| | 英文缩写 | 英文全称 | 中文 |
| 1 | AAALAC | Association for the Assessment and Accreditation of Laboratory Animal Care | 国际实验动物评估及认证协会 |
| 2 | AC | Air Conditioner | 空调 |
| 3 | ACGIH | American Council of Government Industrial Hygienists | 美国政府工业卫生师会议 |
| 4 | ACPH | Air Changes Per Hour | 每小时换气次数 |
| 5 | ADR | Adverse Drug Reaction | 药品不良的反应 |
| 6 | AF&ID | Airflow and Instrument Diagram | 空气及仪表流程图 |
| 7 | AHU | Air Handling Unit | 空气处理单元 |
| 8 | AIHA | American Industrial Hygiene Association | 美国工业卫生协会 |
| 9 | AMCA | Air Movement and Control Association(International) | 空气运动及控制协会(国际) |
| 10 | ANDA | Abbreviated New Drug Application | 简略新药申请 |
| 11 | ANSI | American National Standards Institute | 美国国家标准学会 |
| 12 | APCD | Air Pollution Control Device | 空气污染控制装置 |
| 13 | API | Active Pharmaceutical Ingredient | 活性药物组分(原料药) |
| 14 | AQL | Acceptable Quality Level | 可接受质量水平 |
| 15 | ARI | Air Conditioning and Refrigeration Institute(US) | 空调与制冷学会(美国) |
| 16 | ASHRAE | American Society of Heating, Refrigeration and Air Conditioning Engineers | 美国采暖、制冷与空调工程师协会 |
| 17 | ASM | Active Substance Manufacture | 活性物质生产商 |
| 18 | ASME | American Society of Mechanical Engineers | 美国机械工程师协会 |
| 19 | ASTM | American Society for Testing and Materials(International) | 美国材料与试验协会(国际) |
| B |
| 20 | BAS | Building Automation System | 建筑物自动化系统 |
| | BE | Bioequivalence | 生物等效性 |
| 21 | BL | Biosafety Level | 生物安全水平 |
| 22 | BMS | Building Management System | 建筑物管理系统 |
| 23 | BOM | Bill of Material | 物料清单 |
| 24 | BP | British Pharmacopeia | 英国药典 |
| 25 | BPC | Bulk Pharmaceutical Chemicals | 原料药 |
| 26 | BR | Batch Record | 批记录 |
| 27 | BSC | Bio Safety Cabinet | 生物安全柜 |
| 28 | BSE | Bovine Spongiform Encephalopathy | 牛海绵状脑病/疯牛病 |
| C |
| 29 | CAA | Component Criticality Assessment | 组件关键性的评估 |
| 30 | CAPA | Corrective and Preventive Action | 纠正预防措施 |
| 31 | CCCD | China Certification Committee for Drugs | 中国药品认证委员会 |
| 32 | CCD | Certification Committee for Drugs | 药品认证管理中心 |
| 33 | CDC | Centers for Disease Control and Prevention | 疾病预防控制中心 |
| | CDS | Chromatography Data System | 层析数据系统 |
| 34 | CDER | Center for Drug Evaluation and Research | 药品研究与评价中心 |
| 35 | CEDI | Continuous Electro-de-ionization | 连续电去离子 |
| 36 | CFD | Computational Fluid Dynamics | 计算流体动力学 |
| 37 | CFDA(SFDA是前身) | China Food and Drug Administration | 国家食品药品监督管理总局 |
| 38 | CFR | Code of Federal Regulations | 美国联邦法规 |
| 39 | CFU | Colony Forming Unit | 菌落形成单位 |
| 40 | | Current Good Manufacturing Practice | 现行药品生产质量管理规范,也被称作"国际 GMP规范" |
| 41 | CHW | Chilled Water | 冷冻水 |
| 42 | CIP | Cleaning In Place | 在线清洗 |
| 43 | CIPC | Critical In-Process Control | 关键中间控制点 |
| 44 | CMC | Chemistry Manufacturing Control | 化学制造控制 |
| 45 | CMMC | Computerized Maintenance Management System | 计算机化维护管理系统 |
| 46 | CNC | Controlled Not Classified | 控制未分类 |
| 47 | COA | Certificate of Analysis | 分析报告单 |
| 48 | COD | Critical Operating Data | 关键运行数据 |
| 49 | COM | Commissioning | 试运行 |
| 50 | COP | Cleaning Out of Place | 离线清洗 |
| 51 | COS/CEP | Certificate of Suitability for European Pharmacopeia | 欧洲药典适用性证书 |
