Table of Contents
| 目录 |
1. INTRODUCTION
| 1. 简介
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1.1 Objective
| 1.1目的
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1.2 Regulatory Applicability
| 1.2法规的适用性
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1.3 Scope
| 1.3范围
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2. QUALITY MANAGEMENT
| 2.质量管理
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2.1 Principles
| 2.1总则
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2.2 Responsibilities of the Quality Unit(s)
| 2.2质量部门的责任
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2.3 Responsibility for Production Activities
| 2.3生产作业的职责
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2.4 Internal Audits (Self Inspection)
| 2.4内部审计(自检)
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2.5 Product Quality Review
| 2.5产品质量审核
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3. PERSONNEL
| 3. 人员
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3.1 Personnel Qualifications
| 3.人员的资质
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3.2 Personnel Hygiene
| 3.2 人员卫生
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3.3 Consultants
| 3.3 顾问
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4. BUILDINGS AND FACILITIES
| 4. 建筑和设施
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4.1 Design and Construction
| 4.1 设计和结构
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4.2 Utilities
| 4.2 公用设施
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4.3 Water
| 4.3 水
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4.4 Containment
| 4.4 限制
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4.5 Lighting
| 4.5 照明
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4.6 Sewage and Refuse
| 4.6 排污和垃圾
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4.7 Sanitation and Maintenance
| 4.7 卫生和保养
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5. PROCESS EQUIPMENT
| 5. 工艺设备
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5.1 Design and Construction
| 5.1 设计和结构
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5.2 Equipment Maintenance and Cleaning
| 5.2 设备保养和清洁
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5.3 Calibration
| 5.3 校验
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5.4 Computerized Systems
| 5.4 计算机控制系统
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6. DOCUMENTATION AND RECORDS
| 6. 文件和记录
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6.1 Documentation System and Specifications
| 6.1 文件系统和质量标准
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6.2 Equipment cleaning and Use Record
| 6.2 设备的清洁和使用记录
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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
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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)
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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)
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6.6 Laboratory Control Records
| 6.6 实验室控制记录
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6.7 Batch Production Record Review
| 6.7批生产记录审核
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7. MATERIALS MANAGEMENT
| 7. 物料管理
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7.1 General Controls
| 7.1 控制通则
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7.2 Receipt and Quarantine
| 7.2接收和待验
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7.3 Sampling and Testing of Incoming Production Materials
| 7.3 进厂物料的取样与测试
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7.4 Storage
| 7.4储存
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7.5 Re-evaluation
| 7.5复验
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8. PRODUCTION AND IN-PROCESS CONTROLS
| 8. 生产和过程控制
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8.1 Production Operations
| 8.1 生产操作
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8.2 Time Limits
| 8.2 时限
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8.3 In-process Sampling and Controls
| 8.3 工序取样和控制
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8.4 Blending Batches of Intermediates or APIs
| 8.4 中间体或原料药的混批
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8.5 Contamination Control
| 8.5 污染控制
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9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES
| 9. 原料药和中间体的包装和贴签
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9.1 General
| 9.1 总则
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9.2 Packaging Materials
| 9.2 包装材料
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9.3 Label Issuance and Control
| 9.3 标签发放与控制
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9.4 Packaging and Labeling Operations
| 9.4 包装和贴签操作
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10. STORAGE AND DISTRIBUTION
| 10.储存和分发
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10.1 Warehousing Procedures
| 10.1 入库程序
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10.2 Distribution Procedures
| 10.2 分发程序
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11. LABORATORY CONTROLS
| 11.实验室控制
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11.1 General Controls
| 11.1 控制通则
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11.2 Testing of Intermediates and APIs
| 11.2 中间体和原料药的测试
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11.3 Validation of Analytical Procedures
| 11.3 分析方法的验证
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11.4 Certificates of Analysis
| 11.4 分析报告单
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11.5 Stability Monitoring of APIs
| 11.5 原料药的稳定性监测
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11.6 Expiry and Retest Dating
| 11.6 有效期和复验期
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11.7 Reserve/Retention Samples
| 11.7 留样
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12. VALIDATION
| 12.验证
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12.1 Validation Policy
| 12.1 验证方针
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12.2 Validation Documentation
| 12.2 验证文件
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12.3 Qualification
| 12.3 确认
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12.4 Approaches to Process Validation
| 12.4 工艺验证的方法
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12.5 Process Validation Program
| 12.5 工艺验证的程序
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12.6 Periodic Review of Validated Systems
| 12.6验证系统的定期审核
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12.7 Cleaning Validation
| 12.7 清洗验证
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12.8 Validation of Analytical Methods
| 12.8 分析方法的验证
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13. CHANGE CONTROL
| 13.变更的控制
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14. REJECTION AND RE-USE OF MATERIALS
| 14.拒收和物料的再利用
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14.1 Rejection
| 14.1 拒收
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14.2 Reprocessing
| 14.2 返工
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14.3 Reworking
| 14.3 重新加工
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14.4 Recovery of Materials and Solvents
| 14.4 物料与溶剂的回收
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14.5 Returns
| 14.5 退货
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15. COMPLAINTS AND RECALLS
| 15.投诉与召回
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16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)
| 16.协议生产商(包括实验室)
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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
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17.1 Applicability
| 17.1适用性
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17.2 Traceability of Distributed APIs and Intermediates
| 17.2已分发的原料药和中间体的可追溯性
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17.3 Quality Management
| 17.3质量管理
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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
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17.5 Stability
| 17.5稳定性
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17.6 Transfer of Information
| 17.6 信息的传达
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17.7 Handling of Complaints and Recalls
| 17.7 投诉和召回的处理
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17.8 Handling of Returns
| 17.8 退货的处理
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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
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18.1 General
| 18.1 总则
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18.2 Cell Bank Maintenance and Record Keeping
| 18.2细胞库的维护和记录的保存
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18.3 Cell Culture/Fermentation | 18.3细胞繁殖/发酵
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18.4 Harvesting, Isolation and Purification | 18.4收取、分离和精制
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18.5 Viral Removal/Inactivation steps | 18.5 病毒的去除/灭活步骤
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19. APIs for Use in Clinical Trials | 19. 用于临床研究的原料药
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19.1 General | 19.1 总则
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19.2 Quality | 19.2 质量
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19.3 Equipment and Facilities | 19.3 设备和设施
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19.4 Control of Raw Materials | 19.4 原料的控制
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19.5 Production | 19.5 生产
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19.6 Validation | 19.6 验证
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19.7 Changes | 19.7 变更
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19.8 Laboratory Controls | 19.8 实验室控制
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19.9 Documentation | 19.9 文件
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20. Glossary | 20. 术语
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