GoodManufacturingPractice药品生产质量管理规范.doc

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（OVERTHECOUNTER 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 ManufacturerATC 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, CPAEDQM (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FDAFDA 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)HSAs 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 HOLDERMA 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 OWNERPSU 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 CommitteeAAA 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