制药英文缩写词表
来源：动视网
责编：小OO
时间：2025-09-24 12:25:54
制药英文缩写词表
常见词汇缩写英文缩写英文全称中文AACAirConditioner空调ADRAdverseDrugReaction药品不良反应AHUAirHandlingUnit空气处理单元APIActivePharmaceuticalIngredient活性药物组分（原料药）ANDAAbbreviatedNewDrugApplication简略新药申请AQL AcceptableQualityLevel可接受质量水平ASMActiveSubstanceManufacturer活性物质生产商ASMEAmer
导读常见词汇缩写英文缩写英文全称中文AACAirConditioner空调ADRAdverseDrugReaction药品不良反应AHUAirHandlingUnit空气处理单元APIActivePharmaceuticalIngredient活性药物组分（原料药）ANDAAbbreviatedNewDrugApplication简略新药申请AQL AcceptableQualityLevel可接受质量水平ASMActiveSubstanceManufacturer活性物质生产商ASMEAmer
常见词汇缩写
| 英文缩写 | 英文全称 | 中文 |
| A |
| AC | Air Conditioner | 空调 |
| ADR | Adverse Drug Reaction | 药品不良反应 |
| AHU | Air Handling Unit | 空气处理单元 |
| API | Active Pharmaceutical Ingredient | 活性药物组分（原料药） |
| ANDA | Abbreviated New Drug Application | 简略新药申请 |
| AQL | Acceptable Quality Level | 可接受质量水平 |
| ASM | Active Substance Manufacturer | 活性物质生产商 |
| ASME | American Society of Mechanical Engineers | 美国机械工程师协会 |
| B |
| BMS | Building Monitoring System | 楼宇监测系统 |
| BOM | Bill of Material | 物料清单 |
| BP | British Pharmacopoeia | 英国药典 |
| BPC | Bulk pharmaceutical Chemicals | 原料药 |
| C |
| CAPA | Corrective and Preventive Action | 纠正预防措施 |
| CCA | Component Criticality Assessment | 组件关键性评估 |
| CEP | Certificate of Suitability for European Pharmacopeia | 欧洲药典适用性证书 |
| CFR | Code of Federal Regulations | 美国联邦法规 |
| CFU | Colony Forming Unit | 菌落形成单位 |
| CHW | Chilled Water | 冷冻水 |
| CIP | Clean in Place | 在线清洗 |
| CIPC | Critical In-Process Control | 关键中间控制点 |
| CNC | Controlled Non-Classified | 控制但未分级 |
| COA | Certificate of Analysis | 分析报告单 |
| COM | Commissioning | 试车 |
| COP | Clean out of Place | 离线清洗 |
| CPP | Critical Process Parameter | 关键工艺参数 |
| CQA | Critical Quality Attribute | 关键质量属性 |
| CRO | Contract Research Organization | 合同研究组织（外包） |
| CS | Computerized System | 计算机系统 |
| CTD | Common Technical Document | 通用技术文件 |
| CV | Cleaning Validation | 清洁验证 |
| CMC | Chemistry Manufacturing Control | 化学制造控制 |
| D |
| DMF | Drug Master File | 药物主文件 |
| DS | Design Specification | 设计说明 |
| E |
| EDQM | European Directorate for the Quality of Medicines & HealthCare | 欧洲药品与健康质量理事会 |
| EHS | Environment, Health and Safety | 环境、健康和安全 |
| EMA | European Medicines Agency | 欧洲药监局 |
| EP | European Pharmacopoeia | 欧洲药典 |
| F |
| FAT | Factory Acceptance Test | 出厂验收测试 |
| FDA | FOOD AND DRUG ADMINISTRATION | （美国）食品药品监督管理局 |
| FDS | Function Design Specification | 功能设计说明 |
| FEMA | Failure Mode and Effects Analysis | 失效模式及后果分析 |
| FFU | Fan Filter Unit | 风机过滤单元 |
| FMS | Facility Monitoring System | 设施监控系统 |
| FS | Functional Specification | 功能说明 |
| G |
| GAMP | Good Automated Manufacturing Practice | 优良自动化生产管理规范 |
| GCP | Good Clinical Practice | 药品临床研究管理规范 |
| GEP | Good Engineering Practice | 优良工程管理规范 |
