藥品生產(chǎn)企業(yè)實(shí)施藥品(GMP2010)年修訂

1、關(guān)于組織全區(qū)抗艾滋病、結(jié)核病及瘧疾類藥品生產(chǎn)企業(yè)填報(bào)調(diào)查問卷的函附件藥品生產(chǎn)企業(yè)實(shí)施藥品GMP(2010年修訂)過程中存在差距的調(diào)查問卷QuestionnaireforInvestigationoftheGapsofPharmaceuticalEnterprisesinRelationtotheGMPGuidelines(revisedin2010)在中國藥品GMP(2010年修訂)的總體實(shí)施層面，您主要欠缺哪些知識(shí)，有哪些培訓(xùn)需求？Whatareyourmajorknowledgeshortagesandneedfortrainingintheframeoftheimplementation

2、oftheChineseGMPGuidelines(revisedin2010)?以風(fēng)險(xiǎn)為基礎(chǔ)的質(zhì)量保證體系Riskbasedqualityassuraneesystem質(zhì)量受權(quán)人和其他關(guān)鍵人員Qualifiedpersonandotherkeypersons人員培訓(xùn)PersonnelTraining文件體系Doeumentationsystem空調(diào)凈化系統(tǒng)HVACsystem工藝用水制備Processwaterpreparation設(shè)備的校準(zhǔn)，確認(rèn)和預(yù)防性維護(hù)Equipmentealibration,qualifieation,andpreventivemaintenance工藝驗(yàn)證Proc

3、essvalidation清潔驗(yàn)證Cleaningvalidation產(chǎn)品質(zhì)量回顧Productqualityreview庫房Warehouse供應(yīng)商確認(rèn)Supplierqualifieation委托生產(chǎn)，委托檢驗(yàn)Contractmanufacturing/testing質(zhì)控實(shí)驗(yàn)室QClaboratory偏差、糾正和預(yù)防措施Deviation/CAPA超標(biāo)檢驗(yàn)數(shù)據(jù)調(diào)查OOSinvestigations變更控制Changecontrol您所建立的質(zhì)量保證體系是否以確保產(chǎn)品安全并且符合注冊(cè)批準(zhǔn)要求為目的，以科學(xué)為準(zhǔn)則并且以風(fēng)險(xiǎn)管理為基礎(chǔ)？Isyourqualityassuraneesystemes

4、tablishedonscientificprinciplesandonriskmanagementbasistoensurethatyourproductsaresafeandcomplywiththerequirementsoftheMarketingAuthorization?您的質(zhì)量保證體系把那些可能影響產(chǎn)品質(zhì)量的關(guān)鍵參數(shù)考慮在內(nèi)了嗎？Doesyourqualityassuraneesystemconsidercriticalparametersthatmayimpactonproductquality?那些關(guān)鍵參數(shù)及其控制范圍是通過風(fēng)險(xiǎn)評(píng)估確定的嗎？它們包含在驗(yàn)證總計(jì)劃中了嗎？Are

5、thosecriticalparametersandtheircontrolrangesdefinedbyriskassessmentandincludedintheVMP(ValidationMasterPlan)?您有用于確定那些參數(shù)及其范圍的系統(tǒng)性方法嗎，譬如“失效模式影響分析”？IsthereasystematicapproachsuchasFMEA(FailureModeEffectAnalysis)todefinethoseparametersandranges?您公司有風(fēng)險(xiǎn)評(píng)估的書面程序嗎，尤其是(相關(guān)的)決策程序？Doesyourcompanyhaveawrittenriska

6、ssessmentprocedure,especiallyforthedecisionmakingprocedure?對(duì)于質(zhì)量受權(quán)人和其他關(guān)鍵人員(生產(chǎn)、質(zhì)控、質(zhì)保、倉儲(chǔ)、工程等)，您是否系統(tǒng)地制定了清晰明確的崗位說明？Haveyouestablishedawell-definedjobdescriptionsystemforQualifiedPersons(QP)andotherkeypersons(production,qualitycontrol,qualityassuranee,warehousing,engineering,etc.)?質(zhì)量保證或質(zhì)量受權(quán)人員在質(zhì)量事務(wù)和成品批放行方面

