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GMP英語(yǔ)
PIC/S的全稱為：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制藥檢查草案), 藥品檢查協(xié)會(huì)(PIC/S) ,也有人稱PIC/S為醫(yī)藥審查會(huì)議/合作計(jì)劃（PIC/S）
PIC的權(quán)威翻譯：藥品生產(chǎn)檢查相互承認(rèn)公約
API(Active Pharmaceutical Ingrediet) 原料藥 又稱：活性藥物組分
AirLock 氣閘 Authorized Person 授權(quán)人 Batch/Lot 批次
Batch Number/Lot-Number 批號(hào),；Batch Numbering System 批次編碼系統(tǒng),；
Batch Records 批記錄；Bulk Product 待包裝品,；Calibration 校正,；Clean area潔凈區(qū)；Consignmecnt（Delivery）托銷藥品,。
FDA（FOOD AND DRUG ADMINISTRATION）：（美國(guó)）食品藥品管理局
IND（INVESTIGATIONAL NEW DRUG）：臨床研究申請(qǐng)（指申報(bào)階段,相對(duì)于NDA而
言）,；研究中的新藥（指新藥開(kāi)發(fā)階段，相對(duì)于新藥而言,，即臨床前研究結(jié)束）
NDA（NEW DRUG APPLICATION）：新藥申請(qǐng)
ANDA（ABBREVIATED NEW DRUG APPLICATION）：簡(jiǎn)化新藥申請(qǐng)
TREATMENT IND：研究中的新藥用于治療
ABBREVIATED（NEW）DRUG：簡(jiǎn)化申請(qǐng)的新藥
DMF（DRUG MASTER FILE）：藥物主文件（持有者為謹(jǐn)慎起見(jiàn)而準(zhǔn)備的保密資料,，可以
包括一個(gè)或多個(gè)人用藥物在制備、加工,、包裝和貯存過(guò)程中所涉及的設(shè)備,、生產(chǎn)過(guò)程或物
品。只有在DMF持有者或授權(quán)代表以授權(quán)書的形式授權(quán)給FDA,，F(xiàn)DA在審查IND,、
NDA、ANDA時(shí)才能參考其內(nèi)容）
HOLDER：DMF持有者
CFR（CODE OF FEDERAL REGULATION）：（美國(guó)）聯(lián)邦法規(guī)
PANEL：專家小組
BATCH PRODUCTION：批量生產(chǎn),；分批生產(chǎn)
BATCH PRODUCTION RECORDS：生產(chǎn)批號(hào)記錄
POST-OR PRE- MARKET SURVEILLANCE：銷售前或銷售后監(jiān)督
INFORMED CONSENT：知情同意（患者對(duì)治療或受試者對(duì)醫(yī)療試驗(yàn)了解后表示同意接受治療或試驗(yàn)）
PRESCRIPTION DRUG：處方藥
OTC DRUG（OVER—THE—COUNTER DRUG）：非處方藥
GMP文件常見(jiàn)縮寫
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每個(gè)成員國(guó)
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) 歐洲聯(lián)盟藥品質(zhì)量指導(dǎo)委員會(huì)
EEA 歐洲經(jīng)濟(jì)地區(qū)
EGMA European Generics Medicine Association
ELA Established Licence Application
EMEA European Medicines Evaluation Agency
EMEA （European Agency for the Evaluation of Medicinal Products） 歐洲聯(lián)盟藥品評(píng)價(jià)機(jī)構(gòu)
EP European Pharmacopoeia
EPAR European Public Assessment Reports
ESRA European Society of Regulatory Affairs
European Pharmacopoeia Commission 歐洲藥典委員會(huì)
FDA
FDA Food and Drug Administration
final evaluation report (FER)
free sale certificates (FSCs)
GCP Good Clinical Practice
GCP藥品臨床研究管理規(guī)范
GLP Good Laboratory Practice
GLP 藥品臨床前安全性研究質(zhì)量管理規(guī)范
GMP Good Manufacturing Practice
GMP 藥品生產(chǎn)質(zhì)量管理規(guī)范
GSP藥品銷售管理規(guī)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上市申請(qǐng)
MAH Marketing Authorisation Holder
MAH 銷售許可持有者
MCA Medicines Control Agency
