FDA 行业指南 中英对照 待完成
FDA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 进厂物料的取样与测试7.3 Sampling and Testing of IncomingProduction Materials7.4 Storage 7.4储存7.5 Re-evaluation 7.5复验8. 生产和过程控制8. PRODUCTION AND IN-PROCESSCONTROLS8.1 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 中间体或原料药的混批8.4 Blending Batches of Intermediates orAPIs8.5 Contamination Control 8.5 污染控制9. 原料药和中间体的包装和贴签9. PACKAGING AND IDENTIFICATIONLABELING OF APIs ANDINTERMEDIATES9.1 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 OF14.拒收和物料的再利用MATERIALS14.1 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。
FDA常用词中英文对照
FDA常用词中英对照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EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）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I ND、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U．S．PUBLIC HEALTH SERVICE：美国卫生福利部NIH（NATIONAL INSTITUTE OF HEALTH）：（美国）全国卫生研究所CLINICAL TRIAL：临床试验ANIMAL TRIAL：动物试验ACCELERATED APPROVAL：加速批准STANDARD DRUG：标准药物INVESTIGATOR：研究人员；调研人员PREPARING AND SUBMITTING：起草和申报SUBMISSION：申报；递交BENIFIT（S）：受益RISK（S）：受害DRUG PRODUCT：药物产品DRUG SUBSTANCE：原料药ESTABLISHED NAME：确定的名称GENERIC NAME：非专利名称PROPRIETARY NAME：专有名称；INN（INTERNATIONAL NONPROPRIETARY NAME）：国际非专有名称NARRATIVE SUMMARY记叙体概要ADVERSE EFFECT：副作用ADVERSE REACTION：不良反应PROTOCOL：方案ARCHIVAL COPY：存档用副本REVIEW COPY：审查用副本OFFICIAL COMPENDIUM：法定药典（主要指USP、 NF）．USP（THE UNITED STATES PHARMACOPEIA）：美国药典（现已和NF合并一起出版）NF（NATIONAL FORMULARY）：（美国）国家药品集OFFICIAL＝PHARMACOPEIAL= COMPENDIAL：药典的；法定的；官方的AGENCY：审理部门（指FDA）SPONSOR：主办者（指负责并着手临床研究者）IDENTITY：真伪；鉴别；特性STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）LABELED AMOUNT：标示量REGULATORY SPECIFICATION：质量管理规格标准（NDA提供）REGULATORY METHODOLOGY：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）REGULATORY METHODS VALIDATION：管理用分析方法的验证（FDA对N DA提供的方法进行验证）Dietary supplement：食用补充品。
201507FDA行业指南：分析方法验证（中英文）（上）
201507FDA行业指南：分析方法验证（中英文）（上）Analytical Procedures and Methods Validation for Drugs and Biologics药品和生物制品分析方法验证Guidance for Industry行业指南U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)July 2015Pharmaceutical Quality/CMCAnalytical Procedures and Methods Validation for Drugs and BiologicsGuidance for IndustryAdditional copies are available from:Office of Communications, Division of Drug InformationCenter for Drug Evaluation and ResearchFood and Drug Administration10001 New Hampshire Ave., Hillandale Bldg., 4th FloorSilver Spring, MD 20993Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email:****************.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidan ces/default.htmand/orOffice of Communication, Outreach and DevelopmentCenter for Biologics Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 71, Room 3128Silver Spring, MD 20993Phone: 800-835-4709 or 240-402-7800Email:************.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInf ormation/Guidances/default.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)July 2015Pharmaceutical Quality/CMCAnalytical Procedures and Methods Validation for Drugs and Biologics药物和生物制品分析方法验证Guidance for Industry[1]行业指南This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.本指南代表了FDA对本专题的当前想法。
FDA现场检查行业指南(中英文对照)
FDA行业指南-药品现场检查中被认为是延迟、否认、限制或拒绝的情形一、介绍2012年7月9日，《美国食品和药物管理局安全及创新法案》（FDASIA）被签署成为法律。
FDASIA章节707添加了501（j）到《食品、药品和化妆品法令》（FD&C Act），认为“任何从事生产、加工、包装或持有的生产企业、库房造成现场检查的延迟、否认、限制或拒绝的情况均被认为该产品为假劣药品”。
该指南的目的是对“延迟、否认、限制或拒绝”的情形进行定义。
二、定义1、延迟A、检查计划安排的延迟FDA将会根据当地的情况对检查计划进行适当的调整，例如天气、安保、节假日、其他非工作日、企业的生产计划等。
以下延迟的情况将会被认为产品是假劣药品，包括但不仅限于：●企业不同意建议的检查日期，但没有合理的解释。
