BioPharm Intl Regulatory Sourcebook: GMPs Guide COVID-19 Vaccine Manufacturing

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.

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