Practical Implications of Quality by Design to Chromatographic Method Development

Quality by Design (QbD) was first described by Joseph M. Juran[1], and applied heavily, particularly in the automotive industry. The fundamental premise behind QbD is that quality can be “designed in” to processes through systematic implementation of an optimization  strategy to establish a thorough understanding of the response of the system quality to given variables, and the use of control strategies to continuously ensure quality. The FDA has recently begun to advocate the QbD methodology for the pharmaceutical sector.[2]

There are a number of implications of the concept, including modeling of the influence of values of variables on quality, design of experiments, and ongoing refinement of processes as information is collected. Recently, analytical chemists have begun to advocate the extension of QbD philosophies to the development of analytical methods in addition to the development of manufacturing processes.

Some of the concepts are more applicable than others, and some have been advocated by many method development experts for some time, but modern technology has created an opportunity to revisit strategies for creation of chromatographic methods in particular, and it is certainly interesting to investigate the new opportunities in the context of Quality by Design.

This article will examine the areas where QbD methodologies can help with method development today, with emphasis on practical implementation and modern technologies.