●在检查安排后，企业要求延迟检查日期，但没有合理的解释。
●企业不能回答为什么FDA联系不上企业指定的联系人。
下面给出了将不会被认为是假劣药品的潜在合理解释的一个例子，但不仅限于：●企业没有正在生产，例如每个月只生产一次，企业要求检查日期另定，以便FDA检查时生产正在进行中。
B、检查期间的延迟以下检查期间的延迟情况将会被认为产品是假劣药品，包括但不仅限于：●企业不允许FDA检查官进入某个区域直至一段时间过去之后，即使这个区域是正在进行操作的并且是FDA有权检查的区域，对于这种行为没有合理的解释。
●企业长时间把FDA检查官单独撂在会议室，没有相应的文件或责任人供审查和询问，从而干扰检查官完成其相应的检查。
下面给出了将不会被认为是假劣药品的潜在合理解释的一个例子，但不仅限于：●企业不允许FDA检查官进入无菌工艺区域，直至检查官能满足企业的无菌更衣程序要求。
C、记录提供延迟以下记录提供延迟的情况将会被认为产品是假劣药品，包括但不仅限于：●在检查期间，FDA检查官要求在合理的时间内提供其有权查看的文件和记录，但是企业不能按时提供，且没有合理的解释。
FDA 行业指南 中英对照 待完成
FDA 行业指南中英对照待完成Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER 发布日期：May 1999TABLE OF CONTENTS目录I. II.INTRODUCTION 介绍 BACKGROUND 背景 A. B. C.III.Definitions 定义CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求Additional Considerations 其他需要考虑的事项QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS 包装组件的合格要求以及质量控制 A. B. C. D. E. F. G. H.IV. V.Introduction 介绍General Considerations 通常要求Information That Should Be Submitted in Support of an Original Application for Any Drug Product 为支持任何药品的原始申请所必须提供的信息 Inhalation Drug Products 吸入性药品Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末Other Dosage Forms 其他剂型POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更 TYPE III DRUG MASTER FILES 药品主文件第III类 A. B.VI.A. B.General Comments 总体评述Information in a Type III DMF 第III类DMF中包括的信息 Containers for Bulk Drug Substances 用于原料药的容器 Containers for Bulk Drug Products 用于散装药品的容器BULK CONTAINERS 大包装容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究 ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls DocumentationThis guidance document represents the Agency's current thinking on container closure systems for the packaging of human drugs and biological products. It does not create or confer any rights for or on any person anddoes not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.本指南代表了FDA目前对于人用药品和生物制品包装的容器/封装系统方面的看法。
FDA可在年度报告中提出的变更指南中英文对照范文
FDA可在年度报告中提出的变更指南中英文对照范文第一篇：FDA可在年度报告中提出的变更指南中英文对照范文201006 FDA行业指南可在年报中报告的CMC已批准生产变更草案（中英文）2013-01-22 16:04:09| 分类： FDA|字号订阅Guidance for Industry行业指南CMC Postapproval Manufacturing Changes Reportable in Annual Reports可在年报中报告的CMC已批准生产变更DRAFT GUIDANCE指南草案This guidance document is being distributed for comment purposesonly.本指南文件仅供征求意见。
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.Submit comments to the Division of Dockets Management(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact(CDER)Jon E.Clark at 301-796-2400.关于本草案的问题请联系CDER Jon E.Clark at 301-796-2400U.S.Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research(CDER)June 2010CMCGuidance for Industry行业指南CMC Postapproval Manufacturing Changes Reportable in Annual Reports可在年报中报告的CMC已批准生产变更Additional copies are available from:Office of CommunicationsDivision of Drug Information, WO51, Room 2201 Center for DrugEvaluation and Research Food and Drug Administration 10903 New Hampshire Ave.Silver Spring, MD 20993-0002 Phone: 301-796-3400;Fax: 301-847-8714****************.govplianceRegulatoryInformation/Guidan ces/default.htmU.S.Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research(CDER)June 2010TABLE OF CONTENTS I.INTRODUCTION.介绍 (1)II.BACKGROUND.背景 (1)III.DISCUSSION..讨论 (2)IV.CONTENTS OF ANNUAL REPORT NOTIFICATION.年报通知的内容.........................4 APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS......................................................附件A：可在年报中报告的CMC已批准生产变更Guidance for Industry[1] 行业指南CMC Postapproval Manufacturing Changes Reportable in Annual Reports可在年报中报告的CMC已批准生产变更This draft guidance, when finalized, will represent the Food and Drug Administration’s(FDA’s)current thinking on this topic.It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南草案，如果最终定稿，代表的是FDA目前对这一专题的态度。
