《GMP英语词汇及缩写》
第一部分
PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ，也有人称PIC/S为医药审查会议/合作计划（PIC/S）
PIC的权威翻译：药品生产检查相互承认公约
API(Active Pharmaceutical Ingrediet) 原料药又称：活性药物组分
格列佛游记主要内容AirLock 气闸Authorized Person 授权人Batch/Lot 批次
Batch Number/Lot-Number 批号；Batch Numbering System 批次编码系统；
Batch Records 批记录；Bulk Product 待包装品；Calibration 校正；Clean area洁净区；Consignmecnt（Delivery）托销药品。
FDA（FOOD AND DRUG ADMINISTRA TION）：（美国）食品药品管理局
IND（INVESTIGA TIONAL NEW DRUG）：临床研究申请
（指申报阶段，相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）
NDA（NEW DRUG APPLICA TION）：新药申请
ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请
TREATMENT IND：研究中的新药用于治疗
ABBREVIATED（NEW）DRUG：简化申请的新药
DMF（DRUG MASTER FILE）：药物主文件
（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）
HOLDER：DMF持有者
CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规
PANEL：专家小组
BA TCH PRODUCTION：批量生产；分批生产
BA TCH PRODUCTION RECORDS：生产批号记录
韭菜籽粉
POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督
INFORMED CONSENT：知情同意
（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）
PRESCRIPTION DRUG：处方药
OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药
第二部分GMP文件常见缩写
ABPI Association of the British Pharmaceutical Industry
长方形的面积公式是什么ADR Adver Drug Reaction
AE Adver Event
AIM Active Ingredient Manufacturer
ANDA Abbreviated New Drug Application
ANOV A Analysis of Variance
ASM: Active Substance Manufacturer
ATC Anatomical Therapeutic Chemical
ATX Animal Test Exemption Certificate
BAN British Approved Name
BIRA British Institute of Regulatory Affairs
BNF British National Formulary
BP British Pharmacopoeia
C of A Certificate of Analysis
C of S Certificate of Suitability
CENTRE FOR DRUG EV ALUATION (CDE)
Centre for Pharmaceutical Administration (CPA)
CMS Concerned Member State
CMS每个成员国
COS Certificate of Suitability
CPMP Committee for Proprietary Medicinal Products
CRA Clinical Rearch Associate
CRF Ca Report Form
CRO Contract Rearch Organisation
CTA Clinical Trial Application
CTC Clinical Trial Certificate
CTD Common Technical Document
CTX Clinical Trials Exemption
DDD Defined Daily Do
DGC Daily Global Comparison
DIA Drug Information Association
DMF Drug Master File
Drug Registration Branch (DR, Product Evaluation & Registration Division, CPA
EDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区
EGMA European Generics Medicine Association
ELA Established Licence Application
EMEA European Medicines Evaluation Agency
EMEA （European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European Pharmacopoeia
EPAR European Public Asssment Reports
ESRA European Society of Regulatory Affairs
European Pharmacopoeia Commission 欧洲药典委员会
FDA
FDA Food and Drug Administration
疫情的感受final evaluation report (FER)
free sale certificates (FSCs)
GCP Good Clinical Practice
GCP药品临床研究管理规范
GLP Good Laboratory Practice
GLP 药品临床前安全性研究质量管理规范
GMP Good Manufacturing Practice
GMP 药品生产质量管理规范
GSP药品销售管理规范
Health Sciences Authority (HSA)
HSA’s Medicines Advisory Committee (MAC)
IB Investigators Brochure
ICH International Conference for Harmonisation
IDMC Independent Data-Monitoring Committee
IEC Independent Ethics Committee
IND Investigational New Drug
INN International Non-proprietary Name
International Conference on Harmonisation (ICH)
IPC In Process Control
IRB Institutional Review Board
LICENCE HOLDER
MA Marketing Authorisation
椰子英语怎么读MAA Marketing Authorisation Application
MAA上市申请
MAH Marketing Authorisation Holder
MAH 销售许可持有者
MCA Medicines Control Agency
MHW Ministry of Health and Welfare (Japan)
MR Mutual Recognition
MRA 美国与欧盟的互认协议
MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation Group
MRP Mutual Recognition Procedure
NAS New Active Substance
NCE New Chemical Entity
NDA New Drug Application
new chemical entities (NCEs)
new drug applications (NDAs)
NSAID Non Steroidal Anti Inflammatory Drug
NTA Notice To Applicants
OOS Out of Specification
OTC Over The Counter
PAGB Proprietary Association of Great Britain
Ph Eur European Pharmacopoeia嗟呼
PIL Patient Information Leaflet
PL Product Licence
POM Prescription Only Medicine
PRODUCT OWNER
PSU Periodic Safety Updates
QA Quality Assurance
QC Quality Control
RAJ Regulatory Affairs Journal
RMS Reference Member State
RMS相互认可另一成员国
RSD Relative Standard Deviation
Rx Prescription Only
SAE Serious Adver Event
SMF Site Master File
SOP Standard Operating Procedure
SOP （STANDARD OPERATION PROCEDURE）标准运作程序
SPC/SmPC Summary of Product Characteristics
summary of product characteristics(SPC)
Therapeutic Goods Administration (TGA)
USP US Pharmacopoeia
VMF Veterinary Master File
VPC Veterinary Products Committee
第三部分常用缩略语
A．A．A Addition and Amendments 增补和修订
园林实习报告
AC Air Conditioner 空调器
ADR Adver Drug Reaction 药物不良反应
AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受
AQL Acceptable Quality Level 合格质量标准
ADNA Abbreviated New Drug Application 简化的新药申请
BOM Bill of Material 物料清单
BPC Bulk pharmaceutical Chemiclls 原料药
CBER Center for Biologics Evaluation Rearch 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位
DMF Drug Master File 药品管理档案摩托车科目一考试
CDER Cemter for Drug Evaluation amd Rearch 药物评价与研究中心
CI Corporate Identity (Image) 企业识别（形象）
CIP Cleaning in Place 在线清洗
CSI Consumer Safety Inpctor 消费者安全调查员
CLP Cleaning Line Procedure 在线清洗程序
DAL Defect Action Level 缺陷作用水平
DEA Drug Enforcement Adminestration 管制药品管理
