On 20 May 2022, the United States Food and Drug Administration (FDA), issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages.
The FDA explain the draft guidance’s purpose is to: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.”
Significantly, the draft guidance references, affirms, and expands processes and methodologies described in International Council for Harmonisation’s (ICH) Q9 Quality Risk Management (ICH Q9).
The FDA stress:
“This guidance is intended to add to the elements of the framework described in ICH Q9, to describe considerations for stakeholder oversight for RMPs, and to assist with the interpretation of the quality risk management process within the context of developing RMPs.”
Notably, the FDA provide a recommended risk management plan that augments the quality risk management process described in ICH Q9. Further, the regulator details ‘Risk Considerations for Specific RMPs’, including but not limited to, supply disruption vulnerabilities, manufacturing process weaknesses, and the unreliability of equipment.
The draft guidance is available for download here, and the FDA’s statement on the draft is accessible here.
Importantly, the FDA has invited commentary on the draft guidance. The regulator has indicated comments should be submitted by 19 July 2022.
COVID-19-related supply disruptions have demonstrated the importance of developing risk management mechanisms to ensure supply continuity. Komply can help your organisation in developing risk management procedures to prevent supply disruption, amongst other issues.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com, or call +61 422 909 125 for more information.
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