公司已过新版GMP认证洁净厂房验证模版中英文

GMP规范中英文对照

GMP规范中英文对照Chapter 1: General Provisions第一章总则Article 1: This Regulation is enacted in accordance with the "Drug Administration Law of The People's Republic of China".第一条根据《中华人民共和国药品管理法》规定，制定本规范。

Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products. This Regulation shall be applicable to all the manufacturing processes of drug preparations and to the key manufacturing processes of raw materials which may cause variation in the quality of finished products.第二条本规范是药品生产和质量管理的基本准则。

适用于药品制剂生产的全过程、原料药生产中影响成品质量的关键工序。

Chapter 2: Organization and PersonnelArticle 3: A pharmaceutical enterprise shall establish production and quality control departments. The responsibilities of departments at all levels and personnel shall be clarified, and each department shall be staffed by an appropriate number of management and technical personnel with expert knowledge, manufacturing experience and organization ability. 第三条药品生产企业应建立生产和质量管理机构。

制药验证文件-洁净空压机验证方案(英文版)

Qualification Protocol for New Air Compressor (COMP04)1. Short Description of Project / Facility / System1.1 Project DescriptionAs part of the “Extension of Production Facility, ChangPing” Project (EPCP, No. CNPHCP200502), a new Air Compressor COMP04 will be installed in the existing utilities area for the complementary production of compressed air.For general information, reference is made to:EPCP_11_06_INFRA_URS (current version)●INFRA URS,EPCP_01_00_HLD_URS (current version)●Project URS,EPCP_01_00_HLD_QMP (current version)●Project Qualification Master Plan,EPCP_01_00_HLD_QNA (current version)●Qualification Need Assessment,●Functional Risk Assessment EPCP_11_03_CA_FRA_2.0EPCP - CR 0238●Change request (new compressor)1.2 Functional Description for the ZT compressor with IMD dryer.NB. For the complete functionality of the CA system refer to the functional specification EPCP_11_03_CA_FS in its current version.Air drawn in through air filter (AF) and the open inlet valve of the unloader assembly (UA) is compressed in the low-pressure compressor element (El) and discharged to the intercooler (Ci).The cooled air is further compressed in the high-pressure compressor element (Eh) and discharged through the pulsation damper (AS) and the after cooler (Ca).A check valve (CV) is provided downstream of the pulsation damper (AS).When the compressor switches to unload operation, the air trapped in the pulsation damper and the high-pressure element is blown off via the blow-off silencer (US).The check valve (CV) prevents compressed air downstream the check valve to be blown off.Flow diagramAF Air filter (1) IMD bypass valve M4 Gear motor, IMD AS Pulsation damper (2) IMD air inlet valve EWD ElectronicCV Check valve drain, inlet airUS Blow-off silencer (3) DemisterCa After cooler with integrated drain (4) Nozzle Car Regeneration air cooler, IMD collector (5) IMD outlet valve FN Fan, regeneration air IS Inlet silencer cooler to air outlet valve (customer’sUA Unloader assembly installation)EWDa Electronic drain, after cooler (6) Rotor, IMDOP Oil pump (7) Regulating valve regeneration airCi Intercooler with integrated drain collectorGC Oil sump (gear casing)EWDi Electronic drain, intercoolerCo Oil coolerEh High-pressure compressor elementOF Oil filterEl Low-pressure compressor elementFN1 Cooling fan (ZT)1.3 Main emphasis on quality critical issues1.3.1 GMP Risk AssessmentThe air compressor installation will be in compliance with the valid Project Qualification Master Plan, Doc. No. EPCP_01_00_HLD_QMP, EPCP_11_03_CA_FRA in their current version.1.3.2 Critical measurement instrumentsInstruments for : Operating pressure, Dew point and Temperature.1.3.3 Critical items/functionsSpecification for construction material of operational parts.Air drying process.1.3.4 Qualification strategyThe air compressor qualification is covered by the following documents:URS,GMP and Functional Risk AssessmentQualification Protocol (QP)DQ, IQ & OQQualification Report (QR).Notes:1. No separate CSV Qualification Protocol and Qualification Report are needed since itis a Class 4 system.2. A 21CFR Part 11 Risk Assessment is not requested