Copy of Production Report Aug

BS Brain Storming 脑力激荡Facilities Design and Planning设施规划与设计Material Flow System Analysis物流系统分析Production Planning and Control生产计划与控制Human Engineering人机工程(工效学)Cost Control成本控制Value Engineering价值工程Work Assessment工作评价与考核Engineering Economics Analysis工程经济分析Machine Interference机器干扰Single Minute Exchange of Dies (SMED) 六十秒即时换模Fool-Proof 防止错误法(防错法)Man 人Machine 机Material 料Method 法Environment 环境Temperature(temp)温度Humidity湿度leaning curve学习曲线Time measurement 时间测量Methods of time measurement原则时间测量(MTM)Shop floor observation 现场观测Line Balancing 线平衡Value有价值NO VALUE 无价值Incidental work(necessary)必要Waste挥霍Takt Time生产节拍Transport Empty 伸手Grasp 握取Move 移物Disassemble 折卸Use 应用Assemble 装配Release Load 放手Inspect 检查Search 寻找Select 选择Play 计划Pre-Position预定位Position 定位Hold 持住Rest 休息Unavoidable Delay 迟延Avoidable Delay 故延E: Elimination剔除C :Combination合并R: Re-arrangement重排S :Simplification简化PRA-Probabilistic Risk风险率评估Risk Priority Number (RPN) 风险关键指数What 完毕了什么where 何处做When 何时做who 由谁做Why 为何这样做how 何时做delay等待operation操作inspection检查transportation搬运storage储存Color management 颜色管理Quality Control Circle 品管圈(QCC)Activity-Base Management作业制成本管理(ABM)In-Process Quality Control制程质量管理(IPQC)Incoming Quality Control进料质量管理(IQC)International Organization for Standardization国际原则组织(ISO) Predetermined Motion Time Standard 简称PTS 预定动作时间原则法Methods-time-measurement 措施时间衡量Work factor system 工作原因法(WF)Modolar arrangement of pre-determind time standard MOD法Leveling 平准化= westing 西屋法objective rating 客观评比synthetic leveling 合成评比Work Sampling 工作抽样Motion time analysis 动作时间分析Business Process Reengineering (BPR)企业流程再造Enterprise Resource Planning ERP企业资源规划Economic Order Quantity (EOQ)基本经济订购量Flexible Manufacture System 弹性制造系统(FMS)Finish or Final Quality Control成品质量管理(FQC)In-Process Quality Control制程质量管理(IPQC)Incoming Quality Control进料质量管理(IQC)Just In Time实时管理(JIT)Manufacturing Execution System制造执行系统(MES) Master Production Scheduling主生产排程(MPS) Master Production Planning主生产计划Material Requirement Planning物料需求规划(MRP) Manufacturing Resource Planning制造资源计划(MRPII) Operation Scheduling作业计划Flow shop流水车间Optimized Production Technology最佳生产技术Supply Chain Management供应链管理(SCM)Statistic Process Control记录制程管制(SPC)Total Production Management全面生产管理(TPM) Total Quality Management全面质量管理(TQM)Zero Defect Quality Control零缺陷质量管理:PDCA Cycle PDCA循环:continue Improvement持续改善:Project项目Project Manager项目经理Project Management项目管理Project Plan项目计划Process Improvement现场改善WORK IN PROCESS 半成品Visual management 目视管理bottleneck 瓶颈Layout 布置图quality engineering 质量工程人员(QE)first article inspection 新品首件检查(FAI)first article assurance首件确认(FAA)capability index能力指数(CP)Quality Improvement Team 质量改善小组(QIT)Classification整顿(sorting, organization)-seiriRegulation整顿(arrangement, tidiness)-seitonCleanliness打扫(sweeping, purity)-seisoConservation清洁(cleaning, cleanliness)-seiktsuCulture教养(discipline)-shitsukeSave 节省Safety安全Make-to-stock备货型生产(MTS)Make-to-order订货型生产(MTO)Assemble-to-order按订单装配(ATO)Flexible manufacturing system柔性制造系统Group technology成组技术(GT)Concurrent engineering并行工程(CE)Time compression technology时间压缩技术(TCT)Business process reengineering业务过程重组(BPR)Agile manufacturing敏捷制造(AM)Leap production精细生产(LP)Intelligent manufacturing 智能制造(IM)Computer-aided-manufacturing计算机辅助制造(CAM) Computer-aided-design计算机辅助设计(CAD)Computer-aided-engineering计算机辅助工程(CAE)Computer-aided-process planning计算机辅助工艺编制( CAPP) overall cost leadership成本优先differentiation独具一格Market focus集中一点cost efficiency成本效率quality质量Dependability可靠性Flexibility柔性product date management产品数据管理(PDM)Facility location设施选址Fixed position layout固定式布置process layout工艺过程布置layout based on group technology成组制造单元布置Job design工作设计work measurement工作测量Time study时间研究Basic motion study基本动作世界研究法(BMS)Modolar arrangement of predetermind time standard模特法Human factor engineering人因工程business plan经营计划Fixed capacity固定能力Adjustable capacity可?