| 52 | CPP | Critical Process Parameters | 关键工艺参数 |
| 53 | CQA | Critical Quality Attributes | 关键质量特性 |
| 54 | CRO | Contract Research Organization | 合同研究组织(外包) |
| 55 | CS | Computerized System | 计算机化系统 |
| 56 | CTD | Common Technical Document | 通用技术文件 |
| 57 | CV | Cleaning Validation | 清洁验证 |
| 58 | CV | Concurrent Validation | 同步验证 |
| D |
| 58 | DCC | Document Control Coordinator | 文件控制协调者 |
| 59 | DDC | Direct Digital Control | 直接数字控制 |
| 60 | DI | De-ionization | 离子交换 |
| 61 | DMF | Drug Master File | 药物主文件 |
| 62 | DP | Differential Pressure | 压差 |
| 63 | DQ | Design Qualification | 设计确认 |
| 64 | DS | Design Specification | 设计说明 |
| 65 | DSC | Distributed Control System | 集散控制系统 |
| E |
| 66 | EC | European Commission | 欧洲委员会 |
| 67 | EDI | Electro-de-ionization | 电去离子 |
| 68 | EDL | List of Essential Drugs | 基本药物目录 |
| 69 | EDQM | European Directorate for the Quality of Medicines | 欧洲药品理事会 |
| 70 | EDR | Enhanced Design Review | 增加的设计审核 |
| 71 | EHS | Environment, Health and Safety | 环境,健康和安全 |
| 72 | EMA | European Medicines Agency | 欧洲药品局 |
| 73 | EMS | Environment Monitoring System | 环境监测系统 |
| 74 | EP | European Pharmacopoeia | 欧洲药典 |
| 75 | EPBD | Energy Performance of Buildings Directive(EU) | 建筑能效指令(欧洲) |
| | ELN | Electronic Lab Notebook | 实验室电子笔记本 |
| 76 | EU | European Union | 欧盟 |
| 77 | EU-GMP | European Good Manufacturing Practice | 欧洲GMP |
| | RRP | Enterprise Resource Planning, | 企业资源管理系统 |
| 78 | EU-OSHA (EASHW) | European Union-Occupational Safety and Health Adminstration(European Safety and Health at Work) | 欧盟-职业安全与卫生署(欧洲工作安全与健康局) |
| F |
| 79 | FAT | Factory Acceptance Test | 出厂验收测试 |
| 80 | FAT | Fault Tree Analysis | 过失树分析 |
| 81 | FDA | Food and Drug Administration(US) | (美国)食品药品监督管理局 |
| 82 | FDS | Function Design Specification | 功能设计标准 |
| 83 | FEMA | Failure Mode and Effects Analysis | 失效模式及后果分析 |
| 84 | FFU | Fan Filter Unit | 风机过滤单元 |
| 85 | FMEA | Failure Mode Effects Analysis | 失败模式效果分析 |
| 86 | FMS | Factory Monitoring System | 设施监控系统 |
| 87 | FS | Functional Specification | 功能说明 |
| G |
| 88 | GA | General Arrangement | 总布局图 |
| 89 | GAMP | Good Automated Manufacturing Practice | 优良自动化生产管理规范 |
| 90 | GC | Gas Chromatography | 气相色谱 |
| 91 | GCP | Good Clinical Practice | 药品临床研究管理规范 |
| 92 | GDP | Good Distribution Practice | 药品流通质量管理规范 |
| | GPP | good distributionpractices for pharmaceutical products | 药品优良销售运输规范 |
| 93 | GEP | Good Engineering Practice | 优良工程管理规范 |
| 94 | GLP | Good Laboratory Practice | 药品非临床研究质量管理规范 |
| 95 | GMP | Good Manufacturing Practice for Drugs | 药品生产质量管理规范 |
| 96 | GSP | Good Supply Practice | 药品经营质量管理规范 |
| H |
| 97 | HACCP | Hazard Analysis and Critical Control Point | 危害分析和关键环节控制点 |
| 98 | HAZOP | Hazard and Operability Analysis | 危害与可操作性分析 |
| 99 | HEPA | High Efficiency Particulate Air | 高效空气过滤器 |
| 100 | HMI | Human Machine Interface | 人机界面 |
| 101 | HPLC | High Performance Liquid Chromatography | 高效液相色谱 |
| 102 | HVAC | Heating Ventilation and Air Conditioning | 供热,通风,空调系统 |
| I |