because the control system is notable to store any data.3. The air compressor and its auxiliaries will be commissioned with the support of aVendor Engineer.5. T he Qualification (DQ/IQ/OQ) will be prepared by BNP’s own Engineers, based onthis QP. The Qualification Documentation will be prepared by Luwa.6. The calibration during IQ will be executed by the vendor technician supervised byBNP R&M engineers.7. The qualification strategy and tests scope will be based on the qualification of theexisting air compressor (same supplier, same type). No new GMP and Risk Assessment will be prepared.2. Steps covered in this ProtocolFor the Qualification of the air compressor, the present QP will be followed. The qualification documents for the air compressor will be created (DL and DQ, IQ, OQ) and will be filed with this qualification.NB: This Qualification plan does not include interfacing utilities. For information about the qualification of the CA system, see EPCP_11_03_CA_QP in its current version.Design Qualification (DQ): yes: no: NA: Commissioning (GEP) 1): yes: no: NA: Installations Qualification (IQ): yes: no: NA: Operational Qualification (OQ): yes: no: NA: Operational Qualification (PQ) 2): yes: no: NA:1) Only FAT and correct installation before IQ (SAT)2) PQ will be done by checking the Pressure and microbial test at the exhaust of the new air compressor. No water content testing will be made as the dryness and oil free status is certified by the manufacturer.Copies of the certificates will be filed in the qualification binder.3. Documentation3.1 Qualification Documents List (GPE_FRM_511_0071)Refer to “Qualification Document List for the air com pressor, EPCP_11_03_CA_COMP04_DL” in its current version.3.2 Project Specific SOP’sNo project specific SOPs for the commissioning execution of this new air compressor.3.3 Administration of DocumentsThe Documents are filed according to “Document Management Syst em:Doc. No EPCP_01_00_HLD_DMS” in its current version.4. Basics4.1 Basic SOP’sGPE_SOP_508_0484: Concept for Commissioning and QualificationEPCP-SOP-001: CommissioningGPE_SOP_511_0042: Specification, Execution and Deviation Resolution of TestsGPE_SOP_511_0030 Handling of Changes (Engineering Projects)4.2 Project Specific AgreementsTwo types of training activities will be conducted one training for qualification execution and an other training for operation and maintenance.Qualification execution training is mandatory for all persons taking part in the qualification work. The training will be conducted by Luwa, and each test person shall complete the training before the empowerment to execute qualification and commissioning activities. Operation and maintenance training will be conducted by the EPCP or the vendor. Luwa operators, engineers or technicians should complete the training based on the functional requirements.Luwa Persoamal Training Record (FRM_000037) and Training Record (FRM_000039) will be used to document the training.5. Qualification Activities (Action Plan)5.1 Project Time ScheduleRefer to project time schedule in its current version.5.2 Qualification Activities (included in Project Time Schedule)All qualification activities are summarized in “Section 1.3 Main emphasis on quality critical issues”, “Section 3.1 Qualification Documents List”.6. Organization / Responsibility6.1 Qualification OrganizationRefer to “Qualification Master Plan, EPCP_01_00_HLD_QMP” for responsibilities matrix. 6.2 Project OrganizationThe organization is within the current EPCP organization chart in PPM.7. Attachments to ProtocolAttachment 1 Qualification Document List for air new compressor,EPCP_11_03_CA_COMP04_DL in its current version.。

欧盟GMP附录15确认和验证中英文新版

欧盟GMP附录15确认和验证欧盟GMP附录15确认和验证ANNEX 15 附件15Qualification and Validation确认和验证Table of Contents 目录1. Qualification and Validation 确认和验证2. Planning for Validation 验证计划3. Documentation 文件4. Qualification 确认5. Process Validation 工艺验证6. Cleaning Validation 清洁验证7. Change Control 变更控制8. Revalidation 再验证9. Glossary 术语表Qualification and Validation 确认和验证Principle 原理1.This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.1.本附件描述了确认和验证的原理，适用于医药产品的生产者。

