GMP英语词汇童言真子

GMP英语词汇

2009-09-11 16:13

GMP英语

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

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 ADMINISTRATION）：（美国）食品药品管理局

IND（INVESTIGATIONAL 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 APPLICATION）：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

BATCH PRODUCTION：批量生产；分批生产

BATCH PRODUCTION RECORDS：生产批号记录

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

GMP文件常见缩写

ABPI Association of the British Pharmaceutical Industry

ADR Adverse Drug Reaction

AE Adverse Event

AIM Active Ingredient Manufacturer

ANDA Abbreviated New Drug Application

ANOVA 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 EVALUATION (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 Research Associate

CRF Case Report Form

CRO Contract Research Organisation

CTA Clinical Trial Application

CTC Clinical Trial Certificate

CTD Common Technical Document

CTX Clinical Trials Exemption

DDD Defined Daily Dose

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 Assessment Reports

ESRA European Society of Regulatory Affairs

European Pharmacopoeia Commission 欧洲药典委员会

FDA

FDA Food and Drug Administration

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

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

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 Adverse 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

A．A．A Addition and Amendments 增补和修订

AC Air Conditioner 空调器

ADR Adverse 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 Research 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

CDER Cemter for Drug Evaluation amd Research 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 Insepctor 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

DS Documentation Systim 文件系统

FDA Food and Drug Administration 食品与药品管理局（美国）

GATT General Agreemernt on Tariffs and Trade 关贸总协会

GMP Good Manufacturing Practice Gvp 药品生质量管理规范

GCP Good Clinical Practice 药品临床实验管理规范

GLP Good Laboratory Practice 实验室管理规范

GSP Good Supply Practice 药品商业质量规范

GRP Gook RaTAIL Practice 药品零业质量管理规范

GAP Good Agriculture Practice 药材生产管理规范

GVP Gook Validation Prctice 验证管理规范

GUP Gook Use Practice 药品重用规范

HVAC Heating Ventilation Air Conditioning 空调净化系统

ISO Intematonal Organization for Standardization 车际标准化组织

MOU Memorandum of Understanding 谅解备忘录

PF Porduction File 生产记录用表格

OTC Over the Counter (Drug) 非处方药品

PLA Product License Application 产品许可申请

QA Quality Assurance 质量保证

QC Quality Control 质量控制

QMP Quality Management Procedure 质量管理程序

SDA State Drug Administration 国家药品监督管理局

SMP Standard Managmert Procedure 标准管理程序

SOP Standard Operating Procedure 标准操作程序

TQC Tatal Quality Control 全面质量管理

USA Uneted States Pharmacopeia 美国药典