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