#123;整能力production rate生产率Inventory库存Job-shop production单间小批生产Bill of materials (BOM)物料清单文献Lead time提前期modular bill of materials模块物料清单Maximum part-period gain最大周期收益(MPG) distribution requirements planning分派需求计划scheduling编制作业计划sequencing排序Dispatching派工controlling控制expediting赶工supply chain供应链Purchasing Management采购管理Quick Response迅速顾客反应JIT Purchasing准时采购physical distribution物流Materials handling物料搬运project项目critical path method关键路线法optimistic time最乐观时间Most likely time最也许时间pessimistic time最消极时间Mean time between failure平均故障期(MTBF) Mean time to repair平均维修期(MTTR)plan 计划do 执行check 检查action 处理level production生产平准化optimized production technology最优生产技术(OPT) Overall Equipment Effectiveness整体设备效能Operation Research运筹学Service Sector服务业Operation Management运作管理Operation System运作系统World Class Manufacturing世界级制造Time-based Competition基于时间旳竞争Operation Flexibility运作战略Product Development产品开发Dependent Demand独立需求Economic Order Lot 经济订货批量:Safety Stock安全库存Shortage Costs缺货成本ABC Classing Method A BC分类法Reorder Point订货点Holding Costs存储成本Productivity Improvement Team生产力提高小组(PIT) Productivity Improvement Center生产力提高中心(PIC) Break PAD 折PADBreak PIN 折脚Paste Base 沾BASEapproved by: 核准Apr.(April) 四月assembly(ass’y)组合Aug.(August) 八月Base 底座bifilar 双线并绕Bobbin（BBN）绕线管bottom 底部Brush Epoxy On Core 铁芯刷胶Brush Epoxy On Loop 线圈刷胶checked by: 审核Choke电感clip耳夹close winding密绕component 组件condition条件condition条件copper铜箔立式core铁芯Curing烘烤current 电流CUT WIRE 裁线Dec.(December) 十二月defective product box不良品箱deficient manufacturing procedure制程不良description: 阐明Design Failure Mode and Effect Analysis DFMEA设计Desk Topdip 浸入Direction 方向ECN Engineering Change Notice工程变更告知Electronic Magnetic In EMI 抗电磁干扰Enameled copper wire 漆包线Engineering Change Request 工程变更规定epoxy胶equipment/instrument设备Failure Mode and Effect Analysis FMEA失效模式与效应分析Feb.(February) 二月fixture治具flow chart 流程窗体flux助焊剂FN: Factory Notice 工厂告知FN: Immediated change 立即变更Function test 测试gap 间隙,缝隙HI-POT安规测试IE﹕Industrial Engineering 工业工程impregnation浸泡inductance 电感ink油墨inspection(INSP)检查Insulating Tape绝缘胶布issued date: 发行日期item发料Jan.(January) 一月Joint Quality Engineering (JQE)Jul.(July) 七月Jun.(June) 六月Kapton Tape高温胶布layer 层line线Magnetic Components 磁性组件magnetic 磁性旳Mar.(March) 三月Margin Tape安胶marking印章materials物料May五月ME: Mechanical Engineering 机械工程measurement测试mechanical dimension 外观尺寸MFG: manufacturing制造Mini-TowerModel: 机种Not Deviate Measure 量平整度Nov.(November) 十一月O/I Operation Instruction 作业指导书Oct.(October) 十月OEM:委托代工(Original Equipment Manufacture)oven 烤箱P/n: part number 品名P/R Pilot-Run试作验证pad 垫片PE Production／Process Engineering 制造工程/制程工程pin adjustment对脚PIN BENDING& WIRE TRIMMING 折弯钢片pin 脚plastic 塑料,塑料poor processing 制程不良Pre-soldering 预焊primary(pri)初级process 流程production capacity生产力卧式production control (PC)生管purchasing采购QCC:品管圈(Quality Control Circle)QE:质量工程(Quality Engineering)remark: 备注Reported by: 草拟Revision（REV﹒）: 版本sample样品schematic 构造图second(sec)次级Sept.(September) 九月solder bar锡棒solder iron 烙铁solder wire锡丝soldering焊锡solvent 稀释剂space winding疏绕Specification （Spec）生产规格stand-off 凸点station 站别step步序straighten 弄直,使变直tape 胶带TE: Test Engineering 测试工程terminal 脚,端子Time (时间)timer定期器top顶部,上层transformer 变压器trifler三线并绕tube 套管turn ratio圈数比turn圈数twist绞线vacuum抽真空varnish dipping泡凡立水varnish凡立水warehouse仓库winding direction 绕线方向winding绕线wire trimming理线。

