The 1st Vaccine Plant in Korea to Win EU-GMP Certificate
SK Bioscience announced on May 17 that its facilities, processes, and quality systems in Andong, Korea used for the production of AstraZeneca and Novabax COVID-19 vaccines have received EU-Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA).
This marked the first time that vaccine manufacturing facilities in Korea have obtained EU-GMP certification.
The GMP system describes the minimum standard that a pharmaceutical company must meet in their entire production processes ranging from purchasing raw materials to manufacturing, quality control, and shipping. EU-GMP certification is considered the most stringent in the world along with the U.S. Current GMP (CGMP) system.
The EU-GMP certification will facilitate the entry of the COVID-19 vaccines produced by SK Bioscience into the European market. The company will start preparing for cGMP certification by the U.S. Food and Drug Administration (FDA) in the future.