QA考試試題及答案

1、he Spri ng Festival,we held one session ofSalestotaled 7.425 billion kefficiency of more than 99.8%.-Relia bilityindex: equivalentavaila93.47%nt. Focus onpr omotingtcompa ny managementsyspring a nda utumn ofsecurity inspections,floodcontrol and i nspection,safetyproductionmonth, daysupe rvision ofpr

2、oductionsafetyand theOlympicGamesand otQA考試試題姓名 工號 分數一、填空題 （20分，每空1分）1、企業(yè)應當采取適當措施，避免體表有傷口、患有傳染病或其他可能污染藥品疾病的人員從事 的生產。2 .進入 的人員不得化妝和佩帶飾物。3 .潔凈區(qū)與非潔凈區(qū)之間、不同級別潔凈區(qū)之間的壓差應當 。4 .取樣區(qū)的空氣潔凈度級別應當 。5 .自檢應當有。6 . 批生產記錄的每一頁應當標注產品的 、和。7、生產設備不得對 產生任何不利影響。8 .設備所用的潤滑劑、冷卻劑等不得對藥品或容器造成 。9 .不合格的設備如有可能應當搬出生產和質量控制區(qū)，未搬出前，應當有醒目的

3、。10 .用于藥品生產或檢驗的 ,應當有使用日志。11 .物料供應商的確定及變更應當經 批準后方可采購。12 .不符合貯存和運輸要求的退貨，應當在 監(jiān)督下予以銷毀。13 .配制的每一物料及其重量或體積應當由他人獨立進行 ,并有 記錄14 .主要固定管道應當標明 和。15 .物料和產品發(fā)放及發(fā)運應當符合 和 的原則。二、 選擇題 （50分，每小題 2分）1. 企業(yè)必須建立質量保證系統(tǒng)，同時建立完整的（），以保證系統(tǒng)有效運行。A:文件體系B:組織機構C:質量控制系統(tǒng) D:質量管理體系2. 藥品生產質量管理規(guī)范2010年修訂自（）起施行。A. 2011年6月1日 B. 2011 年5月1日C. 20

4、11年4月1日 D. 2011 年3月1日3. 下述活動也應當有相應的操作規(guī)程，其過程和結果應當有記錄（）A.確認和驗證B.廠房和設備的維護、清潔和消毒C.環(huán)境監(jiān)測和變更控制D.以上都是Delegates,staff: Hell o! inthe r un-uptot million k Wh,a n increase of 757 million kWh.一一I- . Ince2013-work shop,fullheannual Exe cutiveier.Equivalentfoback in2012,careful analysis ofthe currentsit uation,di

5、 scuss 2013 development plans.budget,ani ncrea seof729million kWh.-Securitymeasure s:unpl anned outages2.5time 一.- - - - - -.0.16% re ductionoverthesame peri oda yearearli er.Here,onbehalf of my company2013 workreports to theGeneralAssem bly, for consi deration.PillarI, 2012 back in2012,XX power com

6、panie sadheretot heparty's 17great spiritfor guidance,compre.No personal injury accide nt occurred, no majora cci dentand above,nomajorfireacci dent swithoute nvironme ntalpolluti on acci de nts,safetyforthre econsecutive yearsto mai ntain sta bilityto good一 |_ II. .1 一 L I -I -I -.一 , L, I .I .

7、 L. I I ->.11_ II一一 -Lid- -Majorachievements: first,we shouldadheretothetwo "managementsystem" basis, strengthe ningtechnologi calresearch, strengthenhihensively impleme ntthescientifi c concept of development, promoti ngcostposture.Busine ss fina ncialindicator s:total profits of255mil

8、lionYua.-II - .11.一一 . . .IL . Inewste ps. -The tw o "managementsystem" for improvemegcost-le adershipa n, beyondthetingthe poweroftheip strategy, standards,focuson impl ementation, lea nmanagem ent, continuously impr ove,smooth present safety situati on ofenterpri se manageme nt, busi nes

