制药行业GMP英文词汇

《制药行业GMP英文词汇》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、Approve批准Artwork药品标签AuthorizedPerson，AQWHO关于质量受权人BacteriostaticWaterforInjection抑菌注射用水Batch-basedproduction按批次生产Blending混合Blendingbatches混批Calibration校验Calibration校准Campaign-basedproduction阶段性生产Checked校验Cleananceorsitecleaning清场Cleaning清洁CleaningValidation清洁验证ClinicalTrials临床研究Contamin

2、ation污染ContaminationControl污染控制Continuousproduction连续生产Contractmanufacturing委托生产ContractAnalysis委托检验CoolStorage阴凉储存CriticalDeviation关键偏差CriticalProcessParameter关键工艺参数CriticalProcessingStep关键操作步骤Crosscontamination交叉污染Designqualification,DQ设计确认Deviation偏差DrinkingWater饮用水DryPlace干燥储存educa

3、tion个人学历Equipmentlogbook设备使用日志Excessiveheat过热ExpectedYield,expected预期收率experience工作经验ExpiryDate有效期FactoryAcceptanceTest，FAT供应商工厂的验收测试FreezerStorage冷冻储存HoldingTime贮存期I：Implemente执行Impurityprofile杂质概况In-processControls过程控制In-processSampling过程取样Installationqualification,IQ安装确认Intermediate

4、中间体Logbook使用日志MaintenanceBasicPractice维护基本实践MaintenanceBestPractice维护最佳实践MaintenanceGoodPractice维护良好实践MaintenancePlan维护计划MaintenanceProgram维护管理程序Manufacture制造MasterCellBank,MCB主细胞库mix-ups混淆Non-conformance不合格Operationqualification,OQ运行确认OutofSpecification,OOS超标Performancequalification,P

5、Q性能确认PreliminaryCellBank,PCB原始细胞库PreventiveMaintenance预防性维护Production生产ProductionOperations生产操作PurifiedWater纯化水QaultiyAssurance，QA质量保证Qualification确认QualifiedPerson，QP质量受权人QualityAgreement质量协议QualityControl，QC质量控制QualityManagement，QM质量管理Qualityreview质量审核QualityUnit，QU/QualityOperations

6、，QO质量管理部门Responsible负责Rechecked复验Reconciliation物料平衡RefrigeratorStorage冷藏储存Reject拒收Retestdates复验期RiskAssessment风险评估RoomTemperatureStorage室温储存SafetyEnvironmentHealth,EHS环境、健康及安全Semi-continuousproduction半连续生产SiteAcceptanceTest，SAT用户工厂的验收测试Specification质量标准Stability稳定性SterilePurifiedWater灭

7、菌纯化水SterileWaterforInhalation灭菌吸入用水SterileWaterforInjection灭菌注射用水SterileWaterforIrrigation灭菌冲洗用水SubdividingOperation分装操作TamperEvidence防篡改封签TimeLimits生产时限training培训UpdateBatchProductionRecord,BPR批记录UserRequirementSpecification,URS用户需求标准Validation验证Validationmasterplan验证主计划Verification