版藥品生產(chǎn)質(zhì)量管理規(guī)范考核試題

problemsthatcannotbeignored.Someleadersunwillintsituatingtodomasseswork,massesconceptweak,onmassesfeelingsnotdeep,pendulumnotarewithmassesofrelationship,tnd-bloodtieswithinkmassesworkisrevolutionarywareraofthings,nowobsoletehas,buriedbusinesswork,ignoredmassesworkofsituationcomparedGeneral;someleadersnotdomasseswork,oldmethodregardlessofwith,newnotwith,notunderstandmassespsychological,notunderstandmasseswishes,notsaidmasseslanguage,workmethodsimplestiff,causedmassesofconflictandantipathy;someleaderscan'tdomasseswork,Facedwithalotofcontradictionsamongthepeopleworryaboutfear,panicsetinencountergroupevents,andsomeareevenmismanaged,inflame,sowheororkhassufferedheavylosses,andsoon.Theseproblemswearesoberlyaware,enhancingtheparty'srulingcapability,themaintenanceanddevelopmentoftheparty'sadvancednatureandpurity,andtoeatdoingmasswork,hasbecomethenewurgeonstrengtheningtheparty'sgoverningcapacity-buildingtasks.Combinedpracticeofmaintainingflesh-ahthemasses,urgedthebroadmassesofpartymembersandcadres,especiallyalllevels...Processingtoimproveasaguidetothecountry.""WhatIdidissummedupthesenewthings,bepromoted."ThisisavividmanifestationoftheDengXiaoping'smass.Dengalsoputpeople"supportdoesnotsupport","agreednottoagree","happyhappy","promisenottopromise"asastartingpointanddestinationofdevelopingguidelines,policies,andastheonlystandardformeasuringcompliancewiththewishesofthemassesofthepeople.UndertheguidanceofDengXiaopingty,CentralGovernmentadoptedaseriesofimportantmeasurestostrengthenlinkswiththemasses.InDecember1989,theCPCCentralCommitteemadeonademocraticpartiesandtherelationshipbetweenthepartofthemassesthattheycontact,effectivelycarryingoutthemassline,playedapositiverole.InMarch1990,the13plenarysessionadoptedthedecisiononstrengtheningcontactswiththemassesofthePartynotedthat"createdanddevelopedinthelongstruggleoftheparty'smassline,istorealizetheparty'sideologicalline,thefundamentalpoliticalandorganizationalworkroute",canalwaysmaintainflesh-and-bloodtiesanddevelopmentofthemasses,isdirectlyrelatedtotheriseandfalloftheriseandfallofthepartyandState.InSeptember1994,14adoptedbytheplenarysessionofthePartyonstrengtheningdecisiononseveralmajorissuesofpartybuilding.Therequirementsofthedecisionoftheparty'sleadingbodiesandleadingcadresshoulddevelopademocraticstyleofwork,comefromthemasses,tothemasses,together,sticktothemassline.Partyof13sessionfourintheplenaryyihou,toJiangcomradeforcoreofparty《藥品生產(chǎn)質(zhì)量管理規(guī)范》查核試題姓名：

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成績(jī)：一、選擇題：（請(qǐng)?jiān)跈M線上填上正確答案番號(hào)，不填或填錯(cuò)均不給分，

1－7小題為單項(xiàng)選擇，每題

8分，8－11小題為多項(xiàng)選擇，每題

6分，共80分）1.《藥品生產(chǎn)質(zhì)量管理規(guī)范（

2010年訂正）》自

起實(shí)行。A.2011

年6月

1日

B.2011

年

5月

1日C.2011

年4月

1日

D.2011

年

3月

1日2.干凈區(qū)與非干凈區(qū)之間、不一樣級(jí)別干凈區(qū)之間的壓差應(yīng)該不低于

帕斯卡。必需時(shí)，同樣干凈度級(jí)其余不一樣功能地區(qū)（操作間）之間也應(yīng)該保持合適的壓差梯度。A.20B.15C.10D.53.批號(hào)是指用于辨別一個(gè)特定批的擁有獨(dú)一性的的組合。A.漢字B.拼音C.數(shù)字和（或）字母D.數(shù)字4.下述活動(dòng)也應(yīng)該有相應(yīng)的操作規(guī)程，其過(guò)程和結(jié)果應(yīng)該有記錄包含。A.確認(rèn)和考證B.廠房和設(shè)備的保護(hù)、潔凈和消毒C.環(huán)境監(jiān)測(cè)和更改控制D.以上都是5.發(fā)運(yùn)記錄應(yīng)該起碼保留至藥品有效期后年。A.4B.3C.2D.1改變?cè)o料、與藥品直接接觸的包裝資料、生產(chǎn)工藝、主要生產(chǎn)設(shè)備以及其余影響藥質(zhì)量量的主要要素時(shí)，還應(yīng)該對(duì)更改實(shí)行后最先起碼個(gè)批次的藥質(zhì)量量進(jìn)行評(píng)估。A.2B.3C.4D.以上都不是7.以下說(shuō)法正確的選項(xiàng)是。直接接觸藥品的生產(chǎn)人員上崗前應(yīng)該接受健康檢查，此后每年起碼進(jìn)行一次健康檢查進(jìn)入干凈生產(chǎn)區(qū)的人員不得化妝和佩戴飾物C.生產(chǎn)區(qū)嚴(yán)禁抽煙，但能夠寄存香煙D.以上都是8.物料應(yīng)該依據(jù)其性質(zhì)有序分批儲(chǔ)存和周轉(zhuǎn)，發(fā)放及發(fā)運(yùn)應(yīng)該切合的原則。A．合格先出B．先進(jìn)先出C．急用先出D．近效期先出9.公司成立的藥質(zhì)量量管理系統(tǒng)涵蓋，包含保證藥質(zhì)量量切合預(yù)約用途的有組織、有計(jì)劃的所有活動(dòng)。A．人員B．廠房C．考證D．自檢10.批生產(chǎn)記錄的每一頁(yè)應(yīng)該標(biāo)明產(chǎn)品的。A.規(guī)格B.數(shù)目C.名稱D.批號(hào)11.藥品公司應(yīng)該長(zhǎng)久保留的重要文件和記錄有。A．質(zhì)量標(biāo)準(zhǔn)

B．操作規(guī)程

C．設(shè)備運(yùn)轉(zhuǎn)記錄

D．穩(wěn)固性觀察報(bào)告二、判斷題（請(qǐng)?jiān)谡_說(shuō)法的后邊打

√，錯(cuò)誤的打×，每題

4分，共

20分，）公司的廠房、設(shè)備、設(shè)備和查驗(yàn)儀器應(yīng)該經(jīng)過(guò)確認(rèn)，應(yīng)該采納經(jīng)過(guò)考證的生產(chǎn)工藝、操作規(guī)程和查驗(yàn)方法進(jìn)行生產(chǎn)、操作和查驗(yàn)，并保持連續(xù)的考證狀態(tài)。（）2.操作人員應(yīng)該防止裸手直接接觸藥