Tuesday, April 20, 2021

Good Manufacturing Practice (GMP) Considerations for Responding to COVID-19 Infection in Employees in Drug & Biological Products Manufacturing



 In June 2020, FDA released Guidance for Industry (GFI) entitled “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing”. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding:

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Drug Metabolite Impurities, Pathways & Analytical Techniques

  Metabolites   are the intermediate products of metabolic reactions catalyzed by various enzymes that naturally occur within cells. The ter...