Turn to ICH for risk tools

There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of ICH [the quality risk management guidance of the International Conference on Harmonization] has a good toolbox," she adds. Q9 toolbox

Suggested Articles

Lonza headquarters
Manufacturing

Lonza leader Marc Funk quits after just 9 months as CEO

Lonza CEO Marc Funk is leaving for "personal reasons" after less than a year in the top job. 

by Eric Palmer
Zantac
Manufacturing

What has Zantac recall cost drugmakers? Dr. Reddy's gives a hint

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

by Eric Palmer
Lupin headquarters
Manufacturing

Lupin sells off Japanese operation to tidy up its balance sheet

Just weeks after selling the sterile manufacturing assets of its Kyowa operation in Japan, it has unloaded the rest of its Kyowa drugmaking operation.

by Eric Palmer