“Fear of the unknown” limiting adoption of real-time release testing, FDA says

By Nick Taylor

- Last updated on GMT

Real-time release testing can save money by cutting recalls but “fear of the unknown” is limiting use, a FDA official said.

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.

Related topics: Processing, Processing equipment, QA/QC

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