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PIC/S是Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme的缩写,意为国际药品认证合作组织。 PIC/S达成的目标:开发和促进已协调的GMP标准和指导文件;培训监管机构,特别是GMP检查员;评估(和再评估)GMP检查机构;推动监管机构和国际组织的合作与网络。 PIC/S成立于1995年11月2日,前身是1970年成立的药品审查会Pharmaceutical Inspection Convention (PIC) ,其宗旨是以统一的标准实施药品GMP认证,在自愿的基础上,各成员国相互承认官方GMP认证报告,以降低药品流通的非关税贸易壁垒,节省人力、时间和物质成本。 PIC/S GMP是迄今全球最严谨的GMP规范,因此实施PIC/S GMP后,可进一步提高药品质量,保障用药安全。
药品GMP指南 第一部分 PE 009-15 (Part I)
1 May 2021 CHAPTER 1 - PHARMACEUTICAL QUALITY SYSTEM 第一章药品质量体系 Principle 原则 Pharmaceutical Quality System 药品质量体系 Good Manufacturing Practice for Medicinal Products (GMP) 药品良好生产规范(GMP) Quality Control 质量控制 Product Quality Review 产品质量回顾 Quality Risk Management 质量风险管理 CHAPTER 2 – PERSONNEL 第二章人员 Principle 原则 General 一般要求 Key Personnel 关键人员 Training 培训 Personnel Hygiene 人员卫生 Consultants 顾问 CHAPTER 3 - PREMISES AND EQUIPMENT 第三章设施和设备 Principle 原则 Premises 厂房 General 一般要求 Production Area 生产区域 Storage Areas 储存区域 Quality Control Areas 质量控制区域 Ancillary Areas 辅助区域 Equipment 设备 CHAPTER 4 - DOCUMENTATION 第四章文件 Principle 原则 Required GMP Documentation (by type) 要求的GMP文件(按类型) Generation and Control of Documentation 文件建立和控制 Good Documentation Practices 良好文件规范 Retention of Documents 文件的保存 Specifications 标准 Specifications for starting and packaging materials 起始物料和包装材料标准 Specifications for intermediate and bulk products 中间产品和待包装产品标准 Specifications for finished products 成品标准 Manufacturing Formula and Processing Instructions 生产配方和工艺规范 Packaging Instructions 包装规程 Batch Processing Records 批处理记录 Batch Packaging Records 批包装记录 Procedures and Records 规程和记录 Receipt 入库 Sampling 取样 Testing 检验 Other 其他 CHAPTER 5 – PRODUCTION 第五章生产 Principle 原则 General 一般要求 Prevention of Cross-contamination in Production 防止生产中的交叉污染 Validation 验证 Starting Materials 起始物料 Processing Operations - Intermediate and Bulk Products 工艺操作-中间产品和待包装产品 Packaging Materials 包装材料 Packaging Operations 包装操作 Finished Products 成品 Rejected, Recovered and Returned Materials 不合格、回收、退货物料 Product Shortage due to Manufacturing Constraints 由于生产限制造成的产品短缺 CHAPTER 6 - QUALITY CONTROL 第六章质量控制 Principle 原则 General 一般要求 Good Quality Control Laboratory Practice 良好质量控制实验室规范 Documentation 文件 Sampling 取样 Testing 测试 On-going Stability Programme 持续稳定性计划 Technical Transfer of Testing Methods 分析方法转移 CHAPTER 7 - OUTSOURCED ACTIVITIES 第七章外包活动 Principle 原则 General 一般要求 The Contract Giver 委托方 The Contract Acceptor 受托方 The Contract 合同 CHAPTER 8 - COMPLAINTS AND PRODUCT RECALL 第八章投诉和产品召回 Principle 原则 Personnel and Organisation 人员和组织 Procedures for Handling and Investigating Complaints IncludingPossible Quality Defects 投诉,包括可能的质量缺陷,的处理和调查程序 Investigation and Decision-making 调查和决策 Root Cause Analysis and Corrective and Preventative Actions 根本原因和纠正预防措施 Product Recalls and Other Potential Risk-Reducing Actions 产品召回和其他可能的风险缓解措施 CHAPTER 9 - SELF INSPECTION 自查 Principle 原则 GUIDE TO GOOD MANUFACTURING
