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 Ingredient) 原料药 又称：活性药物组分
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 Ingredient) 原料药 又称：活性药物组分
Air Lock 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；Consignment（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）
PREscri ptION DRUG：处方药
OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药
2楼
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 Organization
CTA Clinical Trial Application
CTC Clinical Trial Certificate
CTD Common Technical document
CTX Clinical Trials Exemption
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3楼
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 License 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
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4楼
Health Sciences Authority (HSA)
HSA’s Medicines Advisory Committee (MAC)
IB Investigators Brochure
ICH International Conference for Harmonization
IDMC Independent Data-Monitoring Committee
IEC Independent Ethics Committee
IND Investigational New Drug
INN International Non-proprietary Name
International Conference on Harmonization (ICH)
IPC In Process Control
IRB Institutional Review Board
LICENCE HOLDER
MA Marketing Authorization
MAA Marketing Authorization Application
MAA上市申请
MAH Marketing Authorization 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 License
POM Prescri ption Only Medicine
PRODUCT OWNER
PSU Periodic Safety Updates
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5楼
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 Prescri ption Only
SAE Serious Adverse Event
SMF Site Master File
SOP Standard Operating Procedure
SOP （STANDARD OPERATION PROCEDURE） 标准运作程序
SPC Summary of Product Characteristics
Therapeutic Goods Administration (TGA)
USP US Pharmacopoeia
VMF Veterinary Master File
VPC Veterinary Products Committee
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6楼
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 Chemicals 原料药
CBER Center for Biologics Evaluation Research 生物制品评价与研究中心
CFU Colony Forming Unit 菌落形成单位
DMF Drug Master File 药品管理档案
CDER Center for Drug Evaluation and 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 Inspector 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 Administration 管制药品管理
DS documentation System 文件系统
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7楼
FDA Food and Drug Administration 食品与药品管理局（美国）
GATT General Agreement on Tariffs and Trade 关贸总协会
GMP Good Manufacturing Practice 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 Good Retail Practice 药品零售业质量管理规范
GAP Good Agriculture Practice 药材生产管理规范
GVP Good Validation Practice 验证管理规范
GUP Good Use Practice 药品使用规范
HVAC Heating Ventilation Air Conditioning 空调净化系统
ISO International Organization for Standardization 国际标准化组织
MOU Memorandum of Understanding 谅解备忘录
PF Production 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
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8楼
SDA State Drug Administration 国家药品监督管理局
SMP Standard Management Procedure 标准管理程序
SOP Standard Operating Procedure 标准操作程序
TQC Total Quality Control 全面质量管理
USA United States Pharmacopoeia 美国药典
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9楼
更衣室 Changing Room
一更 First Changing Room
手消室 Hands Disinfection Room
气闸室 Airlock Room
洁具室 Cleaning Tools Room
清洗室 Cleaning Room
模具室 Dies Room
内包装室 Immediate Package Room
安全门 Emergency Door
外包清室Outer Package Removing Room
存料间Storage Room of Raw Materials
粉碎室 Pulverizing Room
备料室 Materials Preparing Room
硬胶室 Hard Capsules Filling Room
软胶室 Soft Capsules Room
制粒干燥室
Granulating and Drying Room
总混间 Blending Room
中间站 Intermediate Station
压片室Tablets Room Compression Room
包衣室 Coating Room
配浆间 Coating Mixture Preparing Room
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10楼
铝塑包装间Packing Room
传递窗 Transferring Window
外包装室 Outer Packing Room
蒸馏水室 Water Purifying Room
质检室 Quality Control Room
浓配室 Concentrated Solution Room
稀配室 Diluted Solution Room
灌封室Filling and Sealing Room
存瓶室 Ampul Storage Room
洗瓶室 Ampul Cleaning Room
灭菌间 Sterilizing Room
灯检室 Light Inspection Room
粉针室 Lyophilized Sterile Powder Room
冷冻干燥机 Lyophilizer
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11楼
Urine Analyzer 尿液分析仪
blood sugar（glucose ） analyzer血糖分析仪
test strip 测试条
reagent 试剂
Semi-automatic Biochemical Analyzer半自动生化分析仪
Automatic Blood Cell Analyzer全自动血细胞分析仪
Urine sediments analyzer尿沉渣
Bio-safety Cabinet 生物安全柜
Incubator培养箱
High Frequency Electrotome 高频电刀
shadowless lamp无影灯
High speed refrigerated centrifuge高速冷冻离心机
hot air sterilizer热空气消毒箱
microbiological incubator微生物培养箱
Halogen light 卤素灯
disposable sterile injector 一次性无菌注射针
injection set注射器
disposable venous infusion needle一次性静脉输液针
disposable infusion set 一次性使用输液器
blood transfusion set输血器
infusion bag液袋
urine drainage bag集尿袋
blood bag血袋
medical catheter医用导管
stainless steel needle不锈钢医用针管
blood taking needle采血针
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