9、s mathe annual budgetof207 millionYuan,beyondthe Datang companyindex41.89 millionYuan,a n increase of1.76million Yua n,FCM a ssessmentat gradefour.- I _I . _.一一一 一一 一 .- 一. 一 |_ |_.| .stem andt he applicati ona nd implementation ofthe safety loop five-starmanagemenagementa ndcontrolscientific and st

10、andardize d,and thede dicati on ofstaff,managea harmoni ousand dem ocraticatm osphere ofthegoodsit uation.Mai nindicat orsare asfoll ows:-t he battery i ndicat or:powerge nerationtotale d7.815billi onk Wh, beyond t he annual budget implementation ca pacity of315-Energy: pow ersupply standard coal co

11、mpleting312.25 g/k Wh,down 0.1 g /kWh;integrate dauxiliary pow er consumption ratioin 5.12%, down 0.26%; pollutantemissions performancegreatly reduced compar ed to l ast year, carbon 0.09 g/k Wh, sulfur dioxi de0.104 g /kWh NOx0.512 g /kWh; dustrem oval I . I 一 一 L 一 . 一 - -LJ- . _ _ I. _. _ _ _ L.

12、>L . I -. I I I _ _ _|_ - _ _ I. II _I_一 一 ._ _ _| 一一 一.一 一 1I 一 . _ _ze thesystemofsafetycontrol.Further regulatesecurityroutines,safetysupervision a ndmanag ement netw orkrole toplaytoachieve closed-loop. Strengt heni ngthe supervisia nd management of habitualvi olationof, strengthening thesafe

13、ty supervision ofoutsour cing contract ors.Carried out in4. 以下為質量控制實驗室應當有的文件（）。A. 質量標準、取樣操作規(guī)程和記錄、檢驗報告或證書B. 檢驗操作規(guī)程和記錄 包括檢驗記錄或實驗室工作記事簿C. 必要的檢驗方法驗證報告和記錄D. 以上都是5. 主要固定管道應當標明內容物（） 。A名稱B 流向 C 狀態(tài) D 名稱和流向6. 應當對制藥用水及原水的水質進行定期（） ，并有相應的記錄。A 檢查 B 測定 C 監(jiān)測 D 消毒7. 印刷包裝材料應當設置（）妥善存放A 密閉區(qū)域B 一般區(qū)域C 專門區(qū)域D 顯著區(qū)域8. 印刷包裝材料應

14、當由專人保管，并按照操作規(guī)程和（） 發(fā)放。A 需求量B 總量 C 品種數量D 規(guī)格9. 過期或廢棄的印刷包裝材料應當予以（） 并記錄A 保存 B 另外區(qū)域存放C 銷毀 D 計數10. 制藥用水至少應當采用（）A 純化水B 自來水 C 蒸餾水D 飲用水11. 藥品上直接印字所用油墨應當符合（） 。A行業(yè)標準B食用標準要求C藥用標準要求D 藥品質量標準12. 建立專門的文檔，保存經簽名批準的印刷包裝材料（）A 照片 B 復印件 C 原版實樣D 電子文檔13. 生產開始前應當進行檢查，請選出正確的檢查項目：（）A 設備處于待用狀態(tài)B 檢查記錄C 確保設備和工作場所沒有上批遺留的產品、文件或與本批產品

15、生產無關的物料 D 設備處于已清潔狀態(tài)14. 中藥材外包裝上至少應當標明（）A 品名、規(guī)格B 產地 C 采收時間D 調出單位E 質量合格標志15. 在生產過程中應當采取以下措施防止微生物污染（）A 處理后的中藥材不得直接接觸地面，不得露天干燥；ctivities,compre hensive andtamping SafetyFoundation .Troubleshooting,managementmechanism, givefull playtorol eoftechnical supervisi on a nd reali zation oftroubleshooti ng, mana

