A risk assessment is a structured, systematic process used to identify, analyze, and evaluate potential risks to product quality, patient safety, process performance, or regulatory compliance in biopharmaceutical development and manufacturing. In accordance with ICH Q9 guidelines, risk assessments employ formalized tools such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Hazard Analysis and Critical Control Points (HACCP) to prioritize risks based on their severity, probability, and detectability, and to define appropriate risk mitigation and control strategies. Risk assessment is a foundational activity in Quality by Design (QbD), process validation, change control, and GMP compliance within CDMO operations.
