiǎn)分析及評(píng)估：風(fēng)險(xiǎn)管理小組對(duì)這些危險(xiǎn)源進(jìn)行分析討論，確認(rèn)各類(lèi)危險(xiǎn)源對(duì)最終產(chǎn)品質(zhì)量影響的嚴(yán)重性以及風(fēng)險(xiǎn)發(fā)生的可能性。如若可能，可應(yīng)用風(fēng)險(xiǎn)管理工具分析和評(píng)價(jià)風(fēng)險(xiǎn)。風(fēng)險(xiǎn)管理工具的適用性由危險(xiǎn)源的特點(diǎn)和可能造成的嚴(yán)重性確定。Riskanalysisandevaluation:theriskmanagementteamestimatehazardresources,definetheseverityofharmsandlikelihoodofoccurrence.Analyzeandevaluateriskusingriskmanagementtoolsifappropriate

29、.Theappropriatenessofthetoolwillbejustifiedbythenatureandprobableseverityofthehazard.風(fēng)險(xiǎn)控制的目的是為了減少或降低風(fēng)險(xiǎn)使其達(dá)到可接受水平。某種情況下，風(fēng)險(xiǎn)是可接受的。當(dāng)風(fēng)險(xiǎn)超過(guò)可接受水平時(shí)，必須采取相關(guān)措施以降低或避免質(zhì)量風(fēng)險(xiǎn)。Thepurposeofriskcontrolistoreducetherisktoanacceptablelevel.Insomeinstances,itisappropriatetoaccepttherisk.Whenriskexceedsanacceptablelevelthen

30、measuresmustbeproposedformitigationoravoidanceofqualityrisk.風(fēng)險(xiǎn)減少一般包括危害的嚴(yán)重性和可能性的降低。Riskreductionwillgenerallyincludeactionstakentomitigatetheseverityandprobabilityofharm.提高危害的可測(cè)定性的步驟和引起的質(zhì)量風(fēng)險(xiǎn)也可作為風(fēng)險(xiǎn)控制策略的一部分。Processesthatimprovethedetectabilityofhazardsandqualityrisksmayalsobeusedaspartofariskcontrolstr

31、ategy.風(fēng)險(xiǎn)控制方式與風(fēng)險(xiǎn)的嚴(yán)重性相呼應(yīng)。Thewaysofthequalityriskmanagementprocessshouldbecommensuratewiththelevelofrisk.評(píng)估降低風(fēng)險(xiǎn)影響的措施，這些措施可能造成新的風(fēng)險(xiǎn)或增加早前風(fēng)險(xiǎn)的嚴(yán)重性。Evaluatetheimpactofriskreductionmeasuresthatmayintroducenewriskorincreasethesignificanceofearlyrisk.5.5.1.2風(fēng)險(xiǎn)管理小組組長(zhǎng)依據(jù)風(fēng)險(xiǎn)控制方式制定風(fēng)險(xiǎn)控制方式實(shí)施計(jì)劃，實(shí)施計(jì)劃中應(yīng)該包括，但不局限于以下內(nèi)容：風(fēng)險(xiǎn)控制方式

32、、控制方式的開(kāi)始時(shí)間、控制方式的完成時(shí)間、控制方式的負(fù)責(zé)部門(mén)及負(fù)責(zé)人等。Accordingtotheriskcontrolmeasurestheleaderofriskmanagementteamprepareariskcontrolplan,whichincludesbutisnotlimitedtoriskcontrolmeasures,startingtimeandclosingtimeofriskcontrolmeasures,responsiblepersonandresponsibledepartmentforimplementationofriskcontrolmeasures,

33、etc.5.5.1.3質(zhì)量風(fēng)險(xiǎn)分析報(bào)告交相關(guān)部門(mén)會(huì)審，QP批準(zhǔn)質(zhì)量風(fēng)險(xiǎn)分析結(jié)果。QualityriskanalysisreportsarereviewedbyrelevantdepartmentsandtheconclusionsofqualityriskanalysisareapprovedbytheQualifiedPerson.質(zhì)量風(fēng)險(xiǎn)管理記錄DocumentationofqualityriskmanagementQA在質(zhì)量風(fēng)險(xiǎn)管理記錄(編號(hào)：G04.016-R2)中記錄所有的質(zhì)量風(fēng)險(xiǎn)控制實(shí)施情況。Implementationofqualityriskcontrolsisrecorded

