Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing | FDA

Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing | FDA







Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Manufacturing

FDA issued a guidance entitled, “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Manufacturing,” that provides recommendations to pharmaceutical manufacturers, including outsourcing facilities, concerning current good manufacturing practice (CGMP) requirements and expectations to prevent contamination of drugs and exclude sick workers from directly engaging in drug manufacturing. As with any potential new risk, FDA expects pharmaceutical manufacturers to evaluate whether SARS-CoV-2 poses contamination risks under existing manufacturing controls that prevent drug contamination and whether the virus adversely impacts drug safety or quality should contamination occur. The guidance also advises pharmaceutical manufacturers that the U.S. Department of Homeland Security has deemed drug manufacturing workers as essential critical infrastructure workers during the COVID-19 public health emergency.  Pharmaceutical manufacturers are directed to CDC guidance regarding when employees may continue working following exposure or potential exposure to COVID-19, as well as procedures to minimize exposure and transmission in the workplace.

Drug manufacturers should review the CGMP requirements and recommendations regarding restriction of sick employees from production areas, as well as assess the risk of this new coronavirus to their specific drugs, facility, processes and manufacturing controls. The recommendations in the guidance will help prevent or mitigate negative effects on the safety and quality of drugs manufactured by any employee who has confirmed infection of COVID-19, symptoms of COVID-19 or has been exposed or potentially exposed to an infected person. This guidance provides additional recommendations regarding maintaining the drug supply during the COVID-19 public health emergency.