FDA化验室OOS指南中英文_Guidance_for_Industry_OOS_CHEN
Guidance for Industry Investigating Out-of-Specification (OOS)Test Results forPharmaceutical ProductionU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)October 2006Pharmaceutical CGMPs Contains Nonbinding RecommendationsGuidance for Industry Investigating Out-of-Specification (OOS)Test Results forPharmaceutical ProductionAdditional copies are available from: 本文件可自以下途径得到Office of Training and Communication 培训和交流办公室Division of Drug Information HFD-240 药品信息分部Center for Drug Evaluation and Research 药品审评中心Food and Drug Administration 食品药品管理局5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmU.S. Department of Health and Human Services 美国卫生和福利部Food and Drug Administration 食品药品管理局Center for Drug Evaluation and Research (CDER) 药品审评中心October 2006Pharmaceutical CGMPs Contains Nonbinding RecommendationsTABLE OF CONTENTSInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (4)I. INTRODUCTION 介绍 (4)II. BACKGROUND 背景 (5)III. IDENTIFYING AND ASSESSING OOS TEST RESULTS界定和评价OOS检验结果— PHASE I: LABORATORY INVESTIGATION第一步：化验室调查 (6)A. Responsibility of the Analyst 化验员职责 (7)B. Responsibilities of the Laboratory Supervisor化验室主管职责 (8)IV. INVESTIGATING OOS TEST RESULTS 对OOS结果的调查— PHASE II: FULL-SCALE OOS INVESTIGATION 第二步：全面OOS调查 (10)A. Review of Production 生产情况审核 (10)B. Additional Laboratory Testing 附加化验室测试 (11)C. Reporting Testing Results 报告测试结果 (14)V. CONCLUDING THE INVESTIGATION 调查结论 (17)A. Interpretation of Investigation Results 调查结果解释 (18)B. Cautions 注意事项 (19)C. Field Alert Reports (20)GUIDANCE FOR INDUSTRY1行业指南Investigating Out-of-Specification (OOS) Test Results forPharmaceutical Production药物生产中不合格结果的调查This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南代表FDA对本专题现行的想法。
Q7aFDA原料药的GMP行业指南(中英文对照版)
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。
FDA无菌生产指南-中英文对照版.doc
FDA无菌生产指南-中英文对照版Translated from / 译自：Guidance for IndustrySterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice行业指南无菌加工生产的无菌药品—现行的生产质量管理规范(cGMP）U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Office of Regulatory Affairs (ORA)September 2004Pharmaceutical CGMPsCopyright SCI Version 1Copyright SCI Version 1Copyright SCI Version 1TABLE OF CONTENTSI. INTRODUCTION (1)简介II. BACKGROUND (2)背景A.Regulatory Framework (3)法规架构B.Technical Framework (3)技术架构III. SCOPE (5)适用范围IV. BUILDINGS AND FACILITIES (6)厂房和建筑A.Critical Area – Class 100 (ISO 5) (8)关键区域– 100级(ISO 5)B. Supporting Clean Areas (11)辅助洁净区域C. Clean Area Separation (11)净化区的隔离D.Air Filtration (13)空气过滤1.Membrane (13)膜过滤2.High-Efficiency Particulate Air (HEPA) (14)高效颗粒空气过滤器(HEPA)E.Design (17)设计V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING (21)人员的培训，资格认定和监控A.Personnel (22)人员boratory Personnel (26)实验室人员C.Monitoring Program (26)监控程序VI. COMPONENTS AND CONTAINER/CLOSURES (28)药品成分和容器/密封A. Components (28)Copyright SCI Version 1药品成分B. Containers/Closures (31)容器/密封1.Preparation (31)准备2. .................................................................................. Inspection of Container Closure System33容器密封系统的检查VII. ENDOTOXIN CONTROL (35)内毒素控制VIII. TIME LIMITATIONS (37)时间限制IX. VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION (38)无菌加工和灭菌的验证A. Process Simulations (38)工艺模拟1.Study Design (39)研究设计2.Frequency and Number of Runs (41)运行频率和次数3.Duration of Runs (42)运行时间4.Size of Runs (43)批量5.Line Speed (44)运行速度6.Environmental Conditions (44)环境质量7.Media (45)培养基8.Incubation and Examination of Media-Filled Units (46)培养基灌装单位的培养和检查9.Interpretation of Test Results (48)试验结果解释B. Filtration Efficacy (50)过滤功效C. Sterilization of Equipment, Containers, and Closures (53)设备、容器和密封的灭菌1.Qualification and Validation (54)确认和验证2.Equipment Controls and Instrument Calibration (56)设备控制和仪器校准X. LABORATORY CONTROLS (59)实验室控制Copyright SCI Version 1A. Environmental Monitoring (61)环境监测1. ...................................................................................................... General Written Program61书面程序2.Establishing Levels and a Trending Program (63)建立监测标准和趋势分析程序3.Disinfection Efficacy (64)消毒功效4.Monitoring Methods (64)监测方法B. Microbiological Media and Identification (66)微生物培养基及微生物的鉴定C. Prefiltration Bioburden (67)过滤前的生物负荷D. Alternate Microbiological Test Methods (68)可替代的微生物测试方法E. Particle Monitoring (68)颗粒监测XI. STERILITY TESTING (69)无菌试验A. Microbiological Laboratory Controls (71)微生物实验室控制B. Sampling and Incubation (71)取样和培养C. Investigation of Sterility Positives (72)无菌试验阳性结果的调查XII. BATCH RECORD REVIEW: PROCESS CONTROL DOCUMENTATION (77)批生产纪录审核：工艺控制文件化APPENDIX 1: ASEPTIC PROCESSING ISOLATORS (79)附录1: 无菌隔离装置APPENDIX 2: BLOW-FILL- SEAL TECHNOLOGY (87)附录2：吹-灌-封技术APPENDIX 3: PROCESSING PRIOR TO FILLING AND SEALING OPERATIONS (91)附录3：灌装和密封前的工艺REFERENCES (94)参考文献RELEVANT GUIDANCE DOCUMENTS (95)相关指南文件GLOSSARY (96)Copyright SCI Version 1术语表Copyright SCI Version 1Guidance for Industry1Sterile Drug Products Produced byAseptic Processing — Current Good Manufacturing PracticeI.INTRODUCTION简介This guidance is intended to help manufacturers meet the requirements in the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing (Aseptic Processing Guideline). This revision updates and clarifies the 1987 guidance.本指南旨在帮助生产商在应用无菌工艺制造无菌药品和生物制剂时，达到FDA cGMP规章(美国联邦法规的第210及第211节)要求。
FDA-GMP中英文对照标准版
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents 目录1. INTRODUCTION1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 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6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 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 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 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17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语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。
FDA行业指南中英对照待完成
FDA行业指南中英对照待完成FDA Industry Guidance - FDA行业指南Introduction - 引言Scope - 范围This guidance applies to manufacturers, distributors, importers, and other participants in the food, drug, and medical device industries. - 本指南适用于食品、药品和医疗器械行业的制造商、分销商、进口商及其他参与者。
Definitions - 定义For the purposes of this guidance, the following definitions apply: - 为了本指南的目的，将适用以下定义：1. Food - 食品Any article used for food or drink for man or animals. - 任何用于人类或动物的食品或饮料。
2. Drug - 药品Any substance intended for use in the diagnosis, cure, treatment, or prevention of disease. - 任何用于诊断、治愈、治疗或预防疾病的物质。
3. Medical Device - 医疗器械Any instrument, apparatus, or device intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. - 任何用于诊断、治愈、缓解、治疗或预防疾病的仪器、装置或设备。
4. Manufacturer - 制造商Product Quality Requirements - 产品质量要求Manufacturers should ensure that products meet the appropriate quality standards established by the FDA. - 制造商应确保产品符合FDA制定的适当质量标准。
FDA行业指南中英对照待完成