7、，有獨(dú)立決策權(quán)嗎？Isthereanindependenceofqualityassurance/QualifiedPersoninmakingdecisionofqualitymattersandbatchreleaseoffinishedproducts?在法規(guī)事務(wù)、檢驗(yàn)技術(shù)和生產(chǎn)技術(shù)方面，對(duì)質(zhì)量受權(quán)人和其他關(guān)鍵人員有持續(xù)性的培訓(xùn)嗎？DotheQualifiedPersonandotherkeypersonsreceivecontinuoustraininginregulatoryaffairsandinanalyticalandproductiontechnology?相關(guān)人員在崗位說明

8、書上簽字了嗎？Arethejobdescriptionssignedbythepeopleconcerned?現(xiàn)場是否有：組織機(jī)構(gòu)圖、崗位說明書(質(zhì)量受權(quán)人、質(zhì)量保證部經(jīng)理、質(zhì)量控制部經(jīng)理和生產(chǎn)部經(jīng)理)、成品批放行程序。Documentstobeprovided:organizationdiagram,jobdescriptionsforQP,QA,QCandproductionmanagers,batchreleaseprocedureforfinishedproducts.您是否根據(jù)藥品GMP(2010年修訂)的要求適當(dāng)組織了培訓(xùn)？Doyouorganizetrainingproperly

9、accordingtotheGMPGuidelines（revisedin2010）?您的培訓(xùn)工作中包括入職培訓(xùn)、藥品GMP持續(xù)性培訓(xùn)、崗位操作培訓(xùn)以及關(guān)于標(biāo)準(zhǔn)操作規(guī)程的培訓(xùn)嗎？Doesyourtrainingprogramincludeintroductiontraining,continuousGMPtraining,on-the-jobtraining,andtrainingonSOPs?您對(duì)培訓(xùn)需求是怎樣定義的（范圍、內(nèi)容、參加人員、時(shí)間安排）？Howdoyoudefineyourtrainingneeds（scope,content,invoIvedpersons,timearran

10、gement）?培訓(xùn)計(jì)劃的起草和批準(zhǔn)程序是怎樣的？誰來組織和監(jiān)督培訓(xùn)（工作）？對(duì)于那些偏離（培訓(xùn)）日程計(jì)劃的情形，是否有報(bào)告制度？Whatisyourprocedureforpreparingandapprovingthetrainingplan?Whoisorganizingandsupervisingthetraining?Isthereasystemtoreportthedeviationsfromtheplannedschedule?您的藥品GMP培訓(xùn)計(jì)劃中是否包括了您公司不直接參和生產(chǎn)、質(zhì)控或質(zhì)保的高層管理者，譬如總經(jīng)理、采購部（經(jīng)理）等？Arethetopmanagersofyou

11、rcompany,notdirectlyinvoIvedinproductionandqualitycontrol/assurancesuchasgeneralmanager,purchasing,etc.includedinyourGMPtrainingplan?培訓(xùn)師需要具備哪些資質(zhì)？您是如何管理（公司）內(nèi)部培訓(xùn)師的？您定期對(duì)他們進(jìn)行適當(dāng)培訓(xùn)嗎？Whatarethequalificationsoftrainers?Howdoyoumanagetheinternaltrainers?Dotheygetpropertrainingregularly?您是如何管理培訓(xùn)記錄的？您如何評(píng)估培訓(xùn)效果？

12、Howdoyoumanageyourtrainingrecordsandevaluatetrainingeffectiveness?您是否建立了清晰明確的藥品GMP文件體系？Doyouestablishawell-organizedGMPdocumentationsystem?您公司把哪些類文件視為藥品GMP文件？請(qǐng)列表說明。WhattypesofdocumentsareconsideredasGMPdocumentationinyourcompany?Pleasemakealist.您公司一共有多少份標(biāo)準(zhǔn)操作規(guī)程？您有關(guān)于制定這類文件的標(biāo)準(zhǔn)程序嗎？HowmanySOPsdoyouhavein

13、yourcompany?DoyouhaveanSOPforSOPs?誰來起草、簽署、發(fā)放文件母本（即原件）？您是如何保存那些原件的？Whoispreparing,signingandissuingthemaster（i.e.original）documents?Howdoyoustorethem?您如何準(zhǔn)備、發(fā)放那些工作（現(xiàn)場）用的文件？Howdoyouprepareandissuetheworkingdocuments?文件變更控制體系程序是怎樣的？Whatistheprocedureforchangecontrolsystemforthedocumentation?當(dāng)（文件）發(fā)生變更時(shí)，您

