The FDA has released a draft guidance for drug manufacturers that outlines the steps they need to take to reduce the risk of disruptions in drug supply. The guidance, which is based on the principles outlined in the International Council for Harmonisation’s Q9 Quality Risk Management guidance, identifies key risk factors that should be considered when developing risk management plans. Drug manufacturers are urged to implement stronger risk management plans to help safeguard against potential disruptions in supply. The FDA are taking comments on this topic until July 19, 2022, click here to submit your comments to the FDA’s CDER center.
The FDA’s guidance comes at a time when the risk of disruptions in drug supply is heightened. The COVID-19 pandemic has led to increased demand for certain drugs, as well as shortages of other drugs due to manufacturing and shipping disruptions. In addition, many drug manufacturers are facing challenges with raw material shortages and capacity constraints. As a result, it is more important than ever for drug manufacturers to have robust risk management plans in place.
The FDA’s guidance provides a framework for drug manufacturers to consider when developing risk management plans. The guidance outlines the need to identify and assess potential risks, develop mitigation strategies, and establish monitoring and reporting systems. In addition, the guidance recommends that drug manufacturers establish contingency plans in the event of a disruption in drug supply.
Please click this link to read more on the FDA statement, or reach out to Compliance Insight to see how we can help you with your risk management needs.