序号 | 英文缩写 | 英文全称 | 中文全称 |
A | | | |
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 | | | |
1 | BAS | Building Automation System | 建筑物自动化系统 |
2 | BL | Biosafety Level | 生物安全水平 |
3 | BMS | Building Management System | 建筑物管理系统 |
4 | BOM | Bill of Material | 物料清单 |
5 | BP | British Pharmacopeia | 英国药典 |
6 | BPC | Bulk Pharmaceutical Chemicals | 原料药 |
7 | BR | Batch Record | 批记录 |
8 | BSC | Bio Safety Cabinet | 生物安全柜 |
9 | BSE | Bovine Spongiform Encephalopathy | 牛海绵状脑病/疯牛病 |
| | | |
C | | | |
1 | CAA | Component Criticality Assessment | 组件关键性的评估 |
2 | CAPA | Corrective and Preventive Action | 纠正预防措施 |
3 | CCCD | China Certification Committee for Drugs | 中国药品认证委员会 |
4 | CCD | Certification Committee for Drugs | 药品认证管理中心 |
5 | CDC | Centers for Disease Control and Prevention | 疾病预防控制中心 |
6 | CDER | Center for Drug Evaluation and Research | 药品研究与评价中心 |
7 | CEDI | Continuous Electro-de-ionization | 连续电去离子 |
8 | CFD | Computational Fluid Dynamics | 计算流体动力学 |
9 | CFR | Code of Federal Regulations | 美国联邦法规 |
10 | CFU | Colony Forming Unit | 菌落形成单位 |
11 | | Current Good Manufacturing Practice | 现行药品生产质量管理规范 |
12 | CHW | Chilled Water | 冷冻水 |
13 | CIP | Cleaning In Place | 在线清洗 |
14 | CIPC | Critical In-Process Control | 关键中间控制点 |
15 | CMC | Chemistry Manufacturing Control | 化学制造控制 |
16 | CMMC | Computerized Maintenance Management System | 计算机化维护管理系统 |
17 | CNC | Controlled Not Classified | 控制未分类 |
18 | COA | Certificate of Analysis | 分析报告单 |
19 | COD | Critical Operating Data | 关键运行数据 |
20 | COM | Commissioning | 试运行 |
21 | COP | Cleaning Out of Place | 离线清洗 |
22 | COS/CEP | Certificate of Suitability for European Pharmacopeia | 欧洲药典适用性证书 |
23 | CPP | Critical Process Parameters | 关键工艺参数 |
24 | CQA | Critical Quality Attributes | 关键质量特性 |
25 | CRO | Contract Research Organization | 合同研究组织(外包) |
26 | CS | Computerized System | 计算机化系统 |
27 | CTD | Common Technical Document | 通用技术文件 |
28 | CV | Cleaning Validation | 清洁验证 |
29 | CV | Concurrent Validation | 同步验证 |
| | | |
D | | | |
1 | DCC | Document Control Coordinator | 文件控制协调者 |
2 | DDC | Direct Digital Control | 直接数字控制 |
3 | DI | De-ionization | 离子交换 |
4 | DMF | Drug Master File | 药物主文件 |
5 | DP | Differential Pressure | 压差 |
6 | DQ | Design Qualification | 设计确认 |
7 | DS | Design Specification | 设计说明 |
8 | DSC | Distributed Control System | 集散控制系统 |
| | | |
E | | | |
1 | EC | European Commission | 欧洲委员会 |
2 | EDI | Electro-de-ionization | 电去离子 |
3 | EDL | List of Essential Drugs | 基本药物目录 |
4 | EDQM | European Directorate for the Quality of Medicines | 欧洲药品理事会 |
5 | EDR | Enhanced Design Review | 增加的设计审核 |
6 | EHS | Environment, Health and Safety | 环境,健康和安全 |
7 | EMA | European Medicines Agency | 欧洲药品局 |
8 | EMS | Environment Monitoring System | 环境监测系统 |
9 | EP | European Pharmacopoeia | 欧洲药典 |
10 | EPBD | Energy Performance of Buildings Directive(EU) | 建筑能效指令(欧洲) |
11 | EU | European Union | 欧盟 |
12 | EU-GMP | European Good Manufacturing Practice | 欧洲GMP |
13 | 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 | | | |
1 | FAT | Factory Acceptance Test | 出厂验收测试 |
2 | FAT | Fault Tree Analysis | 过失树分析 |
3 | FDA | Food and Drug Administration(US) | (美国)食品药品监督管理局 |
4 | FDS | Function Design Specification | 功能设计标准 |
5 | FEMA | Failure Mode and Effects Analysis | 失效模式及后果分析 |