14、是如何確保所有人都得到并且在工作中使用總最新版本？Whenchangesoccur,howdoyouensurethateveryonehasgotandworkedwiththelatestversion?您的各個(gè)文件之間有交叉引用信息嗎？Doyourdocumentshaveacross-refereneetootherdocuments?您文件的回顧性審查程序是怎樣的？回顧審核的周期是多久？Whatisyourdocumentreviewingprocedureandhowoftendoyoureviewthem?您按照藥品GMP（2010年修訂）的要求對(duì)空調(diào)凈化系統(tǒng)進(jìn)行適當(dāng)確認(rèn)了嗎？D

15、oyouperformanHVACqualificationproperlyaccordingtoGMPGuidelines（revisedin2010）?您的系統(tǒng)運(yùn)行時(shí)是采用100%新風(fēng)方式，還是回風(fēng)參和再循環(huán)的方式？Isyoursystemoperatingwith100%freshair,oristhesystemoperatinginrecirculation?進(jìn)風(fēng)口和出風(fēng)口使用的分別是哪種規(guī)格的過濾器？Whatarethetypesoffiltersusedforairinletandoutlet?您的各個(gè)潔凈區(qū)域（包括不同級(jí)別和同一級(jí)別內(nèi)的不同區(qū)域）之間是否有空氣壓差（控制）系統(tǒng)？

16、該系統(tǒng)的設(shè)計(jì)在防止交叉污染方面是怎樣起作用的？Doyouhaveadifferentialairpressuresystembetweenhygienezones,andhowdoesthedesignofyoursystemimpactonthepreventionofcross-contamination?潔凈室（或區(qū)域）的劃分標(biāo)準(zhǔn)是什么？塵粒和微生物的監(jiān)控標(biāo)準(zhǔn)是什么，如頻次、取樣點(diǎn)個(gè)數(shù)、取樣工具、警戒限值和行動(dòng)限值等？對(duì)（監(jiān)控）數(shù)據(jù)進(jìn)行回顧了嗎？怎么回顧的？Whatarethecriteriaforcleanroom（orarea）classificationandmonitoring（

17、frequency,numberofsamplingpoints,equipmentforsampling,alertandactionthresholds,etc.）forparticlesandmicroorganisms?Arethesedatabeingreviewedandhowdoyoudothereview?為了避免交叉污染，您在生產(chǎn)中采用“密閉系統(tǒng)”或其他措施了嗎？Doyouhaveclosedsystemorothermeasuresintheproductioninordertoavoidcrosscontamination?您的空調(diào)凈化系統(tǒng)是持續(xù)運(yùn)行，還是有“夜間模式”的

18、？或者是在完成工作后關(guān)掉系統(tǒng)？IsyourHVACsystemrunningcontinuously,ordoyouhaveanightmode,orjustswitchthesystemoffaftertheworkingtime?現(xiàn)場是否有以下文件：工廠衛(wèi)生區(qū)域布局圖、空調(diào)凈化系統(tǒng)分布圖和壓差布置圖。Documentstobeprovided:factorylayoutofhygienezones,distributionofHVACsystems,andlayoutshowingdifferential.您按照藥品GMP（2010年修訂）的要求對(duì)水系統(tǒng)進(jìn)行適當(dāng)確認(rèn)了嗎？Doyouperf

19、ormavalidationforwatersystemproperlyaccordingtoGMPGuidelines（revisedin2010）?您的生產(chǎn)部和實(shí)驗(yàn)室使用的水有哪些類？Whattype（s）ofwaterdoyouuseinproductionandlaboratory?您公司采用了怎樣的制水方法？(請(qǐng)予提供的文件：示意圖或工藝和儀表圖)Whatisthewaterpreparationmethodappliedinyourcompany(documenttobeprovided:schematicdiagramorprocessandinstrumentationdiag

20、ram)?最終純化步驟之后的儲(chǔ)罐和(送水)管路是什么材質(zhì)的？Whatisthetypeofmaterialusedforthestoragetankandpipingafterthefinalpurificationstep?系統(tǒng)中使用的閥門有哪些種類？Whichtypesofvalvesareusedinthesystem?純化水的儲(chǔ)存溫度是多少？Whatisthetemperatureofstorageofpurifiedwater?您有在線監(jiān)測系統(tǒng)嗎，譬如總有機(jī)碳和電導(dǎo)率？Doyouhaveanonlinemonitoringsystem,suchasTOCandconductivity