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。

EUGMP-中英文对照[1]

EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS （中英文对照）(a) These are average values. （一）这些都是平均值。

(b) Individual settle plates may be exposed for less than 4 hours. （二）单个沉降皿放置的时间可以少于4小时。

20. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action。

对尘埃粒子和微生物的监控结果，要设置适当的警戒限度和行动限度。

当超出这些限度时，操作规程应说明需要采取的措施。

Isolator technology 隔离技术21. The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment. There are many possible designs of isolators and transfer devices. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from a single door to double door designs to fully sealed systems incorporating sterilization mechanisms. 在生产区采用人员方面的隔离技术，在无菌产品的生产中，会显著降低周围环境微生物污染的风险。

GMP规范中英文对照

GMP规范中英文对照Chapter 1: General Provisions第一章总则Article 1: This Regulation is enacted in accordance with the "Drug Administration Law of The People's Republic of China".第一条根据《中华人民共和国药品管理法》规定，制定本规范。

Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products. This Regulation shall be applicable to all the manufacturing processes of drug preparations and to the key manufacturing processes of raw materials which may cause variation in the quality of finished products.第二条本规范是药品生产和质量管理的基本准则。

适用于药品制剂生产的全过程、原料药生产中影响成品质量的关键工序。

Chapter 2: Organization and PersonnelArticle 3: A pharmaceutical enterprise shall establish production and quality control departments. The responsibilities of departments at all levels and personnel shall be clarified, and each department shall be staffed by an appropriate number of management and technical personnel with expert knowledge, manufacturing experience and organization ability. 第三条药品生产企业应建立生产和质量管理机构。

FDAGMP中英文对照标准

FDA-GMP中英文对照标准版————————————————————————————————作者：————————————————————————————————日期：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-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。

中英文验货报告模板

验货报告
Inspection report
编号：
订单号:Order Number
供方名称SupplierName
订单交期ShippingDate
验货日期Inspection Date
生产单位Production unit
产品名称Description
中验Inline
尾验Final
1.检验清单InspectionList:
Critical严重疵点_Major/主要疵点__Minor/次要疵点__
严重疵点
主要疵点
次要疵点
1.
2.
3.
4.
5.
6.
7.
8.
TTL疵点总数
颜色/colour□严重色差/Serious off color□明显色差/Clear off color□无明显色差/Not have clear off color
干燥剂
desiccant
3,产品品质缺点及结论ProductDefective List&Results:
DEFECTS/DISCREPANCIES/疵点描述AQL___LEVELⅡ
Units Inspected/抽检数量:_____
Critical
Major
Minor
Acceptable Quality level/接受疵点数
3,验货时应最少完成批货量80%的完整包装。
验货员
Inspector(s):
供方代表SupplierRepresentative:
1,此报告仅作为本公司对所抽验的货品质量之确认,如产品在后续验货及到达客户手中仍发现有质量瘕疵,由供方负全部责任.
2,验货标准:MIL-STD-105E II级单次抽样.

