中英文版APIC原料药厂GMP审计表2010(详细)

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20100731 欧盟API GMP 中英文对照 CX 20110112

EUROPEAN COMMISSION 欧盟委员会ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL 企业与工业管理局Consumer goods 消费品Pharmaceuticals 药品Brussels, 03 February 2010 布鲁塞尔2010.02.03ENTR/F/2/AM/an D(2010) 3374EudraLex（European Union Law On drug regulatory affairs）欧盟药品法规The Rules Governing Medicinal Products in the European Union欧盟医药产品管理规则Volume 4卷4Good Manufacturing Practice良好生产规范Medicinal Products for Human and Veterinary Use人用和兽用医药产品Part II: Basic Requirements for Active Substances used as Starting Materials 第二部分：作为起始物料的原料药的基本要求Table of Contents目录1 Introduction1简介1.1 Objective1.1目的1.2 Regulatory Applicability1.2法规适用性1.3 Scope1.3范围2 Quality Management2质量管理2.1 Principles2.1原则2.2 Quality Risk Management2.2质量风险管理2.3 Responsibilities of the Quality Unit(s) 2.3质量部门的职责2.4 Responsibility for Production Activities 2.4生产活动的职责2.5 Internal Audits (Self-Inspection)2.5内部审计（自检）2.6 Product Quality Review2.6产品质量回顾3 Personnel3 人员3.1 Personnel Qualifications3.1 人员资质3.2 Personnel Hygiene3.2 人员卫生3.3 Consultants3.3 顾问4 Buildings and Facilities4 厂房设施4.1 Design and Construction4.1 设计和建造4.2 Utilities4.2 公用工程4.3 Water4.3 水4.4 Containment4.4 限制4.5 Lighting4.5 照明4.6 Sewage and Refuse4.6 废水废物4.7 Sanitation and Maintenance4.7 公共卫生及保养5 Process Equipment5 工艺设备5.1 Design and Construction5.1 设计和建造5.2 Equipment Maintenance and Cleaning5.2 设备的保养和清洁5.3 Calibration5.3 校验5.4 Computerized Systems5.4 计算机系统6 Documentation and Records6 文件和记录6.1 Documentation System and Specifications6.1 文件系统与规格标准6.2 Equipment Cleaning and Use Record6.2 设备清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labelling and Packaging Materials 6.3 原料、中间产品、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)6.4 生产指令（生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)6.5批生产记录（批生产和控制记录）6.6 Laboratory Control Records6.6 实验室控制记录（批检验记录）6.7 Batch Production Record Review6.7批生产记录审核7 Materials Management7 物料管理7.1 General Controls7.1 控制通则7.2 Receipt and Quarantine7.2 接受和待检7.3 Sampling and Testing of Incoming Production Materials7.3 到货物料的取样和检测7.4 Storage7.4 贮存7.5 Re-evaluation7.5 再评估8 Production and In-Process Controls8 生产和过程控制8.1 Production Operations8.1 生产操作8.2 Time Limits8.2 时间限制8.3 In-process Sampling and Controls8.3 中控取样和控制8.4 Blending Batches of Intermediates or APIs8.4 中间产品和原料药的混批8.5 Contamination Control8.5 污染控制9 Packaging and Identification Labelling of APIs and Intermediates 9 中间产品和原料药的包装和贴签9.1 General9.1 总则9.2 Packaging Materials9.2 包装材料9.3 Label Issuance and Control9.3 标签放行和控制9.4 Packaging and Labelling Operations9.4 包装和贴签操作10 Storage and Distribution10 贮存和销售10.1 Warehousing Procedures10.1 入库程序10.2 Distribution Procedures10.2 销售程序11 Laboratory Controls11 实验室控制11.1 General Controls11.1 控制通则11.2 Testing of Intermediates and APIs11.2 中间产品和原料药的检测11.3 