US FDA Sees Slow But Steady Progress In Adoption Of Continuous Manufacturing

15 Jun 2020

• By Joanne S. Eglovitch

The COVID-19 pandemic has prompted the ICH to delay by six months its efforts to develop Q13 guideline on continuous manufacturing, now not expected until May 2022.

Continuous Production on the Metal Gears on Black Background. — Pandemic Delays ICH's Continuous Manufacturing Guidance • Source: Shutterstock

As the pharmaceutical industry's adoption of continuous manufacturing progresses slowly but steadily, an effort that could accelerate the spread of the alternative to traditional batch processing by harmonizing global regulatory approaches has been delayed by six months due to the coronavirus pandemic, an official with the US Food and Drug Administration recently said.

The FDA’s Rapte Madurawe discussed the status of continuous manufacturing in the US as well as the global harmonization efforts...