英文专用短语缩写(WHO预认证).doc

AEFI投诉/接种后不良反应事件Adverse Event s Following Immunization,预防接种异常反应。API Active Pharmaceutical Ingredient药物有效成分生物仿制药分为生物相似性（Biosimilar Approach）和临床可比性（Clinical Comparability Approach）两类, 并且明确了“Stand Alone”BLA Biologics License Application生物制剂执照申请BSE Bovine Spongiform Encephalopathy 疯牛病CA矫正措施(Corrective Action)：当监测结果显示CCP失控时，所应采取的措施。( The actions to be taken when the results of monitoring the CCP indicate a loss of control.) CAPA(Corrective Action & Preventive Action) 纠正和预防措施CCP主要管制点(Critical Control Point, CCP)：为一个点、步骤或程序，若加以控制，则可预防、去除、或减低食品中安全危害至可接受之程度。(A point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels.) CFR Code of Federal Regulation联邦法规编码CP管制点(Control Point, CP)：可控制生物性、物理性及化学性之一个点、步骤或程序(Any point, step, or procedure at which biological, physical, or chemical factors can be controlled.) CL管制界限(Critical limit)：为防止危害发生所设的标准。(A value which separates acceptability from unacceptability.) DMF Drug Master File ECBS世界卫生组织WHO 生物制品标准化专家委员会（The Expert Committee on Biological Standardization，ECBS）EHS是环境 Environment、健康Health、安全Safety的缩写。 EHS管理体系是环境管理体系(EMS)和职业健康安全管理体系(OHSMS)两体系的整合。 环境、职业健康安全管理，简称EHS管理，EHS是环境 Environment、健康Health、安全Safety的缩写。EIR Establishment Inspection Report 制定检验报告EMA欧洲药品管理局EMEA Europe, the Middle East and AfricaEPI计划免疫EPI（Expanded Programme on Immunization），也就是扩大免疫规划。ERPEnterprise Resource Planning 企业资源计划系统FDAHACCP，即Hazard Analysis Critical Control Point，简称HACCP，发音为 Hassip ，中文名称为危害分析和关键控制点。 危害(Hazard)：可能引起伤害之事物。危害可分为生物性，化学性及物理性。(The potential to harm. Hazards can be biological, chemical and physical. ) HVAC Heating，Ventilation，and Air ConditioningHEPA(High efficiency particulate air Filter)，中文意思为高效空气过滤器，达到HEPA标准的过滤网，对于0.1微米和0.3微米的有效率达到99.998%，HEPA网的特点是空气可以通过，但细小的微粒却无法通过。ICHICH（ International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use）人用药物注册技术要求国际协调会。ICH是由欧盟、美国和日本三方的药品注册部门和生产部门组成，六个参加单位分别为： -欧盟，European Union (EU) -欧洲制药工业协会联合会，European Federation of Pharmaceutical Industries Associations (EFPIA) -日本厚生省，Ministry of Health and Welfare，Japan (MHW) -日本制药工业协会，Japan Pharmaceutical Manufacturers Association (JPMA) -美国食品与药品管理局，US Food and Drug Administration(FDA) -美国药物研究和生产联合会，Pharmaceutical Research and Manufacturers of America (PRMA)IND Investigational New Drug Application 研究新药申请IVB疫苗和生物制品司JIT准时生产方式（Just In Time简称JIT），又称作无库存生产方式（stockless production），零库存（zero inventories），一个流（one-piece flow）或者超级市场生产方式（supermarket production）GMP所规定的内容，是食品加工企业必须达到的最基本的条件。监测(Monitor)：执行有计划的观察与测定，以评估CCP是否在控制之下。(To conduct a planned sequence of observations or measurements to assess a CCP is under control.)sLAL Limulus Amebocyte Lysate 鲎试剂MSDS Material Safety Data Sheet 原料安全一览表Non conformance不符合事件NDA New Drug Application 新药申请NRA/NCL国家药监当局/实验室OOS检验结果偏差（out of specification）。根据ICH的定义：偏差（Deviation）：是指对批准指令（生产工艺规程、岗位操作法和标准操作规程等）或规定标准的任何偏离。根据偏差对药品质量影响程度的大小，可将偏差分为微小偏差、一般偏差和严重偏差。根据偏离范围的不同，可将偏差分为OOS（out of specification）、OOT（out of trend）等类别。OOS是指在检验过程中出现的任何偏离标准（包括国家标准、地方标准和企业内部标准）的结果，OOT是指通过追溯生产过程中的记录和数据，得出某一参数的系统趋势，从而制订出此项参数的正常波动范围，如果超出此范围但在标准以内的即为OOT结果。OSS安全和标准部门PAI Pmarket Approval InspectionPSF产品摘要文件PSUR定期安全性更新报告QbD质量源于设计QMS是Quality Management System的简称，中文意思为质量管理体系。QRM质量风险管理SAGE立场文件TSE Transmissible Spongiform Encephalopathy 遗传脑海绵体病USP United States Pharmacopeia 美国药典VVM疫苗西林瓶监测指示卡Vvm：air volume/culture volume/min（通气比）他的意思是：每分钟通气量与罐体实际料液体积的比值。WFI Water for Injection (defined in the USP)Form FD483- Used by an FDA Inspector to describe the observations made during an inspectionThe following acronyms are used in this document.AEFI adverse events following immunizationAHU air-handling unitAR assessment reportsATT Access to Technologies (WHO)API Active Pharmaceutical IngredientBLA CFR Code of Federal RegulationsCHMP Committee for Medicinal Products for Human UseCPMP Committee for Proprietary Medicinal ProductsCTD Common Technical Document for the Registration of Pharmaceuticals for Human UseEMEA European Medicines AgencyEU European UnionGAVI Global Alliance for Vaccines and ImmunizationGCP good clinical practiceGMP good manufacturing practiceHIV human immunodeficiency virusICH International Conference on HarmonizationIVB Department of Immunization, Vaccines and Biologicals (WHO)LSP lot-summary protocolsMA marketing authorizationNRA national regulatory authorityNCL national control laboratoryPAHO Pan American Health OrganizationPDA Parenteral Drug AssociationPSF product summary filePSURs periodic safety updated reportsQA quality as