2010年11月药事法规培训试题及答案

Wewillcontinuetoimprovethecompany'sinternalcontrolsystem,andsteadyimprovementinabilitytomanageandcontrol,optimizebusinessprocesses,toensuresmoothprocesses,responsibilitiesinplace;tofurtherstrengtheninternalcontrols,playacontrolpostindependentoversightroleofevaluationcomplyingwiththird-partyresponsibility;toactivelymakeuseofinternalaudittoolsdetectpotentialmanagement,streamline,standardizerelatedtransactions,strengtheningoperationsinaccordancewithlaw.Deepeningtheinformationmanagementtoensurefullcommunicationzeroresistance.ToconstantlyperfectERP,andBFS++,andPI,andMIS,andSCM,informationsystembasedconstruction,fullintegrationinformationsystem,achievedinformationresourcesshared;toexpandPortalsystemapplicationofbreadthanddepth,playinformationsystemonenterpriseofAssistantrole;toperfectdailyrunmaintenanceoperationofrecords,promoteproblemreasonsanalysisandsystemhandover;tostrengtheningBFS++,andERP,andSCM,technologyapplicationoftraining,improveemployeesapplicationinformationsystemofcapacityandlevel.Humanisticcaretoensurezero.TostrengtheningHumanitiescare,continuestofostercompanywindclear,andgasare,andheartShunofcultureatmosphere;strengtheninglovehelpedtrapped,caredifficultemployees;carriedoutstyleactivities,richemployeeslife;strengtheninghealthandlabourprotection,organizationcareerhealthmedical,controlcareeragainst;continuestoimplementationpsychologicalwarningpreventionsystem,trainingemployeeshealthofcharacter,andstableofmoodandenterprisingofattitude,createdfriendlyfraternityofHumanitiesenvironment.Tostrengthenriskmanagement,ensurethatthebusinessofzerorisk.Tostrengthenedbusinessplansmanagement,willbusinessbusinessplanscovertoalllevel,ensurethebusinesscancontrolincontrol;tocloseconcernfinancial,andcoalelectriclinkage,andenergy-savingscheduling,nationalpolicytrends,strengtheningtrack,activeshould;toimplementationState-ownedassetsmethod,furtherspecificationbusinessfinancialmanagement;toperfectrisktubecontrolsystem,achievedriskrecognition,andmeasure,andassessment,andreport,andcontrolfeedbackofclosedringmanagement,improveriskpreventioncapacity.Tofurtherstandardizetrading,andstrivetoachieveaccordingtolaw,standardizeandfair.Innovationofperformancemanagement,toensurethatpotentialemployeeszerofly.Tostrengthenperformancemanagement,processcontrol,enhanceemployeeevaluationandlevelsofeffectivecommunicationtoimproveperformancemanagement.Tofurtherquantifyandrefineemployeestandards...Work,fullplayparty,andbranch,andmembersinfivetypeEnterpriseconstructionintheofcorerole,andfightingfortressroleandpioneermodelrole;tocontinuestostrengtheningfourgoodleadershipconstruction利用设在基坑边的固定泵输送砼到施工面，人工摊铺，平板振捣器振捣密实，用刮杠沿模板顶将砼刮平，并用木抹搓平压实，确保砼密实和表面平整。砼浇注时埋设支立模板及钢筋支架所需预埋铁件playlevelscadresinenterprisedevelopmentintheofbackbonebackbonerole;tofullstrengtheningmembersyouthwork,fullplayyouthemployeesincompanydevelopmentintheofforcerole;toimproveindependentCommissionagainstcorruptionworklevel,strengtheningonenterprisebusinesskeylinkofeffectivenessmonitored.,Andmaintainstability.Tofurtherstrengthenpublicityandeducation,improvetheoveralllegalsystem.Wemuststrengthensafetymanagement,establishandimprovetheeducation,supervision,andevaluationasoneofthetrafficsafetymanagementmechanism.ToconscientiouslysumuptheOlympicsecuritycontrols,promotingintegratedmanagementtoahigherlevel,higherstandards,ahigherlevelofdevelopment.Employees,todayislunarcalendaronDecember24,theoxBellisabouttoring,atthistimeofyear,weclearlyfeelthepulseoftheXXpowergenerationcompanytoflourish,tomoreclearlyhearXXpowergenerationcompaniesmatureandsymmetrybreathing.Recallingpastoneanotheracrossarailing,weareenthusiasticandfullofconfidence.Futuredevelopmentopportunities,wemoreexcitingfightmorespirited.Employees,letustogetheracross2013fullofchallengesandopportunities,tocreateagreen,low-costoperation,fullofhumanecareofaworld-classpowergenerationcompanyandworkhard!TheoccasionoftheSpringFestival,mysincerewishthatyouandthefamiliesofthestaffinthenewyear,goodhealth,happy,happy!2010年11月药事法规培训一、填空题（每空2分，共50分）1.药品GMP认证检查项目共259项，其中关键项目（条款号前加“*”）项，一般项目项。2.根据药品生产工艺要求，洁净室（区）内设置的称量室或备料室，空气洁净度等级应与生产要求一致，应有和的措施。3.质量受权人具有，这是受权人最核心的内涵。受权人独立于总经理，独立于生产活动而行使质量管理职责，不受到企业利益、财务、生产活动等因素的影响，保证不受到其他因素干扰，不向其他因素妥协，也是受权人制度实施的根本目的。4.物料必须经过或审核，决定是否批放行。5.受权人转授权时，必须有书面的转授权，明确的职责。6.2010年药典二部附录201页中关于原料药及药物制剂稳定性重点考察项目参考表中有关物质（含降解产物及其他变化所生成的产物）应说明生成产物的数目及的变化，如有可能应说明有关物质中何者为原料中的中间体，何者为降解产物，稳定性试验重点考察。7.原料药长期稳定性试验重点考察项目有性状、、含量、有关物质、以及根据品种性质选定的考察项目。8.药物制剂长期稳定性试验重点考察项目有性状、、PH值、可见异物、、无菌。9.药典二部（2010）计量符号中“%（ml/g）”表示溶液中含有溶质若干毫升。“%（g/ml）”表示溶液中含有溶质若干克。10.“精密称定“系指称取重量应准确至所取重量的；”称定“系指称取重量应准确至所取重量的。11.2010年版中国药典二部中“凝血酶冻干粉”水份测定由“干燥失重法”变更为。12．2010版附录中要求注射用水的储存方式和静态储存期限应经过Wewillcontinuetoimprovethecompany'sinternalcontrolsystem,andsteadyimprovementinabilitytomanageandcontrol,optimizebusinessprocesses,toensuresmoothprocesses,responsibilitiesinplace;tofurtherstrengtheninternalcontrols,playacontrolpostindependentoversightroleofevaluationcomplyingwiththird-partyresponsibility;toactivelymakeuseofinternalaudittoolsdetectpotentialmanagement,streamline,standardizerel