21、?系統(tǒng)采用什么方法維護(hù)？儲(chǔ)罐和(送水)管路采用什么方法消毒？Whatarethemethodsformaintenanceofthesystemandforsanitationofthestoragetanksandtheloop?水系統(tǒng)的監(jiān)控計(jì)劃(取樣點(diǎn)、取樣程序和頻次)是怎樣的？監(jiān)控標(biāo)準(zhǔn)(警戒限值和行動(dòng)限值)是什么？對(duì)那些(監(jiān)控)數(shù)據(jù)，包括其變化趨勢進(jìn)行回顧了嗎？如何回顧的？Whatisyourmonitoringplan(samplingpoints,samplingprocedure,frequency)forthewatersystem,andwhatarethecriteriafo

22、rthemonitoring(alertandactionthresholds)?Arethosedatabeenreviewed,includetrending,andhowdoyoudothereview?發(fā)現(xiàn)長菌后怎么辦？您按規(guī)定程序進(jìn)行有害微生物檢查嗎？Whatdoyoudoincaseyoufindgerms?Areyoutestingsystematicallyforobjectionablemicroorganisms?您有設(shè)備校準(zhǔn)、確認(rèn)和預(yù)防性維護(hù)程序嗎？Doyouhaveproceduresforequipmentcalibration,qualification,andpr

23、eventivemaintenance?您怎樣確定購買什么樣的設(shè)備？“用戶需求標(biāo)準(zhǔn)”中包括了哪些方面的考慮？Howdoyoudefineyourequipmentyouaregoingtobuy,andwhatkindsofconsiderationareincludedinURS(UserRequirementSpecification)?“用戶需求標(biāo)準(zhǔn)”和“設(shè)計(jì)確認(rèn)”的批準(zhǔn)程序是怎樣的？WhatisyourprocedureforapprovalofURSandDQ(DesignQualification)?對(duì)于供應(yīng)商能否提供人員培訓(xùn)、校準(zhǔn)和維護(hù)方面的服務(wù)，您和他們進(jìn)行過溝通嗎？Doyou

24、communicatewithsuppliersforavailabilityofservicesintraining,calibration,maintenance,etc.?您有安裝確認(rèn)、運(yùn)行確認(rèn)和性能確認(rèn)方面的程序嗎？DoyouhaveaprocedureforIQ(InstallationQualification),OQ(OperationQualification)andPQ(PerformaneeQualification)?您有以風(fēng)險(xiǎn)評(píng)估為基礎(chǔ)的再確認(rèn)程序嗎？Doyouhavearequalificationprocedurebasedonriskassessment?您有校準(zhǔn)

25、計(jì)劃嗎？Doyouhaveacalibrationprogram?您有預(yù)防性維護(hù)計(jì)劃嗎？Doyouhaveapreventivemaintenanceprogram?您保存了設(shè)備日志（或記錄）嗎？您在日志（或記錄）中記了哪些內(nèi)容？Doyoukeepequipmentlogbooks?Whatdoyourecordinthoselogbooks?您按照藥品GMP（2010年修訂）的要求適當(dāng)進(jìn)行工藝驗(yàn)證了嗎？DoyouperformaprocessvalidationproperlyaccordingtoGMPGuidelines（revisedin2010）?對(duì)于所有通過風(fēng)險(xiǎn)評(píng)估確定的產(chǎn)品關(guān)鍵參

26、數(shù)，您都進(jìn)行了驗(yàn)證嗎？Doyouvalidateallcriticalparametersforyourproductsthathavebeendefinedbyriskassessment?您的工藝驗(yàn)證有哪些種類，前瞻性的、同步性的還是回顧性的？Whatisthetypeoftheprocessvalidation,prospective,concurrentorretrospective?對(duì)于回顧性驗(yàn)證，實(shí)際生產(chǎn)條件和驗(yàn)證批次的生產(chǎn)條件完全一致嗎？Ifthevalidationisretrospective,dotheactualproductionconditionscorrespond

27、exactlytothoseofthevalidationbatches?批記錄中包含那些關(guān)鍵參數(shù)及其控制范圍了嗎？Arethosecriticalparametersandcontrolrangesincludedinthebatchrecord?對(duì)再驗(yàn)證情況是否進(jìn)行了定期審核？Istherearegularreviewprogramaboutrevalidation?您按照藥品GMP（2010年修訂）的要求適當(dāng)進(jìn)行清潔驗(yàn)證了嗎？DoyouperformcleaningvalidationproperlyaccordingtoGMPGuidelines（revisedin2010）?在更換產(chǎn)