16、g ement,improv ed pr ocess manageme nt.Thi s yearcomplete d theboiler lower headerleakag ,boil erpressure,a majorriskmanagement, completed29 ofgreat risksand 3 Ge neralpr oblems of governa nce.Com pletechemistrylab construction,thermalcontrol,and com pletethe boilerscale i ntegrated management,hosts

17、haftingvi bration of10 scientif ica nd te chnologi calpr oje cts,suchas.Completesupercritical630MW on-line simulation systemdevelopme ntand applicati on ofcir culati ngwater MCCstandbypower transformation,thetransformation ofdesulfuri zation waste water,t heunitwatersupply systemofcompre he nsive tr

18、eatment anddi schargevalvemodificati on ofcoalmill5 key technologi caltransformation pr oject s,group hea lth is impr oved. -Scie ncea nd te chnology i nnovation i s furtheincrea sed.Stre ngthen thecharacteri stics ofsupercriticalunit majorissues,gradually clearing t he parti cularity ofsuper critic

19、al unit a nd regularity.Dev elopedmot oroiltimemanagement,switch acti on times, statistics,coal -ai dedmea sureme nt software,impr ovesthe production l eveloflean ma nag ement.Increase d investme ntin sciencea nd technolog y, reporting scie ncea ndte chnology proje cts a nd 14te chnical proje cttota

20、lcostper centage ofthe total annual production out put of0.25%."Large -scalecoal-fire d powerpla ntflue gasde sulfuri zation, de nitrificationcomplete development andappli cation ofkeytechnol ogies" project,w on thenati onalscie ncea ndte chnology progressse cond pri ze.630MW supercritical

21、 unit s optimized contr olstrategiesand the630MWdevelopmentanda ppli cation of on-li ne sim ulation system forsupercritica lunit s,supercriti cal 600MW units ofturbi ne drivenboilerfeedpump set ofcom prehe nsivetreatme ntofdefects Data ng technology respectively one or twoa ndthird.Meanwhile,informa

22、tiontechnologyachieveme nts,the companywa s name d "Chi na powerinformati on technology benchmarki ng enter prises."-Re pairand mainte nance ha simprove dfurthe r.Modifythe i nspecti on standards andstandards on aregularbasis, standardizi ng work procedures, checkinga nd i nspecti on pr oj

23、e ct.Dee pening the BFS+ system,a nd im plementsmai ntena ncei nformationshare d.Reorga nizing R B logicagain,a nd ensurethe success oftheR B. Innovating theme chanism ofmainte nance manag ement, implemented a proje ctmanager sy stem.Successfulcompletionoftwo autonomous mainte nance, reli abilityimp

24、r ovedstea dily.Impleme ntingtwo c-levelmainte nance,pr oje ctthemselve s48.7%and 42.3% ,respectivel y.Accom plish tw o cir culati ngpum ps re pairand over haul offour Mills,mai ntena nceteams togetexercise.Promotetheworkofenergy saving a nd consumptionreduci ng, completethe unitenergyconsumptiondia

25、gnosis,plant waterbala ncetest,10 energy -saving proje cts. Second,we should adhere to "three"onthe economic benefits of improving ,outrea chspring a nda utumn ofsecurity inspecti ons,floodcontrol a nd i nspection,safetyproductionmont h, daysupe rvision ofpr oductionsafetyand theOlympicGam

26、esand ot herDelegates,staff: Hell o! inthe r un-uptot he Spri ng Festival,we held one session offourstaffrepresentativesConference2013 -work shop,full back in2012,careful analysisofthecurrentsit uation,di scuss 2013 development plans.Here,onbehalfofmycompany2013 workreports to theGeneralAssem bly, f

27、or consi deration.PillarI, 2012 back in2012,XX power companie sadheretot heparty's 17great spiritfor guidance,comprehensively impleme ntthescientifi c concept of development, promoti ngcost-le adership strategy, standards,focuson impl ementation, lea nmanagem ent, continuously impr ove,smooth pr