| GLP | Good Laboratory Practice | 药品临床前安全性研究质量管理规范 |
| GMP | Good Manufacturing Practice | 药品生产质量管理规范 |
| GSP | Good Supply Practice | 药品经营质量管理规范 |
| H |
| HACCP | Hazard Analysis and Critical Control Point | 危害分析和关键环节控制点 |
| HEPA | High Efficiency Particulate Air | 高效空气过滤器 |
| HMI | Human Machine Interface | 人机界面 |
| HVAC | Heating Ventilation Air Conditioning | 供热、通风与空调系统 |
| I |
| ICH | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | 人用药品注册技术要求国际协调会 |
| IND | INVESTIGATIONAL NEW DRUG | 临床研究申请 |
| INN | International Non-proprietary Name | 国际非专利名 |
| IQ | Installation Qualification | 安装确认 |
| ISPE | International Society for Pharmaceutical Engineering | 国际制药工程协会 |
| L |
| LIMS | Laboratory Information Management System | 实验室信息管理系统 |
| M |
| MA | Marketing Authorisation | 上市许可 |
| MAA | Marketing Authorisation Application | 上市申请 |
| MBR | Master Batch Record | 主生产批记录 |
| N |
| NDA | NEW DRUG APPLICATION | 新药申请 |
| O |
| QA | Quality Assurance | 质量保证 |
| QbD | Quality by Design | 质量源于设计 |
| QC | Quality Control | 质量控制 |
| OFD | Operation Flow Diagram | 操作流程图 |
| OOS | Out of Specification | 超标 |
| OOT | Out of Trend | 超出正常趋势 |
| OQ | Operational Qualification | 运行确认 |
| P |
| PAT | Process Analytical Technology | 过程分析技术 |
| PCS | Process Control System | 工艺控制系统 |
| PIC/S | Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme | 药品检查公约/药品检查合作计划 |
| PID | Piping and Instruments Diagram | 管路及仪表布置图 |
| PLC | Programmable Logic Controller | 可编程逻辑控制器 |
| PMD | Process Module Diagram | 工艺模块图 |
| POU | Point of Use | 使用点 |
| PQ | Performance Qualification | 性能确认 |
| PQR | Product Quality Review | 产品质量回顾 |
| PW | Purified Water | 纯化水 |
| PS | Pure Steam | 纯蒸汽 |
| PV | Process Validation | 工艺验证 |
| Q |
| QM | Quality Management | 质量管理 |
| QMS | Quality Management System | 质量管理体系 |
| R |
| RABS | Restricted Access Barrier System | 进入隔离系统 |
| RTM | Requirements Traceability Matrix | 需求追溯矩阵 |
| S |
| SAT | Site Acceptance Test | 现场验收测试 |
| SCADA | Supervisory Control and Data Acquisition System | 数据采集与监控系统 |
| SIA | System Impact Assessment | 系统影响评估 |
| SIP | Sterilize In Place (Steam In Place) | 在线灭菌 |
| SMF | Site Master File | 工厂主文件 |
| SOP | Standard Operational Procedure | 标准操作规程 |
| T |
| TOC | Total Organic Carbon | 总有机碳 |
| U |
| UDF | Unidirectional Flow | 单向流 |
| URS | User Requirement Specification | 用户需求说明 |
| USP | US Pharmacopoeia | 美国药典 |
| V |
| VMP | Validation Master Plan | 验证主计划 |
| VP | Validation Protocol | 验证方案 |
| VR | Validation Report | 验证报告 |
| W |
| WFI | Water for Injection | 注射用水 |
制药英文缩写词表
常见词汇缩写英文缩写英文全称中文AACAirConditioner空调ADRAdverseDrugReaction药品不良反应AHUAirHandlingUnit空气处理单元APIActivePharmaceuticalIngredient活性药物组分（原料药）ANDAAbbreviatedNewDrugApplication简略新药申请AQL AcceptableQualityLevel可接受质量水平ASMActiveSubstanceManufacturer活性物质生产商ASMEAmer
