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News|Articles|June 16, 2022
FDA Publishes Draft Quality Risk Management Guidance
Author(s)Pharmaceutical Technology Editors
The draft ICH Q9(R1) document details the importance of quality risk management principles.
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FDA announced on June 15, 2022 that it has published the International Council for Harmonisation’s (ICH)
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.
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