Quality Risk Management (QRM) is a systematic process for the identification, assessment, control, communication, and review of risks to the quality of a biopharmaceutical product throughout its lifecycle, from early development through commercial manufacturing. Defined within ICH Q9 guidelines, QRM employs structured tools such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and risk ranking and filtering to prioritize risks based on their probability, severity, and detectability. It is a fundamental component of Quality by Design (QbD), process validation, and GMP compliance in CDMO operations.