Guida nee for In dustryContainer Closure Systems for Paekag ing Huma n Drugs and Biologies Chemistry, Manu faetur ing and Con trols Doeume ntati on行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS 目录I. INTRODUCTION 介绍II. BACKGROUND 背景A. Defin iti ons 定义B. CGMP, CPSC and USP Requireme nts on Co ntain ers and Closures. CGMP, CPSC 和USP对容器和密封的要求C. Additio nal Con sideratio ns 其他需要考虑的事项III. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS 包装组件的合格要求以及质量控制A. In troduetion 介绍B. Ge neral Con sideratio ns 通常要求C. In formati on That Should Be Submitted in Support of an Orig inal Applieati on for AnyDrug Produet为支持任何药品的原始申请所必须提供的信息D. In halation Drug Produets 吸入性药品E. Drug Produets for Injeetio n and Ophthalmie Drug Produets 注射剂和眼科用药F. Liquid-Based Oral and Topieal Drug Produets and Topieal Delivery Systems 液体口月服和外用药品和外用给药系统G. Solid Oral Dosage Forms and Powders for Reeo nstitution 口服固体剂型和待重新溶解的粉末H. Other Dosage Forms 其他剂型IV. POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V. TYPE III DRUG MASTER FILES 药品主文件第III 类A. General Comme nts 总体评述B. In formation in a Type III DMF 第III 类DMF 中包括的信息VI. BULK CONTAINERS 大包装容器A. Con tai ners for Bulk Drug Substa nces 用于原料药的容器B. Con tai ners for Bulk Drug Produets 用于散装药品的容器REGULATORY REQUIREMENTS 药政要求ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING关于包装，所适用的政策指ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES参考文献1GUIDANCE FOR INDUSTRY 1 2 3 4Container Closure Systems for Packag ing Huma n Drugs and BiologicsChemistry, Manu facturi ng and Con trols Docume ntati ondetermi ne to be un acceptable. 可以采取与本指南的内容不一致的措施，但是我们建议申请人就明显的差异预先与CDER或CBER的审核人员进行讨论。
FDA外用制剂检查指南中英文版
GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS局部外用药物检查指南Note: This document is reference material for investigators and other FDA personnel. The document does not bind（进退两难） FDA, and does no confer（赠予） any rights,privileges （特权）, benefits（权益）, or immunities（豁免） for or on any person(s).注：该指南是FDA 检查官和其他工作人员的参考材料。
该指南不是约束FDA，但也不赋予任何人特权，利益或豁免的权利。
I. PURPOSE（目的）The purpose of this guide is to provide field investigators, who arefamiliar with the provisions（食品） of the Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals, with guidance on inspecting selected facets（方面） of topical（局部的） drug product production. The subjects covered in the guide are generally applicable to all forms of topical drug products, including those that are intended to be sterile（无菌的）. However, this guide does not address（介绍） every problem area that the investigator may encounter（碰见）, nor every policy that pertains to（附属）topical drug products.该指南的目的是向熟悉食品CGMP规程的检察官提供药品CGMP的指导，提供局部外用药物检查方面的指南。
FDA有关术语中英对照
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EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）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EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品）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。
FDA清洁工艺验证指南中英文对照
FDA清洁工艺验证指南中英文对照FDA（Food and Drug Administration）是美国食品药品监督管理局的简称。
FDA的清洁工艺验证指南提供了有关如何验证食品加工设备和工艺的清洁性的指导，确保产品的安全。
下面是FDA清洁工艺验证指南的英文全文对照。
FDA Cleaning Process Validation GuideIntroduction简介This document provides guidance on how to validate the cleaning processes used in food processing equipment to ensure their cleanliness. Cleaning validation is an essential step in preventing cross-contamination and ensuring the production of safe products.本文提供了关于如何验证食品加工设备中使用的清洁程序以确保其清洁度的指导。
清洁工艺验证是防止交叉污染和确保生产安全产品的关键步骤。
General Principles基本原则1. Validation should be based on a scientific and risk-based approach, taking into account the specific characteristics of the equipment and the product being manufactured.验证应基于科学和风险评估的方法，考虑到设备和正在生产的产品的特殊特性。
