Over the past two years, several pharmaceutical firms have received Emergency Use Authorization (EUA) for COVID vaccines and therapeutic products. Although the EUAs can be dry reading with a lot of boilerplate type text, in some instances, these documents and other memoranda provide insight into FDA’s ongoing decision-making process balancing the public health needs with the use of drug substances and associated products which may not fully comply with FDA GMP requirements. No easy answers are to be found here, but FDA seems to be making its best attempts at a balance of risk versus benefits. 

An interesting takeaway from the inspections described in this article is that the inspections do not identify novel practices and novel interpretations of GMP requirements. FDA simply identifies shortcomings in areas and practices that have long been cited in GMP inspections. Somehow, we in industry just cannot get some of these operations “right.” The GAO also recently issued a report that addressed the FDA’s limited inspection practices for the three vaccines subject to EUAs in 2021.

The inspections we will address here are those of:

  • Emergent BioSolutions in Maryland, who manufactured the vaccine drug substance for both Johnson & Johnson (J&J) and AstraZeneca,
  • Eli Lilly facilities in New Jersey and Indianapolis where drug product and drug substance for COVID therapeutic antibody treatments respectively are manufactured, and
  • FUJIFILM who manufactures the Novavax vaccine drug substance

Continue Reading

Read the rest of this exclusive FREE in-depth analysis by GMP Consultant Barbara W. Unger who draws from Redica’s actionable intelligence.

COVID 483s banner