FDA Releases Draft Quality Risk Management Guidelines


The draft ICH Q9(R1) document details the importance of quality risk management principles.

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June 15, 2022 that it had published the International Council for Harmonization’s (ICH) Q9(R1) Quality risk management draft guidance document.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

The integration of QRM into industry and regulatory operations is also discussed. The document includes two annexes. Appendix I provides information on QRM methods and tools such as Failure Mode Effects Analysis, Fault Tree Analysis, Hazard Analysis and Critical Control Points, etc. Annex II breaks down QRM as parts of integrated quality management.

“In the pharmaceutical sector, the principles and framework of ICH Q9, together with the official ICH training material that supports this guideline, help to improve 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 part of an effective quality system,” the agency said on its website.

Source: FDA


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