2. The validation process should be well-documented and include clear objectives, acceptance criteria, and a description of the methods used.验证过程应有良好的记录，并包括明确的目标、准入标准和方法描述。
FDA行业指南 委托生产质量协议 中英文
Contract Manufacturing Arrangements for Drugs: Quality AgreementsGuidance for Industry行业指南：药品委托生产安排：质量协议U.S. Department of Health and Human Services Food and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)Guidance for IndustryAdditional copies are available from:Office of Communications, Division of Drug Information Center for Drug Evaluation and ResearchFood and Drug Administration10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353Email: druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOffice of Communication, Outreach and Development Center for Biologics Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 71, Room 3128Silver Spring, MD 20993-0002Phone: 800-835-4709 or 240-402-8010Email: ocod@/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orPolicy and Regulations Staff, HFV-6Center for Veterinary Medicine Food and Drug Administration7519 Standish Place, Rockville, MD 20855/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)TABLE OF CONTENTS 目录TABLE OF CONTENTS 目录 (3)I. INTRODUCTION前言 (4)II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING指定委托生产的人和事 (6)III. RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT MANUFACTURING委托生产所涉及各方的职责7 IV. DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS在质量协议中记录CGMP活动 (10)A.What Is a Quality Agreement? 什么是质量协议？ (10)B.Elements of a Quality Agreement 质量协议的要素 (11)V. ILLUSTRATIVE SCENARIOS案例 (17)A.Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受托场所是否都对CGMP负责？18B.CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 适用于所有合同场所，包括分析化验室的CGMP (19)C.Owners and Contract Facilities Perform Change Control Activities 所有者和受托方实施变更控制活动20VI. RECOMMENDATIONS建议 (21)Contract Manufacturing Arrangements for Drugs:QualityAgreementsGuidance for Industry1行业指南：药品委托生产安排：质量协议I.INTRODUCTION 前言This guidance describes FDA’s current thinking on defining, establishing, and documentingmanufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how partiesinvolved in contract drug manufacturing can use quality agreements to delineate theirmanufacturing activities to ensure compliance with CGMP.本指南讲述了FDA当前对于受到CGMP约束的药品委托生产所涉及各方如何定义、设立和记录生产活动的看法，尤其是药品委托各方如何使用质量协议来描绘其生产活动，以确保符合CGMP。
美国FDA分析方法验证指引中英文对照
美国FDA分析方法验证指南中英文对照美国FDA分析方法验证指南中英文对照八、、I.INTRODUCTIONThis guida nee provides recomme ndati ons to applica nts on submitt ing an alytical procedures, validati on data, and samples to support the docume ntati on of the identity, strength, quality, purity, and potency of drug substances and drug products.1.绪论本指南旨在为申请者提供建议，以帮助其提交分析方法，方法验证资料和样品用于支持原料药和制剂的认定，剂量，质量，纯度和效力方面的文件。
This guida nce is in ten ded to assist applica nts in assembli ng in formati on, submitt ing samples, and prese nti ng data to support an alytical methodologies. The recomme ndati ons apply to drug substa nces and drug products covered in new drug applicati ons (NDAs), abbreviated new drug applicati ons (ANDAs), biologics license applications (BLAs), product license applications (PLAs), and supplements to these即plicatio ns.本指南旨在帮助申请者收集资料，递交样品并资料以支持分析方法。