34、inQualityRiskManagementRecord(No.:G04.016-R2)byQA.質(zhì)量風(fēng)險(xiǎn)分析的方法Qualityriskanalysismethodology在風(fēng)險(xiǎn)分析及評(píng)估過(guò)程中，如若可能，應(yīng)用風(fēng)險(xiǎn)管理工具分析和評(píng)估風(fēng)險(xiǎn)。風(fēng)險(xiǎn)評(píng)估工具的適用性由危險(xiǎn)源的特點(diǎn)和可能造成的嚴(yán)重性確定。Analyzeandevaluateriskusingriskmanagementtoolsifappropriate.Theappropriatenessofthetoolwillbejustifiedbythenatureandprobableseverityofthehazard.基本風(fēng)險(xiǎn)管

35、理工具有：Basicriskmanagementtoolsinclude:a)簡(jiǎn)易化工具(流程圖、檢查表、頭腦風(fēng)暴等等)Facilitationdevices(flowcharts,checksheets,brainstorming,etc)失敗模式效果分析(FMEA)FailureModeEffectsAnalysis(FMEA)危害分析及關(guān)鍵控制點(diǎn)(HACCP)魚(yú)骨圖分析FishboneAnalysis支持的統(tǒng)計(jì)學(xué)工具Supportingstatisticaltools-某些質(zhì)量風(fēng)險(xiǎn)管理工具檢測(cè)危險(xiǎn)的能力(可測(cè)定性)被認(rèn)為是對(duì)風(fēng)險(xiǎn)的評(píng)估。Insomeriskmanagementtools,

36、theabilitytodetecttheharm(detectability)isconsideredintheestimationofrisk.風(fēng)險(xiǎn)評(píng)估的結(jié)果要么是對(duì)風(fēng)險(xiǎn)的定量評(píng)估，要么是對(duì)風(fēng)險(xiǎn)范圍的定性描述。當(dāng)風(fēng)險(xiǎn)被定性描述為“高”“中”“低”時(shí)，盡量要對(duì)其進(jìn)行詳細(xì)描述。Theoutputofariskassessmentwilleitherbeaquantitativeestimateofriskoraqualitativedescriptionofarangeofrisk.Whenriskisexpressedusingqualitativedescriptors,suchas“hi

37、gh”,“medium”,or“l(fā)ow”,thesemustbedefinedinasmuchdetailaspossible.風(fēng)險(xiǎn)評(píng)估的關(guān)閉Closingofriskassessment風(fēng)險(xiǎn)控制方式實(shí)施結(jié)束后，風(fēng)險(xiǎn)管理小組組長(zhǎng)根據(jù)風(fēng)險(xiǎn)控制實(shí)施計(jì)劃實(shí)施的結(jié)果，填寫(xiě)質(zhì)量風(fēng)險(xiǎn)評(píng)估表(編號(hào)：G04.016-氣)第三部分內(nèi)容：風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估，對(duì)控制后的風(fēng)險(xiǎn)項(xiàng)目按5.5項(xiàng)重新進(jìn)行風(fēng)險(xiǎn)評(píng)估，以確定風(fēng)險(xiǎn)是否消除或降低風(fēng)險(xiǎn)至可接受的程度。Attheendofexecutionofriskcontrolprotocol,accordingtotheoutputsofriskcontrol,the

38、leaderofriskmanagementteamfillsoutthethirdpartofQualityRiskAssessmentSheet(No,:G04.016-R1),RiskReassessment,to深圳九新藥業(yè)有限公司GosunPharmaceuticalCo.,Ltd.深圳九新藥業(yè)有限公司GosunPharmaceuticalCo.,Ltd.標(biāo)題：版本：第一版頁(yè)號(hào)：010/13Version01Page:藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure編號(hào)Documentnumber：Q/GSG04.016-11ZGreass

