产品质量回顾操作规程

resource-processingenterprisestheproportionofproductionvalueofindustrialoutputreached......%.High-techindustrialoutputvalueaccountsforonly......%,belowthecity-wideaverage......Apercentagepoint,and......Ofapercentagepoint.Levelofindustrialdevelopment,backboneenterprisesgrow,totalinvestmentinstrategicindustriesandthegrowthrateoftheseindicatorsinall......Rankingsarerelativelybackward.Atpresent,theincreasinglyserioussituationofenergysavingandemissionreduction,newnormalrequiredshouldfocusmoreonthequalityandefficiencyofeconomicdevelopment.Improvementofqualityandefficiencymustrelyonadvancedtechnologyandtalentsintothelead.Threeistoimplementthreeisthemaindrivingforceforacceleratingurbanization.Urbanizationisanimportantcharacteristicofurbanpopulationgrowth,urbanexpansion,improvethequalityofpeople'slives.Realizationofthesefactors,needtoattractgoodasthecarrieroftheproject,providejobsformorepeople,maketownsmoreattractive,promoteeconomicdevelopmentthroughouttheregion.Onlybyvigorouslypromotingthree,wecanattractmoreprojects,moreenterprises,forthetowntobuildasolidfoundation,toprovideaninexhaustiblepower.Fouristheimplementationofthreeisthetoppriorityofeverytown,street,Department.ThreeastheCounty'sfirstproject,corework,eachtownmustseize,grasptherealityofthestreet.Atpresent,theCountyalsofullytakeintoaccountthepracticaldifficultiesexistinvillagesandtowns,determinedbythewagesof运营保障部分行政管理、物业管理、党群工作和IT信息四个职能方向。行政管理下设综合主管、综合管理（内勤）、后勤保障、固定资产管理resource-processingenterprisestheproportionofproductionvalueofindustrialoutputreached......%.High-techindustrialoutputvalueaccountsforonly......%,belowthecity-wideaverage......Apercentagepoint,and......Ofapercentagepoint.Levelofindustrialdevelopment,backboneenterprisesgrow,totalinvestmentinstrategicindustriesandthegrowthrateoftheseindicatorsinall......Rankingsarerelativelybackward.Atpresent,theincreasinglyserioussituationofenergysavingandemissionreduction,newnormalrequiredshouldfocusmoreonthequalityandefficiencyofeconomicdevelopment.Improvementofqualityandefficiencymustrelyonadvancedtechnologyandtalentsintothelead.Threeistoimplementthreeisthemaindrivingforceforacceleratingurbanization.Urbanizationisanimportantcharacteristicofurbanpopulationgrowth,urbanexpansion,improvethequalityofpeople'slives.Realizationofthesefactors,needtoattractgoodasthecarrieroftheproject,providejobsformorepeople,maketownsmoreattractive,promoteeconomicdevelopmentthroughouttheregion.Onlybyvigorouslypromotingthree,wecanattractmoreprojects,moreenterprises,forthetowntobuildasolidfoundation,toprovideaninexhaustiblepower.Fouristheimplementationofthreeisthetoppriorityofeverytown,street,Department.ThreeastheCounty'sfirstproject,corework,eachtownmustseize,grasptherealityofthestreet.Atpresent,theCountyalsofullytakeintoaccountthepracticaldifficultiesexistinvillagesandtowns,determinedbythewagesof1目的1.1.采用一系列的生产或质量控制数据的回顾性分析，来确认在现行的生产工艺及控制方法条件下产出的产品其安全性、有效性、持续性及质量符合规定的水平。1.2.发现明显趋势，对产品作出正确分析和评价，以利于更好地改进。1.3.通过向药品监管部门上报产品年度质量回顾分析，可使药品监管部门掌握企业的年度产品质量动态及企业质量管理的效果，总结经验，纠正偏差，提高监管效率。1.4.通过产品质量回顾分析，可以向企业决策层提供最新产品质量信息，还可以成为生产、质量、注册事务和不良反应监测之间交流的重要工具，有利于产品质量的持续改进及提高。1.5.寻找改进产品或降低成本的途径。1.6.评估变更控制系统的有效性。2范围产品质量回顾应包括本企业生产的所有产品，包括委托生产及委托加工的产品。3责任参与产品年度质量回顾的职责部门包括：质量部（QA、QC）、生产技术部、物资部、研发部、设备部等部门。依据各职能部门的工作职责，分工如下：3.1药品质量受权人的职责3.1.1督促企业按计划开展产品年度质量回顾；3.1.2批准产品年度质量回顾报告；3.1.3每年将企业生产的产品（包括委托生产或委托加工产品）的年度质量回顾情况，以书面形式报告当地药品监督管理部门；3.2质量部QA的职责3.2.1建立企业的产品质量回顾管理程序并负责对相关人员进行有效地培训；3.2.2负责制订产品年度回顾计划；3.2.3协调产品年度回顾数据的收集；3.2.4起草年度回顾报告；3.2.5组织相关部门对报告的讨论；3.2.6跟踪及评价报告中确定的纠正或/及预防措施的实施情况并报告；3.2.7产品质量回顾信息汇总、会议召集、报告的整理、评价、审批、汇报、分发及归档。resource-processingenterprisestheproportionofproductionvalueofindustrialoutputreached......%.High-techindustrialoutputvalueaccountsforonly......%,belowthecity-wideaverage......Apercentagepoint,and......Ofapercentagepoint.Levelofindustrialdevelopment,backboneenterprisesgrow,totalinvestmentinstrategicindustriesandthegrowthrateoftheseindicatorsinall......Rankingsarerelativelybackward.Atpresent,theincreasinglyserioussituationofenergysavingandemissionreduction,newnormalrequiredshouldfocusmoreonthequalityandefficiencyofeconomicdevelopment.Improvementofqualityandefficiencymustrelyonadvancedtechnologyandtalentsintothelead.Threeistoimplementthreeisthemaindrivingforceforacceleratingurbanization.Urbanizationisanimportantcharacteristicofurbanpopulationgrowth,urbanexpansion,improvethequalityofpeople'slives.Realizationofthesefactors,needtoattractgoodasthecarrieroftheproject,providejobsformorepeople,maketownsmoreattractive,promoteeconomicdevelopmentthroughouttheregion.Onlybyvigorouslypromotingthree,wecanattractmoreprojects,moreenterprises,forthetowntobuildasolidfoundation,toprovideaninexhaustiblepower.Fouristheimplementationofthreeisthetoppriorityofeverytown,street,Department.ThreeastheCounty'sfirstproject,corework,eachtownmustseize,grasptherealityofthestreet.Atpresent,theCountyalsofullytakeintoaccountthepracticaldifficultiesexistinvillagesandtowns,determinedbythewagesof运营保障部分行政管理、物业管理、党群工作和IT信息四个职能方向。行政管理下设综合主管、综合管理（内勤）、后勤保障、固定资产管理Countyfinancialisresponsi