EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
The European Medicines Agency (EMA) announced on June 11, 2021 that its committee for human medicines (CHMP) has approved Recipharm’s Monts, France facility for the production of Moderna COVID-19 vaccine finished product. Several other sites were given a positive opinion by CHMP for batch control/testing.
The new site follows two other sites approved by CHMP in June for the manufacture of API and finished product intermediates in the United States. “Together, these changes are expected to allow the production of an additional one to two million vials of ready-to-use vaccine for the European Union market every month. This will increase the supply of the vaccine in the European Union,” the agency stated in a press release.
Source: EMA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
