Changing and improving processes in Pharma after the original submission to the FDA

In February 2019 the FDA started to encourage Pharmaceutical Manufacturers to do what other industries have done for many decades – look for ways of changing the process to improve quality and reduce costs.

This was a significant change of mindset as previously it was “if you can’t demonstrate the process has been operated as it was defined in the original submission, you may lose the license to manufacture”.

Innovations in drug manufacturing

The following FDA article https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-programs-promote-adoption-innovations-drug has this statement supporting this change:

 "It's also important to consider that the manufacturing of these products may evolve after they have come to market, as companies make updates and improvements to their processes. These updates can help improve quality and reduce costs. When these changes are made, it’s the FDA’s responsibility to review them to recognize and mitigate any risks that a manufacturing change might introduce. In doing so, the FDA is careful to strike the appropriate balance between understanding how these changes could impact product quality and ensuring that companies can swiftly and efficiently make changes to process that can increase production efficiency, bolster quality and ultimately, help increase competition in the marketplace."

In theory at any rate, Pharmaceutical Manufacturers now have the scope to improve quality and reduce costs in the same way other manufacturers have been doing for a long time. It would be interesting to hear if and how things have changed over the last 15 months and how Pharmaceutical Manufacturers started to make the most of this opportunity. Did manufacturers start initiatives to improve existing processes?

What is your experience? What are your thoughts? Please share them in the comments with us.