Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the particle size and size distribution of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are often considered to be important. However, why is this the case and what guidance is available to help decide whether a method selected for particle size analysis is appropriate?
In this second webinar in the series, we will consider how the principles of Analytical Quality by Design (AQbD) can be applied to the development of a particle sizing method, using the technique of laser diffraction as an example. Starting from an understanding of why particle size analysis is performed, we will consider how the design space for a particle sizing method can be defined. We will then consider the regulatory guidance relating to the assessment of the precision, robustness and ruggedness of the method. Our goal will be to provide a process for defining an appropriate method that is able to rigorously support product quality control assessments while being flexible enough to be realistically applied throughout the lifetime of a pharmaceutical product.