Japan-Handling of Application for GMP Conformity Audit

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GMP常用词汇

GMP常用词汇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 ADMINISTRA TION）：（美国）食品药品管理局IND（INVESTIGA TIONAL 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 APPLICA TION）：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BA TCH PRODUCTION：批量生产；分批生产BA TCH 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 IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOV A Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EV ALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA （European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 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 BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．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）GA TT 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HV AC 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。

gmp认证申请书事例

gmp认证申请书事例英文回答：GMP Certification Application Template.Introduction.The purpose of this application is to provide the necessary information to the GMP Certification Body (CB) to assess the applicant's compliance with the GMP requirements.Section 1: Applicant Information.Applicant Name:Address:Phone Number:Email Address:Website:Section 2: Product Information.Product Name(s):Description of Product(s):Intended Use(s) of Product(s):Manufacturing Process:Section 3: Quality Management System.3.1 Quality Policy.Statement of the company's quality policy and its commitment to GMP compliance.3.2 Organizational Structure.Organizational chart showing the roles and responsibilities of personnel involved in GMP activities.3.3 Training.Description of the training program for personnel involved in GMP activities, including the frequency and content of training.3.4 Documentation Control.Description of the system for controlling and maintaining GMP-related documentation, including SOPs, records, and reports.3.5 Change Control.Description of the system for managing changes to GMP-related documentation, materials, and processes.3.6 Internal Audits.Description of the program for conducting internal audits of GMP compliance, including the frequency and scope of audits.3.7 Corrective and Preventive Actions.Description of the system for addressing and resolving GMP non-compliances, including the process for identifying, investigating, and implementing corrective and preventive actions.3.8 Product Recall.Description of the system for managing product recalls, including the process for notifying customers and authorities.Section 4: Manufacturing Facility.4.1 Location and Description.Physical address and description of the manufacturingfacility, including the size and layout.4.2 Equipment and Utilities.List of equipment and utilities used in GMP operations, including their calibration and maintenance schedules.4.3 Environmental Monitoring.Description of the environmental monitoring program, including the parameters monitored, the frequency of monitoring, and the action limits.4.4 Sanitation and Pest Control.Description of the sanitation and pest control program, including the frequency and methods of cleaning and pest control.Section 5: Personnel.5.1 Hygiene and Personal Protective Equipment.Description of the requirements for hygiene and personal protective equipment (PPE) for personnel involved in GMP operations.5.2 Health Qualifications.Description of the health qualifications required for personnel involved in GMP operations.Section 6: Testing and Quality Control.6.1 Raw Material Testing.Description of the testing methods and acceptance criteria for raw materials used in GMP operations.6.2 In-Process Testing.Description of the testing methods and acceptance criteria for in-process materials.6.3 Finished Product Testing.Description of the testing methods and acceptance criteria for finished products.6.4 Stability Testing.Description of the stability testing program for finished products.Section 7: Distribution.7.1 Storage and Transportation.Description of the storage and transportation conditions for finished products.7.2 Distribution Records.Description of the system for maintaining records of distribution, including the dates of distribution, quantities, and customer information.Section 8: Complaints and Adverse Events.Description of the system for handling customer complaints and adverse events, including the process for investigating and responding to complaints.Section 9: Declarations.Declaration by the applicant that the information provided in the application is true and accurate.Declaration by the applicant that the applicant is committed to maintaining compliance with GMP requirements.中文回答：GMP认证申请书示例。

日本药事法J-PAL[1]_training_materials

日本gmp与iso13485的区别63基础设施jgmpart24关闭的门窗建筑和设备能防止被微粒子和微生物的污染建筑能防止被排出物污染设备能保质保量的提供产品及生产过程中所需用水非工作人员不能入内无罢工任何设备不许有门通口直接对外面防止污染competence
Competence. Certainty. Quality.
GQP and GVP / role of supervisors
市场监督
QA Supervisor
Safety Control Supervisor
市场营销
Competence. Certainty. Quality.
营业执照的类型 •每个生产工厂必须有执照(注:不适用于零部件供应商) •生产工厂可以是在日本国外 •营业执照有下列类别医疗器械 1. 动物组织 (relevant to PAL, Article 43) 2. 无菌医疗器械 3. 其它通用器械 4. II & III 类器械的包装 IVD 试剂reagent 1. Radiation 2. Non-radiation 3. License for labeling & packaging of 2 medicine
Foreign Manufacturing facility
Class III, IV
*2
Class II: RCB, e.g
Japan
Foreign restrictive approval holder
Marketing Business
*1 application issued by manufacturing facility with MB(MAH)’s stamp *2 approval or certificate

常用GMP英文词汇

国际组织ISO（International Organization for Standardization）：国际标准化组织日常办事机构是中央秘书处，设在瑞士日内瓦WHO（World Health Organization）：世界卫生组织是联合国属下的专门机构，国际最大的公共卫生组织，总部设于瑞士日内瓦PIC/S（Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme）：国际医药品稽查协约组织由欧洲自由贸易区（EFTA）组建ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human U se）：人用药物注册技术要求国际协调会由欧盟（EU）、欧洲制药工业协会联合会（EFPIA）、日本厚生省（MHW）、日本制药工业协会（JPMA）、美国FDA、美国药物研究生产联合会（PRMA）等机构组成WHO、EFTA、加拿大卫生保健局（CHPB）为观察员ISPE（International Society for Pharmaceutical Engineering）：国际制药工程协会是致力于培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一，在美国坦帕州设有全球总部，在布鲁塞尔设有欧洲总部，亚洲总部在新加坡HHS（United States Department of Health and Human Services）：美国卫生及公共服务部（美国卫生部）FDA（Food and Drug Administration）：美国食品药品监督管理局（HHS下属机构） PDA（Parenteral Drug Association）：美国注射剂协会 EPA（Environmental Protection Agency）：美国国家环境保护局CDER（Center for Drug Evaluation and Research）：FDA药物评价与研究中心EMEA（The European Agency for the Evaluation of Medicinal Products）：欧洲药物评审组织MHW（Ministry of Health and Welfare）：日本厚生省，现改为厚生劳动省MHLW （Ministry of Health, Labor and Welfare），负责医疗卫生和社会保障的主要部门 D&B（Dun & Bradstreet）：邓白氏公司DUNS（DataUniversal Numbering System）：邓白氏公司提供的唯一的公司代号，用于信用评级等在SMF文件中会用到ATCC（American Type Culture Collection）：美国模式培养物集存库 ASTM（American Society for Testing Materials）：美国材料与试验协会法规GMP（Good Manufacturing Practice）：药品良好生产规范cGMP（Current Good Manufacture Practices）：动态药品生产管理规范，即现行的 GLP（Good Laboratory Practice）：药物非临床研究质量管理规范，及优良实验室规范 GSP（Good Supplying Practice）：药品经营质量管理规范，及良好的药品供应规范 GAP（Good Agricultural Practice for Chinese Crude Drugs）：中药材生产质量管理规范 GDP （Good Documentation Practice）：良好文件管理 GEP（Good Engineering Practice）：工程设计规范GAMP（Good Automated Manufacturing Practice）：优良自动化生产规范 USP（united states pharmacopeia）：美国药典 EP（European Pharmacopeia）：欧洲药典 JP（Japanese Pharmacopoeia）：日本药典 CFR（Code of Federal Regulations）：美国联邦法律CFR 21 Part 11（Code of Federal Registry Part11）：联邦法规法律标题21第11部分 CEP/COS （Certificate of Suitability to the monographs of European Pharmacopoeia）：欧洲药典适应性认证证书CEP认证，COS 证书CTD（Common Technical Document）：国际注册用常规技术文件CTD文件是国际公认的文件编写格式，用来制作一个向药品注册机构递交的结构完善的注册申请文件 EHS（Environment、Health、Safety）：环境-健康-安全管理体系HACCP（Hazard Analysis and Critical Control Point）：（保健食品）危害分析和关键控制点 REACH （REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals）：欧盟规章《化学品注册、评估、许可和限制》，欧盟建立的，并于2007年6月1日起实施的化学品监管体系ICH法规ICH-Q1A：新原料药和制剂的稳定性试验ICH-Q1B：稳定性试验：新原料药和制剂的光稳定性试验ICH-Q1C：稳定性试验：新剂型的要求ICH-Q1D：新原料药和制剂的稳定性试验的括号法和矩阵法设计ICH-Q1E：稳定性数据的评价ICH-Q1F：气候带Ⅲ和Ⅳ注册申请的稳定性数据ICH-Q2A：分析步骤验证：正文ICH-Q2B：分析步骤验证：方法学ICH-Q3A：原料药中的杂质ICH-Q3B：新制剂中的杂质ICH-Q3C：杂质；残留溶剂的指导原则ICH-Q4：药典ICH-Q4A：药典的同一化ICH-Q4B：各地区使用的药典正文评估和建议ICH-Q5A：来源于人或动物细胞系的生物技术产品的病毒安全性评价ICH-Q5B：生物技术产品的质量：rDNA衍生蛋白质产品生产细胞的表达构建体分析ICH-Q5C：生物技术产品的质量：生物制品生物技术产品的稳定性试验ICH-Q5D：用于生物技术产品及生物制品生产的细胞基质的来源和鉴定ICH-Q5E：生物技术产品生物制品在工艺变更时的可比性ICH-Q6A：质量标准新原料药和制剂的检测以及可接受标准：化学物质ICH-Q6B：质量标准：生物技术产品及生物制品的检测方法和可接受标准ICH-Q7：原料药良好制造规范(ICH-Q7A的新版)ICH-Q7A：原料药的GMP规范ICH-Q8：药物研发指南ICH-Q9：质量风险管理ICH- Q10（PQS）：药物质量体系ICH-Q11：原料药研发与生产常见术语QA（Quality Assurance）：质量保证QC（Quality Control）：质量控制CQA（Critical Quality Attribute）：关键质量属性QRM（Quality Risk Management）：质量风险管理IPC（InproceicsQuality Control）：制程品质控制/中控OOS（Out of Specification）：检验结果超标OOT（Out of Trend）：超趋势结果OOL（Out of Limit）：超出极限的结果，如温湿度等OOE（Out of Expectation）：超期望结果SOP（Standard Operation Procedure）：标准操作规程DMF（Drug Master File）：药品主文件SMF（Site Master File）：工厂主文件URS（User Requirement Specification）：用户需求标准FAT（Factory Acceptance Test）：工厂验收测试SAT（Site Acceptance Test）：现场验收测试FS（Functional Specification）：功能标准DS（Design Specification）：设计标准DQ（Design Qualification）：设计确认IQ（Installation Qualification）：安装确认OQ（Operational Qualification）：运行确认PQ（Performance Qualification）：性能确认RQ（Requalification）：再确认CAPA（Corrective Action & Preventive Action）：纠正预防系统，Q10的四大要素之一QbD（Quality byDesign）：质量源于设计PMC（Product Material Control）：生产物料控制PC生产控制；MC物料控制CMC（Chemistry and manufacture control）：生产和化学控制APR（Annual Products Review）：年度质量回顾CNC（Controlled Non-Classified Area）：受控非洁净区应用技术APS（Aseptic Processing Simulation）：培养基模拟灌装CIP（Cleaning in Place）：原位清洗（全自动，如针剂配制系统）WIP（Washing in Place）：在线清洁（半自动，需要手动的拆卸，如流化床）SIP（Sterilization in Place）：在线灭菌BFS（Blowing Filling and Sealing）：吹-灌-封PA T（Process Analytical Technology）：过程分析技术PLC（Programmable Logic Controller）：可编程逻辑控制EDI（Electrodeionization）：一种制备纯化水的离子交换技术MAC（Minimum Acceptable Cycle）：最低可接受程序SAM（Steam-Air Mixture）：蒸汽空气混合气体灭菌程序WIT（Water IntrusionTest）：水侵入测试（东富龙疏水性滤器的在线进行完整性测试的方法） BP（Bubble Point Test）：起跑点试验FF（Forward Flow/Diffusive Flow）：前进流、扩散流试验HPLC（High Performance Liquid Chromatography）：高效液相色谱GC（Gas Chromatography）：气相色谱FTIR（Fourier Transform Infrared spectroscopy）：傅氏转换红外线光谱分析仪MS（Mass Spectroscopy）：质谱LC/MS：液质联用GC/MS：气质联用TOC（Total Organic Carbon）：总有机碳NVR（NonvolatileResidue）：不挥发残留物RFS（Ready for Sterilization）：免洗胶塞RFU（Ready for Use）：即用胶塞物品名称SVP（Small V olume Parenteral）：小容量注射剂 LVP（Large Volume Parenteral）：大容量注射剂 APA （Aseptic Processing Area）：无菌区P&ID（Piping and Instrument Diagram）：工艺管道仪表流程图 PFD（Process Flow Diagram）：工艺流程图 UFD （Utility Flow Diagram）：公用工程流程图HV AC（Heating Ventilation Air Conditioning）：供热空气调节净化系统 HEPA（High Efficiency Particulate Air Filter）：高效过滤器 FFU（Fan Filter Units）：风机滤器单元 AHU（Air Handling Unit）：空气处理单元COA（Certificate of Analysis）：分析证书/检验报告书/检验报告单 BPR（Batch Production Record）：批生产记录API（Active Pharmaceutical Ingredients）：药物活性成分，通常指的原料药 WFI（Water for Injection）：注射用水DOP：为邻苯二甲酸二辛酯，HEPA检漏用的气溶胶 PAO：聚-α-烯烃，HEPA检漏用的气溶胶 IBC （IntermediateBulkContainer）：中型散装容器 FBD（Fluid Bed Dryer）：流化床IRTD（IntelligentResistance Temperature Detector）：智能热电阻温度探头，标准温度探头 SV（Solenoid Valve）：电磁阀FV：气动阀P/HG（Porous/Hard Goods Loads）：多孔/坚硬装载，包括过滤器、胶塞、软管、拖把、工作服、塞子、清洁器具或设备的更换部件。

