(503e) Use of Quality by Design Principles in Pharmaceutical Product Development

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.