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）

        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 Organization

        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 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 医学全在线www.med126.com

        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 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 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 Summary of Product Characteristics

        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 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

        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

        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