版藥品生產質量管理規(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《藥品生產質量管理規(guī)范》查核試題姓名：

部門：

日期：

成績：一、選擇題：（請在橫線上填上正確答案番號，不填或填錯均不給分，

1－7小題為單項選擇，每題

8分，8－11小題為多項選擇，每題

6分，共80分）1.《藥品生產質量管理規(guī)范（

2010年訂正）》自

起實行。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、不一樣級別干凈區(qū)之間的壓差應該不低于

帕斯卡。必需時，同樣干凈度級其余不一樣功能地區(qū)（操作間）之間也應該保持合適的壓差梯度。A.20B.15C.10D.53.批號是指用于辨別一個特定批的擁有獨一性的的組合。A.漢字B.拼音C.數(shù)字和（或）字母D.數(shù)字4.下述活動也應該有相應的操作規(guī)程，其過程和結果應該有記錄包含。A.確認和考證B.廠房和設備的保護、潔凈和消毒C.環(huán)境監(jiān)測和更改控制D.以上都是5.發(fā)運記錄應該起碼保留至藥品有效期后年。A.4B.3C.2D.1改變原輔料、與藥品直接接觸的包裝資料、生產工藝、主要生產設備以及其余影響藥質量量的主要要素時，還應該對更改實行后最先起碼個批次的藥質量量進行評估。A.2B.3C.4D.以上都不是7.以下說法正確的選項是。直接接觸藥品的生產人員上崗前應該接受健康檢查，此后每年起碼進行一次健康檢查進入干凈生產區(qū)的人員不得化妝和佩戴飾物C.生產區(qū)嚴禁抽煙，但能夠寄存香煙D.以上都是8.物料應該依據(jù)其性質有序分批儲存和周轉，發(fā)放及發(fā)運應該切合的原則。A．合格先出B．先進先出C．急用先出D．近效期先出9.公司成立的藥質量量管理系統(tǒng)涵蓋，包含保證藥質量量切合預約用途的有組織、有計劃的所有活動。A．人員B．廠房C．考證D．自檢10.批生產記錄的每一頁應該標明產品的。A.規(guī)格B.數(shù)目C.名稱D.批號11.藥品公司應該長久保留的重要文件和記錄有。A．質量標準

B．操作規(guī)程

C．設備運轉記錄

D．穩(wěn)固性觀察報告二、判斷題（請在正確說法的后邊打

√，錯誤的打×，每題

4分，共

20分，）公司的廠房、設備、設備和查驗儀器應該經過確認，應該采納經過考證的生產工藝、操作規(guī)程和查驗方法進行生產、操作和查驗，并保持連續(xù)的考證狀態(tài)。（）2.操作人員應該防止裸手直接接觸藥