常见GMP术语翻译

双锥真空回转干燥器
SS Reactor
不锈钢反应罐
Tray dryer
盘式烘箱
Analysis
在表示实验室检验时，统一翻成“检验”，不要翻成分析
Analysis Report No.
检验报告单号
校验
Validation Protocols
验证方案
Doc. Ref. No.
参照文件编码
Validation Reports
验证报告
Document
No.
文件编码
controlled copy
受控复印件
Effective Date
生效日期
uncontrolled copy
非受控复印件
Form No.
按要求
intimation
通知
block
车间
requisition
申请
HDPE
高密度聚乙烯
status tags
状态标记
LDPE
低密度聚乙烯
environmental monitoring
环境监控
flow meter
流量计
microbial load
微生物负载
swab test
擦拭实验
Acceptance Criteria
药政检查
Definitions
定义
OOS Investigation
超标调查
Responsibility
责任
Internal audits
自检
Procedure
程序
Customer audits
客户审计
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GMP英语翻译配料间weighing room灌封间filling room动力区power areas无菌室sterile /aseptic room灭菌间sterilization room质检室QC room灯检间visual inspection room包装间packaging room缓冲间buffer room更衣室changeroom洗瓶间ampoule washing room控制区controlled areas无菌室男更man changeroom of 10000 clean areas 待包装品区bulk product areas空盘区empty-tray areas电梯lift,elevator安全门 fire exit准备间prepare room储瓶间 ampoule storage room男卫生间 man toilet女卫生间woman toilet控制室 controlled room煤气coal gas氧气oxygen配电室男更man changeroom女更woman changeroom十万级100000 area万级10000 area 制水间A．A．A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会（美国）ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别（形象）CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局（美国）GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning T ools Room清洗室 Cleaning Room模具室 Dies Room内包装室 Immediate Package Room安全门 Emergency Door外包清室Outer Package Removing Room存料间Storage Room of Raw Materials 粉碎室 Pulverizing Room备料室 Materials Preparing Room硬胶室 Hard Capsules Filling Room软胶室 Soft Capsules Room制粒干燥室Granulating and Drying Room总混间 Blending Room中间站 Intermediate Station压片室Tablets Room Compression Room 包衣室 Coating Room配浆间 Coating Mixture Preparing Room 铝塑包装间Packing Room传递窗 Transferring Window外包装室 Outer Packing Room蒸馏水室 Water Purifying Room质检室 Quality Control Room浓配室 Concentrated Solution Room稀配室 Diluted Solution Room灌封室Filling and Sealing Room存瓶室 Ampul Storage Room洗瓶室 Ampul Cleaning Room灭菌间 Sterilizing Room灯检室 Light Inspection Room粉针室 Lyophilized Sterile Powder Room 冷冻干燥机 Lyophilizer办公室 Office培养室 Culture room更鞋室 Changing shoes room阳性检查室 Positive test room更衣室(男) Changeroom (man)缓冲间 Buffer room更衣室(女) Changeroom ( woman)洁具间 Cleaning room仪器室 Instrument room不溶性微粒检查室 Particulate matter test room 细菌内毒素检查室 Bacterial endotoxins test room 准备室 Preparation room培养室 Culture room气瓶室 Gas cylinders room留样观察室 Samples keeping room无菌检查室 Sterility test room留样准备室 Samples Retained Preparation room 加速试验室 Accelerated Stability test lab.纯化水制水间T he purified water-making room 电热室 Thermoelectricity room灭菌室 Sterilization room准备室 Preparation room贮藏室 Storage冷藏室 Cold storage安全门 Exit洗衣房 Laundry room微生物检查室 Microbiology room档案室 Muniment room图书室 Library培训会议室 Training\\meeting room电热室 Thermoelectricity room水份测定室 Water assay room通风室 Ventilator room标准溶液室 Standard solutions room高温设备室 High temperature devices room天平室 Balance room中药标本室 Traditional Chinese medicine specimens room 展览室 Showroom红外检测室 Infrared assay room化学测定室 Chemistry lab冷藏室 Cold storage冷库留样室 Samples Retained room(Cold Condition)有0人推荐阅读(158)|评论(3)|引用(1) |举报。

