Quality Risk Management

Patient safety is a growing and an ongoing concern across the pharmaceutical world. Implementing quality risk management (QRM) procedures throughout the manufacturing to supply of drugs is essential to ensure the safety of drugs and prevent them from being non-compliant during production. Quality Risk Management is a complete and continuing process of reducing product quality risks during its lifecycle to optimize its benefits and equilibrium with the risk. It is the process of evaluating, controlling, communicating, and reviewing risks to the quality of the pharmaceutical formulation. Using this knowledge, the pharmaceutical industry and regulators can appraise, communicate, control, and evaluate risks. The Quality Risk Management process includes the level of effort, systematic procedure, and documentation which should be appropriate for the level of risk. Risk management is the first step in the quality risk management process which includes risk identification, analysis, and evaluation. In this chapter, we have covered the four processes of Quality Risk Management: namely, quality risk assessment, quality risk control, quality risk communication, and quality risk review. The present book chapter covers the history, objective, scope, QRM process, risk management methods, risk control, risk reduction, and case studies related to quality risk management.