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# Guidance on Resuming Normal Drug/Biologic Manufacturing
- URL: https://www.fdaweb.com/guidance-on-resuming-normal-drug-biologic-manufacturing/
- Published: 2020-09-11T12:00:00.000Z
- Updated: 2026-09-14T16:28:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147632

FDA has issued a temporary guidance entitled [*Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MTEuMjY5NzE3OTEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGlhLzE0MjA1MS9kb3dubG9hZD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.AIjuiUG378TPbVwa4Yu6Jo4UrdZ4Cv%5FpXPIASWt50L4/s/1255931999/br/84235741330-l?ref=fdaweb.com) to help drug/biologic product manufacturers to “transition from operations impacted by the Covid-19 public health emergency to normal manufacturing operations.” The document provides recommendations on prioritizing products as normal manufacturing operations resume and to “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,” the agency says.

The guidance, FDA explains, addresses “unusual challenges, such as employee illness and absenteeism, travel restrictions, site closures, and supply chain disruptions” that have occurred during the pandemic and impacted GMP responsibilities. “If a manufacturer departed from established CGMP activities, the manufacturer should identify these deviations and any necessary remediation actions,” it says. Product manufacturers should evaluate these actions as part of their risk management activities, it says, adding that the results of the evaluation will help prioritize resumption activities. Drug and biological products that are in shortage or vulnerable to shortage are a high priority, according to the guidance.

FDA also says it “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.”