FDA Publishes Draft Quality Risk Management Guidance

FDA announced on June 15, 2022 that it has published the International Council for Harmonisation’s (ICH) Q9(R1) Quality Risk Management draft guidance document. The draft version details the general quality risk management (QRM) process including risk assessment, risk control, risk communication, and risk review. It also discusses methodology for risk management and risk-based decision making.

The integration of QRM into the industry and regulatory operations is also discussed. The document includes two annexes. Annex I provides information on QRM methods and tools such as failure mode effects analysis, fault tree analysis, hazard analysis and critical control points, and more. Annex II breaks down QRM as parts of integrated quality management.

“In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators. The importance of quality systems has been recognized in the pharmaceutical industry, and it is evident that quality risk management is a valuable component of an effective quality system,” the agency stated on its website.

Source: FDA