文档介绍：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(cGMP)
. 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
Guidance for Industry
Sterile Drug Products
Produced by Aseptic Processing — Current Good Manufacturing Practice
Additional copies are available from:
Office of Training munication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
r/guidance/
or
Office munication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
r/.
(Tel) Voice Information System at 800-835-4709 or 301-827-1800
. 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
I. INTRODUCTION 1
简介
II. BACKGROUND 2
背景
A. Regulatory Framework 3
法规架构
B. Technical Framework 3
技术架构
III. SCOPE 4
适用范围
IV. BUILDINGS AND FACILITIES 5
厂房和建筑
A. Critical Area – Class 100 (ISO 5) 5
关键区域– 100级(ISO 5)
B. Supporting Clean Areas 5
辅助洁净区域
C. Clean Area Separation 5
净化区的隔离
D. Air Filtration 5
空气过滤
1. Membrane 5
膜过滤
2. High-Efficiency Particulate Air (HEPA) 5
高效颗粒空气过滤器(HEPA)
E. Design 5
设计
V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING 5
人员的培训,资格认定和监控
A. Personnel 5
人员
B. Laboratory Personnel 5
实验室人员
C. Monitoring Program 5
监控程序
VI. COMPONENTS AND CONTAINER/CLOS