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

On 19 June 2020 the FDA announced the availability of the final guidance for industry.

FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding:

  • Manufacturing controls to prevent contamination of drugs
  • Risk assessment of SARS-CoV-2 as it relates to drug safety or quality
  • Continuity of manufacturing operations
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