Guidance for Industry 行业指南
Investigating Out-of-Specification (OOS)
Test Results for Pharmaceutical Production
药品生产中OOS结果的调查
Additional copies are available from: 本文件可自以下途径得到
Office of Training and Communication 培训和交流办公室
Division of Drug Information HFD-240 药品信息分部
Center for Drug Evaluation and Research 药品审评中心
Food and Drug Administration 食品药品管理局
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm
U.S. Department of Health and Human Services美国卫生和福利部
Food and Drug Administration 食品药品管理局
Center for Drug Evaluation and Research (CDER)药品审评中心
October 2006
