APPLICATIONS OF QUALITY RISK ASSESSMENT IN QUALITY BY DESIGN (QbD) DRUG SUBSTANCE PROCESS DEVELOPMENT
Alan D. Braem, Gillian Turner · 2019
This chapter outlines the role of quality risk assessment in quality-by-design development, various risk assessment approaches and tools, and examples of how these tools may be applied at various stages of drug substance development. It discusses how risk assessments can be used early in the development cycle for risk-based prioritization of development efforts and identification of potential critical quality attributes and process parameters. For later stages, the chapter describes how risk assessments enable identification of a robust control strategy and how they are typically used for formal identification of criticality, and also touches on the associated regulatory implications. The chapter covers the assessment of residual risk after control strategies are implemented, risk review, and operational risk assessment. The examples shared are focused on small molecule drug substances rather than biologics that, due to their complexity, have additional challenges to address in the risk management process.