MHW Ministry of Health and Welfare (Japan)
MR Mutual Recognition
MRA 美國(guó)與歐盟的互認(rèn)協(xié)議
MRAs (Mutual Recognition Agreements) 互相認(rèn)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相互認(rèn)可另一成員國(guó)
RSD Relative Standard Deviation
Rx Prescription Only
SAE Serious Adverse Event
SMF Site Master File
SOP Standard Operating Procedure
SOP （STANDARD OPERATION PROCEDURE） 標(biāo)準(zhǔn)運(yùn)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 增補(bǔ)和修訂
AC Air Conditioner 空調(diào)器
ADR Adverse Drug Reaction 藥物不良反應(yīng)
AFDO Association of Food and Drug Officials 食品與藥品官員協(xié)會(huì)（美國(guó)）
ACC Accept 接受
AQL Acceptable Quality Level 合格質(zhì)量標(biāo)準(zhǔn)
ADNA Abbreviated New Drug Application 簡(jiǎn)化的新藥申請(qǐng)
BOM Bill of Material 物料清單
BPC Bulk pharmaceutical Chemiclls 原料藥
CBER Center for Biologics Evaluation Research 生物制品評(píng)價(jià)與研究中心
CFU Colony Forming Unet 菌落形成單位
DMF Drug Master File 藥品管理檔案
CDER Cemter for Drug Evaluation amd Research 藥物評(píng)價(jià)與研究中心
CI Corporate Identity (Image) 企業(yè)識(shí)別（形象）
CIP Cleaning in Place 在線清洗
CSI Consumer Safety Insepctor 消費(fèi)者安全調(diào)查員
CLP Cleaning Line Procedure 在線清洗程序
DAL Defect Action Level 缺陷作用水平
DEA Drug Enforcement Adminestration 管制藥品管理
DS Documentation Systim 文件系統(tǒng)
FDA Food and Drug Administration 食品與藥品管理局（美國(guó)）
GATT General Agreemernt on Tariffs and Trade 關(guān)貿(mào)總協(xié)會(huì)
GMP Good Manufacturing Practice Gvp 藥品生質(zhì)量管理規(guī)范
GCP Good Clinical Practice 藥品臨床實(shí)驗(yàn)管理規(guī)范
GLP Good Laboratory Practice 實(shí)驗(yàn)室管理規(guī)范
GSP Good Supply Practice 藥品商業(yè)質(zhì)量規(guī)范
GRP Gook RaTAIL Practice 藥品零業(yè)質(zhì)量管理規(guī)范
GAP Good Agriculture Practice 藥材生產(chǎn)管理規(guī)范
GVP Gook Validation Prctice 驗(yàn)證管理規(guī)范
GUP Gook Use Practice 藥品重用規(guī)范
HVAC Heating Ventilation Air Conditioning 空調(diào)凈化系統(tǒng)
ISO Intematonal Organization for Standardization 車際標(biāo)準(zhǔn)化組織
MOU Memorandum of Understanding 諒解備忘錄
PF Porduction File 生產(chǎn)記錄用表格
OTC Over the Counter (Drug) 非處方藥品
PLA Product License Application 產(chǎn)品許可申請(qǐng)
QA Quality Assurance 質(zhì)量保證
QC Quality Control 質(zhì)量控制
QMP Quality Management Procedure 質(zhì)量管理程序
SDA State Drug Administration 國(guó)家藥品監(jiān)督管理局
SMP Standard Managmert Procedure 標(biāo)準(zhǔn)管理程序
SOP Standard Operating Procedure 標(biāo)準(zhǔn)操作程序
TQC Tatal Quality Control 全面質(zhì)量管理
USA Uneted States Pharmacopeia 美國(guó)藥典
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