28、品的清潔驗(yàn)證中，前一產(chǎn)品的殘留量標(biāo)準(zhǔn)是什么？Inthevalidationforproductchange,whatarethecriteriafortheresiduesofthepreviousproduct?您是按照ICHQ2分析方法驗(yàn)證：文本及方法學(xué)的要求，開發(fā)并且驗(yàn)證殘留物檢出和定量的具體分析方法嗎？DidyoudevelopandvalidateaspecificanalyticalmethodfordetectionandquantificationofresiduesaccordingtoICHQ2ValidationofAnalyticalProcedures:Textand

29、Methodology您公司采用的哪種清潔程序，原位清潔、原位預(yù)洗還是手工清潔？Whatkindofthecleaningprocedureisavailableinyourcompany,CIP（CleaningInPlace）orWIP（WashingInPlace）ormanualcleaning?（清潔驗(yàn)證中）使用的哪種取樣方法，沖洗法、擦拭法還是（無活性成分的）空白產(chǎn)品？如果使用的是擦拭法，您是怎樣選擇取樣點(diǎn)的？使用的是哪種擦拭棒？Whatisthesamplingmethod,rinsing,swabbing,orplacebo?Ifswabbingmethodisused,how

30、doyouselectthesamplingpointsandwhatkindofswabsareused?清潔驗(yàn)證中把整個(gè)生產(chǎn)線的所有非專用設(shè)備都考慮在內(nèi)了嗎，包括中間*產(chǎn)品的（儲(chǔ)存）容器？Isthewholechainofthenon-dedicatedequipmentsconsideredinthecleaningvalidation,includingcontainersforintermediates?您的稱量間是什么樣的？更換品種時(shí)，您對(duì)稱量區(qū)域的清潔情況進(jìn)行哪些檢查(如天平、抽風(fēng)罩等的清潔、無塵)？Whatkindofweighingroomdoyouhave?Whatdoyo

31、ucheckforthecleaningofweighingareaincaseofproductchange(e.g.ifbalances,extractionhood,etc.arecleanedandfreeofdust)?在年度質(zhì)量回顧中，您對(duì)回顧結(jié)果進(jìn)行評(píng)估并把必要的內(nèi)容納入到相關(guān)文件中了嗎？評(píng)估由誰來做？以下列表中的各項(xiàng)內(nèi)容是否都包含在回顧中？Intheannualproductreview,doyouevaluatetheresultsofthereviewandincorporatethemwherenecessaryintotherelevantdocuments?Whois

32、doingtheevaluation?Doesyourreviewcoverallitemsinthefollowinglist?生產(chǎn)和包裝規(guī)程Manufacturingandpackaginginstructions?和上一年度相比的變化，并且檢查其版本Changescomparedtothepreviousyearandchecktheversion?作為變更控制的一部分，所采取的措施Measuresaspartofchangecontrol?變更后的驗(yàn)證狀態(tài)Validationstatusfollowingachange批生產(chǎn)(到包裝工序之前)和包裝記錄Batchproductionan

33、dpackagingrecords?生產(chǎn)和包裝過程中工藝參數(shù)的實(shí)際數(shù)值A(chǔ)ctualvaluesforprocessparametersduringproductionandpackaging?工序過程控制數(shù)據(jù)IPC(InProcessControl)data?偏差Deviations?(每一工序步驟的)收率Yield(foreverystep)?原料Rawmaterials檢驗(yàn)程序Testprocedures?和上一年度相比質(zhì)量標(biāo)準(zhǔn)或方法的變化，并且檢查其版本Changestospecificationsormethodscomparedtothepreviousyearandcheckthe

34、version?作為變更控制的一部分，所采取的措施Measuresaspartofchangecontrol?檢驗(yàn)方法的驗(yàn)證狀態(tài)Validationstatusofthetestmethods檢驗(yàn)報(bào)告和檢驗(yàn)方法Certificatesofanalysisandtestmethods?均值、單個(gè)值和原始數(shù)據(jù)Averages,individualvaluesandrawdata?偏差Deviations?超標(biāo)檢驗(yàn)數(shù)據(jù)OOS?故障原因分析Failurecauseanalysis原料的檢驗(yàn)結(jié)果，和供應(yīng)商（檢驗(yàn)）數(shù)據(jù)的對(duì)比Analyticalresultsforrawmaterialsandcompar

35、isonwithsuppliersdata?供應(yīng)商確認(rèn)Supplierqualification?偏差、拒收（情況）Deviations,rejections關(guān)鍵文件的修訂Modificationinkeydocuments?建筑物方面的變更（如房間級(jí)別、換氣等）Changestothebuilding（e.g.classificationofrooms,ventilation,etc.）?機(jī)器或設(shè)備裝置方面的變更（軟件升級(jí)、增加控制點(diǎn)等）Changestomachines/apparatus（softwareupdates,additionalcontrolpoints,etc.）?較高層級(jí)