GMP英语

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。

GMP常用英语单词

Abbreviated New drug简化申请的新药Accelerated approval加速批准Adverse effcet副作用Adverse reaction不良反应Agency审理部门ANDA(Abbreviated New drug application)简化新药申请Animal trial动物试验Archival copy存档用副本Batch production records生产批号记录Batch production批量生产CFR （Code of federal regulation ）(美)联邦法规Clinical trial临床试验COS/CEP欧洲药典符合性认证Dietary supplement食品补充品DMF(Drug master file)药物主文件Drug substance原料药Generic name非专利名称ICH(International Conference onHarmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议IND(Investigation new drug)临床研究申请（指申报阶段，相对于NDA）；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）Informed consent知情同意INN(international nonproprietary name)国际非专有名称Investigator研究人员；调研人员Labeled amount标示量NDA(New drug application)新药申请NF(National formulary)(美)国家药品集NIH(National Institute of Health)(美)国家卫生研究所Panel专家小组preparing and Submitting起草和申报Prescription drug处方药Proprietary name专有名称Regulatory methodology质量管理方法Regulatory methods validation管理用分析方法的验证Regulatory specification质量管理规格标准Review copy审查用副本Sponsor主办者（指负责并着手临床研究者）Standard drug标准药物Strength规格；规格含量（每一剂量所含有效成分的量）Submission申报；递交Treatment IND研究中的新药用于治疗生产工艺相关Acceptance criteria可接受标准air driers手烘箱Airlock Room气闸室analytical methods分析方法anhydrous无水API原料药Assay 含量at rest静态batch size批量Blending Batches混批Blending Room总混间calibrating校正case-by-case具体分析centigrate摄氏度Changing Room更衣室Charge-in进料chemical properties化学性质Clarity,completeness,or PH of solutions溶液的澄明度、溶解完全性及PH值cleaning agents清洗媒介cleaning procedures清洁程序Cleaning Tools Room洁具室Coating Mixture Preparing Room配浆间Commercial scale可配伍性Concentrated Solution Room浓配室consistency of the process工艺的稳定性critical process关键步骤dedicated专用的Documentation System文件系统dosage form剂型electronic form电子格式electronicsignatures电子签名Emergency Door安全门established schedule预先计划Excipient辅料exhaust排气fermentation发酵Granulation颗粒HAVC(Heating ventilation and air conditioning)空调净化系统Heavy metal重金属historical date历史数据Hydrochloric acid盐酸in operation动态incoming materials进厂物料in-house testing内控检测installation qualification(IQ)安装确认intermediate中间体intermal audits self-inspection自检laboratory control record实验室控制记录laboratory information managementsystem(LIMS)实验室信息管理系统local authorities当地药政部门Loss on drying干燥失重Meet the requirement符合要求Melting point熔点Melting range熔程microbiological specifications微生物标准microorganisms微生物Milling磨粉Mix-ups混放modified facilities设施变更molecular formula分子式Non-dedicated equipment非专用设备Operational qualification(OQ)运行确认Out-of-specification不合格Packaging包装Particle size粒度Perform a blank determination作一个空白对照Personnel Hygiene人员卫生pilot scale中试规模potable water饮用水premises设施process parameters工艺参数Process validation工艺验证，过程验证product quality reviews产品质量回顾production batch records批生产记录proposed indication适应症purification纯化performance qualification(PQ)性能确认Process flow diagrams(PFDS)工艺流程图product validation产品验证regulatory inspection evaluation药政检查Related substance有关物质release放行Residual solvents残留溶剂retention periods保留期限Retention samples留样retention time保留时间Retrospective validation回顾性验证Revalidation再验证review and approve审核并批准route of administration给药途径Sanitation环境卫生scale-up reports报产报告serious GMP deficiencies严重GMP缺陷Sip sterilization in place在线灭菌sodium hydroxide氢氧化钠Specific rotation比旋度specifications标准stability date稳定性数据stability monitoring program稳定性监控计划status状态sterile APIs无菌原料药sterilization消毒succ essive batches连续批号supplier供应商technical transfer技术转化total microbial counts微生物总数traceable可追踪的turnover packages验证文件集Validation master plan验证总计划Validation report验证报告常用中译英系统system物料平衡reconciliation批batch or lot批号batch number批生产记录batch records文件document标准操作规程standard operating proceddures (SOP)生产工艺规程master formula工艺用水water for processing纯化水purified water注射用水water for injection状态标志status mark/label中间产品intermediate product理论产量theoretical yield物料material待验quarantine起始原料staring material洁净室(区)clean room(zone)待包品bulk product成品finished product灭菌sterilization控制点control point质量监督quality surveillance生产过程控制in-process control退货returned product拒收rejected交叉污染cross contamination放行released质量要求quality requirement可追溯性traceability计量确认metrologial confirmation人员净化室room for cleaning human body物料净化室room for cleaning material悬浮粒子airborne particles洁净度cleanliness净化cleaning传递箱pass box洁净服clean working garment洁净工作台clean bench静态at-rest动态operational粗效过滤器roughing filter中效过滤器medium efficiency filter高效过滤器hepa filter安装确认instalation qualification(IQ)运行确认operational qualification(OQ)性能确认performance qualification(PQ)工艺验证process validation。

