Q9 Guidance Establishes Common Terminology for Risk Management

On Monday, the US Food and Drug Administration published the draft of International Conference on Harmonization’s (ICH) Q9 guidance, Quality Risk Management, for review and comment.

The draft outlines risk-management principles for drug development and manufacturing and describes common methods such as hazard analysis and critical control points (HAACP) and failure-mode effects analysis (FMEA). The document also suggests pharmaceutical operations and regulatory activities to which the approaches can be applied, including areas such as quality management, drug development, and regulatory inspection and assessment of postapproval manufacturing changes.

David J. Horowitz, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER), says the document’s utility is that it standardizes terminology and conceptual models. “It will facilitate dialogue about what risk means in the context of pharmaceutical quality, and what some of the approaches to controlling quality risk are,” he says. This will facilitate industry acceptance of risk management, he adds, by giving manufacturers confidence that they’ll be able to explain their approaches to international regulators using common terminology.

The risk-management guidance also will help industry and regulators apply concepts outlined in other ICH guidance documents, Horowitz says. “A risk-based approach is very important for implementation of quality-by-design,” he says, referring to the concept underlying the ICH Q8 guidance, Pharmaceutical Development. “It’s also very important for the implementation of quality systems, which is going to be the ICH Q10 document.” FDA issued its own draft guidance on the same topic in October of last year.

The publication of the draft guidance in the three ICH regions is part of step two of the four-step ICH process. Horowitz declined to venture a guess about when the process would be completed. “This guidance is relatively straightforward and has a fairly discrete scope,” he commented, “so I’m hopeful that we can get this done relatively quickly for ICH.”

–Laura Bush