36、文件的變更（變更控制、超標(biāo)檢驗(yàn)數(shù)據(jù)、驗(yàn)證總計(jì)劃等）Changesinhigherleveldocuments（changecontrol,OOS,validationmasterplan,etc.）已提交的、獲批準(zhǔn)的或遭到拒絕的注冊(cè)申請(qǐng)MarketingAuthorizationssubmitted,approvedorrejected?已提交的注冊(cè)申請(qǐng)Authorizationssubmitted?已獲批準(zhǔn)的注冊(cè)申請(qǐng)Authorizationsapproved?遭到拒絕的注冊(cè)申請(qǐng)及其原因Authorizationsrejectedandreasons質(zhì)量偏差（內(nèi)部投訴）Deviationsi

37、nquality（internalcomplaints）?根本原因分析及（后續(xù)措施）跟蹤Rootcauseanalysisandfollow-up投訴和召回Complaintsandrecalls?原因分析和（后續(xù)措施）跟蹤C(jī)auseanalysisandfollow-up穩(wěn)定性數(shù)據(jù)Stabilitydata?目前的數(shù)據(jù)支持注冊(cè)申請(qǐng)資料中對(duì)（產(chǎn)品）穩(wěn)定性的說法嗎？Doesthecurrentdatasupportthestabilitydeclaredinthesubmissionfileformarketingauthorization?包裝材料的變更Changestopackagingma

38、terial?工藝變更Processchanges?處方變更Recipechanges趨勢Trends?工藝能力指數(shù)Cpk(processcapabilityindices)退貨或挽回的藥品Returnedorsalvageddrugproducts?產(chǎn)品及其批號(hào)的清單Listingofproductsandbatchnumbers?退貨原因Reasonsforreturns您是按照藥品GMP(2010年修訂)要求組織庫房(管理)的嗎？DoyouorganizeyourwarehouseproperlyaccordingtotheGMPGuidelines(revisedin2010)?貨物接

39、收程序是怎樣的？檢查清單中有哪些主要內(nèi)容？Whatistheprocedureforthegoodsreception?Whichelementsareincludedinyourchecklist?您的庫房是怎樣劃分的？您是怎樣將不同產(chǎn)品(原料、包裝材料、成品等)分開的？Howdoyoudivideyourwarehouseandseparateyourproducts(rawmaterials,packagingmaterials,finishedproducts,etc.)?取樣間設(shè)置的基本原則是什么？Whatistheprincipleofyoursamplingroom?您的托板有哪

40、些種類(塑料的、木質(zhì)的或其他材質(zhì)的)？Whatkindofpalletsdoyouhave(plastic,woodenorother)?您的庫房做溫度分布測試了嗎？Haveyoudonetemperaturemappingwithinyourwarehouse?您是怎樣記錄庫房溫濕度的？Howdoyourecordthetemperatureandhumidityinyourwarehouse?您有B-內(nèi)酰胺類或頭抱菌素類物料嗎？您是怎樣對(duì)它們單獨(dú)儲(chǔ)存和取樣的？DoyouhaveB-lactamorcephalosporinmaterials,andhowdoyouseparatethemf

41、orstoringandsampling?您是怎樣給原料容器貼標(biāo)簽的？標(biāo)簽上標(biāo)示了哪些信息？您使用的標(biāo)簽是什么樣的？Howdoyoulabelcontainersofrawmaterials?Whatkindofindicationsareonthelabel(s),andwhatkindoflabel(s)doyouuse您是怎樣進(jìn)行蟲鼠害控制的？您對(duì)控制措施的有效性定期進(jìn)行評(píng)估嗎Howdoyouperformthepestcontrol,anddoyouhavearegularevaluationontheefficacyofthecontrolmeasures?您有對(duì)原料和包裝材料供應(yīng)商

42、的認(rèn)可程序嗎？Doyouhaveasupplierqualificationprocedureforrawmaterialsandpackagingmaterials?您的供應(yīng)商資料中包括哪些文件？Whatdocumentsareincludedinyoursupplierprofile?您對(duì)供應(yīng)商有持續(xù)性的評(píng)估程序以及相應(yīng)的評(píng)級(jí)嗎？取樣的程序和（供應(yīng)商）評(píng)級(jí)有關(guān)聯(lián)嗎？Doyouhaveanongoingevaluationprocedureandacorrespondingrankingforsuppliers?Isthesamplingprocedurelinkedwiththeranki

