----------------------------精品word文檔值得下載值得擁有--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------質(zhì)量控制與質(zhì)量風(fēng)險控制培訓(xùn)試題姓名：成績：一、填空題1、藥品生產(chǎn)企業(yè)的質(zhì)量管理部門應(yīng)負(fù)責(zé)的質(zhì)量管理和檢驗(yàn)，受直接領(lǐng)導(dǎo)。2、質(zhì)量管理部門應(yīng)配備一定數(shù)量的和，并有與藥品、檢驗(yàn)要求相適應(yīng)的、、。3、成品取樣一般來說要在、、分別取樣，并單獨(dú)或混合后送檢。4、自檢可使系統(tǒng)處于良好的工作狀態(tài)，并能保證系統(tǒng)完好性和準(zhǔn)確性。5、質(zhì)量控制部門的任務(wù)是、、、、。二、判斷題1、QA的含義是質(zhì)量控制。2、取樣人員可以不是質(zhì)檢人員，可以授權(quán)其他人，但必須是培訓(xùn)合格的人員。3、質(zhì)量管理文件是質(zhì)量保證的基本要求，它體現(xiàn)于GMP的各方面。4、質(zhì)量管理部門應(yīng)會同生產(chǎn)科對主要物料供應(yīng)商質(zhì)量體系進(jìn)行評估。5、質(zhì)量控制部必須獨(dú)立于生產(chǎn)和其他部門。一、填空題1、藥品生產(chǎn)全過程、企業(yè)負(fù)責(zé)人2、質(zhì)量管理、檢驗(yàn)人員、生產(chǎn)規(guī)模、品種、場所、儀器、設(shè)備3、生產(chǎn)開始、中間、結(jié)束階段4、硬件、軟件5、取樣、檢查、檢驗(yàn)、監(jiān)督、發(fā)放或拒收二、判斷題1、×2、√3、√4、×5、√5771001803090012095579036822859633082577100180309001238657613739973576069657710018030900135945780775799025155125771001803090012387577164982601818051577100180309001213857213119215891832657710018030900123595790368223610760535771001803090012356576135286143791742577100180309001235557508786970469327917088100343355274101229944325833379170881003433552751018667329388320081708810034335610710158115250150052217088100343356108101000180059871732170881003433542951010741941426870171708810034335618410187866086962880217088100343356185101775831174086674170881003433561091010860143735728461708810034335611010115220721601491617088100343355237101027041605702709170881003433552381012293648614254141708810034335616910186220440263571817088100343354928101760654089788804577100180309001209557903682285963308257710018030900123865761373997357606965771001803090013594578077579902515512577100180309001238757716498260181805157710018030900121385721311921589183265771001803090012359579036822361076053577100180309001235657613528614379174257710018030900123555750878697046932791708810034335527410122994432583337917088100343355275101866732938832008170881003433561071015811525015005221708810034335610810100018005987173217088100343354295101074194142687017170881003433561841018786608696288021708810034335618510177583117408667417088100343356109101086014373572846170881003433561101011522072160149161708810034335523710102704160