10-Shinichi Yamagami-新型制药密闭系统的设计

Functional Barrier Level
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Step 4. Optimum Combination “Ｇowning”
Typical TypicalGowning GowningProcedure Procedure& &Functional FunctionalBarrier BarrierLevel Level
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Equipment Containment Level
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Step 4. Optimum Combination “Equipment”
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Step 3. Required Barrier Level
PB-ECL State Large volume of powder Small volume of powder Wet powder Very small amount of powder or liquid Powder/liquid to be contained
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日本GMP第一部分

药品的生产控制和质量控制规范1．总则定义第一项1.本规范中的术语“标签和包材”是指产品的容器、外包材、说明书以及贴在容器和外包材上的标签。

2.本规范中的术语“批”是指在一个生产周期中的一个连续的生产过程中生产出来的具有均一性质的一批产品。

[包括原料和生产过程中出现的、经进一步加工成为成品的物质（以下提到时称为“中间体”；第三项下的第一段第二条、第六项下的第一段第2-D条和第二段的第1-A，F，J条、以及第八项下的第一段第1-A和B条）。

3.本规范中的术语“控制单位”是指已经经证实为具有均一品质的一批标签和包装材料。

4.本规范中的术语“验证”是指确认和证明从生产厂房和设备、操作步骤和过程以及其他生产控制和质量控制方法（以下称为“操作规程”）得出的预期结果。

5.本规范中的术语“洁净区”所指的范围包括生产操作区（以下称为“作业区”）、原材料称重和药物配制区以及容器清洗后的晾放区。

6.本规范中的术语“无菌区”所指的范围包括作业区里无菌药物和消毒后容器晾放的区域、药物灌装及容器密封区、无菌操作区例如执行无菌检验及相似操作的区域。

生产控制主管及QC主管第二项1.药品生产商（以下称为“生产商”）应该在每一个生产车间指定一个负责生产控制单位的人为生产控制主管以及一个负责质量控制单位的人为QC主管，他们在产品安全药剂师的监督下履行职责。

2.质量控制单位应该独立于生产控制单位之外。

3.生产控制主管不应该被赋予具有任免与之协作的QC主管的权利。

产品安全药剂师第三项1.产品安全药剂师应该履行以下职责：(1). 监督生产控制主管和QC主管；(2). 通过对生产控制和质量控制的结果进行适当的评估，决定是否放行产品出车间；(3). 依据报告的文件，确保验证、自检、培训以及在第15项下的第5段第1条指定的确认工作能顺利而恰当的执行（报告的文件见第10项下的第1段第2条、第11项下的第1段第2条、第14项下的第一段的第2条以及第15项下的第5段第2条）。

版GMP英文版

版GMP英文版IntroductionThe Good Manufacturing Practices (GMP) is a set of guidelines that ensure the quality, safety, and efficacy of medical products. These guidelines aim to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product. The updated version of GMP is the GMP version 5.0, also known as the GMP5. The GMP5 is an English language version of GMP that has been translated and adapted to suit the international audience.PurposeThe purpose of GMP5 is to regulate the production, quality control, storage, and distribution of medicines to ensure their safety, efficacy, and consistency. These guidelines are developed to establish minimum requirements to be observed by manufacturers for the production of safe and effective medicines. GMP5 is an essential document for the pharmaceutical industry as it sets out principles that should be followed during the manufacturing process of medical products.ScopeThe scope of GMP5 covers all aspects of medicinal products, including their manufacture, testing, packaging, labeling, storage,and distribution. It applies to all forms of medicines, including tablets, capsules, injections, and creams. The GMP5 guidelines also apply to the production of biological products, including vaccines, blood products, and gene therapies.General Principles of GMPThe GMP5 guidelines are based on a few fundamental principles that should be applied during the drug manufacturing process. Here are some of those general principles:- Quality should be built into the manufacturing process throughout the entire lifecycle starting from the design stage, through the manufacturing process and continuing topost-marketing surveillance.- All manufacturing processes should be clearly defined and documented in written procedures.- Any changes to the manufacturing process should be documented and validated before implementation.- There should be adequate testing and inspection of raw materials, in-process materials, and finished products to ensure their identity, strength, quality, and purity.- There should be a system for the documentation and archiving of all records relevant to the product manufacturing process.Good Manufacturing Practices for Premises and EquipmentGMP5 guidelines for premises and equipment are critical in ensuring the production of safe and effective medical products. Premises used for manufacturing medicines should be designed,constructed, and maintained taking into account the need to avoid the risk of errors and contamination. Equipment must be maintained and calibrated, with all repairs being documented following well-established procedures. All machines and facilities should be kept clean and in good condition to prevent contamination and other forms of damage.Good Manufacturing Practices for PersonnelThe GMP5 ensures that personnel involved in the manufacturing process of medical products are appropriately trained and qualified for their job functions. Companies are responsible for ensuring the safety of employees by providing adequate training on safety procedures, hygiene, and the handling of chemicals. The guidelines emphasize the importance of regular training for employees throughout the entire manufacturing process.Good Manufacturing Practices for Documentation and RecordsThe GMP5 guidelines require all personnel involved in the manufacturing process of medicinal products to followwell-established documentation procedures. Proper documentation of all aspects of the manufacturing process is critical in the proof of safety, efficacy, and consistency of the final product. All records relating to quality checks, product specification, and manufacturing operations must be documented and retained for a minimum of five years.ConclusionThe pharmaceutical industry is one of the most regulated industries in the world, and the GMP guidelines offer essential guidance and minimum requirements for ensuring the safety, efficacy, and consistency of medicinal products. These guidelines reduce the risk of harm or death to patients due to the consumption of unsafe or ineffective products. The GMP5 has been translated into English to enable international adoption, bringing quality medical products to everyone around the world. Manufacturers have a responsibility to follow the GMP5 guidelines to ensure that they produce safe and effective medicinal products that meet international standards.。

医疗器械GMP手册英文版

9
Organization and Management
10
Quality System
15
Personnel Training and Qualification
18
Facilities and Equipment
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Inspection Methods and Procedures
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Handling Inspection Samples
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General
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References
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Scope
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Definitions
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Administrative Requirements
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Independence, Impartiality, Integrity
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Confidentiality
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Records, Documents and Data Controls
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Inspection Reports, Issue, Withdrawal of Licenses, GMP Certificates
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Sub-contracting
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Quality Improvement & Corrective and Preventive Action (CAPA)
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Handling Suspected Quality Defects and Rapid Alert System
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Publications

GMP一些英语词汇

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 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 RoomManagement of Standard Operating Procedures (SOP) Management of Technical DocumentsGuidelines for SamplingGeneral Guidelines for Quality ControlManagement of Reference Materials (Standard Materials) Management of Titrants, Standard Solutions and Reagents General Guidelines for V alidationOperation and Maintenance of Analytical Instruments Management of Data Records and Documents Cleaning of Production EquipmentNumbering of Production EquipmentInternal GMP AuditProcedure for Product Quality ReviewGuideline for Facility Sanitation and SafetyMaterial ManagementBatch Number AssignmentDeviation Report and HandlingHandling of Rejected MaterialsHandling Out-of-Specification ResultsRelease of MaterialsGuidelines for Change ControlQuality Audit and Management for SuppliersGeneral Guidelines for ReprocessingRecycling of Mother Liquors and ReagentsDrafting Stability Protocols 标准操作程序（SOP）管理办法技术文件管理办法抽样管理制度质量检验制度对照品（标准品）管理办法滴定液、标准液和试剂的管理验证管理分析测试仪器设备的使用和维护保养数据记录与记录文件管理规定生产设备清洗规定生产设备编号管理办法企业内部GMP自检(内部审计)制度产品质量审核工厂的清洁、安全管理规定生产部门物料管理批号编制规定偏差报告和调查处理不合格品的处理O-O-S结果调查程序物料放行变更控制程序供应商质量审计管理办法产品返工的有关规定母液回收和溶剂回收管理药品稳定性试验管理Defining Manufacturing Date and Retest DateQC Test SpecificationGuidelines for Ordinary RetentionLaboratory SafetyComplaint HandlingGuidelines of Check-ups for Production PersonnelManagement of Material Code NumberGeneral Requirements for Personnel and Environment in Clean Rooms Procedure for Postproduction ClearanceMaintenance of Production and Cleaning Equipment in Clean Rooms Management of Working Garments in Clean RoomsProduct Packaging and LabelingGuidelines for Material WeighingResponsibility and Power of Quality Assurance Department Warehousing and Distribution of Raw Materials and Packaging Materials Storage of MaterialsDegraded Use of Raw Materials and Packaging Materials Warehousing and Distribution of ProductsManagement of Measuring InstrumentsNumbering of Measuring InstrumentsMetrological Certification and Usage of Measuring InstrumentsClass A, B, C Management of Measuring InstrumentsReporting Program of Out-of-Calibration Measuring Instruments Maintenance of Production EquipmentPersonnel Training ProgramWaste Handling of Anti-cancer Products 生产日期、复测期的标注检验分析技术标准常规留样管理办法化验室安全操作投诉处理药品生产人员体检管理办法物料代号管理规定洁净室（区）人员、环境管理规定清场验收制度清洁工具、生产用具管理办法洁净区工作服管理办法成品的包装和贴签物料称量的规定QA的职责和权力原料、包材的入库验收和发放物料的贮存原料、包材的降格使用规定成品的入库和发放计量器具管理制度计量器具编号规定计量器具印证使用管理办法计量器具A,B,C三级管理办法计量器具失准报告程序生产设备的维护和维修保养人员培训制度抗肿瘤类废弃物处理办法Guideline for Documentation ReviewCorrective Actions and Preventative Actions (CAPA) Data Backup of Chromatographic Working Station Management of Forms, Sheets, Labels and Stickers GMP Site Inspection 文件审核细则缺陷的整改和预防（CAPA）色谱工作站数据的备份记录表格、标牌和贴签管理规定GMP现场检查。

