FDA Releases Guidance on COVID-19 CGMP Considerations for Drug Manufacturers

Drug manufacturers have responded to the COVID-19 pandemic by adopting critical measures to ensure continuity in their operations—continuity that is vital to safeguarding the global drug supply. In doing so, they have faced unprecedented challenges with regard to ensuring the health of their employees, preventing COVID-19 transmission at their facilities, and mitigating associated risks to product safety and quality. In light of these challenges, the U.S. Food and Drug Administration (FDA) released a guidance document on June 19, 2020, to advise manufacturers of human and animal drug and biological products on how to manage the unique risks associated with COVID-19 infection in employees.