Background

Drug shortage is a significant public health threat. It can cause the delay or even the denial of critically needed care for patients. Proactively assessing risks to drug manufacturing processes and supply chains, coupled with an understanding of market vulnerabilities, can enable the support of robust manufacturing operations that help to maintain the availability of a high-quality drug through the drug’s life cycle.

FDA Contribution

FDA initiated a guide in May 2022 to help drug/API manufacturers to 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.

Guidance

The guidance describes a framework for 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.

Summary

The content is not binding by law. It is intended to provide clarity regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Link to report: Risk Management Plans (fda.gov)