原料药GMP指南(中英文对照)

Q7a（中英文对照）FDA原料药GMP指南Table of Contents目录1. INTRODUCTION 1. 简介Objective目的Regulatory Applicability法规的适用性Scope范围2. QUALITY MANAGEMENT 2.质量管理Principles总则Responsibilities of the Quality Unit(s)质量部门的责任生产作业的职责Responsibility for ProductionActivitiesInternal Audits (Self Inspection)内部审计（自检）Product Quality Review产品质量审核3. PERSONNEL 3. 人员Personnel Qualifications 3.人员的资质Personnel Hygiene人员卫生Consultants顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施Design and Construction设计和结构Utilities公用设施Water水Containment限制Lighting照明Sewage and Refuse排污和垃圾Sanitation and Maintenance卫生和保养5. PROCESS EQUIPMENT 5. 工艺设备Design and Construction设计和结构Equipment Maintenance and Cleaning设备保养和清洁Calibration校验Computerized Systems计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录Documentation System andSpecifications文件系统和质量标准 Equipment cleaning and Use Record设备的清洁和使用记录Records of Raw Materials, Intermediates, API Labeling and Packaging Materials原料、中间体、原料药的标签和包装材料的记录Master Production Instructions (MasterProduction and Control Records)生产工艺规程（主生产和控制记录）Batch Production Records (BatchProduction and Control Records)批生产记录（批生产和控制记录） Laboratory Control Records实验室控制记录Batch Production Record Review批生产记录审核7. MATERIALS MANAGEMENT7. 物料管理General Controls控制通则Receipt and Quarantine接收和待验Sampling and Testing of Incoming进厂物料的取样与测试Production MaterialsStorage储存Re-evaluation复验8. PRODUCTION AND IN-PROCESS CONTROLS8. 生产和过程控制Production Operations生产操作Time Limits时限In-process Sampling and Controls工序取样和控制中间体或原料药的混批Blending Batches of Intermediates orAPIsContamination Control污染控制9. 原料药和中间体的包装和贴签9. PACKAGING AND IDENTIFICATION LABELINGOF APIs AND INTERMEDIATESGeneral总则Packaging Materials包装材料Label Issuance and Control标签发放与控制Packaging and Labeling Operations包装和贴签操作10. STORAGE AND DISTRIBUTION10.储存和分发Warehousing Procedures入库程序Distribution Procedures分发程序11. LABORATORY CONTROLS11.实验室控制General Controls控制通则Testing of Intermediates and APIs中间体和原料药的测试 Validation of Analytical Procedures分析方法的验证Certificates of Analysis分析报告单Stability Monitoring of APIs原料药的稳定性监测 Expiry and Retest Dating有效期和复验期Reserve/Retention Samples留样12. VALIDATION12.验证Validation Policy验证方针Validation Documentation验证文件Qualification确认Approaches to Process Validation工艺验证的方法Process Validation Program工艺验证的程序Periodic Review of Validated Systems验证系统的定期审核Cleaning Validation清洗验证Validation of Analytical Methods分析方法的验证13. CHANGE CONTROL13.变更的控制14. REJECTION AND RE-USE OF MATERIALS14.拒收和物料的再利用 Rejection拒收Reprocessing返工Reworking重新加工Recovery of Materials and Solvents物料与溶剂的回收Returns退货15. COMPLAINTS AND RECALLS15.投诉与召回16. CONTRACT MANUFACTURERS (INCLUDINGLABORATORIES)16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者Applicability适用性Traceability of Distributed APIs andIntermediates已分发的原料药和中间体的可追溯性 Quality Management质量管理Repackaging, Relabeling, and Holding of APIs and Intermediates 原料药和中间体的重新包装、重新贴签和待检Stability稳定性Transfer of Information信息的传达Handling of Complaints and Recalls投诉和召回的处理 Handling of Returns退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18. 用细胞繁殖/发酵生产的原料药的特殊指南General总则细胞库的维护和记录的保存 Cell Bank Maintenance and RecordKeepingCell Culture/Fermentation细胞繁殖/发酵Harvesting, Isolation and Purification收取、分离和精制Viral Removal/Inactivation steps病毒的去除/灭活步骤19.APIs for Use in Clinical Trials19.用于临床研究的原料药 General总则Quality质量Equipment and Facilities设备和设施Control of Raw Materials原料的控制Production生产Validation验证Changes变更Laboratory Controls实验室控制Documentation文件20. Glossary20. 术语Q7a GMP Guidance for APIsQ7a原料药的GMP指南1. INTRODUCTION 1. 简介Objective目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

GMP文件常见缩写

GMP英语1.ABBREVIATED（NEW）DRUG：简化申请的新药2.AirLock 气闸3.ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请4.API(Active Pharmaceutical Ingrediet) 原料药又称：活性药物组分5.Authorized Person 授权人6.Batch Number/Lot-Number 批号7.Batch Numbering System 批次编码系统8.BATCH PRODUCTION RECORDS：生产批号记录9.BATCH PRODUCTION：批量生产；分批生产10.Batch Records 批记录11.Batch/Lot 批次12.Bulk Product 待包装品13.Calibration 校正14.CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规15.Clean area 净区16.Consignmecnt（Delivery）托销药品17.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）18.FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局19.HOLDER：DMF持有者20.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）RMED 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）22.NDA（NEW DRUG APPLICATION）：新药申请23.OTC DRUG（OVER—THE—COUNTER DRUG）：非处方药24.PANEL：专家小组25.PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical InspectionCooperation 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）26.PIC的权威翻译：药品生产检查相互承认公约27.POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监督28.PRESCRIPTION DRUG：处方药29.TREATMENT IND：研究中的新药用于治疗GMP文件常见缩写ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member State 每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA （European Agency for the Evaluation of Medicinal Products）欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)GCP Good Clinical PracticeGCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 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 BrochureICH International Conference for Harmonisation IDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 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 ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP （STANDARD OPERATION PROCEDURE）标准运作程序SPC/SmPC Summary of Product Characteristicssummary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA．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。