| 103 | IA | Impact Assessment | 影响评估 |
| 104 | IAQ | Indoor Air Quality | 室内空气质量 |
| 105 | ICH | International Conference on Harmonization 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 |
| 106 | IEST | Institute of Environmental Sciences and Technology(US) | 美国环境科学与技术学会 |
| 107 | IND | Investigational New Drug | 临床研究申请 |
| 108 | INN | International Non-proprietary Name | 国家非专利名 |
| 109 | IPC | In-process Controls | 过程控制 |
| 110 | IQ | Installation Qualification | 安装确认 |
| 111 | IR | Infrared Spectrophotometer | 红外分光光度计 |
| 112 | ISO | International Standard Organization | 国际标准化组织 |
| 113 | ISPE | International Society for Pharmaceutical Engineering | 国际制药工程协会 |
| | IT | Information Technology | 信息技术 |
| J |
| 114 | JP | Japanese Pharmacopoeia | 日本药典 |
| L |
| 115 | LAF | Laminar Air Flow | 单向流 |
| 116 | LEL | Lower Explosion Limit | 爆炸下限 |
| 117 | LEV | Local Exhaust Ventilation | 局部排风 |
| | LES | Lab Execution Systems | 实验室执行系统 |
| 118 | LIMS | Laboratory Information Management System | 实验室信息管理系统 |
| 119 | LOD | Limit of Detection | 检测限 |
| 120 | LOQ | Limit of Quantitation | 定量限 |
| 121 | LSI | Langelier Saturation Index | 朗格利尔指数/饱和指数 |
| M |
| 122 | MA | Marketing Authorization | 上市许可 |
| 123 | MAA | Marketing Authorization Application | 上市申请 |
| 124 | MBR | Master Batch Record | 主生产批记录 |
| 125 | MCB | Master Cell Bank | 主细胞库 |
| 126 | MOA | Method Of Analysis | 分析方法 |
| 127 | MOH | Ministry of Health(China) | 卫生部(中国) |
| 128 | MP&CR | Master Production and Control Record | 主生产和控制记录 |
| 129 | MSDS | Material Safety Data Sheet | 化学品安全技术说明书 |
| 130 | MTBF | Mean Time Between Failure | 平均故障间隔时间 |
| | MHRA | Medicines & Healthcare products Regulatory Agency | 医药保健品管理机构(英国药监局) |
| N |
| 131 | NDA | New Drug Application | 新药申请 |
| 132 | NEMA | National Electrical Manufactures Association | 美国电气制造商协会 |
| 133 | NF | National Formulary | (美国)国家药品集 |
| O |
| 134 | OFD | Operation Flow Diagram | 操作流程图 |
| 135 | OOS | Out of Specification | 超标 |
| 136 | OOT | Out of Trend | 超出正常趋势 |
| 137 | OQ | Operation Qualification | 运行确认 |
| 138 | OSD | Oral Solid Dosage | 口服固体制剂 |
| 139 | OSHA | Occupational Safety and Health Administration(US) | 职业安全与健康署(美国) |
| 140 | OTC | Over-the-counter | 非处方 |
| P |
| 141 | P&ID | Piping and Instruments Diagram | 管路及仪表布置图 |
| 142 | PAT | Process Analytical Technology | 过程分析技术 |
| 143 | PCB | Preliminary Cell Bank | 原始细胞库 |
| 144 | PCS | Process Control System | 工艺控制系统 |
| 145 | PDA | Parenteral Drug Association | 国际注射剂协会 |
| 146 | PDCA | Plan, Do, Check, Action | 计划、执行、检查、处理 |
| 147 | PFDS | Process Flow Diagrams | 工艺流程图 |
| 148 | PGR | Particle Generation Rate | 微粒生成率 |
| 149 | PHA | Preliminary Hazard Analysis | 初步危害分析 |
| 150 | PI | Package Insert | 说明书 |
| 151 | PIC | Person In Charge | 负责人 |
| 152 | PIC/S | Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme | 国际医药品稽查协约组织 |
| 153 | PID | Proportional and Integral and Derivative | 比例、积分和微分 |
| 154 | PLC | Programmable Logic Controller | 可编辑逻辑控制器 |
| 155 | PM | Preventive Maintenance | 预防性维修 |
| 156 | PMD | Process Module Diagram | 工艺模块图 |
