The Wall Street Journal via the Pharmalot blog reports that the FDA may soon require pharma companies to do more on site audits with their outsourcing partners. This comes on the heels of several celebrated quality incidents with crtical raw materials manufactured in China in 2009-2010 -- but this regulatory edict is expected to apply to outsourcing partners in any geography.
The Rx-360 Audit sharing program, described in a previous post, would seem to be a perfect concept for supporting this regulation. As a reminder, the Rx-360 program will enable members from both pharmaceutical and supplier side to share audit results from more than 30 suppliers from various geographic regions - North America, Europe, India and China.
Here's the FDA presentation on this topic. Download Fda ppt drug quality
Posted by Bruce Lehr June 17th 2010.