above the past two years, FDA offic...

above the past two years, FDA officials have issued numerous guidances and revised compliance programs as part of an initiative to revise circulating good manufacturing practices (cGMPs) to fit the 21st centenary The agency aims to encourage manufacturers to adopt modern production technologies and quality-based a whole s and promote risk-based management approaches for industry and within FDA itself.

A final report issued in September summarizes FDA's accomplishments during the initial assessment phase of this initiative. This 30-page white paper describes for what reason quality systems and ...