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anisationalstructure生产production质量相关事物qualityrelatedactivities包装packaging偏差deviation重包装repackaging关键偏差Criticaldeviations贴标labelling评价evaluation重贴标relabelling药政检查regulatoryinspections质量控制qualitycontrol严重GMP缺陷seriousGMPdeficiencies放行release审核并批准reviewandapprove储存storage委派delegate销售distribution拒收reject安全方面safetyaspects包装物和标签packagingandlabellingmaterials环境保护protectionoftheenvironment实验室控制记录laboratorycontrolrecord国家法律nationallaws标准specifications注册registration主生产文件masterproductioninstructions人用药humandrug自检internalauditsself-plaints化学合成chemicalsynthesis维护maintaining提取extraction校正calibrating发酵fermentation稳定性数据stabilitydata排除exclude复验/失效日期retestorexpirydates临床试验clinicaltrials存储条件storageconditions起始物料StartingMaterial产品质量回顾productqualityreviews结构单元structuralfragment批生产记录productionbatchrecords供应商supplier设施premises化学性质chemicalproperties设施变更modifiedfacilities具体分析case-by-anisms潜在污染potentialcontamination非无菌non-sterile微生物标准microbiologicalspecifications专用的Dedicated混淆mix-essivebatches交叉污染cross-contamination非专用设备Non-puterizedSystems文件系统DocumentationSystem电子格式electronicform修订历史revisionhistories电子签名electronicsignatures扩产报告scale-upreports中间控制in-processcontrols技术转化technicaltransfer内控检测in-housetesting开发历程报告developmenthistoryreports中试规模pilotscale保留期限retentionperiods历史数据historicaldata生产工艺规程MasterProductionInstructions不合格Out-of-ingmaterials预验证Prospectivevalidation回顾性验证retrospectivevalidation结晶crystalliza