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. The product lifecycle for drug products as presented in ICH Q10 consists of four lifecycle stages: pharmaceutical development, technology transfer, commercial manufacture, and product discontinuation. ICH Q10 describes a pharmaceutical quality system model based on International Organization for Standardization (ISO) quality system concepts as applied to the product lifecycle. Statistical process control (SPC) and statistical quality control (SQC) utilize similar statistical methodologies, however, distinct differences exist between the two applications. This chapter summarizes the regulatory and compendial framework and statistical tools and statistical thinking that can be considered in demonstrating a process is suitable to be routinely releasing drug product to the market and is under a state of statistical control.
