(553f) Quality Risk Analysis of a Tablet Coating Process

In this presentation, we will demonstrate how the Failure Mode and Effect Analysis (FMEA) technique can be adopted as a tool for the management of quality risk associated with a tablet coating process. The drug product process chosen for this analysis, involves the coating of an Active Pharmaceutical Ingredient (API) onto core tablets. Content uniformity is a critical quality attribute. The FMEA analysis examines all the processing parameters that can impact the content uniformity in the final drug product. Other critical quality attributes are also identified, with their corresponding systems and subsystems. The risk analysis, using the FMEA approach, quantifies each failure mode, and ranks them according to an overall risk priority number (RPN). PAT applications, mechanistic model development, design of experiments (DOE), and other specific engineering controls that can be used to mitigate quality risks with high RPN's will also be discussed.