PRACTICE FOR MEDICINAL PRODUCTS PART II 药品GMP指南 第二部分 PE 009-15 (Part II) 1 May 2021 1. INTRODUCTION 介绍 1.1 Objective 目的 1.2 Scope 范围 2. QUALITY MANAGEMENT 质量管理 2.1 Principles 原则 2.2 Quality Risk Management 质量风险管理 2.3 Responsibilities of the Quality Unit(s) 质量部门职责 2.4 Responsibility for Production Activities 生产部门职责 2.5 Internal Audits (Self Inspection) 内审(自查) 2.6 Product Quality Review 产品质量回顾 3. PERSONNEL 人员 3.1 Personnel Qualifications 人员确认 3.2 Personnel Hygiene 人员卫生 3.3 Consultants 顾问 4. BUILDINGS AND FACILITIES 厂房和设施 4.1 Design and Construction 设计和构造 4.2 Utilities 公用设施 4.3 Water 水 4.4 Containment 隔离器 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 设计和构造 5.2 Equipment Maintenance and Cleaning 设备维护和清洁 5.3 Calibration 校准 5.4 Computerized Systems 计算机化系统 6. DOCUMENTATION AND RECORDS 文件和记录 6.1 Documentation System and Specifications 文件体系和标准 6.2 Equipment Cleaning and Use Record 设备清洁和使用记录 6.3 Records of Raw Materials, Intermediates, API Labelling and PackagingMaterials 原辅料,中间产品,API标签和包装材料 6.4 Master Production Instructions (Master Production and Control Records) 主生产规程(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 一般控制 7.2 Receipt and Quarantine 入库和验收 7.3 Sampling and Testing of Incoming Production Materials 来料取样和检验 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 时间限制 8.3 In-process Sampling and Controls 中控取样和控制 8.4 Blending Batches of Intermediates or APIs 中间产品或API的混合批次 8.5 Contamination Control 污染控制 9. PACKAGING AND IDENTIFICATION LABELLING OFAPIS AND INTERMEDIATES API和中间产品的包装和识别标签 9.1 General 一般要求 9.2 Packaging Materials 包装材料 9.3 Label Issuance and Control 标签发放和控制 9.4 Packaging and Labelling Operations 包装和标签操作 10. STORAGE AND DISTRIBUTION 储存和运输 10.1 Warehousing Procedures 仓储程序 10.2 Distribution Procedures 发运程序 11. LABORATORY CONTROLS 实验室控制 11.1 General Controls 一般控制 11.2 Testing of Intermediates and APIs 中间产品和API的检验 11.3 Validation of Analytical Procedures - see Section 12. 分析方法验证-见章节12 11.4 Certificates of Analysis 检验报告 11.5 Stability Monitoring of APIs API的稳定性监测 11.6 Expiry and Retest Dating 失效期和复验期 11.7 Reserve/Retention Samples 留样 12. VALIDATION 验证 12.1 Validation Policy 验证政策 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 工艺验证程序 12.6 Periodic Review of Validated Systems 验证体系定期回顾 12.7 Cleaning Validation 清洁验证 12.8 Validation of Analytical Methods 分析方法验证 13. CHANGE CONTROL 变更控制 14. REJECTION AND RE-USE OF MATERIALS 物料拒绝和再利用 14.1 Rejection 拒绝 14.2 Reprocessing 返工 14.3 Reworking 重新加工 14.4 Recovery of Materials and Solvents 物料和溶剂回收 14.5 Returns 退货 15. COMPLAINTS AND RECALLS 投诉和召回 16. CONTRACT MANUFACTURERS (INCLUDINGLABORATORIES) 委托生产商(包括实验室) 17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS,REPACKERS AND RELABELLERS 代理商,中间商,贸易商,分销商,重新包装商和重新贴标签商 17.1 Applicability 适用性 17.2 Traceability of Distributed APIs and Intermediates API和中间体追溯性 17.3 Quality Management 质量管理 17.4 Repackaging, Relabelling and Holding of APIs and Intermediates API、中间体的重新包装,重新贴签和保存 17.5 Stability 稳定性 17.6 Transfer of Information 信息传递 17.7 Handling of Complaints and Recalls 投诉和召回处理 17.8 Handling of Returns 退货处理 18. SPECIFIC GUIDANCE FOR APIs MANUFACTUREDBY CELL CULTURE/FERMENTATION 细胞培养/发酵生产API的特定指南 18.1 General 一般要求 18.2 Cell Bank Maintenance and Record Keeping 细胞库维护和记录保存 18.3 Cell