FDA published ICH Q9(R1) Quality Risk Management as final Guidance. It updates the original Q9 from 2006. As with all FDA implementations of ICH guidelines, there will be minor changes in language to accommodate US law on Guidance (e.g., use of ‘will’ or ‘shall’ is normally changed to ‘should’ since FDA Guidance are always recommendations).
Having sat through numerous risk discussion on drug development teams, as well as CAPA assessments, I find this text in the Introduction most appropriate with regard to the differences in individual perspective influence on risk assessment.
It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In addition, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. Therefore, it is important that subjectivity is managed and minimized. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient is of prime importance when managing the risk to product quality and availability, when availability risks arise from quality/manufacturing issues.
In addition to defining key elements of the process early in the Guidance, 8 example Quality Risk Management methods and a number of statistical software tools are discussed in the first Annex. The second Annex discusses potential applications for Quality Risk Management.
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