Risk Management in Pharmaceutical Development: A Short Review

ICH Q8, Q9 and Q10 emphasize the systemic and science based risk management process to pharmaceutical formulation development in order to ensure quality of products. The objective of this review is to familiarize the readers with risk management principles and the way it can fit the formulation development research. The review explains the process of risk management the step by step through risk assessment (which involve risk identification/listing, risk analysis/quantification and risk prioritization/ranking/evaluation), risk response/treatment (which involve risk avoidance, risk reduction, risk sharing/transfer and risk acceptance), risk monitoring and control and risk reporting/communication. Quality risk management of pharmaceutical development involves defining the quality target product profile (QTPP) and identifying the critical quality attributes (CQAs). Further, the risk management principles can be systematically applied to identify the critical factors that affect the CQAs and to evaluate and control those factors successfully, which eventually ensure the product quality.