Culture/Fermentation 细胞培养/发酵 18.4 Harvesting, Isolation and Purification 提取,分离和纯化 18.5 Viral Removal/Inactivation Steps 病毒去除/灭活的步骤 19. APIs FOR USE IN CLINICAL TRIALS 临床试验用API 19.1 General 一般要求 19.2 Quality 质量 19.3 Equipment and Facilities 设备和设施 19.4 Control of Raw Materials 原料控制 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 ANNEXES 附录 Annex 1 (Manufactureof sterile medicinal products) 附录1 无菌药品生产 Principle 原则 General 一般要求 Clean room and clean air device classification 洁净室和洁净空气设备分级 Clean room and clean air device monitoring 洁净室和洁净空气设备监测 Isolator technology 隔离技术 Blow/fill/seal technology 吹-灌-封技术 Terminally sterilised products 最终灭菌产品 Aseptic preparation 无菌配制 Personnel 人员 Premises 设施 Equipment 设备 Sanitation 卫生 Processing 加工 Sterilisation 灭菌 Sterilisation by heat 热力灭菌 Moist heat 湿热灭菌 Dry heat 干热 Sterilisation by radiation 辐射灭菌 Sterilisation with ethylene oxide 环氧乙烷灭菌 Filtration of medicinal products which cannot be sterilised intheir final container 无法在最终容器中灭菌的药品的过滤 Finishing of sterile products 无菌产品成品 Quality control 质量控制 Annex 2A(Manufacture of advanced therapy medicinal products for human use)19 附录2A 人用先进治疗药品的生产 Scope 范围 Principle 原则 Part A: General guidance A部分:一般指南 Supplimentary provisions to PIC/S GMP Guide Part I PIC/S GMP指南第一部分的补充规定 Chapter 1 Pharmaceutical quality system 章节1 药品质量体系 Chapter 2 Personnel 章节2 人员 Chapter 3 Premises and equipment 章节3 设备设施 Chapter 4 Documentation 章节4 文件 Chapter 5 Production 章节5 生产 Chapter 6 Quality control 章节6 质量控制 Chapter 7 Outsourced activities 章节7 外包活动 Chapter 8 Complaints and product recall 章节8 投诉和产品召回 Part B: Specific guidance on selected product types B部分:所选产品类型特定指南 Common glossary to Annex 2A and 2B 术语 Annex 2B 附录2B (Manufacture of biological medicinal substancesand products for human use) 人用生物API和产品的生产 Scope 范围 Principle 原则 Part A: General guidance A部分:通用指南 Personnel 63 人员 Premises and equipment 设备设施 Animals 动物 Documentation 文件 Production 生产 Starting and raw materials 起始物料和原料 Seed lot and cell bank system 种子批和细胞库系统 Operating principles 操作原则 Quality control 质量控制 Part B: Specific guidance on selected product types B部分:所选产品类型的特定指南 Annex 3 (Manufactureof radiopharmaceuticals) 附录3 放射性药物的生产 Principle 原则 Introduction 介绍 Quality assurance 质量保证 Personnel 人员 Premises and equipment 设备设施 Documentation 文件 Production 生产 Quality control 质量控制 Reference and retention samples 对照和留样 Distribution 运输 Glossary 术语 Annex 4 (Manufactureof veterinary medicinal products other than immunologicals) 附录4 兽药产品(非免疫学产品)的生产 Manufacture of premixes for medicated feeding stuffs 饲料药物预混料的生产 The manufacture of ectoparasiticides 外驱虫药的生产 The manufacture of veterinary medicinal products containingpenicillins 含有青霉素的兽药产品的生产 Retention of samples 留样 Sterile veterinary medicinal products 无菌兽药产品 Annex 5 (Manufactureof immunological veterinary medical products) 附录5 免疫学兽药产品的生产 Principle 原则 Personnel 人员 Premises 设施 Equipment 设备 Animals and animal houses 动物和动物房 Disinfection Waste disposal 消毒废物处理 Production 生产 Starting materials 起始物料 Quality control 质量控制 Annex 6 (Manufactureof medicinal gases) 附录6 医用气体生产 Principle 原则 Manufacture