GMP常见英文缩写（本站推荐）

GMP常见英文缩写（本站推荐）第一篇：GMP常见英文缩写（本站推荐）GMP常见英文缩写AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备 API(Active Pharmaceutical Ingredient):活性药物物质,即原料药 ANDA(Abbreviated New Drug Application):简化新药申请ADR(Adverse Drug Reaction):不良反应BSE(Bovine Spongiform Encephalopathy):疯牛病BPCS(Business Planning and Control System):业务计划及控制系统 BIA(Business impact assessment): 商业影响评估cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 CCCD(China Certification Committee for Drugs):中国药品认证委员会CIP(Cleaning In Place):在线清洁CV(Concurrent Validation):同步验证CDER(Center for Drug Evaluation and Research): 药品研究与评价中心COA(Certificate Of Analysis):分析报告单CFR(Code of Federal Regulation):(美国)联邦法规CDC(Centers for Disease Control and Prevention):疾病预防控制中心COS/ CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书 CCD(Certification Committee for Drugs):药品认证管理中心CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会 CTD(Common Technical Document):通用技术文件CDC(Centers for Disease Control and Prevention): 疾病预防控制中心 GMP(Good Manufacturing Practice):药品生产质量管理规范ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use):人用药品注册技术要求国际协调会 EU(European Union):欧洲联盟EFPIA(European Federation of PharmaceuticalIndustries Associations):欧洲制药工业协会联合会MHW(Ministry of Health and Welfare,Japan):日本厚生省JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会 FDA(US Food and Drug Adminiistration):美国食品与药品管理局PRMA(Pharmaceutical Research and Manufacturers of America):美国药物研究和生产联合会WHO(World Health Organization):世界卫生组织IFPMA(International Federation of Pharmaceutical Manufacturers Associations): 国际制药工业协会联合会TQC(Total Quality Control),TQM(Total Quality Management): 全面质量管理PDCA(Plan,Do,Check,Action):计划,执行,检查,处理QA(Quality Assurance):质量保证QC(Quality Control):质量控制QS(Quality System):质量体系 QM(Quality Management): 质量管理SOP(Standard Operating Procedure): 标准操作规程SMP(Standard Management Procedure):标准管理程序SOR(Standard Operating Record): 标准操作记录GEP(Good Engineering Practice):工程设计规范HVAC(Heating Ventilation and Air Conditioning):空调净化系统DQ(Design Qualification):设计确认IQ(Installation Qualification):安装确认OQ(Operational Qualification):运行确认PQ(Performance Qualification):性能确认OOS(Out-Of-Specification):检验不合格;超标 PFDS(Process Flow Diagrams):工艺流程图MRA(cMutual Reognition Agreements): 现场检查多边认同协议 DMF(Drug Master File): EDMF(European Drug Master File）欧盟药物主文件EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 ORA(Office of Regulatory Affairs):药政事务办公室GGPs(Good Guidance Practices): 优良指南规范MOA(Method Of Analysis):分析方法VMP(Validation Master Plan):验证主计划VP(Validation Protocol):验证方案MSDS(Material Safety Data Sheet):物料安全技术说明书NDA(New Drug Application):新药申请OTC(Over-the-counter):非处方INN(International Nonproprietary Name)国际非专有名称USP(the united state pharmacopeia): 美国药典NF(National Formulary):(美国)国家药品集GAP(Good Agricultural Practice):中药材种植管理规范GCP(Good Clinical Practice):药物临床试验质量管理规范 GLP(Good Laboratory Practice):药物实验室管理规范GSP(Good Supply Practice):药品经营质量管理规范 GUP(Good Use Practice):药品使用质量管理规范 SM(Starting Material):起始物料PMF(Plant Master File);SMF(Site Master File):工厂主文件EDL(List of Essential Drugs): 基本药物目录 PI(Package Insert):说明书PCT(Patent Cooperation Treaty): 专利合作条约PPAC(Patent Protection Association of China):中国专利保护协会 PIC(Person In Charge):负责人PDS(Pharmaceutical Development Services): 整体新药研发机构 SPC(Summary of Product Characteristics):产品特性摘要第二篇：GMP英文缩写1.AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备2.API(Active Pharmaceutical Ingredient):活性药物物质即原料药3.ANDA(Abbreviated New Drug Application):简化新药申请4.ADR(Adverse Drug Reaction):不良反应5.BSE(Bovine Spongiform Encephalopathy):疯牛病6.BPCS(Business Planning and Control System):业务计划及控制系统7.BIA(Business impact assessment): 商业影响评估8.cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范 CD(China Certification Committee for Drugs):中国药品认证委员会10.CIP(Cleaning In Place):在线清洁11.CV(Concurrent Validation):同步验证12.CDER(Center for Drug Evaluation and Research): 药品研究与评价中心13.COA(Certificate Of Analysis):分析报告单14.CFR(Code of Federal Regulation):(美国)联邦法规15.CDC(Centers for Disease Control and Prevention):疾病预防控制中心16.COS / CEP(Certificate of Suitability for European Pharmacopeia):欧洲药典适用性证书D(Certification Committee for Drugs):药品认证管理中心18.CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会19.CTD(Common Technical Document):通用技术文件20.CDC(Centers for Disease Control and Prevention): 疾病预防控制中心21.GMP(Good Manufacturing Practice):药品生产质量管理规范22.ICH(International Conference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use):人用药品注册技术要求国际协调会 23.EU(European Union):欧洲联盟24.EFPIA(European Federation of Pharmaceutical Industries Associations):欧洲制药工业协会联合会25.MHW(Ministry of Health and Welfare,Japan):日本厚生省26.JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会27.FDA(US Food and Drug Adminiistration):美国食品与药品管理局28.PRMA(Pharmaceutical Research and Manufacturers of America):美国药物研究和生产联会29.WHO(World Health Organization):世界卫生组织30.IFPMA(International Federation of Pharmaceutical Manufacturers Associations):国际制药工业协会联合会31.TQC(Tota lQuality Control),TQM(Total Quality Management): 全面质量管理32.PDCA(Plan,Do,Check,Action):计划执行检查处理33.QA(Quality Assurance):质量保证 34.QC(Quality Control):质量控制 35.QS(Quality System):质量体系36.QM(Quality Management): 质量管理37.SOP(Standard Operating Procedure): 标准操作规程38.SMP(Standard Management Procedure):标准管理程序39.SOR(Standard Operating Record): 标准操作记录 40.GEP(Good Engineering Practice):工程设计规范41.HVAC(Heating Ventilation and Air Conditioning):空调净化系统42.DQ(Design Qualification):设计确认43.IQ(Installation Qualification):安装确认44.OQ(Operational Qualification):运行确认 45.PQ(Performance Qualification):性能确认46.OOS(Out-Of-Specification):检验结果偏差，有别于偏差47.PFDS(Process Flow Diagrams):工艺流程图48.MRA(cMutual Reognition Agreements): 现场检查多边认同协议 49.DMF(Drug Master File):药物主文件50.EDMF(European Drug Master File)欧盟药物主文件51.EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局 52.ORA(Office of Regulatory Affairs):药政事务办公室53.GGPs(Good Guidance Practices): 优良指南规范54.MOA(Method Of Analysis):分析方法 55.VMP(Validation Master Plan):验证主计划 56.VP(Validation Protocol):验证方案57.MSDS(Material Safety Data Sheet):物料安全技术说明书58.NDA(New Drug Application):新药申请59.OTC(Over-the-counter):非处方60.INN(International Nonproprietary Name):国际非专有名称P(the united state pharmacopeia): 美国药典62.NF(National Formulary):(美国)国家药品集63.GAP(Good Agricultural Practice):中药材种植管理规范64.GCP(Good Clinical Practice):药物临床试验质量管理规范65.GLP(Good Laboratory Practice):药物实验室管理规范66.GSP(Good Supply Practice):药品经营质量管理规范67.GUP(Good Use Practice):药品使用质量管理规范 68.SM(Starting Material):起始物料69.PMF(Plant Master File);SMF(Site Master File):工厂主文件70.EDL(List of Essential Drugs): 基本药物目录 71.PI(Package Insert):说明书72.PCT(Patent Cooperation Treaty): 专利合作条约73.PPAC(Patent Protection Association of China):中国专利保护协会 74.PIC(Person In Charge):负责人75.PDS(Pharmaceutical Development Services):整体新药研发机构 76.SPC(Summary of Product Characteristics):产品特性摘要第三篇：常用制药及GMP英文缩写ISO（International Organization for Standardization）：国际标准化组织日常办事机构是中央秘书处，设在瑞士日内瓦WHO（World Health Organization）：世界卫生组织是联合国属下的专门机构，国际最大的公共卫生组织，总部设于瑞士日内瓦PIC/S（Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme）：国际医药品稽查协约组织由欧洲自由贸易区（EFTA）组建ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use）：人用药物注册技术要求国际协调会由欧盟（EU）、欧洲制药工业协会联合会（EFPIA）、日本厚生省（MHW）、日本制药工业协会（JPMA）、美国FDA、美国药物研究生产联合会（PRMA）等机构组成WHO、EFTA、加拿大卫生保健局（CHPB）为观察员ISPE（International Society for Pharmaceutical Engineering）：国际制药工程协会是致力于培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一，在美国坦帕州设有全球总部，在布鲁塞尔设有欧洲总部，亚洲总部在新加坡HHS（United States Department of Health and Human Services）：美国卫生及公共服务部（美国卫生部）FDA（Food and Drug Administration）：美国食品药品监督管理局（HHS下属机构）PDA（Parenteral Drug Association）：美国注射剂协会EPA （Environmental Protection Agency）：美国国家环境保护局CDER（Center for Drug Evaluation and Research）：FDA药物评价与研究中心EMEA（The European Agency for the Evaluation of Medicinal Products）：欧洲药物评审组织MHW（Ministry of Health and Welfare）：日本厚生省，现改为厚生劳动省MHLW（Ministry of Health, Labor and Welfare），负责医疗卫生和社会保障的主要部门 D&B（Dun & Bradstreet）：邓白氏公司DUNS（DataUniversal Numbering System）：邓白氏公司提供的唯一的公司代号，用于信用评级等在SMF文件中会用到GMP（Good Manufacturing Practice）：药品良好生产规范cGMP（Current Good Manufacture Practices）：动态药品生产管理规范，即现行的GLP（Good Laboratory Practice）：药物非临床研究质量管理规范，及优良实验室规范GSP（Good Supplying Practice）：药品经营质量管理规范，及良好的药品供应规范GAP（Good Agricultural Practice for Chinese Crude Drugs）：中药材生产质量管理规范GDP（Good Documentation Practice）：良好文件管理GEP （Good Engineering Practice）：工程设计规范GAMP（Good Automated Manufacturing Practice）：优良自动化生产规范USP（united states pharmacopeia）：美国药典EP （European Pharmacopeia）：欧洲药典JP（Japanese Pharmacopoeia）：日本药典CFR（Code of Federal Regulations）：美国联邦法律CFR 21 Part 11（Code of Federal Registry Part11）：联邦法规法律标题21第11部分CEP/COS（Certificate of Suitability to the monographs of European Pharmacopoeia）：欧洲药典适应性认证证书CEP认证，COS证书CTD（Common Technical Document）：国际注册用常规技术文件CTD文件是国际公认的文件编写格式，用来制作一个向药品注册机构递交的结构完善的注册申请文件EHS（Environment、Health、Safety）：环境-健康-安全管理体系HACCP（Hazard Analysis and Critical Control Point）：（保健食品）危害分析和关键控制点REACH（REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals）：欧盟规章《化学品注册、评估、许可和限制》，欧盟建立的，并于2007年6月1日起实施的化学品监管体系 ICH-Q1A：新原料药和制剂的稳定性试验ICH-Q1B：稳定性试验：新原料药和制剂的光稳定性试验ICH-Q1C：稳定性试验：新剂型的要求ICH-Q1D：新原料药和制剂的稳定性试验的括号法和矩阵法设计ICH-Q1E：稳定性数据的评价ICH-Q1F：气候带Ⅲ和Ⅳ注册申请的稳定性数据 ICH-Q2A：分析步骤验证：正文ICH-Q2B：分析步骤验证：方法学ICH-Q3A：原料药中的杂质 ICH-Q3B：新制剂中的杂质ICH-Q3C：杂质；残留溶剂的指导原则 ICH-Q4：药典ICH-Q4A：药典的同一化ICH-Q4B：各地区使用的药典正文评估和建议ICH-Q5A：来源于人或动物细胞系的生物技术产品的病毒安全性评价ICH-Q5B：生物技术产品的质量：rDNA衍生蛋白质产品生产细胞的表达构建体分析ICH-Q5C：生物技术产品的质量：生物制品/生物技术产品的稳定性试验ICH-Q5D：用于生物技术产品及生物制品生产的细胞基质的来源和鉴定 ICH-Q5E：生物技术产品/生物制品在工艺变更时的可比性ICH-Q6A：质量标准新原料药和制剂的检测以及可接受标准：化学物质ICH-Q6B：质量标准：生物技术产品及生物制品的检测方法和可接受标准ICH-Q7：原料药良好制造规范(ICH-Q7A的新版)ICH-Q7A：原料药的GMP规范 ICH-Q8：药物研发指南 ICH-Q9：质量风险管理ICH-Q10（PQS）：药物质量体系QA（Quality Assurance）：质量保证QC（Quality Control）：质量控制QRM（Quality Risk Management）：质量风险管理IPC （InproceicsQuality Control）：制程品质控制/中控OOS（Out of Specification）：检验结果超标 OOT（Out of Trend）：超趋势结果OOL（Out of Limit）：超出极限的结果，如温湿度等OOE （Out of Expectation）：超期望结果SAL（SterilityAssuranceLevel）：无菌保证水平灭菌后微生物的存活概率的负对数，要求≥6SAL=−lg存活率=F0D−lgN0D值：杀灭90%的微生物所需要的时间，D值越大，微生物死亡越难，D值与细菌的耐热性成正比Z值：指灭菌时间减少到原来的10%所需要升高的温度或是相同的灭菌时间内杀死99%的微生物所需要提高的温度F值：为一定温度下，给定Z值所产生的灭局效果与参比温度T0下给定Z值所产生的灭菌效果相同时所相当的时间F值用于干热灭菌F0值：为一定温度下，Z值为10℃产生的灭菌效果与120℃，Z 值为10℃时产生的灭菌效果相当的时间，t分钟内的灭菌效果相当于120℃下灭菌F0分钟的效果F0被称为标准灭菌时间，用于热压灭菌LRV：除菌过滤的对数下降值LRV=lgN0-lgN SOP（Standard Operation Procedure）：标准操作规程 DMF（Drug Master File）：药品主文件 SMF（Site Master File）：工厂主文件URS（User Requirement Specification）：用户需求标准FS （Functional Specification）：功能标准DS（Design Specification）：设计标准 DQ（Design Qualification）：设计确认IQ（Installation Qualification）：安装确认OQ（Operational Qualification）：运行确认PQ（Performance Qualification）：性能确认 RQ（Requalification）：再确认CAPA（Corrective Action & Preventive Action）：纠正预防系统，Q10的四大要素之一QbD（Quality byDesign）：质量源于设计COA（Certificate of Analysis）：分析证书/检验报告书/检验报告单 BPR（Batch Production Record）：批生产记录API（Active Pharmaceutical Ingredients）：药物活性成分，通常指的原料药 PMC（Product Material Control）：生产物料控制PC 生产控制；MC物料控制CMC（Chemistry and manufacture control）：生产和化学控制APR（Annual Products Review）：质量回顾 KPI（Key Performance Indicators）：关键业绩指标P&ID（Piping and Instrument Diagram）：工艺管道仪表流程图 PFD（Process Flow Diagram）：工艺流程图 UFD（Utility Flow Diagram）：公用工程流程图CIP（Cleaning in Place）：原位清洗（全自动，如针剂配制系统）WIP（Washing in Place）：在线清洁（半自动，需要手动的拆卸，如流化床）SIP（Sterilization in Place）：在线灭菌WFI （Water for Injection）：注射用水HVAC（Heating Ventilation Air Conditioning）：供热空气调节净化系统 HEPA（High Efficiency Particulate Air Filter）：高效过滤器DOP：为邻苯二甲酸二辛酯，HEPA检漏用的气溶胶PAO：聚-α-烯烃，HEPA检漏用的气溶胶 IBC（IntermediateBulkContainer）：中型散装容器BFS（Blowing Filling and Sealing）：吹-灌-封PAT （Process Analytical Technology）：过程分析技术PLC （Programmable Logic Controller）：可编程逻辑控制CPP （Critical Process Parameters）：关键工艺参数FBD（Fluid Bed Dryer）：流化床AHU（Air Handling Unit）：空气处理单元SAT （SiteAcceptance T est）：现场验收测试 FAT（Factory Acceptance Test）：工厂验收测试第四篇：常见电力英文缩写B-MCR：锅炉的最大连续工况，B-ECR：锅炉的最经济连续工况，THA：汽轮机热耗率验收工况，TRL：铭牌功率，VWO：调节阀全开工况，AMS：asset management system 设备管理系统说明：为西屋公司OVATION系统的一个软件包，实现对智能变送器、智能执行器的诊断、调校、故障预测、定期校验管理等功能，采用该系统能节省大量的设备调试时间及维护量。

