Abstract

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.