of active substance gases 活性成分气体的生产 Manufacture of medicinal gases 医用气体生产 Personnel 人员 Premises and equipment 设备设施 Documentation 文件 Production 生产 Quality control 质量控制 Transportation of packaged gases 已灌装气体的运输 Glossary 术语 Annex 7 (Manufactureof herbal medicinal products) 附录7 草药产品的生产 Principle 1 原则 Premises 厂房 Storage areas 储存区域 Production area 生产区域 Equipment 设备 Documentation 文件 Specifications for starting materials 起始物料标准 Processing instructions 工艺规程 Quality Control 质量控制 Annex 8 (Sampling ofstarting and packaging materials) 附录8 起始物料和包装材料的取样 Principle 原则 Personnel 人员 Starting materials 起始物料 Packaging material 包装材料 Annex 9 (Manufactureof liquids, creams and ointments) 附录9 液体,乳膏,软膏的生产 Principle 原则 Premises and equipment 设备设施 Production 生产 Annex 10 (Manufactureof pressurised metered dose aerosol preparations for inhalation) 附录10 用于吸入的加压计量气溶胶制剂的生产 Principle 原则 General 通用指南 Premises and equipment 设备设施 Production and quality control 生产和质量控制 Annex 11 (Computerisedsystems) 附录11 计算机化系统 Principle 原则 General 一般要求 Risk management 风险管理 Personnel 人员 Suppliers and service providers 供应商和服务提供商 Project phase 项目阶段 Validation 验证 Operational phase 运行阶段 Data 数据 Accuracy checks 准确性检查 Data storage 数据保存 Printouts 打印输出 Audit trails 审计追踪 Change and configuration management 变更和配置管理 Periodic evaluation 定期评价 Security 安全性 Incident management 事件管理 Electronic signature 电子签名 Batch release 批放行 Business continuity 业务连续性 Archiving 归档 Glossary 术语 Annex 12 (Use ofionising radiation in the manufacture of medicinal products) 附录12 在药品生产中使用电离辐射 Introduction 介绍 Responsibilities 责任 Dosimetry 剂量 Validation of the process 工艺验证 Commissioning of the plant 工厂调试 General 一般要求 Gamma irradiators 伽马辐射器 Electron beam irradiators 电子束辐射器 Premises 厂房 Processing 加工 Gamma irradiators 伽马辐射器 Electron beam irradiators 电子束辐射器 Documentation 文件 Microbiological monitoring 微生物监测 Annex 13 (Manufactureof investigational medicinal products) 附录13 临床试验用药生产 Principle 原则 Glossary 术语 Quality management 质量管理 Personnel 人员 Premises and equipment 厂房和设备 Documentation 文件 Specifications and instructions 标准和规程 Order 指令 Product specification file 产品标准文件 Manufacturing formulae and processing instructions 生产配方和工艺规程 Packaging instructions 包装指令 Processing, testing and packaging batch records 加工、测试和包装批记录 Production 生产 Packaging materials 包装材料 Manufacturing operations 生产操作 Principles applicable to comparator product 适用于对照产品的原则 Blinding operations 设盲 Randomisation code 随机代码 Packaging 包装 Labelling 贴标 Quality control 质量控制 Release of batches 批放行 Shipping 运输 Complaints 投诉 Recalls and returns 召回和退货 Recalls 召回 Returns 退货 Destruction 销毁 Annex 14 (Manufactureof medicinal products derived from human blood or plasma) 附录14 从人血或血浆中提取的药品的生产 Glossary 术语 Scope 范围 Principles 原则 Quality management 质量管理 Traceability and post collection measures 可追溯性和事后收集措施 Premises and equipment 厂房和设备 Manufacturing 生产 Quality control 质量管理 Release of intermediate and finished products 中间产品和成品放行 Retention of plasma pool samples 血浆池样品的留样 Disposal of waste 废弃物处理 Addendum 附录 Annex 15 (Qualificationand validation) 附录15 确认与验证 Principle 原则 General 一般要求 