39、esstheriskasspecifiedinarticle5.5andtodetermineiftheriskiseliminatedorreducedtoanacceptablelevel.風(fēng)險(xiǎn)控制執(zhí)行完畢后的風(fēng)險(xiǎn)再評(píng)估內(nèi)容應(yīng)包括但不限于以下內(nèi)容：控制方式實(shí)施后的風(fēng)險(xiǎn)結(jié)果、實(shí)施風(fēng)險(xiǎn)控制方式前后的風(fēng)險(xiǎn)對(duì)比、實(shí)施結(jié)論等。Riskreassessmentincludesbutisnotlimitedtooutputsofriskcontrols,comparisonbetweentheriskbeforeandafterexecutionofriskcontrols,conclusion,etc

40、.5.8.3質(zhì)量風(fēng)險(xiǎn)評(píng)估表(編號(hào)：G04.016-RJ第三部分內(nèi)容交相關(guān)部門(mén)會(huì)審，如果結(jié)論經(jīng)會(huì)審確認(rèn)風(fēng)險(xiǎn)已經(jīng)消除或降低至可接受程度的，則接受風(fēng)險(xiǎn)，由QP關(guān)閉風(fēng)險(xiǎn)管理程序；如果結(jié)論經(jīng)會(huì)審確認(rèn)風(fēng)險(xiǎn)沒(méi)有消除或降低至可接受的程度，拒絕風(fēng)險(xiǎn)，按照5.5的程序，重新啟動(dòng)風(fēng)險(xiǎn)管理程序，重新啟動(dòng)風(fēng)險(xiǎn)管理程序仍沿用原來(lái)的編號(hào)，但需在編號(hào)后加RX,X代表一位流水號(hào)。舉例：QRA11-07-01R1，表示編號(hào)為QRA11-07-01的風(fēng)險(xiǎn)評(píng)估重新進(jìn)行了1次評(píng)估。RelevantdepartmentsreviewthethirdpartofQualityRiskAssessmentSheet(No,:G04.016-

41、R1).Ifthereviewcometoaconclusionthattheriskiseliminatedorreducedtoanacceptablelevel,theriskwillbeacceptedandtheQualifiedPersonclosetheriskmanagementprocess;otherwise,theriskmanagementprocessshallbeinitiatedagainasspecifiedinarticle5.5.AddingRXattheendoftheoriginalQRAnumberastheQRAnumberofqualityrisk

42、re-assessmentprocess,Xrepresentserialnumber.Forexample:QRA11-07-01R1,representingonere-assessmentofthequalityriskassessmentwhichnumberedQRA11-07-01.5.8.4質(zhì)量風(fēng)險(xiǎn)評(píng)估表(編號(hào)：G04.016-R1)第三部分內(nèi)容完成后，作為最終風(fēng)險(xiǎn)評(píng)估驗(yàn)收的標(biāo)準(zhǔn)之一,來(lái)判斷風(fēng)險(xiǎn)評(píng)估是否最終完成。ThecontentofthethirdpartofQualityRiskAssessmentSheet(No,:G04.016-R1)isutilizedtojusti

43、fywhetherariskassessmentprocessisfinished.檔案存儲(chǔ)ArchivalandStorage完成的質(zhì)量風(fēng)險(xiǎn)評(píng)估表(編號(hào)：G04.016-R/質(zhì)量風(fēng)險(xiǎn)管理記錄(編號(hào)：G04.016-R2)由質(zhì)量管理部文件QA歸檔。QualityRiskAssessmentSheet(No,:G04.016-R1)andQualityRiskManagementRecord(No,:G04.016-R2)arearchivedbyQApersonnelinchargeofdocumentation.標(biāo)題：藥品質(zhì)量風(fēng)險(xiǎn)管理規(guī)程Title:QualityRiskManagementProcedure版本：第一版頁(yè)號(hào)：011/13Version01Page:編號(hào)Documentnumber：Q/GSG04.016-11ZG質(zhì)量風(fēng)險(xiǎn)回顧Qualityriskreview每年在年度回顧中