ABSTRACT
This chapter addresses statistical considerations in implementing a framework for the assessment of quality for inhalation aerosol products, such as, metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products intended for commercial distribution. Although this framework focuses on the statistical quality control aspects of MDI and DPI drug products developed using traditional product development approaches, it is also a component of the quality assessment for products developed using a risk- and science-based approach, where the intent could be to utilize advanced statistical process control procedures. The International Council for Harmonization (ICH) defines quality as “the degree to which a set of inherent properties of a product, system or process fulfills requirements” (ICH Q6A 1999). For most MDI and DPI products developed traditionally, pharmaceutical quality is regarded as the suitability of a drug substance or drug product for intended use, which is operationally achieved by demonstrating that a product has been manufactured in accordance with Current Good Manufacturing Practice (CGMP) regulations and the inherent properties conform to regulatory specifications (Woodcock 2004). For MDIs and DPIs developed using a risk- and science-based approach, good pharmaceutical quality is: (1) producing product that has an acceptable minimal risk of not clinically performing as labeled, 250(2) producing product absent of contamination, and (3) supplying product that is readily available to the patient (Yu and Woodcock 2015). Regardless of the development approach, controlling the quality of any drug product is a statutory requirement. The degree of success a firm achieves, in controlling the pharmaceutical quality of its MDI and DPI drug products, is related to the proper application of statistical quality control and/or statistical process control methods throughout the product’s lifecycle.
