The US Food and Drug Administration (FDA) “encourages and supports” real-time release testing and many larger companies possess the technical capabilities. However, adoption is limited by problems, both real and perceived.
“On the perceived side, I think a lot of it is the fear of the unknown. Companies haven’t used these approaches before and they’re concerned about how they work”, Christine Moore, acting director, office of new drug quality assessment at the FDA, told in-PharmaTechnologist.
Companies that overcome these fears will benefit. “As they have more robust processes they’re going to have less problems, less failures, recalls etc. It’s difficult to put a money figure on problems that don’t happen, but I think that’s where the real cost savings…are going to be”, Moore said.