FDA Tries to Clear Up Continuous Manufacturing Ambiguities

27 Mar 2015

• By Joanne S. Eglovitch

FDA seeks “creative” solutions to clear up the regulatory ambiguities associated with continuous manufacturing. Agency also notes “teething problems” with continuous manufacturing implementation.

FDA officials explained that a different control strategy is needed to demonstrate drug quality for solid oral drugs made by continuous mode than batch mode, reflecting the very different nature of these manufacturing processes.

FDA is attempting to clear up some of the ambiguities associated with continuous manufacturing, and this pronouncement reflects the agency’s...