28、esent safety situati on ofenterpri se manageme nt, busi ness ma nagementa nd controlscientific and standardize d,and thede dicati on ofstaff,managea harmoni ousand dem ocraticatm osphere ofthegoodsit uation.Mai nindicat orsare asfoll ows:-t he battery i ndicat or:powerge nerationtotale d7.815billi o

29、nk Wh, beyond t he annual budget implementation ca pacity of315million k Wh,a n increase of 757 million kWh.Salestotaled 7.425 billion k Wh,exceedi ng sale s of330 million kWhtheannual Exe cutive budget,ani ncrea se of729 millionkWh. -Securitymea sure s:unpl anned outages2.5time s.Nopersonalinjury a

30、ccide nt occurred, no majora cci dentand above,nomajorfireacci dent swithoute nvironme ntalpolluti on acci de nts,safetyforthre econsecutive yearsto mai ntain sta bilityto good posture.Busine ss fina ncialindicator s:total profits of255millionYua n, beyondthe annual budgetof207 millionYuan,beyondthe

31、 Datang companyindex41.89 millionYuan,an increase of1.76million Yua n,FCM a ssessmentat gradefour.-Energy: pow ersupply standard coal completing312.25 g/k Wh,down 0.1 g /kWh;integrate dauxiliary pow er consumption ratioin 5.12%, down 0.26%; pollutantemissions performancegreatly reduced compar ed to

32、l ast year, carbon 0.09 g/k Wh, sulfur dioxi de0.104 g /kWh NOx0.512 g /kWh; dustrem ovalefficiency of more t han 99.8%.-Relia bilityindex: equivalentavailabilityfactorin93.47% ,incr ease d 7.95% from ayearearlier.Equivalentforced outage rate 0.08%,0.16%reductionoverthe same peri oda yearearli er.Ma

33、jorachievements:first,we shoul dadheretot hetwo "manage mentsystem" basis, stre ngthe ningtechnologi calresearch, strengthenhiddenhazardscontroland intrinsic safety Enterprise construction tooknewste ps. -The tw o "managementsystem" for improvement.Focus onpr omotingthe powerofth

34、ecompa ny managementsy stem andt he applicati ona nd implementati on ofthe safety loop five-starmanagementsystem,improvethesafetymanagement system, realizethesystem ofsafetycontrol.Further regulatesecurityroutines,safetysupervision a ndmanag ement netw orkrole to playtoachieve closed-loop. Strengt h

35、eni ngthe supervisi on a nd management of ha bitualvi olationof, strengtheningthesafety supervisi on ofoutsour cing contract ors.Carried out inB 應當使用流動的工藝用水洗滌揀選后的中藥材；C 用過的水可以用于洗滌其他藥材D 不同的中藥材不得同時在同一容器中洗滌16. 藥品的批準文號的有效期為（）A、3 年 B 、 4 年 C 、 5 年 D 、 7 年17. 根據藥品說明書和標簽管理規(guī)定（局令第24 號） 規(guī)定，如藥品標簽中標注有效期至2009 年 0

36、1 月，表示該藥品可以使用到（）A、2009年 1 月 31 日 B 、 2008年 12 月 31 日C、2009年 1 月 1 日 D 、 2008年 12 月 1 日18. 某一藥品標簽上儲存條件為涼暗處，則該藥品儲存溫度應為（）A、30 度以下B 、 2-10 度 C 、 0-20 度 D 、 25 度以下19. 藥品生產、經營企業(yè)和藥品使用單位的藥品購銷或購進記錄必須保存（）A、超過有效期1年 B、不少于3年C、超過藥品有效期1年，但不得少于2年D超過藥品有效期1年，但不得少于3年20. 哪種情況不需要再驗證（）A. 設備保養(yǎng)、維護后；B. 關鍵工藝和質量控制方法變更；C.生產操作規(guī)