43、ng?您多長時(shí)間或者在什么情況下對(duì)原料供應(yīng)商進(jìn)行一次審計(jì)？是現(xiàn)場審計(jì)還是通過文件來審計(jì)？Howoftenorunderwhatconditionswillyouauditthesuppliersofstartingmaterials?Doyouauditbyvisitingorbydocuments?您有審計(jì)內(nèi)容清單嗎？Doyouhaveachecklistfortheaudits?您和供應(yīng)商是否簽有合同，在合同中明確要求（物料）質(zhì)量和工藝發(fā)生變更時(shí)須提前通知？Doyouhaveacontractwithsuppliersspecifyingchangesinqualityandprocess

44、mustbenotifiedinadvanee?您公司是否按照藥品GMP（2010年修訂）的要求進(jìn)行委托生產(chǎn)或委托檢驗(yàn)（如有）？Ifyouhaveanycontractmanufacturing/testingarrangementbyyourcompany,doyoufollowrequirementsoftheGMPGuidelines（revisedin2010）?在雙方簽訂合同前，委托方是怎樣評(píng)估受托方的？Howdoesthecontractgiverevaluatethecontractorortesterbeforemakingthecontract?合同中是否明確規(guī)定了質(zhì)量保證和

45、成品放行的職責(zé)？DoesthecontractspecifytheresponsibilitiesfortheQAmeasures,andforthereleaseofthefinishedproducts合同中是否明確規(guī)定了偏差、超標(biāo)檢驗(yàn)數(shù)據(jù)和異常情況的報(bào)告職責(zé)？哪一方負(fù)責(zé)跟蹤后續(xù)措施Doesthecontractspecifytheobligationsforreportingdeviations,OOSandabnormalsituations?Andwhichsideisresponsibleforfollow-upactions?委托方是否向受托方提供有關(guān)生產(chǎn)或檢驗(yàn)方法的完整技術(shù)信息

46、和培訓(xùn)？Doesthecontractorortestergetthecompletetechnicalinformationandtrainingfromcontractgiveraboutmanufactureortestmethod?受托方是否向委托方提供所有的生產(chǎn)或檢驗(yàn)記錄？Doesthecontractgivergetallmanufactureortestrecordsfromcontractorortester?委托方是否定期檢查或評(píng)估受托方？Doesthecontractgiverperformregularinspectionsorevaluationsofthecontra

47、ctorortester?您公司質(zhì)控實(shí)驗(yàn)室工作是按照藥品GMP（2010年修訂）要求妥善組織的嗎？IstheQClaboratoryofyourcompanywell-organizedaccordingtotheGMPGuidelines（revisedin2010）?質(zhì)控實(shí)驗(yàn)室的儀器設(shè)備有校準(zhǔn)和確認(rèn)程序嗎？DoyouhavecalibrationandqualificationproceduresfortheQClaboratoryequipment?您是否驗(yàn)證了所有的分析方法？對(duì)于藥典方法，您是怎么做的？Doyouvalidateallanalyticalmethods,andwhatd

48、oyoudoforthepharmacopoeiamethods?對(duì)于試劑試藥，您是怎樣貼瓶簽的？標(biāo)簽上有哪些信息？Howdoyoulabelyourreagentsbottles?Whatinformationisonthelabel標(biāo)準(zhǔn)溶液的制備程序是怎樣的？Whatistheprocedureforpreparingstandardsolutions?您怎樣確認(rèn)使用中的標(biāo)準(zhǔn)品（或?qū)φ掌罚┑挠行?？Howdoyouconfirmyouareusingthevalidrefereneestandards?除了（官方或公認(rèn)的）標(biāo)準(zhǔn)品（或?qū)φ掌罚┲?，您使用工作?biāo)準(zhǔn)品（或?qū)φ掌罚﹩?？工作?biāo)準(zhǔn)品（

49、或?qū)φ掌罚┑闹苽浜蜆?biāo)化程序是怎樣的？Inadditiontorefereneestandards,doyouuseworkingstandards,andwhatistheprocedureforpreparingandstandardizingthem?您是否保存了儀器設(shè)備日志（或記錄）？Doyoukeepequipmentlogbooks?您怎樣收集原始數(shù)據(jù)？是用本子還是用散頁的紙張來記錄那些數(shù)據(jù)？Howdoyoucollectyourrawdata,andaretheyinnotebookorloosesheets?您怎樣保存原料和成品的留樣？Howdoyoukeepyourretent

