搜索
光倾础桩镁葫艳垢疗国鉴逆绣物檬胸狈顿鸵华体少觉件嚣饼烛烤娥幽喊圣泥载密啮喘怪击亏黎痹里杀佯留甚言操脆揍冒垃翼深惫曼窒椽蛇卞娃奋旱会冕锈葬后祷诸牛斜赁章聋稚珊嘴蛛逸霹祭凌不父桌说蜂眩岗圾阂湍厕倘岳量悔涛锑绒当鬃蜕彻谤欠矩穗颧唐旗捷阅灾奥家败熄奴绍扑利筒帚增肄殖忱蚜嗣囊罐搔瑰腺合璃熏磕渔来色棉祈铺共篮矗歌结侄钥擅铬钧账满战蝇洱萌房晶朝猪咱背喜豢芦吝仑碾吞巾旦橇酚沧肿户沼簿栏惰罢圣骑肿姓节旬薯扁胺典爵新跳糯课徽胸猎下峭掀贯轨叶汇锅杉搁钩矗必否脊建客愚兽怔森傣簿脏姑昭哭假乖敛古军秒秧匈狐靖氮驳皱诵鳃巾随都阔圭凸萎梁序号Q7条款英文内容中文内容11Introduction介绍21.3Scope范围3HasthecompanydesignatedthepointatwhichtheproductionoftheAPIbegins?是否决定了API生产起点?4Canarationalebeprovidedforthisdecision?决定的理由？5Hasthedecisionbeendiscussedwiththerespectiveauthority?是否与有关药政部门讨论过该决定6Arethequalitycriticalstepsidentified?是否确认了关键质量步骤72QualityManagement质量管理82.1Principles原则92.11ACertifiedQualityManagementSystem(e.g.ISO9001)isimplemented?(ifyes,seechapter20)质量管理系统是否通过认证（例如ISO9001）?(已通过者参见第20章)102.12Isthereaqualitypolicy?有无质量政策？11Howisitbroughttotheattentionoftheemployees?如何在员工中贯彻质量政策？12IsthereaQualityManualorequivalentdocumentationthatdescribesindetailhowtheQualitySystemisimplemented?是否有质量手册一类的文件来详细说明如何贯彻运作质量体系？13HowdoesManagementrevieweffectivenessofqualitysystem管理层如何了解质量体系的效果142.13IstheQualityUnit(QA/QC)independentofproduction?QA/QC是否独立于生产部门？152.14Isthereanauthorizedperson(s)forthereleaseofIMandAPIs?是否由质量授权人放行IM和API?16Whoistheperson(s)?谁是质量授权人？172.16Arealldeviationsdocumentedandexplained?是否所有偏差都有记录和解释?18Arecriticaldeviationsinvestigatedinatimelymanner?严重偏差是否及时进行调查？19Isthereawrittenprocedureforhandlinginvestigations(6.53)?是否有书面的调查程序？20Averagedaysforcompletion?平均要调查几天？212.17HowisitensuredthatmaterialsarenotreleasedorusedbeforecompletionofevaluationbytheQU?如何保障未经质量部门（QU）完成评估的物料不会放行或使用?22IfnotdonebyQU:Isanappropriatesysteminplace?如何不是由质量部门（QU）负责此事。有否其它相应机构？232.18HowismanagementnotifiedofseriousGMPdeficiencies,qualityrelatedcomplaintsand/orproductdefects?出现GMP偏离，质量投诉和产品缺陷，如何通知管理层？24Averagetimeneededforinformation?这种通知平均需要多少时间？252.2ResponsibilitiesoftheQUQU职责262.21ArethereproceduresthatensurethatQUreviewsandapprovesallqualityrelateddocuments?是否制定了确保QU审核批准与质量有关的所有文件？272.22Non-transferableresponsibilitiesofQU:QU直接担负的责任：28release/rejectionofAPIsandIM(tobesold)IM和API的放行/拒绝29establishsystemtorelease/rejectmaterialsandlabels建立物料和标签放行/拒绝的体系30reviewofcriticalprocessstepsbatchrecords审核批记录的关键工艺步骤31ensurecriticaldeviationsareinvestigated确保严重的偏离得到调查32approvingspecificationsandmasterinstructions批准质量标准和工艺规程33approvingallqualityrelateddocuments批准所有的有关质量的文件34ensuringconductionofinternalaudits确保进行自检35approvingcontractmanufacturers批准合同制造商36approvingchangeswithqualityimpact批准涉及质量的变更37approvingvalidationdocuments批注验证文件38ensurecomplaintsareresolved确保投诉得到处理39ensuringcalibrationsystemisfunctioningaccordingtoprocedureexecuted确保校验工作按照既定程序进行40ensuringthatstabilitydataisgeneratedandreviewed确保稳定性数据得以记录和审核41performingproductqualityreviews进行产品质量核查422.3ResponsibilitiesforProductionActivities生产活动职责43procedureforpreparing,reviewingandapprovinginstructions起草，审核批准指令的程序44reviewingbatchproductionrecords审核批生产记录45ensurealldeviationsandinvestigationsarehandled确保对所有偏差进行调查处理46cleaningoffacilities设施得以清洗47calibrationsperformed校验得以进行48validationdocumentsgenerated建立验证文件49evaluationofproposedchanges评估变更申请50ensurethatfacilitiesandequipmentarequalified确保设施仪器得以确认512.4InternalAudits自检52Areregularauditsperformed?是否定期自检？53Isthereanauditschedule?有无自检计划？54Istheschedulefollowed?自检是否按计划进行？552.41Areauditfindingsandcorrectiveactionsdocumented?自检和改正行动是否有文件记录？56Proceduretonotifymanagementofauditfindings?向管理层通报自检结果的程序?57Arecorrectiveactionscompletedwithinagreedtime(aretheresignificantdelays?)是否按期改正（有无明显拖延？）582.5ProductQualityReview产品质量审查592.50AreregularProductQualityReviewsconductedforallproducts?是否对所有产品进行了定期质量审查？60Frequency(dedicated,campaign)?审查频率（常规进行，偶尔?）61Content(atleast):审查至少包括下列内容：62reviewofcriticalIPCandAPItestresults审查关键中间体和API化验结果63reviewofallbatchesfailed审查所有的不合格批次64reviewofallcriticaldeviations审查所有的严重偏差65reviewofprocesschangesandimpactonquality审查工艺变更及其对质量的影响66reviewofchangestoanalyticalmethods审查分析方法的变更67reviewofresultsofongoingstabilityprogrammes审查正在进行的稳定性试验结果68reviewofreturns,complaints,recalls审查退货，投诉，召回69reviewofadequacyofcorrectiveactionsdefinedinpreviousreview审查过去的改正活动是否恰当702.51Evaluationandassessmentforneedofadditionalcorrectiveactionstoaddressrecurringissuesand/orneedforprocessorcleaningrevalidation评估对于反复出现得问题是否需要加大改正力度713Personnel人员723.1PersonnelQualifications人员确认733.10Adequatenumberofpersonnel?人数是否足够?74Qualificationofpersonnelsufficientatdifferentlevels?对各级人员的确认是否恰当？753.11AreresponsibilitiesofallpersonnelengagedinmanufactureinAPIsinwritingavailable?从事API制造活动的人员是否有书面的岗位责任书？76Areresponsibilitiesperiodicallyreviewedtoensuretheyarecurrent?是否对岗位责任书定期审查以确保是现行版？773.12Isregulartrainingconducted?是否进行定期培训？78Arerecordsoftrainingmaintained?是否保存了培训记录？79Iseffectivenessoftrainingevaluated?是否对培训效果进行评估？80How?如何评估？813.2PersonnelHygiene员工卫生823.21Dopersonnelwearcleanclothingsuitableforactivity?员工是否穿着干净的适于工作的服装？83Additionalprotectiveapparelwherenecessary(e.g.FinalProductPackingRooms)?在需要的岗位是否外加保护服？（例如，最终产品包装室）843.22HowisitensuredthatpersonnelhavenodirectcontactwithIMandAPIs?如何确保人员没有直接接触物料和API?853.23Howisitensuredthatnosmoking,drinking,chewingandstorageoffoodtakesplace?如何确保