37、程變更；D.主要原輔料、內包材變更；E.生產一定周期后；21. 工藝驗證的主要內容有（）A.工藝參數的合理性、準確性；B.生產控制手段的可靠性、重現性；C. 廠房設施、設備的適用性；D. 中間產品、成品質量的符合性；E. 主要原輔料、內包材變更；22. 每批藥品的留樣數量應至少滿足（）次全檢量。A: 1 次 B: 2 次 C: 3 次 D: 4 次23. 留樣應當按照注冊批準的貯存條件至少保存至藥品有效期后（） 年；A: 1 年B: 2 年 C: 3 年 D: 4 年24. 發(fā)現或懷疑某批藥品存在缺陷，應當考慮檢查（） ，查明其是否受到影響。A 其他批次的藥品B. 穩(wěn)定性樣品C. 成品留樣D.

38、 原輔料留樣ctivities,compre hensive andtamping SafetyFoundation .Troubleshooting,managementmechanism, givefull playtorol eoftechnical supervisi on a nd reali zation oftroubleshooti ng, manag ement,improv ed pr ocess manageme nt.Thi s yearc omplete d theboiler lower headerleakage,boil erpressure,a majorri

39、skmanagement,completed29 ofgreat risksand 3 Ge neralpr oblems of governa nce.Com pletechemistrylab construction,thermalcontrol,andcom pletethe boilerscale i ntegrated management,hostshaftingvi bration of10 scientifica nd te chnologi calpr oje cts,suchas.Completesupercritical630MW on-line simulation

40、systemdevelopme ntand applicati on ofcir culati ngwater MCCstandbypower transformation,thetransformation ofdesulfuri zation waste water,t heunitwatersupply systemofcomprehensive treatment anddi schargevalvemodificati on ofcoalmill5 key technologi caltransformation pr oject s,group hea lth is impr ov

41、ed. -Scie ncea nd te chnology i nnovation i s furtheincrea sed.Stre ngthen thecharacteri stics ofsupercriticalunit majorissues,gradually clearing the parti cularity ofsuper critical unit a nd regularity.Developedmotoroiltimemanagement,switch acti on times, statistics,coal -ai dedmea sureme nt softwa

42、re,impr ovesthe production l eveloflean manag ement.Increase d investme ntin sciencea nd technolog y, reporting sciencea ndte chnology proje cts a nd 14te chnical proje cttotalcostper centage ofthe total annual production out put of0.25%."Large -scalecoal-fire d powerpla ntflue gasde sulfuri za

43、tion, de nitrificationcomplete development andappli cation ofkeytechnol ogies" project,w on thenati onalscie ncea ndte chnology progressse cond pri ze.630MW supercritical unit s optimized contr olstrategiesand the630MWdevel opme ntanda ppli cation of on-line sim ulation system forsupercritica l

44、unit s,supercritical 600MW units ofturbi ne drivenboilerfeedpump set ofcom prehe nsivetreatme ntofdefects Datang technology respectively one or twoa ndthird.Meanwhile,informationtechnologyachieveme nts,the companywa s name d "China powerinformati on technology benchmarki ng enter prises."-

45、Repairand mainte nance ha simprove dfurthe r.Modifythe i nspecti on standards andstandards on aregularbasis, standardizi ng workprocedures, checkinga nd i nspecti on pr oje ct.Dee pening the BFS+ system,and im plementsmai ntena ncei nformationshare d.Reorga nizing R B logicagain,a nd ensurethe succe

46、ss oftheR B. Innovating theme chanism ofmainte nance manag ement, implemented a proje ctmanager system.Successfulcompletionoftwo autonomous mainte nance, reli abilityimpr ovedstea dily.Impleme ntingtwo c-levelmainte nance,pr oje ctthemselve s48.7%and 42.3% ,respectivel y.Accom plish tw o cir culati

47、ngpum ps re pairand overhaul offour Mills,mai ntena nceteams togetexercise.Promote thework ofenergy saving and consumptionreduci ng, completethe unitenergyconsumptiondiagnosis,pla nt waterbala ncetest,10 energy -saving proje cts. Second,we should adhere to "three"onthe economic benefits of

