FDA Publishes Guidance on CGMP Requirements During COVID-19

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The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

FDA published guidance on June 19, 2020 detailing the agency’s recommendations for current good manufacturing practices (CGMP) requirements for addressing COVID-19 infection in employees engaging in drug manufacturing. The guidance was issued to help mitigate and prevent effects on drug safety and quality by employees confirmed to be either infected with COVID-19 or potentially exposed to someone with COVID-19.

“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,” FDA stated in a press release. Some of the recommendations presented in the guidance document to prevent contamination of drugs from COVID-19-infected employees include cleaning and sanitizing nonproduction areas more frequently; updating cleaning and sanitizing procedures for production areas; expanding existing procedures to include gloves, face masks, and/or gowning if not already in place; and restricting employee access to manufacturing areas.

The US Department of Homeland Security has stated that drug manufacturing workers are considered essential critical infrastructure, according to the guidance document, and manufacturers should follow Centers for Disease Control guidance regarding when COVID-19 exposed, or potentially exposed workers, can return to work.


The guidance also includes information about maintaining the supply during the COVID-19 pandemic.

Source: FDA