Validation of Analytical Procedures11.3 分析方法的验证11.4 Certificates of Analysis11.4 分析报告11.5 Stability Monitoring of APIs11.5 原料药的稳定性监测11.6 Expiry and Retest Dating11.6 失效和复检日期11.7 Reserve/Retention Samples11.7 留样12 Validation12 验证12.1 Validation Policy12.1 验证方针12.2 Validation Documentation12.2 验证文件12.3 Qualification12.3 确认12.4 Approaches to Process Validation12.4 工艺验证方法12.5 Process Validation Program12.5 工艺验证计划12.6 Periodic Review of Validated Systems12.6 验证系统的定期审核12.7 Cleaning Validation12.7 清洁验证12.8 Validation of Analytical Methods12.8 分析方法验证13 Change Control13 变更控制14 Rejection and Reuse of Materials14 物料的拒收和再利用14.1 Rejection14.1 拒收14.2 Reprocessing14.2 返工14.3 Reworking14.3 重新加工14.4 Recovery of Materials and Solvents14.4 物料和溶剂的回收利用14.5 Returns14.5 退回15 Complaints and Recalls15 投诉和召回16 Contract Manufacturers (including Laboratories)16 合同生产企业（包含实验室）17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers 17 代理商、经纪商、贸易商、经销商、重新包装商和重新贴签商17.1 Applicability17.1 适用性17.2 Traceability of Distributed APIs and Intermediates17.2 已销售中间产品和原料药的追踪17.3 Quality Management17.3 质量管理17.4 Repackaging, Relabelling and Holding of APIs and Intermediates 17.4 中间产品和原料药的重新包装、重新贴签和处理17.5 Stability17.5 稳定性17.6 Transfer of Information17.6 信息的传输17.7 Handling of Complaints and Recalls17.7 投诉和召回的处理17.8 Handling of Returns17.8 退货的处理18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18 用于细胞培养/发酵而得原料药的特殊指南18.1 General18.1 总则18.2 Cell Bank Maintenance and Recordkeeping18.2 细胞库的维护和记录保存18.3 Cell Culture/Fermentation18.3 细胞培养/发酵18.4 Harvesting, Isolation, and Purification18.4 收获、分离和精制18.5 Viral Removal/Inactivation Steps18.5 病毒除去/灭火步骤19 APIs for Use in Clinical Trials19 用于临床试验的原料药19.1 General19.1 总则19.2 Quality19.2 质量19.3 Equipment and Facilities19.3 设备设施19.4 Control of Raw Materials19.4 原料的控制19.5 Production19.5 生产19.6 Validation19.6 验证19.7 Changes19.7 变更19.8 Laboratory Controls19.8 实验室控制19.9 Documentation19.9 文件20 Glossary20 词汇表1 Introduction1 介绍This guideline was published in November 2000 as Annex 18 to the GMP Guide reflecting the EU’s agreement to ICH Q7A and has been used by manufacturers and GMP inspectorates on a voluntary basis. Article 46 (f) of Directive 2001/83/EC and Article 50 (f) of Directive 2001/82/EC; as amended by Directives 2004/27/EC and 2004/28/EC respectively, place new obligations on manufacturing authorisation holders to use only active substances that have been manufactured in accordance with Good Manufacturing Practice for starting materials. The directives go on to say that the principles of Good Manufacturing Practice for active substances are to be adopted as detailed guidelines. Member States have agreed that the text of former Annex 18 should form the basis of the detailed guidelines to create Part II of the GMP Guide.本指南已经在2000年11月以GMP指南附录18的形式公布过，它反应了欧盟对ICH Q7A的认可以，该指南已经被生产商和GMP检查员在自愿的原则下所使用。

