文档介绍：原料药GMP指南(中英文对照)
EC_Q7a
278
Q7a（
6
Production Operations
生产操作
Time Limits
时限
In-process Sampling and Controls
工序取样和控制
Blending Batches of Intermediates or APIs
中间体或原料药的混批
Contamination Control
污染控制
9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES
9. 原料药和中间体的包装和贴签
General
总则
Packaging Materials
包装材料
Label Issuance and Control
标签发放与控制
Packaging and Labeling Operations
包装和贴签操作
EC_Q7a
7
10. STORAGE AND DISTRIBUTION
Warehousing Procedures
入库程序
Distribution Procedures
分发程序
11. LABORATORY CONTROLS
General Controls
控制通则
Testing of Intermediates and APIs
中间体和原料药的测试
Validation of Analytical Procedures
分析方法的验证
Certificates of Analysis
分析报告单
Stability Monitoring of APIs
原料药的稳定性监测
Expiry and Retest Dating
有效期和复验期
EC_Q7a
8
Reserve/Retention Samples
留样
12. VALIDATION
Validation Policy
验证方针
Validation Documentation
验证文件
Qualification
确认
Approaches to Process Validation
工艺验证的方法
Process Validation Program
工艺验证的程序
Periodic Review of Validated Systems
Cleaning Validation
清洗验证
Validation of Analytical Methods
分析方法的验证
13. CHANGE CONTROL
EC_Q7a
9
14. REJECTION AND RE-USE OF MATERIALS
Rejection
拒收
Reprocessing
返工
Reworking
重新加工
Recovery of Materials and Solvents
物料与溶剂的回收
Retur