48、 improving ,outrea chDelegates,staff: Hello! inthe run-uptothe Spri ng Festival,weheld one session offourstaffrepresentativesConfere nce2013-work shop,fullback in2012,careful analysis ofthe currentsit uation,di scuss 2013 development plans.Here,onbehalf of my company2013 workreports to theGeneralAss

49、em bly, for consi deration.PillarI, 2012back in2012,XX power companie sadheretot heparty's17great spiritfor guidance,comprehensively impleme ntthescientifi c concept of development, promoti ngcost-le adershipstrategy, standards,focuson implementation, leanmanagement, continuously improve,smooth

50、present safety situation ofenterpri se manageme nt, busi ness ma nagementa ndcontrolscientific and standardize d,and thede dicati on ofstaff,managea harmoniousand democraticatm osphere ofthegoodsit uation.Mai nindicat orsare asfoll ows:-t he battery i ndicat or:powerge nerationtotale d7.815billi onk

51、 Wh, beyond t he annual budget implementation ca pacity of315million k Wh,a n increase of 757 million kWh.Salestotaled 7.425billion k Wh,exceeding sales of330 million kWhtheannual Executive budget,ani ncrea seof729million kWh.-Securitymea sure s:unpl anned outages2.5time s.No personal injury acciden

52、t occurred,no majoracci dentand above,nomajorfireacci dent swithoute nvironme ntalpollution acci de nts,safetyforthreeconsecutive yearsto maintain stabilityto good posture.Busine ss financialindicator s:total profits of255millionYuan, beyondthe annualbudgetof207 millionYuan,beyondthe Datang companyi

53、ndex41.89 millionYuan,a n increaseof1.76million Yua n,FCM a ssessmentat gradefour.-Energy:pow ersupply standard coalcompleting312.25 g/k Wh,down 0.1 g/kWh;integrate dauxiliary power consumption ratioin 5.12%,down 0.26%; pollutantemissions performancegreatly reducedcompar ed to last year, carbon 0.09

54、g/k Wh, sulfur dioxi de0.104 g/kWh NOx0.512 g/kWh; dustrem ovalefficiency of more than 99.8%.-Relia bilityindex: equivalentavailabilityfactorin 93.47%,incr eased 7.95% from ayearearlier.Equivalentforced outage rate 0.08%,0.16% re ductionoverthesame perioda yearearli er.Majorachievement s: first,we s

55、houl dadheretothetwo "managementsystem" basis, strengthe ningtechnologi calresearch, strengthenhiddenhazards controland intrinsic safety Enterprise construction tooknewste ps.-The two "managementsystem" for improvement. Focus onpromotingthe powerofthecompa ny managementsy stem an

56、dt he applicationa nd implementati on ofthesafety loop five-starmanagementsystem,improvethe safetymanagement system, realize thesystem ofsafetycontrol.Further regulatesecurityroutine s,safetysupervisi on a ndmanagement networkrole toplaytoachieve closed-loop. Strengtheni ngthe supervisi on a nd mana

57、gement of ha bitualvi olationof, strengthening thesafety supervisi on ofoutsour cing contractors.Carried out in25. 物料的質量評價應當有明確的結論，如 、 、 ；（ ）A:批準放行、不合格或其他決定B:批準放行、待驗或不合格C:批準放行、不合格或讓步接收D:批準放行、不合格或復驗三、判斷題（每題1 分，共計15 分）1. 企業(yè)所有人員上崗前應當接受健康檢查。（）2. 潔凈區(qū)與非潔凈區(qū)之間的壓差應當不低于10 帕斯卡，不同級別潔凈區(qū)之間的壓差應當不低于5 帕斯卡。 （）3. 每批產品經質量受權人批準后方可放行。（）4. 制藥用水應當適合其用途，并符合 中華人民共和國藥典的質量標準及相關要求。制藥用水至少應當采用純化水。（）5. 每批藥品的檢驗記錄應當包括中間