Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. A year’s worth of FDA warning letters suggest ...

The U.S. Department of Agriculture’s Process Verification Program could provide an avenue for firms to certify the veracity of non-GMO claims without indirectly suggesting that genetic engineering is ...

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015. To ensure that biotech manufacturing processes can consistently deliver high quality ...