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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 PRODUCTSPART 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 INTERMEDIATESAPI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1211.4 Certificates of Analysis检验报告11.5 Stability Monitoring of APIsAPI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,REPACKERSAND 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 IntermediatesAPI和中间体追溯性17.3 Quality Management质量管理17.4 Repackaging, Relabelling and Holding of APIs and IntermediatesAPI、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 guidanceA部分：一般指南Supplimentary provisions to PIC/S GMP Guide Part IPIC/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 typesB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 guidanceA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 typesB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VMPQualification 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