Q7A-GMP中英文对照-整理

Q7a（中英文对照）Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成分（API）的GMP指南Table of Contents 目录1. INTRODUCTION 1. 前言1.1 Objective 1.1目的1.2 Regulatory Applicability 1.2法规适用性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质量部门的职责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. 厂房和设施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. DOCUMENTA TION AND RECORDS 6. 文件和记录6.1 Documentation System and Specifications 6.1 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, API6.3 原料、中间体、API的标签和包装材料的记录Labeling and Packaging Materials6.4 Master Production Instructions (Master6.4 主生产指令（主生产和控制记录）Production and Control Records)6.5 Batch Production Records (Batch Production6.5 批生产记录（批生产和控制记录）and Control Records)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. MA TERIALS 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 Incoming Production7.3 来料的取样与检测Materials7.4 Storage 7.4储存7.5 Re-evaluation 7.5再评价8. PRODUCTION AND IN-PROCESS8. 生产和过程控制CONTROLS8.1 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 or APIs 8.4 中间体或API的混批8.5 Contamination Control 8.5 污染控制9. PACKAGING AND IDENTIFICATION9. API和中间体的包装和贴签LABELING OF APIs AND INTERMEDIATES9.1 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API的检测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（或称检验报告）11.5 Stability Monitoring of APIs 11.5 API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 OF MATERIALS 14.拒收和物料的再利用14.1 Rejection 14.1 拒收14.2 Reprocessing 14.2 再处理14.3 Reworking 14.3 返工14.4 Recovery of Materials and Solvents 14.4 物料与溶剂的回收14.5 Returns 14.5 退回15. COMPLAINTS AND RECALLS 15.投诉与召回16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)16.合同生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.代理商、中间商、贸易商、分销商、分装者和再贴签者17.1 Applicability 17.1适用性17.2 Traceability of Distributed APIs andIntermediates17.2分发的API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 ofAPIs and Intermediates17.4 APIs和中间体的再包装、再贴签和搁置17.5 Stability 17.5稳定性17.6 Transfer of Information 17.6 信息传递17.7 Handling of Complaints and Recalls 17.7 投诉和召回的处理17.8 Handling of Returns 17.8 退回物处理18. Specific Guidance for APIs Manufactured byCell Culture/Fermentation18. 对细胞培养/发酵生产的API的特殊指南18.1 General 18.1 总则18.2 Cell Bank Maintenance and Record Keeping 18.2细胞库的维护和记录保存18.3 Cell Culture/Fermentation 18.3细胞培养/发酵18.4 Harvesting, Isolation and Purification 18.4收取、分离和纯化18.5 Viral Removal/Inactivation steps 18.5 病毒去除/灭活步骤19. APIs for Use in Clinical Trials 19. 用于临床研究的API19.1 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 文档记录20. Glossary 20. 术语Q7a活性药物成分（API）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生产活性药用成分（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。

PIC S VMP 验证主计划(中英文对照)

OPERATIONAL QUALIFICATION STERILE PROCESS VALIDATIONCLEANING VALIDATION (1/25)1. DOCUMENT HISTORYAdoption by PIC/S Committee 10 - 11 December 1998Entry into force of version PR 1/99-1 01 March 1999Entry into force of version PI 006-1 01 September 20012. INTRODUCTIONThe basic principles and application of qualification and validation are describedin Annex 15 to the PIC/S and EU Guide to GMP. This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows:Ø Validation Master PlanØ Installation and Operational QualificationØ Non-Sterile Process ValidationØ Cleaning ValidationThe four Recommendations comprising this document define general principles pertaining to each of the topics.2. 导言PIC/S和EU GMP指导原则的附录15中对确认(Qualification)和验证(Validation)的基本原则及应用进行了阐述。

WHO原料药GMP现场检查(中英文)

针对API生产GMP检查过程中所发现关键问题的检查，并寻求可能的解决方案
Part Three, 18.1–18.59

Module 14
Slide 2 of 23
WHO - EDM
Active Pharmaceutical Ingredients
原料药
Areas to be Covered 涉及范围
Module 14
Slide 15 of 23
WHO - EDM
Active Pharmaceutical Ingredients
原料药
Production (continued)生产（接上）