中英文对照FDA原料药GMP指南

Q7a（中英文对照）FDA原料药GMP指南Table of Contents 目录1. INTRODUCTION 1. 简介1.1 Objective 1.1目的1.2 Regulatory Applicability 1.2法规的适用性1.3 Scope 1.3范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1总则2.2 Responsibilities of the Quality Unit(s) 2.2质量部门的责任2.3 Responsibility for Production Activities 2.3生产作业的职责2.4 Internal Audits (Self Inspection) 2.4内部审计（自检）2.5 Product Quality Review 2.5产品质量审核3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.人员的资质3.2 Personnel Hygiene 3.2 人员卫生3.3 Consultants 3.3 顾问4. BUILDINGS AND FACILITIES 4. 建筑和设施4.1 Design and Construction 4.1 设计和结构4.2 Utilities 4.2 公用设施4.3 Water 4.3 水4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 排污和垃圾4.7 Sanitation and Maintenance 4.7 卫生和保养5. PROCESS EQUIPMENT 5. 工艺设备5.1 Design and Construction 5.1 设计和结构5.2 Equipment Maintenance and Cleaning 5.2 设备保养和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机控制系统6. DOCUMENTATION AND RECORDS 6. 文件和记录6.1 Documentation System andSpecifications6.1 文件系统和质量标准6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.3 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (MasterProduction and Control Records)6.4 生产工艺规程（主生产和控制记录）6.5 Batch Production Records (BatchProduction and Control Records)6.5 批生产记录（批生产和控制记录）6.6 Laboratory Control Records 6.6 实验室控制记录6.7 Batch Production Record Review 6.7批生产记录审核7. MATERIALS MANAGEMENT 7. 物料管理7.1 General Controls 7.1 控制通则7.2 Receipt and Quarantine 7.2接收和待验7.3 Sampling and Testing of IncomingProduction Materials7.3 进厂物料的取样与测试7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. PRODUCTION AND IN-PROCESSCONTROLS8. 生产和过程控制8.1 Production Operations 8.1 生产操作8.2 Time Limits 8.2 时限8.3 In-process Sampling and Controls 8.3 工序取样和控制8.4 Blending Batches of Intermediates orAPIs8.4 中间体或原料药的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9. 原料药和中间体的包装和贴签9.1 General 9.1 总则9.2 Packaging Materials 9.2 包装材料9.3 Label Issuance and Control 9.3 标签发放与控制9.4 Packaging and Labeling Operations 9.4 包装和贴签操作10. STORAGE AND DISTRIBUTION 10.储存和分发10.1 Warehousing Procedures 10.1 入库程序10.2 Distribution Procedures 10.2 分发程序11. LABORATORY CONTROLS 11.实验室控制11.1 General Controls 11.1 控制通则11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的测试11.3 Validation of Analytical Procedures 11.3 分析方法的验证11.4 Certificates of Analysis 11.4 分析报告单11.5 Stability Monitoring of APIs 11.5 原料药的稳定性监测11.6 Expiry and Retest Dating 11.6 有效期和复验期11.7 Reserve/Retention Samples 11.7 留样12. V ALIDATION 12.验证12.1 Validation Policy 12.1 验证方针12.2 Validation Documentation 12.2 验证文件12.3 Qualification 12.3 确认12.4 Approaches to Process Validation 12.4 工艺验证的方法12.5 Process Validation Program 12.5 工艺验证的程序12.6 Periodic Review of Validated Systems 12.6验证系统的定期审核12.7 Cleaning Validation 12.7 清洗验证12.8 Validation of Analytical Methods 12.8 分析方法的验证13. CHANGE CONTROL 13.变更的控制14. REJECTION AND RE-USE OFMATERIALS14.拒收和物料的再利用14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 返工14.3 Reworking 14.3 重新加工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退货15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 17.1适用性17.2 Traceability of Distributed APIs andIntermediates17.2已分发的原料药和中间体的可追溯性17.3 Quality Management 17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.4原料药和中间体的重新包装、重新贴签和待检17.5 Stability 17.5稳定性17.6 Transfer of Information 17.6 信息的传达17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18. 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and RecordKeeping18.2细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 18.3细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 18.4收取、分离和精制18.5 Viral Removal/Inactivation steps 18.5 病毒的去除/灭活步骤19.APIs for Use in Clinical Trials 19.用于临床研究的原料药19.1 General 19.1 总则19.2 Quality 19.2 质量19.3 Equipment and Facilities 19.3 设备和设施19.4 Control of Raw Materials 19.4 原料的控制19.5 Production 19.5 生产19.6 Validation 19.6 验证19.7 Changes 19.7 变更19.8 Laboratory Controls 19.8 实验室控制19.9 Documentation 19.9 文件20. Glossary 20. 术语Q7a GMP Guidance for APIs Q7a原料药的GMP指南1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. 本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。

