分享|欧盟发布《起始物料生产审计指南》-2018
欧盟APIC发布了《APIC GUIDE FOR AUDITING REGISTERED STARTING MATERIAL MANUFACTURERS(APIC指南:已注册起始物料生产商审计指南)》-2018,该指南旨在为起始物料生产商及其用户企业提供以下指导:
Consider key areas of focus for such audits审计关注的关键领域
Consider the application of risk management principles in their audit process审计过程中风险管理原则的应用
Consider key parameters of a quality management system needed for themanufacture of such materials该物料生产商所需要具备的质量管理体系的关键要素
该指南适用于人用药品API起始物料的生产,也同样适用于兽用药品API起始物料的生产。
该指南内容包括如下:
1. PREAMBLE
序
2. INTRODUCTION
简介
2.1 Objective
目的
2.2 Regulatory Applicability
监管适用性
2.3 Scope
范围
3. QUALITY MANAGEMENT
质量管理
3.1 Principles
原则
3.2 Internal Audits (Self Inspection)
内部审计(自检)
4. PERSONNEL
人员
4.1 Personnel Qualification
人员资质
4.2 Personnel Hygiene
人员卫生
5. BUILDINGS AND FACILITIES
厂房和设施
5.1 Design and Construction
设计和构造
5.2 Water
水
5.3 Containment
控制
5.4 Lighting
照明
5.5 Sanitation and Maintenance
卫生和维护
6. PROCESS EQUIPMENT
工艺设备
6.1 Design and Construction
设计和构造
6.2 Equipment Maintenance and Cleaning
设备维护和清洁
6.3 Calibration
校准
6.4 Computerized Systems
计算机化系统
7. DOCUMENTATION AND RECORDS
文件和记录
7.1 Documentation System and Specifications
文件系统和规范
7.2 Master Production Instructions (Master Production and Control Records)
主生产文件(主生产和控制记录)
7.3 Batch Production Records (Batch Production and Control Records)
批生产记录(批生产和控制记录)
7.4 Laboratory Control Records
实验室控制记录
7.5 RSM Batch Documentation Review and Batch Release
起始物料生产商文件审核和批放行
8. MATERIALS MANAGEMENT
物料管理
8.1 General Controls
一般控制
8.2 Receipt and Quarantine
收货和验货
8.3 Storage
储存
9. PRODUCTION AND IN-PROCESS CONTROLS
生产和中间控制
9.1 Production Operations
生产操作
9.2 In-process Sampling and Controls
生产过程取样和控制
9.3 Contamination Control
污染控制
10. PACKAGING AND IDENTIFICATION LABELLING OF RSM
起始物料的包装和识别标签
10.1 Packaging Materials
包装材料
10.2 Packaging and Labelling Operations
包装和贴签操作
11. STORAGE AND DISTRIBUTION
储存和运输
11.1 Warehousing Procedures
仓储规程
11.2 Distribution Procedures
发运规程
12. LABORATORY CONTROLS
实验室控制
12.1 General Controls
一般控制
12.2 Testing of RSM
起始物料的检验
12.3 Certificates of Analysis
检验报告书
12.4 Expiry and Retest Dating
有效期和复验期
12.5 Reserve/Retention Samples
留样
13. VALIDATION
验证
14. CHANGE CONTROL
变更控制
15. REPROCESSING OR REWORK OF MATERIALS
返工和重新加工
15.1 General
一般原则
15.2 Recovery of Materials and Solvents
物料和溶剂回收
15.3 Returns
退货
16. COMPLAINTS
投诉
17. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)
合同制造(包括实验室)
18. SPECIFIC GUIDANCE FOR RSM MANUFACTURED BY FERMENTATION
通过发酵生产的起始物料的特殊指南
18.1 General
一般原则
18.2 Fermentation
发酵
18.3 Harvesting, Isolation and Purification
收取、分离和精制
19. GLOSSARY
术语
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