QbD confronts batch for API makers

Batch processes are easy, so you can't necessarily blame API makers for using them. But a little quality-by-design creativity, coupled with an understanding of API physical properties and reaction kinetics, can lead to continuous manufacturing processes that improve the bottom line and establish leadership.

The manipulation of unit operations and modular plants can facilitate QbD, according to Girish Malhotra, president at tech consultancy EPCOT International. The apparent opposition of QbD practices and those of batch processing is no excuse for using methods that can be improved in terms of speed and cost. And as we've reported, the FDA appears to be increasingly QbD-minded.

Modular plants can be used in the production of many fine and specialty chemicals, says Malhotra in a blog. Those with knowledge of alternative manufacturing methods "can easily produce some of the actives using continuous processes," which are often faster and cheaper, Malhotra writes.

- here's the blog