Continuous Manufacturing and Real-time Release Testing
Rameshwar Nalawade,
Group Leader,
STEERLife India Pvt Ltd
A medicinal product must comply with the requirements stated in the authorized
specifications for release and shelf life. Real time release testing is a system of release
that gives assurance that the product is of intended quality, based on the information
collected during the manufacturing process, through product knowledge and on process
understanding and control.
Continuous manufacturing represents the future of advanced pharmaceutical
manufacturing and will produce significant improvements in efficiency, safety, cost and
speed to market.
Continuous manufacturing can offer significant quality and cost advantages over batch
manufacturing of pharmaceutical drugs and drug products.
Real time release testing is a best system for continuous manufacturing.
My topic will be connecting continuous manufacturing through real time release
testing with respect to Process Quality by design and Analytical quality by design
in pharmaceutical development.
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