ABSTRACT

Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry   [open pdf - 117KB]

From the Introduction: "FDA [U.S. Food and Drug Administration] plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: [1] Manufacturing controls to prevent contamination of drugs; [2] Risk assessment of SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] as it relates to drug safety or quality; [3] Continuity of manufacturing operations."

Publisher:
Date:
2020-06
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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