Translated from / 译自：
Guidance for Industry
Sterile Drug Products
Produced by Aptic Processing —
操作系统
Current Good Manufacturing Practice 范德法特
行业指南
无菌加工生产的无菌药品
—现行的生产质量管理标准(cGMP〕包装设计展开图
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (CBER)
Office of Regulatory Affairs (ORA)
September 2004
Pharmaceutical CGMPs
Guidance for Industry
Sterile Drug Products
Produced by Aptic Processing — Current Good Manufacturing Practice
Additional copies are available from:
Office of Training and Communication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Rearch
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
or
Office of Communication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Rearch
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
(Tel) Voice Information System at 800-835-4709 or 301-827-1800空间密码破解器
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
Center for Biologics Evaluation and Rearch (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
男生发色
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
雷锋说过的名言 空气过滤
膜过滤
高效颗粒空气过滤器(HEPA)创业故事网
设计
人员的培训，资格认定和监控
人员
手机cpu
实验室人员
监控程序
药品成分和容器/密封
药品成分
容器/密封
准备
容器密封系统的检查
内毒素控制
时间限制
无菌加工和灭菌的验证
工艺模拟
研究设计
运行频率和次数
运行时间
批量
