A Working Definition of Quality by Design (QbD): Understanding its Application to the Development and Manufacturing of Biopharmaceuticals

by Mark F. Witcher, PhD
Volume 13, Issue 1 (Spring 2014)

This paper places the “Quality by Design” (QbD) in an overall context and provides the following straightforward definition so that QbD can be effectively used to solve a wide variety of important problems:
Quality by Design–During the design stage, to achieve a well-defined goal, iteratively apply science and engineering methods to anticipate, identify, understand, resolve, and control problems that will be encountered during testing, operating, and verifying the goal over its lifecycle.
The viewpoint of the paper is to view QbD as “Success by Design.” The definition is based on answering the following question: What will be required to provide assurance that the enabler developed during the design stage will successfully reach the goal over the entire lifecycle before leaving the design stage? The paper argues that QbD should not be implemented as a program, but used as a tool. To provide understanding, the paper explores underlying concepts, the history of QbD, develops a working definition, and then applies it to biopharmaceutical development and manufacturing...

Citation:
Witcher MF. A Working Definition of Quality by Design (QbD): Understanding its Application to the Development and Manufacturing of Biopharmaceuticals. BioProcess J, 2014; 13(1): 6-11.
http://dx.doi.org/10.12665/J131.Witcher.

Posted online April 2, 2014.