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50ensurethatfacilitiesandequipmenta...