gmp指南原料药解读及应用实践

gmp指南原料药解读及应用实践英文回答：GMP Guidelines for Raw Materials.GMP (Good Manufacturing Practices) guidelines for raw materials provide a framework for ensuring the quality and safety of active pharmaceutical ingredients (APIs) and other raw materials used in pharmaceutical manufacturing. These guidelines establish requirements for the control of raw materials throughout their lifecycle, from sourcing to storage and use.Key Elements of GMP Raw Material Guidelines.Supplier Qualification: Establishing and maintaining a robust supplier qualification process to assess the quality of raw material suppliers.Material Specifications: Developing and maintainingdetailed specifications for all raw materials, including identity, purity, potency, and other relevant parameters.Receiving and Inspection: Establishing procedures for receiving and inspecting raw materials upon arrival to ensure they meet specifications.Storage and Handling: Implementing appropriate storage and handling conditions to maintain the quality andintegrity of raw materials until use.Testing and Analysis: Conducting regular testing and analysis of raw materials to verify their compliance with specifications and applicable regulatory standards.Traceability and Accountability: Maintaining traceability throughout the raw material lifecycle, from supplier to finished product, to facilitate product recall and investigations.Change Control: Implementing a change control process to ensure that any changes to raw material specificationsor sources are evaluated and approved.Benefits of GMP Guidelines for Raw Materials.Improved Product Quality: Ensures the consistent quality and reliability of raw materials used in pharmaceutical manufacturing.Patient Safety: Minimizes the risk of drug-related adverse events by ensuring the purity and integrity of raw materials.Regulatory Compliance: Helps pharmaceutical companies meet regulatory requirements and avoid fines or product recalls.Cost Savings: Reduces the risk of product failures, recalls, and lost revenue associated with poor-quality raw materials.Enhanced Reputation: Demonstrates a commitment to quality and patient safety, enhancing the reputation ofpharmaceutical companies.中文回答：GMP原料药解读及应用实践。

中国gmp附录英文版

中国gmp附录英文版Title: China GMP Appendices - English EditionIntroduction:The Good Manufacturing Practice (GMP) is a set of guidelines that ensure the quality and safety of pharmaceutical products.In China, the GMP regulations are crucial for the pharmaceutical industry to maintain international standards.This document provides an English translation of the appendices to the Chinese GMP guidelines, aiming to assist international professionals in understanding and implementing these standards.Appendix 1: Quality Management SystemThis appendix outlines the requirements for establishing and maintaining a quality management system in pharmaceutical manufacturing.It includes principles such as document control, change management, and internal audits.Appendix 2: Personnel Qualifications and TrainingThis section emphasizes the importance of qualified personnel and their training programs.It provides guidelines on the qualifications, responsibilities, and training requirements for different roles within a pharmaceutical company.Appendix 3: Premises and FacilitiesThis appendix focuses on the design, construction, and maintenance of manufacturing premises and facilities.It includes requirements for cleanrooms, production areas, storage, and utilities to ensure a suitable environment for pharmaceutical manufacturing.Appendix 4: EquipmentThis section outlines the requirements for the selection, installation, and maintenance of equipment used in pharmaceutical manufacturing.It includes guidelines for cleaning, calibration, and validation to ensure reliable and accurate production processes.Appendix 5: ProductionThis appendix provides detailed guidelines on the production process, including the handling of starting materials, in-process controls, and batch production records.It emphasizes the importance of adherence to manufacturing procedures and specifications.Appendix 6: Quality ControlThis section discusses the quality control requirements for pharmaceutical products.It includes guidelines for testing raw materials, intermediate products, and finished products, as well as specifications for release and distribution.Appendix 7: Quality AssuranceThis appendix focuses on the role of quality assurance in ensuring GMP compliance.It covers activities such as batch release, productrecalls, and supplier evaluations, aiming to maintain the overall quality of pharmaceutical products.Appendix 8: Complaints and RecallsThis section provides guidance on handling customer complaints and managing product recalls.It emphasizes the importance of prompt investigation, effective corrective actions, and communication with regulatory authorities.Appendix 9: Contract Manufacturing and AnalysisThis appendix addresses the specific requirements for contract manufacturing and contract analysis in the pharmaceutical industry.It includes guidelines for establishing agreements, managing responsibilities, and ensuring compliance with GMP standards.Appendix 10: GlossaryThis glossary defines key terms and phrases used throughout the Chinese GMP appendices.It helps readers understand the terminology and concepts specific to the pharmaceutical industry in China.ote: This document is an unofficial English translation of the Chinese GMP appendices and is provided for reference purposes only.For the official regulations and guidelines, please refer to the original documents issued by the Chinese regulatory authorities.By providing this English edition of the China GMP appendices, we aim to facilitate a better understanding of the regulatory requirementsfor international professionals working in the pharmaceutical industry.It is essential to consult the original Chinese documents for complete and accurate information.。

国外GMP对制药设备的要求

产的中间体或原料药调查关键仪器相对于合格校验标准的偏差，以便确定这些偏差的质量是否有影响。
Q7A对制药设备控制与要求
5 计算机控制系统 5.1 应当有计算机系统操作和维护的书面SOP 5.2 对计算机化系统所做的变更应当按照变更SOP进行，并应当经过正式批准并做验证 5.3 所有变更记录都应当保存，包括对系统的硬件、软件和任何其它关键组件的修改和升级。这些记录应当证明该系统维持在验证过的状态。
5.9 除计算机系统外，数据可以用第二种方式记录。
第四部分：CHN GMP对制药设备控制与要求
第三十一条设备的设计、选型、安装应符合生产要求，易于清洗、消毒或灭菌，便于生产操作和维修、保养，并能防止差错和减少污染。
第三十二条与药品直接接触的设备表面应光洁、平整、易清洗或消毒、耐腐蚀，不与药品发生化学变化或吸附药品。设备所有的润滑剂、冷却剂等不得对药品或容器造成污染。
• 3.37 所使用的清洗和清洁设备应经过选择，它们的使用不应成为一个污染源。
• 3.38 设备的安装应能够防止安装后的误操作风险或污染。
• 3.39 生产设备不得对产品带来危害。接触产品的设备部件与产品不得发生反应、混容和吸附以至于达到影响产品质量的程度，避免带来任何危害。
Equipment 设备
• Equipment 设备
Equipment 设备
• 3.34 生产设备的设计、位置和维修维护应适合于其用途。
• 3.35 维修和维护操作不得对产品质量带来任何风险。
• 3.36 生产设备的设计应易于做到彻底的清洁。其清洁应按照详细的书面程序进行，生产设备只能储存于干净和干燥的环境中。
Equipment 设备
• 3.2,如果必须使用脱落纤维的过滤器，那么必须另用0.22微米的不脱落纤维的滤膜终端过滤. （如实际生产条件限制，可用0.45微米），以降低注射剂内微粒数量；

