Continuous Manufacturing Guidance Issued by FDA – Can Generics Successfully Implement this Strategy?

Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here).  Talk about a controversial proposition!  The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business.  Why?  I am not always clear on the answer to that question, but change is always difficult, especially when the benefit of the outcome is challenged.

Nonetheless, innovation may eventually move the industry to embrace this change and now a guidance document further explains the FDA’s view on the use of the continuous manufacturing process.  The guidance discusses, among other things:

  • Process dynamics
  • Definition of a batch
  • Control strategy
  • Process validation
  • Scale-up using changes in time or material flow rates
  • Real-time release testing
  • Stability
  • Bridging the current manufacturing process to a continuous manufacturing process
  • Where to place continuous manufacturing into the application

There are also definitions of terms and references provided.  The guidance sheds additional light on the process and extolls its benefits.  Will the generic industry begin to embrace the process or continue to believe it is not right for them?  Only time will tell.