Food and Drugs Administration

Advisory Committee for Pharmaceutical Science

Manufacturing Subcommittee

May 21-22, 2003 Briefing Information

Cover Letter, Helen Winkle (PDF)

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, FDA (PDF)

Summary Progress Report Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, FDA (PDF)

Sterile Drug Products Produced by Aseptic Processing (Draft), FDA (PDF)