中英文版APIC原料药厂GMP审计表XXX

Are regular Product Quality Reviews conducted for all products?
是否对所有产品进行了定期质量审查？
60
Frequency (dedicated, campaign)?
审查频率（常规进行，偶然?）
61
Content (at least):
审查至少包括下列内容：
62
review of critical IPC and API test results
审查关键中间体和API化验结果
63
review of all batches failed
审查所有的不合格批次
64
review of all critical deviations
审查所有的严峻偏差
65
review of process changes and impact on quality
36
approving changes with quality impact
批准涉及质量的变更
37
approving validation documents
批注验证文件
38
ensure complaints are resolved
确保投诉得到处理
39
ensuring calibration system is functioning according to procedure executed
ensure that facilities and equipment are qualified
确保设施仪器得以确认
51
2.4
Internal Audits
自检
52

精编(医疗药品)中英文版APIC原料药厂GMP审计表

决定的理由？
5
Hasthedecisionbeendiscussedwiththerespectiveauthority?
是否仍；之上；且；当下；和；可是；能够；俩；见；某公司；运营；有关药政部门讨论过该决定
6
Arethequalitycriticalstepsidentified?
是否确认了关键质量步骤
18
Arecriticaldeviationsinvestigatedinatimelymanner?
严重偏差是否及时进行调查？
19
Isthereawrittenprocedureforhandlinginvestigations(6.53)?
是否有书面的调查程序？
20
Averagedaysforpletion?
确保进行自检
35
approvingcontractmanufacturers
批准合同制造商
36
approvingchangeswithqualityimpact
批准涉及质量的变更
37
approvingvalidationdocuments
批注验证文件
38
ensureplaintsareresolved
是否有质量手册一类的文件来详细说明如何贯彻运作质量体系？
13
HowdoesManagementrevieweffectivenessofqualitysystem
管理层如何了解质量体系的效果
14
2.13
IstheQualityUnit(QA/QC)independentofproduction?
QA/QC是否独立于生产部门？
是否制定了确保QU审核批准仍；之上；且；当下；和；可是；能够；俩；见；某公司；运营；质量有关的所有文件？

APIC原料药厂清洁验证指南(201405-中英文).docx

APIC原料药厂清洁验证指南（201405 中英文）ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC)GUIDANCE ON ASPECTS OF CLEANING VALIDATIONIN ACTIVE PHARMACEUTICAL INGREDIENT PLANTSAPIC 原料药工厂中清洁验证指南May 2014Table of Contents1.0 FOREWORD 前言The original version of this guidance document has now been updated by the APIC Cleaning Validation Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC.本指南文件的原版本现已由APIC清洁验证工作组代表CEFIC的APIC委员会进行了更新。

The Task Force members are:- 以下是工作组的成员Annick Bonneure, APIC, BelgiumTom Buggy, DSM Sinochem Pharmaceuticals, The NetherlandsPaul Clingan, MacFarlan Smith, UKAnke Grootaert, Janssen Pharmaceutica, BelgiumPeter Mungenast, Merck KGaA, Germany.Luisa Paulo, Hovione FarmaCiencia SA, PortugalFilip Quintiens, Genzyme, BelgiumClaude Vandenbossche, Ajinomoto Omnichem, BelgiumJos van der Ven, Aspen Oss B.V., The NetherlandsStefan Wienken, BASF, Germany.With support and review from:- 以下为提供支持和进行审核的人员Pieter van der Hoeven, APIC, BelgiumAnthony Storey, Pfizer, U.K.Rainer Fendt, BASF, Germany.The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike.原料药生产工厂的清洁验证一直是法规人员、公司和客户等关注的问题。

2010版药品GMP认证工作及审计案例(2014年4月)-PPT文档

重点细化了软件要求，弥补了98版GMP的不足强化了质量管理体系、质量风险管理以及文件
管理强调了药品生产与药品注册及上市后监管的联
系增强了指导性、可操作性，方便开展检查工作
（二）新版GMP内容变化
1、认证检查时主要围绕药品GMP的内容来进行。 2、采用国际（通用）分类方式对检查缺陷进行分类（严重、
新版GMP基本要求
适用于所有药品的生产详细描述了药品生产质量管理的基本要求基本保留了98版GMP的大部分章节和主要
内容涵盖了WHO的GMP主要原则和欧盟GMP基
本要求中的内容修订强调人员和质量体系的建设明确提出了质量风险管理的概念
新版GMP的特点
强调执行基础是诚实守信，将 “安全、有效、质量可控”的原则融入到GMP中
某企业生产一片剂品种时，提取设备一天最大的产能是10万片，而一天的实际产量是 40万片
例5：中药以假代真
大黄用土大黄，山药用广山药、黄柏用关黄柏，血竭用龙血竭，金银花用山银花等
分析原因
一是故意（土大黄与大黄两者价钱相差4倍多，土大黄和大黄按药典方法是完全可以区分的，但是很多企业在进货时把关不严就出现类似问题。）
主要、一般）。
3、将弄虚作假等欺诈行为定为严重缺陷。 4、增加可根据实际存在风险大小，将几项一般缺陷或主要缺
陷经综合评定后，上升为主要缺陷或严重缺陷的规定。
5、增加了如企业对上次检查发现的缺陷未按承诺完成有效整改的，则该缺陷的严重程度应在本次检查中升级的规定。
6、增加了根据企业的整改情况结合检查组报告，综合评定企业此次是否通过药品GMP认证检查的规定。
能做，又没及时办理委托检验手续没有标准品经常生产的品种有的项目认为没问题不做
药品管理法