Drug Production Validation Guidelines 2003 Edition - EnglishTranslationIntroductionThe Drug Production Validation Guidelines were first published in 2003 to provide a comprehensive framework and set of recommendations for validating pharmaceutical manufacturing processes. This document presents an English translation of the guidelines, which aim to ensure the safety, quality, and efficacy of pharmaceutical products.ScopeThe Drug Production Validation Guidelines apply to all stages of the drug manufacturing process, including the production of active pharmaceutical ingredients (APIs) and finished dosage forms. The guidelines provide direction for both new drug products and existing ones that undergo changes in their manufacturing processes.Purpose of ValidationThe primary purpose of drug production validation is to demonstrate that the manufacturing processes consistently produce pharmaceutical products that meet the predetermined quality attributes, ensuring their safety and efficacy. Validation also helps in identifying and controlling potential sources of variability that may affect the quality of the products.General Principles1. Process DesignThe guidelines emphasize the importance of robust process design, which involves defining critical process parameters and establishing appropriate control strategies. Process design should consider factors such as quality, safety, efficiency, and regulatory requirements.2. Process QualificationProcess qualification involves confirming the suitability and capability of the manufacturing process through a series of documented tests, studies, and evaluations. Three stages of process qualification are identified: installation qualification, operational qualification, and performance qualification.3. Continued Process VerificationOnce a process is qualified, continued process verification is necessary to ensure that the manufacturing process remains in a state of control. This involves ongoing monitoring, analysis of process data, and periodic re-evaluation to identify and address any potential sources of variability or process deviations.Validation Master Plan1. PurposeThe Validation Master Plan (VMP) provides an overview of the entire validation process and establishes the validation strategy for the drug manufacturing facility. It outlines key activities, responsibilities, and timelines for validation activities.2. ContentsThe VMP should include the following sections: - Introduction and scope - Validation policy and objectives - Roles and responsibilities - Validation activities and schedules - Change control procedures - Documentation requirements - Validation protocols and reports - Deviation management - Training requirements Validation Documentation1. Validation ProtocolsValidation protocols are detailed documents that outline the series of tests, experiments, and observations to be performed during the qualification and validation processes. They should describe the acceptance criteria, sampling plan, and test methods.2. Validation ReportsValidation reports summarize the results obtained during the qualification and validation activities. They should include a description of the tests performed, data analysis, conclusions, and any deviations or discrepancies identified.3. Change ControlChange control procedures should be in place to manage any changes to the validated manufacturing processes. The guidelines recommend that any proposed changes be evaluated for potential impact on product quality and documented in change control records.ConclusionThe Drug Production Validation Guidelines provide a robust framework for ensuring the safety, quality, and efficacy of pharmaceutical products through the validation of manufacturing processes. By following these guidelines, drugmanufacturers can mitigate risks, control variability, and produce high-quality pharmaceuticals. It is essential for pharmaceutical companies to adopt and adhere to these guidelines to comply with regulatory requirements and ensure patient safety.。

SCI长难句呼吸内科第一章—社区获得性肺炎Community-acquired pneumonia is still a significant cause of morbidity and mortality and is often misdiagnosed and inappropriately treated.Although it can be caused by a wide variety of micro-organisms, the pneumococcus,atypicals,Staphylococcus aureus and certain Gram-negative rods are the usual pathogens encountered.Antimicrobial therapy should be started as soon as possible particularly in those requiring admission to hospita.社区获得性肺炎仍然具有很高的发病率和死亡率，且经常被误诊和不恰当地治疗。

虽然它可以由多种微生物引起，但涉及的常见病原体有肺炎球菌、非典型球菌、金黄色葡萄球菌和某些革兰氏阴性杆菌。

特别是（对于）那些需要住院的患者，抗菌治疗应尽快开始。

知识点总结：1pneum(o)-前缀，肺2pneumonia n.肺炎3pneumococcus n.肺炎球菌4atypical adj.非典型的5Staphylococcus aureus n.金黄色葡萄球菌6Gram-negative rods n.革兰氏阴性杆菌7pathogen n.病原体8antimicrobial adj.抗菌的Mandell munity-acquired pneumonia:An overview.Postgrad Med.2015 Aug;127(6):607-15.SCI长难句呼吸内科第二章—肺脓肿A lung abscess is an infectious pulmonary disease characterised by the presence of a pus-filled cavity within the lung parenchyma.The content of an abscess often drains into the airways spontaneously,leading to an air-fluid level visible on chest X-rays and CT scans. Primary lung abscesses occur in patients who are prone to aspiration or in otherwise healthy individuals;secondary lung abscesses typically develop in association with a stenosing lung neoplasm or a systemic disease that compromises immune defences,such as AIDS,or after organ transplantation.肺脓肿是一种感染性肺部疾病，其特征是肺实质内有充满脓的空洞。