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# Guide on GMP Considerations Due to Infected Employee
- URL: https://www.fdaweb.com/guide-on-gmp-considerations-due-to-infected-employee/
- Published: 2020-06-19T12:00:00.000Z
- Updated: 2026-09-14T16:18:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147048

FDA has released a [guidance ](https://www.fda.gov/media/139299/download?ref=fdaweb.com)entitled “Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Products Manufacturing.” The document provides recommendations to drug and biological product manufacturers about manufacturing controls to prevent contamination of drugs, Covid-19 risk assessments as it relates to drug safety or quality, and continuity of manufacturing operations. The policy is intended to remain in effect only for the duration of the Covid-19 public health emergency.

FDA says that drug manufacturers should vigilantly monitor employees who perform drug manufacturing functions and have been exposed to others with confirmed or suspected Covid-19 for infection symptoms. Employees who test positive or have Covid-19 symptoms must be excluded from drug manufacturing areas in accordance with applicable GMP requirements. “To ensure compliance with GMP requirements, drug product manufacturers must ensure that employees practice good sanitation and health habits, in accordance with 21 CFR 211.28(b),” it says. “Additionally, FDA recommends that (active pharmaceutical ingredient) manufacturers ensure that employees practice good sanitation and health habits as described in ICH Q7, Section III.B., Personnel Hygiene (3.2).”