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USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and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.


FDA recognizes that drug shortages pose a significant public health threat because they can delay, and in some cases even deny, critically needed care for patients. Recent publications have explained that proactively assessing risks to drug manufacturing processes and supply chains, coupled with an understanding of market vulnerabilities, have enabled stakeholders to support robust manufacturing operations that help to maintain the availability of a high-quality drug through the drug’s life cycle.

Based on recent publications and reports, the majority of drug shortages are associated with quality issues.


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.


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) and in addition, FDA also recommends risk factors to consider when developing the content of the RMPs.


Click on the LINK to know more about this guidance.


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