Organising and Planning for Qualification and Validation 组织和计划确认与验证 Documentation, including VMP 文件,包括VMP Qualification Stages for Equipment, Facilities and Systems 设备,设施和系统的确认阶段 Re-qualification 再确认 Process Validation 工艺验证 Verification of Transportation 运输确认 Validation of Packaging 包装验证 Qualification of Utilities 共用系统确认 Validation of Test Methods 分析方法验证 Cleaning Validation 清洁验证 Change Control 变更控制 Glossary 术语 Annex 16 [Qualifiedperson and batch release]* 附录16质量受权人和批放行 Annex 17 (Real TimeRelease Testing and Parametric Release) 附录 17 实时放行和参数放行 Principle 原则 Scope 范围 Real Time Release Testing (RTRT) 实时放行 Parametric Release and Sterilisation 参数放行和灭菌 Glossary 术语 Annex 18 [GMP Guide foractive pharmaceutical ingredients]** 附录18 活性药物成分GMP Annex 19 (Reference andretention samples) 附录19 对照样品和留样 Scope 范围 Principle 原则 Duration of storage 储存时间 Size of reference and retention samples 对照样品和留样样品量 Storage conditions 储存条件 Written agreements 书面协议 Reference samples – General points 对照样品-概述 Retention samples – General points 留样样品-概述 Reference and retention samples for parallel imported/ paralleldistributed products 进口/销售产品的平行留样 Reference and retention samples in the case of closedown of a manufacturer 制造商倒闭的情况下对照样品和留样 Annex 20 (Quality riskmanagement)*** 189 附录20 质量风险管理 Foreword and scope of application 189 前言和适用范围 Introduction 189 介绍 Scope 191 范围 Principles of quality risk management 质量风险管理原则 General quality risk management process 一般质量风险管理程序 Responsibilities 责任 Initiating a quality risk management process 启动质量风险管理程序 Risk assessment 风险评估 Risk control 风险控制 Risk communication 风险沟通 Risk review 风险审核 Risk management methodology 风险管理方法 Integration of quality risk management into industry andregulatory operations 将质量风险管理整合到行业和监管操作中 Definitions 定义 References 参考文献 Appendix I: Risk Management Methods and Tools 附录1:风险管理方法和工具 Basic Risk Management Facilitation Methods 基本风险管理简化方法 Failure Mode Effects Analysis (FMEA) 失效模式和影响分析(FMEA) Potential Areas of Use(s) 可能的应用领域 Failure Mode, Effects and Criticality Analysis (FMECA) 失效模式,影响和危害性分析 Fault Tree Analysis (FTA) 故障树分析(FTA) Hazard Analysis and Critical Control Points (HACCP) 危害分析和关键控制点(HACCP) Hazard Operability Analysis (HAZOP) 危害可操作性分析(HAZOP) Preliminary Hazard Analysis (PHA) 预先危害性分析(PHA) Risk Ranking and Filtering 风险排序与过滤 Supporting Statistical Tools 支持性统计工具 Appendix II: Potential Applications For Quality Risk Management 附录2:质量风险管理潜在应用 Quality Risk Management as Part of Integrated Quality Management 质量风险管理作为综合质量管理的一部分 Quality Risk Management as Part of Regulatory Operations 质量风险管理作为监管操作的一部分 Quality Risk Management as Part of Development 质量风险管理作为开发的一部分 Quality Risk Management for Facilities, Equipment and Utilities 设施、设备和公用系统的质量风险管理 Quality Risk Management as Part of Materials Management 质量风险管理作为物料管理的一部分 Quality Risk Management as Part of Production 质量风险管理作为生产的一部分 Quality Risk Management as Part of Laboratory Control andStability Studies 质量风险管理作为实验室控制和稳定性试验的一部分 Quality Risk Management as Part of Packaging and Labelling 质量风险管理作为包装和贴标签的一部分 GLOSSARY 术语
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