6 | FFU | Fan Filter Unit | 风机过滤单元 |
7 | FMEA | Failure Mode Effects Analysis | 失败模式效果分析 |
8 | FMS | Factory Monitoring System | 设施监控系统 |
9 | FS | Functional Specification | 功能说明 |
| | | |
G | | | |
1 | GA | General Arrangement | 总布局图 |
2 | GAMP | Good Automated Manufacturing Practice | 优良自动化生产管理规范 |
3 | GC | Gas Chromatography | 气相色谱 |
4 | GCP | Good Clinical Practice | 药品临床研究管理规范 |
5 | GEP | Good Engineering Practice | 优良工程管理规范 |
6 | GLP | Good Laboratory Practice | 药品非临床研究质量管理规范 |
7 | GMP | Good Manufacturing Practice | 药品生产质量管理规范 |
8 | GSP | Good Supply Practice | 药品经营质量管理规范 |
| | | |
H | | | |
1 | HACCP | Hazard Analysis and Critical Control Point | 危害分析和关键环节控制点 |
2 | HAZOP | Hazard and Operability Analysis | 危害与可操作性分析 |
3 | HEPA | High Efficiency Particulate Air | 高效空气过滤器 |
4 | HMI | Human Machine Interface | 人机界面 |
5 | HPLC | High Performance Liquid Chromatography | 高效液相色谱 |
6 | HVAC | Heating Ventilation and Air Conditioning | 供热,通风,空调系统 |
| | | |
I | | | |
1 | IA | Impact Assessment | 影响评估 |
2 | IAQ | Indoor Air Quality | 室内空气质量 |
3 | 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 |
4 | IEST | Institute of Environmental Sciences and Technology(US) | 美国环境科学与技术学会 |
5 | IND | Investigational New Drug | 临床研究申请 |
6 | INN | International Non-proprietary Name | 国家非专利名 |
7 | IPC | In-process Controls | 过程控制 |
8 | IQ | Installation Qualification | 安装确认 |
9 | IR | Infrared Spectrophotometer | 红外分光光度计 |
10 | ISO | International Standard Organization | 国际标准化组织 |
11 | ISPE | International Society for Pharmaceutical Engineering | 国际制药工程协会 |
| | | |
J | | | |
1 | JP | Japanese Pharmacopoeia | 日本药典 |
| | | |
L | | | |
1 | LAF | Laminar Air Flow | 单向流 |
2 | LEL | Lower Explosion Limit | 爆炸下限 |
3 | LEV | Local Exhaust Ventilation | 局部排风 |
4 | LIMS | Laboratory Information Management System | 实验室信息管理系统 |
5 | LOD | Limit of Detection | 检测限 |
6 | LOQ | Limit of Quantitation | 定量限 |
7 | LSI | Langelier Saturation Index | 朗格利尔指数/饱和指数 |
| | | |
M | | | |
1 | MA | Marketing Authorization | 上市许可 |
2 | MAA | Marketing Authorization Application | 上市申请 |
3 | MBR | Master Batch Record | 主生产批记录 |
4 | MCB | Master Cell Bank | 主细胞库 |
5 | MOA | Method Of Analysis | 分析方法 |
6 | MOH | Ministry of Health(China) | 卫生部(中国) |
7 | MP&CR | Master Production and Control Record | 主生产和控制记录 |
8 | MSDS | Material Safety Data Sheet | 化学品安全技术说明书 |
9 | MTBF | Mean Time Between Failure | 平均故障间隔时间 |
| | | |
N | | | |
1 | NDA | New Drug Application | 新药申请 |
2 | NEMA | National Electrical Manufactures Association | 美国电气制造商协会 |
3 | NF | National Formulary | (美国)国家药品集 |
| | | |
O | | | |
1 | OFD | Operation Flow Diagram | 操作流程图 |
2 | OOS | Out of Specification | 超标 |
3 | OOT | Out of Trend | 超出正常趋势 |
4 | OQ | Operation Qualification | 运行确认 |
5 | OSD | Oral Solid Dosage | 口服固体制剂 |
6 | OSHA | Occupational Safety and Health Administration(US) | 职业安全与健康署(美国) |
7 | OTC | Over-the-counter | 非处方 |
| | | |
P | | | |
1 | P&ID | Piping and Instruments Diagram | 管路及仪表布置图 |
2 | PAT | Process Analytical Technology | 过程分析技术 |
3 | PCB | Preliminary Cell Bank | 原始细胞库 |
4 | PCS | Process Control System | 工艺控制系统 |
5 | PDA | Parenteral Drug Association | 国际注射剂协会 |
6 | PDCA | Plan, Do, Check, Action | 计划、执行、检查、处理 |
7 | PFDS | Process Flow Diagrams | 工艺流程图 |
