Continuous Manufacturing - FDA Perspective on Submissions and Implementation

The advantages of Continuous Manufacturing (CM) are presented in a presentation entitled "Continuous Manufacturing - FDA Perspective on Submissions and Implementation" by Dr. Christine M.V. Moore, CDER, FDA, September 2011. The FDA even sees a potential for reduced costs in this technology.

Until today, a clear definition of batch / lot is of great importance under cGMP. New approaches to CM must be found, such as by means of defining a production time period for a batch or a lot.

Apart from that, the FDA sees no objection against CM in the rules!

Spectroscopic methods (NIR, FTIR and Raman) are mentioned as examples for typical in-process methods for Continuous Manufacturing.

In conclusion, the presentation points out that - in the meantime - the science exists to enable continuous manufacturing of pharmaceuticals and that there are no regulatory hurdles for implementing it. However, there is a lack of experience concerning this new technology and therefore early and frequent discussion with the Agency is recommended before implementing CM.

"Continuous Manufacturing" is also one of the key topics addressed at the University of Heidelberg QbD/PAT Conference on 26 and 27 September 2012 at the Marriott Hotel in Heidelberg. With Prof. Dr. Fernando Muzzio (Rutgers University, USA), Prof. Dr. Richard Lakerveld (previously Novartis MIT Center for CM, USA, now University of Delft, NL) and Steve Hammond (Pfizer, USA) the world's leading experts in this field are present in Heidelberg!

Please also see the complete FDA presentation "Continuous Manufacturing – FDA Perspective on Submissions and Implementation" for further information.

Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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