Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

FDA Announces Availability of Temporary Guidance on Resuming Normal Drug and Biologics Manufacturing During the COVID-19 Public Health Emergency

FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,”  to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.  During the COVID-19 public health emergency, manufacturers may have faced and continue to face unusual challenges, such as employee illness and absenteeism, travel restrictions, site closures, and supply chain disruptions. Measures to prevent COVID-19 transmission, such as quarantines and social distancing, may have been implemented across the company. These challenges may impact normal manufacturing operations and CGMP activities may have been delayed, reduced, or otherwise modified  as described in the guidance for industry “ Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.”  The absenteeism guidance provides recommendations for manufacturers of specified drugs in managing quality assurance during a period of high absenteeism due to a pandemic and describes high-level considerations for resuming normal operations. This temporary guidance, however, provides more detailed considerations and is specific to the COVID-19 public health emergency. If a manufacturer departed from established CGMP activities, the manufacturer should identify these deviations and any necessary remediation actions. The manufacturer should evaluate these actions as part of their risk management approach. The results of the evaluation will help the manufacturer prioritize resumption activities. High priority should be given to drugs and biological products that are in shortage or vulnerable to shortage. FDA recognizes that in some cases, remediation activities that a manufacturer started during the public health emergency may not be completed until after the public health emergency ends. In such cases, the manufacturer should continue to follow the recommendations in this guidance after the public health emergency ends.