Технологический процесс
Непрерывное производство

 

 

FDA Perspective on Continuous Manufacturing
IFPAC Annual Meeting
Baltimore, January , 2012
Sharmista Chatterjee, Ph.D.
CMC Lead for QbD
ONDQA/CDER/FDA

 

Pharmaceutical Manufacturing: The Path Ahead..
" Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing." Dr. Janet Woodcock, AAPS Annual meeting, October 2011

 

Outline
Difference between "Batch" and "Continuous"
Engineering perspective
Regulatory perspective
Scientific considerations for continuous processing
Ongoing collaborative research
Concluding remarks