Packaging包装
packaging material selection包材选择 procedures to prevent error预防差错的程序 labelling, including:标贴，包括：
– – – – – – – Product name产品名称 Quality质量 Batch number批号 Expiry or retest date有效期或复检期 Warnings, if required警示，必要时 Storage conditions贮存条件 Part Three, 18.43–18.45 Names of manufacturers and suppliers生产商和供应商名称
Active pharmaceutical ingredients原料药
meet specifications符合质量标准 limits for residue and reactants残留和反应物的限量 sterile APIs无菌原料药
Part Three, 18.41–18.42

IPEC全文译稿中英文对照

FOREWORD 前言The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. 辅料的质量对保证药品的安全、质量和功效是至关重要的。

辅料的应用范围广泛，是药品生产配方的基本成分。

辅料的特性直接影响药品的配方，包括化妆品的外观、稳定性和活性成分的输送。

因此，应用适当的GMP 规则是辅料的基础。

In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.与制剂和原料药相比，没有明确的针对辅料的GMP的规则。

GMP认证文件偏差中英文

STANDARD OPERATING PROCEDURE 标准操作规程Title : QUALITY DEVIATION MANAGEMENT 题目：质量偏差管理Procedure:编号:Effective Date:生效日期:Supersedes:替代:Review Date:复审日期：Unmodified Review History:Affected Department / Area :受影响的部门/ 区域:1.PURPOSE 目的Whenever a product, material or system fails to meet the specifications or in the event of a failure to comply with relevant documentation or regulatory requirements, an appropriate investigation must be undertaken, the cause(s) identified and the necessary corrective actions taken当产品、物料或系统不符合质量标准要求或某事件不符合相关文件或法规要求时，必须进行适当的调查，查明原因并采取必要的改正措施。

2.SCOPE 范围This SOP covers all failures and unplanned incidents related to Chemical components, Packaging materials, Drug Products, Processes, Systems, Equipments, Utilities and Facilities used to produce and control them.本SOP适用于处理所有失误及非计划性故障事件，含概用于产品并控制产品的化学成分、包装材料、药品、工艺、系统、设备、公共设施和厂房等。

某公司已过新版GMP认证洁净厂房验证模版(中英文)汇总

Installation Qualification Protocol洁净室安装确认方案System No. 系统编号: CLR-01Index 目录1.PURPOSE目的 (3)2.SCOPE范围 (3)3.RESPONSIBILITY职责 (3)4.REGULATION AND GUIDANCE 法规和指南 (3)5.ABBREVIATIONS缩略语 (3)6.SYSTEM DESCRIPTION 系统描述 (3)7.GOOD DOCUMENTATION PRACTICE文件管理规范 (5)8.TEST LIST测试列表 (6)9.PERSONNEL IDENTIFICATION人员确认 (6)10.PROCEDURE过程 (7)10.1先决条件 (7)10.2文件确认 (10)10.3图确认 (11)10.4房间组件检查 (13)10.5仪器仪表校验 (15)10.6洁净室建造装修检查 (17)10.7电器安装检查 (22)11. DEVIATION REPORT偏差报告 (28)1. Purpose目的本安装确认方案的目的是测试、检查和洁净室是按照相应设计要求和供应商的建议进行安装的。

安装确认的测试和检查的结果将按照该验证方案进行记录。

安装确认将确定直接影响系统的关键部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。

测试和检查的结果将按照该验证方案进行记录。

2. Scope范围本方案确定了***********公司口服固体项目车间的洁净室（位号：***********）的安装确认。

3. Responsibility职责4. Regulation and Guidance 法规和指南(SFDA) GMP 2010版中国药典2010版现行版ISPE指南5“调试和确认”洁净厂房设计规范GB13554-925. Abbreviations缩略语6. System Description 系统描述口服固体制剂的洁净室包括以下级别D级区对产品无影响的房间无需验证。

q7A-GMP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 and Specifications6.1 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 Materials6.3 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 (Batch Production 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. PACKAGING AND IDENTIFICATION9. 原料药和中间体的包装和贴签 LABELING 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 RELABELLERS17.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 and 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 Record Keeping18.2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 steps18.5 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials19. 用于临床研究的原料药 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 puritycharacteristics that they purport, or arerepresented, 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。