FDA-无菌药品生产指南(中英文版)介绍
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Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research
IV. BUILDINGS AND FACILITIES .................................................................................... 6 厂房和建筑
A. Critical Area – Class 100 (ISO 5) ................................................................................................. 8 关键区域– 100 级 (ISO 5)
Center for Biologics Evaluation and Research Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.
Food and Drug Administration 5600 Fishers Lane
Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training and Manufacturers Assistance, HFM-40
Office of Regulatory Affairs (ORA) September 2004
Pharmaceutical CGMPs
Copyright SCI Version 1
Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
(Tel) Voice Information System at 800-835-4709 or 3Hale Waihona Puke Baidu1-827-1800
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)
II. BACKGROUND ............................................................................................................... 2 背景
A. Regulatory Framework ................................................................................................................. 2 法规架构
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)
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）
Office of Regulatory affairs (ORA)
September 2004 Pharmaceutical CGMPs
Copyright SCI Version 1
Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1 简介
B. Technical Framework.................................................................................................................... 3 技术架构
III. SCOPE ............................................................................................................................... 4 适用范围
B. Supporting Clean Areas .............................................................................................................. 11 辅助洁净区域
IV. BUILDINGS AND FACILITIES .................................................................................... 6 厂房和建筑
A. Critical Area – Class 100 (ISO 5) ................................................................................................. 8 关键区域– 100 级 (ISO 5)
Center for Biologics Evaluation and Research Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.
Food and Drug Administration 5600 Fishers Lane
Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication, Training and Manufacturers Assistance, HFM-40
Office of Regulatory Affairs (ORA) September 2004
Pharmaceutical CGMPs
Copyright SCI Version 1
Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
(Tel) Voice Information System at 800-835-4709 or 3Hale Waihona Puke Baidu1-827-1800
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)
II. BACKGROUND ............................................................................................................... 2 背景
A. Regulatory Framework ................................................................................................................. 2 法规架构
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)
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）
Office of Regulatory affairs (ORA)
September 2004 Pharmaceutical CGMPs
Copyright SCI Version 1
Contains Nonbinding Recommendations
TABLE OF CONTENTS
I. INTRODUCTION............................................................................................................. 1 简介
B. Technical Framework.................................................................................................................... 3 技术架构
III. SCOPE ............................................................................................................................... 4 适用范围
B. Supporting Clean Areas .............................................................................................................. 11 辅助洁净区域