This guidance is intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages. RMPs can provide stakeholders with a framework to proactively identify, prioritize, and implement strategies to mitigate hazards that can cause a supply disruption. Such a supply disruption may lead to a drug shortage.
Effective quality risk management can facilitate better, more informed decisions; can provide FDA with greater assurance that stakeholders understand and can manage the associated risks; and can potentially affect the extent and level of direct regulatory oversight. Based on recent publications and reports, the majority of drug shortages are associated with quality issues. This guidance describes a framework for stakeholders to consider when developing RMPs that aligns with principles stated in the International Council for Harmonisation (ICH) guidance for industry Q9 Quality Risk Management (June 2006).
In addition, FDA also recommends risk factors to consider when developing the content of the RMPs.