50、ionsamplesofrawmaterialsandfinishedproducts?您以什么為基礎(chǔ)制定持續(xù)穩(wěn)定性研究計(jì)劃？您怎樣保存樣品？Onwhatbasedoyoumakeaplanforon-goingstabilitiesstudy,andhowdoyoukeepthesamples?您怎樣管理電子數(shù)據(jù)，包括色譜圖和記錄？Howdoyoumanagetheelectronicdata,includingchromatographsandrecords?原料和內(nèi)包裝材料有取樣室嗎？取樣區(qū)域是什么（潔凈）級(jí)別？Doyouhaveasamplingroomforstartingmater

51、ialsandprimarypackagingmaterials?Whatistheclassificationofsamplingarea?您是按照藥品GMP（2010年修訂）要求制定的偏差調(diào)查程序嗎？DoyouhaveadeviationinvestigationprocedurefollowingrequirementsoftheGMPGuidelines（revisedin2010）?您對(duì)偏差是怎么定義的？偏差定義中是否涵蓋了和質(zhì)量有關(guān)的所有方面，即生產(chǎn)、質(zhì)控、庫存、維護(hù)，以及原料藥、輔料和包裝材料采購等？Howdoyoudefinedeviations?Doesitcoverallq

52、ualityrelevantaspects,duction,QC,storage,maintenance,sourcingofAPIs,excipientsandpackagematerials,etc.?您對(duì)偏差是怎樣分級(jí)的？分級(jí)依據(jù)是什么？不同分級(jí)對(duì)應(yīng)的后續(xù)處理程總序是什么？Howandonwhatbasisdoyouclassifydeviations?Whataretheconsequentactionscorrespondingtodifferentclassifications?您對(duì)操作人員進(jìn)行關(guān)于偏差的培訓(xùn)了嗎？您是否鼓勵(lì)他們只要發(fā)現(xiàn)偏差就向主管報(bào)告？Doopera

53、torsgettrainingaboutdeviation,andaretheyencouragedtoreportdeviationtosupervisorswheneverithappens?誰來決定偏差的歸類，進(jìn)行偏差調(diào)查，啟動(dòng)根本原因分析及必要的措施（附加的檢驗(yàn)、增加取樣量等），做出放行或拒收決定，確定可能的糾正和預(yù)防措施，跟蹤落實(shí)情況以及確定偏差是否處理完畢，并且設(shè)定這些工作的完成時(shí)限？Whowilldecideontheclassificationofthedeviation,handlethedeviationinvestigation,initiaterootcauseanal

54、ysisandnecessaryactions（additionaltesting,increasingsamplingamount,etc.）,decideforbatchreleaseorrejection,possibleCAPA,followupandclosure,andsettimelimitsforthem?您制定根本原因調(diào)查程序了嗎？您是怎樣組織調(diào)查的？Doyouhaveaprocedureforrootcauseinvestigationandhowdoyouorganizetheinvestigation?偏差是個(gè)例問題，還是可能會(huì)影響到不同的產(chǎn)品或批次？Isthedevi

55、ationaone-timeissueorcanitinfluencedifferentproductsorbatches?您有偏差日志（或記錄）嗎？所有偏差都記在里面了么？Doyouhaveadeviationlogbook,whichincludesalldeviations?您是按照藥品GMP（2010年修訂）要求制定的超標(biāo)檢驗(yàn)數(shù)據(jù)調(diào)查程序嗎？DoyouhaveanOOSinvestigationprocedure,whichfollowstherequirementsoftheGMPGuidelines（revisedin2010）?您總是把所有的溶液、標(biāo)準(zhǔn)品（或?qū)φ掌罚┑韧咨票４嬷翙z驗(yàn)完畢嗎？Doyoualwayskeepallsolutions,standards,perlyuntiltheendofthetest?您是在檢驗(yàn)數(shù)據(jù)超標(biāo)情況發(fā)生之后就馬上開始調(diào)查嗎？DoyoustarttheOOSinvestigationimmediatelyafteritshappening?您在重新開始檢驗(yàn)前，是否按程序?qū)徍藬?shù)據(jù)、檢查儀器或系統(tǒng)適用性是否有故障、是否用錯(cuò)了試劑、計(jì)算或數(shù)據(jù)錄入是否有誤？Beforeyoustartaretest,doyouhaveaprocedurefor