原料药GMP指南设计(中英文对照)

实用文档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 Quality2.2质量部门的责任Unit(s)2.3生产作业的职责2.3 Responsibility for ProductionActivities2.4 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(Master Production 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-PROCESS CONTROLS 8. 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 IDENTIFICATION LABELINGOF APIs AND INTERMEDIATES9. 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. VALIDATION 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 ValidatedSystems12.6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 OF MATERIALS 14.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 (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17.1 Applicability 17.1适用性17.2 Traceability of Distributed APIsand Intermediates17.2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 andPurification18.4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 APIsQ7a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中英文对照

GMP相关的英文缩写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.9. CCCD(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.17. CCD (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 Requ irements for Registration of Pharmaceuticals 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合会.29. WHO(World Health Organization):世界卫生组织.30. IFPMA(International Federation of Pharmaceutical Manufacturers As sociations):国际制药工业协会联合会.31. TQC(Total Quality 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):检验不合格;超标.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.61. USP(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.。

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序号
Q7条
款
英文内容
中文内容
1
1
Introduction
介绍
2
1.3
Scope
范围
3
Has the company designated the point at which the production of the API begins?
是否决定了API生产起点？
4
Can a rationale be provided for this decision?
and/or product defects?
岀现GMP偏离，质量投诉和产品缺陷，如何通知管理层？
24
Average time needed for information?
这种通知平均需要多少时间？
25
2.2
Responsibilities of the QU
QU职责262源自21Are there procedures that ensure that QUreviews and approves all quality related documents?
质量管理
8
2.1
Principles
原则
9
2.11
A Certified Quality Management System (e.g. ISO 9001) is implemented? (if yes, see chapter 20)
质量管理系统是否通过认证（例如ISO9001）?（已通过者参见第20
是否制定了确保QU审核批准与质量有关的所有文件？
27
2.22
Non-transferable responsibilities of QU:
QU直接担负的责任：
28
release/rejection of APIs and IM (to be sold)
IM和API的放行/拒绝
29
establish system to release/reject materials and labels
决定的理由？
5
Has the decision been discussed with the respective authority?
是否与有关药政部门讨论过该决定
6
Are the quality critical steps identified?
是否确认了关键质量步骤
7
2
Quality Management
QA/QC是否独立于生产部门？
15
2.14
Is there an authorized person(s) for the release of IM and APIs?
是否由质量授权人放行IM和API?
16
Who is the person(s)?
谁是质量授权人？
17
2.16
Are all deviations documented and explained?
是否有书面的调查程序？
20
Average days for completion?
平均要调查几天？
21
2.17
How is it ensured that materials are not released or used before completion of evaluation by the QU?
如何保障未经质量部门（QU完成评估的物料不会放行或使用？
22
If not done by QU: Is an appropriate system in place?
如何不是由质量部门（QU负责此事。有否其它相应机构？
23
2.18
Howis managementnotified of serious GMPieficiencies,quality related complaints
早）
10
2.12
Is there a quality policy?
有无质量政策？
11
How is it brought to the attention of the employees?
如何在员工中贯彻质量政策？
12
Is there a Quality Manual or equivalent documentation that describes in detail how the Quality System is implemented?
是否有质量手册一类的文件来详细说明如何贯彻运作质量体系？
13
How does Management review effectiveness of quality system
管理层如何了解质量体系的效果
14
2.13
Is the Quality Unit (QA/QC) independent of production?
36
approving changes with quality impact
批准涉及质量的变更
37
approving validation documents
批注验证文件
38
ensure complaints are resolved
确保投诉得到处理
39
ensuring calibration system is functioning according to procedure executed
批准质量标准和工艺规程
33
approving all quality related documents
批准所有的有关质量的文件
34
ensuring conduction of internal audits
确保进行自检
35
approving contract manufacturers
批准合同制造商
是否所有偏差都有记录和解释？
18
Are critical deviations investigated in a timely manner?
严重偏差是否及时进行调查？
19
Is there a written procedure for handling investigations (6.53)?
建立物料和标签放行/拒绝的体系
30
review of critical process steps batch records
审核批记录的关键工艺步骤
31
ensure critical deviations are investigated
确保严重的偏离得到调查
32
approving specifications and master instructions