Quality by Design for Particle Size Analysis

Particle size analysis of pharmaceutical powders or dispersions is of great importance due to the potentially significant impact of particle size on safety, efficacy and quality of the drug product. The development of an appropriate particle sizing method is fundamental to establishing particle size specifications, which may be critical for control of drug product performance as well as ensuring manufacturing consistency. This presentation will describe a quality by design (QbD) approach to development of particle sizing methods. While QbD primarily focuses on product design and process development, it can be extended to development of analytical methods as well. In this approach, several QbD strategies (e.g., analytical target profile, method selection, risk assessment, control strategy, etc.) have been applied during the method development to ensure that the particle sizing method is rugged and robust and provides optimum performance. As a result, this more systematic approach could facilitate continual improvement throughout the method’s lifecycle of use.