文档介绍：Q7A 活性药物成分(API)的GMP指南
EC_Q7a
Q7a(中英文对照)
FDA原料药GMP指南
Table of Contents
目录
13>. INTRODUCTION
1. 简介
Objective
Regulatory Applicability
Scope
2. QUALITY MANAGEMENT
Principles
Responsibilities of the Quality Unit(s)
Responsibility for Production Activities
Internal Audits (Self Inspection)
(自检)
Product Quality Review
3. PERSONNEL
3. 人员
Personnel Qualifications
Personnel Hygiene
人员卫生
Consultants
顾问
4. BUILDINGS AND FACILITIES
4. 建筑和设施
Design and Construction
设计和结构
Utilities
公用设施
Water
水
Containment
限制
Lighting
照明
Sewage and Refuse
排污和垃圾
Sanitation and Maintenance
卫生和保养
5. PROCESS EQUIPMENT
5. 工艺设备
Design and Construction
设计和结构
Equipment Maintenance and Cleaning
设备保养和清洁
Calibration
校验
Systems
计算机控制系统
6. DOCUMENTATION AND RECORDS
6. 文件和记录
Documentation System and Specifications
文件系统和质量标准
Equipment cleaning and Use Record
设备的清洁和使用记录
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
Master Production Instructions (Master Production and Control Records)
生产工艺规程(主生产和控制记录)
Batch Production Records (Batch Production and Control Records)
批生产记录(批生产和控制记录)
Laboratory Control Records
实验室控制记录
Batch Production Record Review
7. MATERIALS MANAGEMENT
7. 物料管理
General Controls
控制通则
Receipt and Quarantine
Sampling and Testing of ing Production Materials
进厂物料的取样与测试
Storage
Re-evaluation
8. PRODUCTION AND IN-PROCESS CONTROLS
8. 生产和过程控制
Production Operations
生产操作
Time Limits