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Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS目录I.INTRODUCTION介绍II.BACKGROUND 背景A.Definitions 定义B.CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求C.Additional Considerations 其他需要考虑的事项III.QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS包装组件的合格要求以及质量控制A.Introduction 介绍B.General Considerations 通常要求rmation That Should Be Submitted in Support of an Original Application for Any DrugProduct 为支持任何药品的原始申请所必须提供的信息D.Inhalation Drug Products 吸入性药品E.Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药F.Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统G.Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末H.Other Dosage Forms 其他剂型IV.POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V.TYPE III DRUG MASTER FILES 药品主文件第III类A.General Comments 总体评述rmation in a Type III DMF 第III类DMF中包括的信息VI.BULK CONTAINERS 大包装容器A.Containers for Bulk Drug Substances 用于原料药的容器B.Containers for Bulk Drug Products 用于散装药品的容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls DocumentationI．INTRODUCTION介绍This document is intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics.3 This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics , issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs.4 This guidance is not intended to describe the information that should be providedabout packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。
本文件替代了FDA在1987年2月发布的另一份指南，以及替代了仿制药办公室在1995年6月30日向行业内发布的包装政策声明信。
本指南不描述药品的包装操作。
Approaches which differ from those described in this guidance may be followed, but the applicant is encouraged to discuss significant variations in advance with the appropriate CDER chemistry review staff or CBER review staff. This is to prevent applicants or sponsors from spending unnecessary time and effort in preparing a submission that the FDA may later determine to be unacceptable. 可以采取与本指南的内容不一致的措施，但是我们建议申请人就明显的差异预先与CDER或CBER的审核人员进行讨论。
这样做的目的是为了避免申请人或发起人花费不必要的时间和努力准备申报资料，而这种申报资料经FDA认定是不可接受的。
II．BACKGROUND背景The Federal Food, Drug, and Cosmetic Act (the Act) mandates the need for adequate information related to packaging materials. Section 501(a)(3) of the Act states that a drug is deemed to be adulterated "if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...." In addition, section 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of drugs (see Attachment A). 联邦食品、药品和化妆品法案（简称“法案”）要求必须提供包装材料的充分信息。
法案的第501(a)(3)部分规定，如果某个药品的包装材料含有有毒、有害的物质，导致药品损坏健康，那么该药品为劣药。
另外，法案的第502部分规定，如果某药品在包装方面有缺失，则被认为是贴错标签。
还有，法案第505部分要求详细描述包装药品时所用的方法，所用的设施和控制措施（见附件A）。
Section 505(b)(1)(D) of the Act states that an application shall include a full description of the methods used in, the manufacturing, processing and packing of such drug. This includes facilities and controls used in the packaging a drug product. 法案的第505(b)(1)(D)部分规定，申请人必须完整描述该药品的生产、加工和包装。
其中包括包装药品时的设施和控制措施。
A.Definitions5定义Materials of construction6 refer to the substances (e.g., glass, high density polyethylene(HDPE) resin, metal) used to manufacture a packaging component. 组成材料是指用来生产包装组件的物质（例如玻璃，HDPE树脂，金属）A packaging component means any single part of a container closure system. Typicalcomponents are containers (e.g., ampules, vials, bottles), container liners (e.g., tube liners),closures (e.g., screw caps, stoppers), closure liners, stopper overseals, container inner seals,administration ports (e.g., on large-volume parenterals (LVPs)), overwraps, administrationaccessories, and container labels. A primary packaging component means a packagingcomponent that is or may be in direct contact with the dosage form. A secondary packagingcomponent means a packaging component that is not and will not be in direct contact with thedosage form. 包装组件是指一个容器/封装系统的任何单独部分。