Excerpt taken from BioPharm International October 2020 Regulatory Sourcebook article titled: GMPs Guide COVID-19 Vaccine Manufacturing.
“The FDA Guidance highlights the pertinent CGMP [current good manufacturing practice] considerations for all vaccine manufacturing and serves as a reminder of statutory GMP expectations for COVID-19 vaccines specifically,” says Karolyn Gale, senior director, regulatory affairs, Emergent BioSolutions."
View the full article here.