| 157 | POU | Point of Use | 使用点 |
| 158 | PPAC | Patent Protection Association of China | 中国专利保护协会 |
| 159 | PPE | Personal Protective Equipment | 个人防护设备 |
| 160 | PPM | Parts Per Million | 每百万分之一 |
| 161 | PQ | Performance Qualification | 性能确认 |
| 162 | PQR | Product Quality Review | 产品质量回顾 |
| 163 | PS | Pure Steam | 纯蒸汽 |
| | PSUR | Periodic Safety Update Reports | 定期安全性更新报告 |
| 164 | PV | Process Validation | 工艺验证 |
| 165 | PVP | Project Validation Plan | 项目验证计划 |
| 166 | PVR | Project Validation Report | 项目验证报告 |
| 167 | PW | Purified Water | 纯化水 |
| Q |
| 168 | QA | Quality Assurance | 质量保证 |
| 169 | QbD | Quality by Design | 质量源于设计 |
| 170 | QC | Quality Control | 质量控制 |
| 171 | QM | Quality Management | 质量管理 |
| 172 | QRM | Quality Risk Management | 质量风险管理 |
| 173 | QS | Quality System | 质量体系 |
| R |
| 174 | R&D | Research and Development | 研发 |
| 175 | RA | Risk Analysis | 风险分析 |
| 176 | RABS | Restricted Access Barrier System | 限制进入隔离系统 |
| 177 | RCFA | Root Cause Failure Analysis | 故障根源分析 |
| 178 | RH | Relative Humidity | 相对湿度 |
| 179 | RO | Reverse Osmosis | 反渗透 |
| 180 | RRF | Risk Ranking and Filtering | 风险排列和过滤 |
| 181 | RTM | Requirements Traceability Matrix | 需求追溯矩阵 |
| S |
| 182 | SAT | Site Acceptance Test | 现场验收测试 |
| 183 | SCADA | Supervisory Control and Data Acquisition System | 数据采集与监控系统 |
| 184 | SDI | Silt Density Index | 污染密度指数 |
| 185 | SFDA | State Food and Drug Administration(China) | 国家食品药品监督管理局(中国) |
| 186 | SI | International System of Unit | 国际单位制 |
| 187 | SIA | System Impact Assessment | 系统影响评估 |
| 188 | SIP | Sterilize In Place (Steam In Place ) | 在线灭菌 |
| 189 | SM | Starting Material | 起始物料 |
| 190 | SMF | Site Master File | 工厂主文件 |
| 191 | SMP | Standard Management Procedure | 标准管理程序 |
| 192 | SOP | Standard Operating Procedure | 标准操作规程 |
| 193 | SPC | Summary of Product Characteristics | 产品特性摘要 |
| 194 | STP | Standard Temperature and Pressure | 标准温度和压力 |
| T |
| 195 | TAB | Testing, Adjusting and Balancing | 测试、调整和平衡 |
| 196 | TGA | Therapeutic Goods Administration | (澳大利亚)治疗商品管理局 |
| 197 | TLC | Thin-Layer Chromatography | 薄层色谱 |
| 198 | TLV | Threshold Limit Value | 临界极限值 |
| 199 | TOC | Total Organic Carbon | 总有机碳 |
| 200 | TS | Technical Specification | 技术标准文件 |
| 201 | TSE | transmissible spongiform encephalopathy | 传染性海绵状脑病 |
| U |
| 202 | UDF | Unidirectional Flow | 单向流 |
| 203 | ULPA | Untra Low Penetration Air | 超高效空气过滤器 |
| 204 | UPS | Uninterrupted Power Supply | 不间断电源 |
| 205 | URS | User Requirement Specification | 用户需求说明 |
| 206 | USP | US Pharmacopoeia | 美国药典 |
| 207 | UV | Ultraviolet Spectrophotometer | 紫外线分光光度计 |
| V |
| 208 | VAV | Variable Air Volume | 变风量空调系统 |
| 209 | VMP | Validation Master Plan | 验证主计划 |
| 210 | VOC | Volatile Organic Compound | 挥发性有机化合物 |
| 211 | VP | Validation Protocol | 验证方案 |
| 212 | VR | Validation Report | 验证报告 |
| W |
| 213 | WCB | Working Cell Bank | 工作细胞库 |
| 214 | WFI | Water for Injection | 注射用水 |
| 215 | WGBC | World Green Building Council | 世界绿色建筑委员会 |
| 216 | WHO | World Health Organization | 世界卫生组织 |