SK Bioscience has successfully completed a written review of its four vaccines under the World Health Organization's (WHO) Prequalification (PQ) certification for Good Manufacturing Practices (GMP). The assessment, conducted without an on-site inspection, acknowledges the manufacturing and quality control capabilities of its facility in Andong.
On July 9, SK Bioscience announced that the written GMP review for its WHO PQ-certified vaccines has been finalized.
The vaccines under review include the Skycellflu and Skycellflu4 influenza vaccines, the Skyvaricella varicella vaccine, and the Skytifo typhoid vaccine. WHO GMP reviews are conducted every three years and typically involve direct visits to production facilities to assess manufacturing and quality control systems.
SK Bioscience stated, "The fact that WHO confirmed GMP compliance without an on-site visit demonstrates a high level of trust in our Andong facility." The company noted that the written alternative review is also related to the designation of the Ministry of Food and Drug Safety as a WHO-recognized regulatory authority.
The Andong facility, known as L HOUSE, received EU GMP certification in 2021 and has passed GMP verification from various domestic and international regulatory bodies.
Additionally, SK Bioscience is collaborating with the Gates Foundation to develop an artificial intelligence (AI)-based vaccine development platform, which is expected to reduce uncertainties in the vaccine development process and enable more scientific and efficient decision-making.
* This article has been translated by AI.
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