FDA无菌生产指南-中英文对照版

Translated from / 译自：
Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing —
Current Good Manufacturing Practice
行业指南
无菌加工生产的无菌药品
—现行的生产质量管理规范(cinclude中文GMP）
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Office of Regulatory Affairs (ORA)
September 2004
Pharmaceutical CGMPs


TABLE OF CONTENTS
    简介
    背景
    法规架构
    技术架构
    适用范围
    厂房和建筑
    关键区域– 100级 (ISO 5)
    辅助洁净区域
    净化区的隔离
    空气过滤
    膜过滤
    高效颗粒空气过滤器(HEPA)
    设计
    人员的培训，资格认定和监控