8 | PGR | Particle Generation Rate | 微粒生成率 |
9 | PHA | Preliminary Hazard Analysis | 初步危害分析 |
10 | PI | Package Insert | 说明书 |
11 | PIC | Person In Charge | 负责人 |
12 | PIC/S | Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme | 国际医药品稽查协约组织 |
13 | PID | Proportional and Integral and Derivative | 比例、积分和微分 |
14 | PLC | Programmable Logic Controller | 可编辑逻辑控制器 |
15 | PM | Preventive Maintenance | 预防性维修 |
16 | PMD | Process Module Diagram | 工艺模块图 |
17 | POU | Point of Use | 使用点 |
18 | PPAC | Patent Protection Association of China | 中国专利保护协会 |
19 | PPE | Personal Protective Equipment | 个人防护设备 |
20 | PPM | Parts Per Million | 每百万分之一 |
21 | PQ | Performance Qualification | 性能确认 |
22 | PQR | Product Quality Review | 产品质量回顾 |
23 | PS | Pure Steam | 纯蒸汽 |
24 | PV | Process Validation | 工艺验证 |
25 | PVP | Project Validation Plan | 项目验证计划 |
26 | PVR | Project Validation Report | 项目验证报告 |
27 | PW | Purified Water | 纯化水 |
| | | |
Q | | | |
1 | QA | Quality Assurance | 质量保证 |
2 | QbD | Quality by Design | 质量源于设计 |
3 | QC | Quality Control | 质量控制 |
4 | QM | Quality Management | 质量管理 |
5 | QRM | Quality Risk Management | 质量风险管理 |
6 | QS | Quality System | 质量体系 |
| | | |
R | | | |
1 | R&D | Research and Development | 研发 |
2 | RA | Risk Analysis | 风险分析 |
3 | RABS | Restricted Access Barrier System | 限制进入隔离系统 |
4 | RCFA | Root Cause Failure Analysis | 故障根源分析 |
5 | RH | Relative Humidity | 相对湿度 |
6 | RO | Reverse Osmosis | 反渗透 |
7 | RRF | Risk Ranking and Filtering | 风险排列和过滤 |
8 | RTM | Requirements Traceability Matrix | 需求追溯矩阵 |
| | | |
S | | | |
1 | SAT | Site Acceptance Test | 现场验收测试 |
2 | SCADA | Supervisory Control and Data Acquisition System | 数据采集与监控系统 |
3 | SDI | Silt Density Index | 污染密度指数 |
4 | SFDA | State Food and Drug Administration(China) | 国家食品药品监督管理局(中国) |
5 | SI | International System of Unit | 国际单位制 |
6 | SIA | System Impact Assessment | 系统影响评估 |
7 | SIP | Sterilize In Place (Steam In Place ) | 在线灭菌 |
8 | SM | Starting Material | 起始物料 |
9 | SMF | Site Master File | 工厂主文件 |
10 | SMP | Standard Management Procedure | 标准管理程序 |
11 | SOP | Standard Operating Procedure | 标准操作规程 |
12 | SPC | Summary of Product Characteristics | 产品特性摘要 |
13 | STP | Standard Temperature and Pressure | 标准温度和压力 |
| | | |
T | | | |
1 | TAB | Testing, Adjusting and Balancing | 测试、调整和平衡 |
2 | TLC | Thin-Layer Chromatography | 薄层色谱 |
3 | TLV | Threshold Limit Value | 临界极限值 |
4 | TOC | Total Organic Carbon | 总有机碳 |
5 | TS | Technical Specification | 技术标准文件 |
6 | TSE | transmissible spongiform encephalopathy | 传染性海绵状脑病 |
| | | |
U | | | |
1 | UDF | Unidirectional Flow | 单向流 |
2 | ULPA | Untra Low Penetration Air | 超高效空气过滤器 |
3 | UPS | Uninterrupted Power Supply | 不间断电源 |
4 | URS | User Requirement Specification | 用户需求说明 |
5 | USP | US Pharmacopoeia | 美国药典 |
6 | UV | Ultraviolet Spectrophotometer | 紫外线分光光度计 |
| | | |
V | | | |
1 | VAV | Variable Air Volume | 变风量空调系统 |
2 | VMP | Validation Master Plan | 验证主计划 |
3 | VOC | Volatile Organic Compound | 挥发性有机化合物 |
4 | VP | Validation Protocol | 验证方案 |
5 | VR | Validation Report | 验证报告 |
| | | |
W | | | |
1 | WCB | Working Cell Bank | 工作细胞库 |
2 | WFI | Water for Injection | 注射用水 |
3 | WGBC | World Green Building Council | 世界绿色建筑委员会 |
4 | WHO | World Health Organization | 世界卫生组织 |