Prabir K. Basu1, Stephan X. M. Boerrigter2, Manish Mehta3, and Kenneth R. Morris2. (1) Purdue University, Hovde Hall, Room 315, 610 Purdue Mall, West Lafayette, IN 47907-2040, (2) Industrial and Physical Pharmacy, Purdue University, IN 47907, (3) Industrial Engineering, Purdue University, IN
The pharmaceutical industry and the regulatory authorities are trying to implement Quality by Design principles in pharmaceutical product design to improve quality of manufactured products and to speed up product development. Several pharmaceutical companies are also heavily engaged in improving quality of manufacturred products by using the so-called "Six-Sigma" approach. How do these concepts fit in with each other?
The paper will try to interpret what Quality by Design really means for the pharmaceutical industry and will attempt to present a process or roadmap that the industry could follow using available quality management tools right from the stage of early product development into manufacturing.