常用制药GMP英文词汇

国际组织ISO（International Organization for Standardization）：国际标准化组织日常办事机构是中央秘书处，设在瑞士日内瓦WHO（World Health Organization）：世界卫生组织是联合国属下的专门机构，国际最大的公共卫生组织，总部设于瑞士日内瓦PIC/S（Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme）：国际医药品稽查协约组织由欧洲自由贸易区（EFTA）组建ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use）：人用药物注册技术要求国际协调会由欧盟（EU）、欧洲制药工业协会联合会（EFPIA）、日本厚生省（MHW）、日本制药工业协会（JPMA）、美国FDA、美国药物研究生产联合会（PRMA）等机构组成WHO、EFTA、加拿大卫生保健局（CHPB）为观察员ISPE（International Society for Pharmaceutical Engineering）：国际制药工程协会是致力于培训制药领域专家并提升制药行业水准的世界最大的非盈利性组织之一，在美国坦帕州设有全球总部，在布鲁塞尔设有欧洲总部，亚洲总部在新加坡HHS（United States Department of Health and Human Services）：美国卫生及公共服务部（美国卫生部）FDA（Food and Drug Administration）：美国食品药品监督管理局（HHS下属机构）PDA（Parenteral Drug Association）：美国注射剂协会EPA（Environmental Protection Agency）：美国国家环境保护局CDER（Center for Drug Evaluation and Research）：FDA药物评价与研究中心EMEA（The European Agency for the Evaluation of Medicinal Products）：欧洲药物评审组织MHW（Ministry of Health and Welfare）：日本厚生省，现改为厚生劳动省MHLW（Ministry of Health, Labor and Welfare），负责医疗卫生和社会保障的主要部门D&B（Dun & Bradstreet）：邓白氏公司DUNS（Data Universal Numbering System）：邓白氏公司提供的唯一的公司代号，用于信用评级等在SMF文件中会用到ATCC（American Type Culture Collection）：美国模式培养物集存库ASTM（American Society for Testing Materials）：美国材料与试验协会法规GMP（Good Manufacturing Practice）：药品良好生产规范cGMP（Current Good Manufacture Practices）：动态药品生产管理规范，即现行的GLP（Good Laboratory Practice）：药物非临床研究质量管理规范，及优良实验室规范GSP（Good Supplying Practice）：药品经营质量管理规范，及良好的药品供应规范GAP（Good Agricultural Practice for Chinese Crude Drugs）：中药材生产质量管理规范GDP（Good Documentation Practice）：良好文件管理GEP（Good Engineering Practice）：工程设计规范GAMP（Good Automated Manufacturing Practice）：优良自动化生产规范USP（united states pharmacopeia）：美国药典EP（European Pharmacopeia）：欧洲药典JP（Japanese Pharmacopoeia）：日本药典CFR（Code of Federal Regulations）：美国联邦法律CFR 21 Part 11（Code of Federal Registry Part11）：联邦法规法律标题21第11部分CEP/COS（C ertificate o f S uitability to the monographs of E uropean P harmacopoeia）：欧洲药典适应性认证证书CEP认证，COS证书CTD（Common Technical Document）：国际注册用常规技术文件CTD文件是国际公认的文件编写格式，用来制作一个向药品注册机构递交的结构完善的注册申请文件EHS（Environment、Health、Safety）：环境-健康-安全管理体系HACCP（Hazard Analysis and Critical Control Point）：（保健食品）危害分析和关键控制点REACH（REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals）：欧盟规章《化学品注册、评估、许可和限制》，欧盟建立的，并于2007年6月1日起实施的化学品监管体系ICH法规ICH-Q1A：新原料药和制剂的稳定性试验ICH-Q1B：稳定性试验：新原料药和制剂的光稳定性试验ICH-Q1C：稳定性试验：新剂型的要求ICH-Q1D：新原料药和制剂的稳定性试验的括号法和矩阵法设计ICH-Q1E：稳定性数据的评价ICH-Q1F：气候带Ⅲ和Ⅳ注册申请的稳定性数据ICH-Q2A：分析步骤验证：正文ICH-Q2B：分析步骤验证：方法学ICH-Q3A：原料药中的杂质ICH-Q3B：新制剂中的杂质ICH-Q3C：杂质；残留溶剂的指导原则ICH-Q4：药典ICH-Q4A：药典的同一化ICH-Q4B：各地区使用的药典正文评估和建议ICH-Q5A：来源于人或动物细胞系的生物技术产品的病毒安全性评价ICH-Q5B：生物技术产品的质量：rDNA衍生蛋白质产品生产细胞的表达构建体分析ICH-Q5C：生物技术产品的质量：生物制品/生物技术产品的稳定性试验ICH-Q5D：用于生物技术产品及生物制品生产的细胞基质的来源和鉴定ICH-Q5E：生物技术产品/生物制品在工艺变更时的可比性ICH-Q6A：质量标准新原料药和制剂的检测以及可接受标准：化学物质ICH-Q6B：质量标准：生物技术产品及生物制品的检测方法和可接受标准ICH-Q7：原料药良好制造规范(ICH-Q7A的新版)ICH-Q7A：原料药的GMP规范ICH-Q8：药物研发指南ICH-Q9：质量风险管理ICH- Q10（PQS）：药物质量体系ICH-Q11：原料药研发与生产常见术语QA（Quality Assurance）：质量保证QC（Quality Control）：质量控制CQA（Critical Quality Attribute）：关键质量属性QRM（Quality Risk Management）：质量风险管理IPC（Inproceics Quality Control）：制程品质控制/中控OOS（Out of Specification）：检验结果超标OOT（Out of Trend）：超趋势结果OOL（Out of Limit）：超出极限的结果，如温湿度等OOE（Out of Expectation）：超期望结果SOP（Standard Operation Procedure）：标准操作规程DMF（Drug Master File）：药品主文件SMF（Site Master File）：工厂主文件URS（User Requirement Specification）：用户需求标准FAT（Factory Acceptance Test）：工厂验收测试SAT（Site Acceptance Test）：现场验收测试FS（Functional Specification）：功能标准DS（Design Specification）：设计标准DQ（Design Qualification）：设计确认IQ（Installation Qualification）：安装确认OQ（Operational Qualification）：运行确认PQ（Performance Qualification）：性能确认RQ（Requalification）：再确认CAPA（Corrective Action & Preventive Action）：纠正预防系统，Q10的四大要素之一QbD（Quality by Design）：质量源于设计PMC（Product Material Control）：生产物料控制PC生产控制；MC物料控制CMC（Chemistry and manufacture control）：生产和化学控制APR（Annual Products Review）：年度质量回顾CNC（Controlled Non-Classified Area）：受控非洁净区应用技术APS（Aseptic Processing Simulation）：培养基模拟灌装CIP（Cleaning in Place）：原位清洗（全自动，如针剂配制系统）WIP（Washing in Place）：在线清洁（半自动，需要手动的拆卸，如流化床）SIP（Sterilization in Place）：在线灭菌BFS（Blowing Filling and Sealing）：吹-灌-封PAT（Process Analytical Technology）：过程分析技术PLC（Programmable Logic Controller）：可编程逻辑控制EDI（Electrodeionization）：一种制备纯化水的离子交换技术MAC（Minimum Acceptable Cycle）：最低可接受程序SAM（Steam-Air Mixture）：蒸汽空气混合气体灭菌程序WIT（Water Intrusion Test）：水侵入测试（东富龙疏水性滤器的在线进行完整性测试的方法）BP（Bubble Point Test）：起跑点试验FF（Forward Flow/Diffusive Flow）：前进流、扩散流试验HPLC（High Performance Liquid Chromatography）：高效液相色谱GC（Gas Chromatography）：气相色谱FTIR（Fourier Transform Infrared spectroscopy）：傅氏转换红外线光谱分析仪MS（Mass Spectroscopy）：质谱LC/MS：液质联用GC/MS：气质联用TOC（Total Organic Carbon）：总有机碳NVR（Nonvolatile Residue）：不挥发残留物RFS（Ready for Sterilization）：免洗胶塞RFU（Ready for Use）：即用胶塞物品名称SVP（Small Volume Parenteral）：小容量注射剂LVP（Large Volume Parenteral）：大容量注射剂APA（Aseptic Processing Area）：无菌区P&ID（Piping and Instrument Diagram）：工艺管道仪表流程图PFD（Process Flow Diagram）：工艺流程图UFD（Utility Flow Diagram）：公用工程流程图HVAC（Heating Ventilation Air Conditioning）：供热空气调节净化系统HEPA（High Efficiency Particulate Air Filter）：高效过滤器FFU（Fan Filter Units）：风机滤器单元AHU（Air Handling Unit）：空气处理单元COA（Certificate of Analysis）：分析证书/检验报告书/检验报告单BPR（Batch Production Record）：批生产记录API（Active Pharmaceutical Ingredients）：药物活性成分，通常指的原料药WFI（Water for Injection）：注射用水DOP：为邻苯二甲酸二辛酯，HEPA检漏用的气溶胶PAO：聚-α-烯烃，HEPA检漏用的气溶胶IBC（I ntermediate Bulk Container）：中型散装容器FBD（Fluid Bed Dryer）：流化床IRTD（Intelligent Resistance Temperature Detector）：智能热电阻温度探头，标准温度探头SV（Solenoid Valve）：电磁阀FV：气动阀P/HG（Porous/Hard Goods Loads）：多孔/坚硬装载，包括过滤器、胶塞、软管、拖把、工作服、塞子、清洁器具或设备的更换部件。

美国cGMP现场检查的主要内容

美国cGMP现场检查的主要内容美国cGMP现场检查的主要内容美国cGMP现场检查的主要内容1.FDA检查官按原料药的生产顺序从原料到成品包装及出厂的顺序来进行检查，FDA对工艺过程中的一些关键步骤的操作条件、方法及设备进行的验证（V alidation）非常重视。

2.FDA检查官对原料药的原材料的质量控制与管理极为重视，其中包括原材料入库、堆垛、标记及标签、检验及发放的制度。

3.原料药生产工艺范围极广，通常FDA官员重点检查生产关键中间体的第一次反应的步骤，对于非合成药物，则重点放在药物的分离与提取的第一步上。

4.FDA从1991年起决定要对生产工艺进行验证，凡未进行过工艺验证的厂家，FDA要强调进行工艺验证的检查，对于一个新产品，从中试阶段起应建立起完整的验证体系直到放大到工业规模，对已采用多年的生产工艺则应作一次回顾性的验证，生产工艺验证一般不是永恒性的，凡有变动，应重新进行验证。

5.对生产设备诸如发酵罐、种子罐、结晶罐、反应罐、离心机、干燥器、混合器的清洗规程均应经过验证，在交叉使用设备生产不同的产品时尤为重要。

6.供出口美国的成品批量对于一般的美国终端用户来说批量较大为好，这样可以减少批检验所需的成本。

7.FDA对工厂的生产工艺用水等均要求提供质量标准及检验结果的资料。

对制剂用水的要求比对原料药的要求更为严格。

8.对原料药的包装容器上的标签应与对制剂药的要求一样进行严格的控制。

9.对生产上的每一道工序及岗位的操作过程，仓库的成品及原材料管理，质量控制及质量保证的操作及管理等的标准操作规程。

10.FDA非常重视对生产记录的检查，对原材料的入库、检验及发放、生产工艺过程的控制、成品的质量检验以及各项重点项目的验证等均要求有完整的原始记录及整套的批记录，FDA官员在工厂检查要任意取样抽查批记录，批记录的真实性与完整性能具体体现工厂的GMP管理的水平。

11.生产设备包括生产车间及质检等部门的房屋建筑结构、生产线的系列设备、水、电、汽及压缩空气等的附属设施，设备的布局等。