The company announced that it has completed the WHO´s three-year periodic GMP review for its WHO Prequalification (PQ)-approved vaccines, including the influenza vaccines SKYCellflu and SKYCellflu Quadrivalent, the varicella vaccine SKYVaricella, and the typhoid conjugate vaccine SKYTyphoid, through a documentary assessment. The review was completed on July 9.

WHO GMP inspections are typically conducted through on-site inspections to verify manufacturing operations and quality management systems at production facilities. However, for SK bioscience´s Andong L HOUSE manufacturing facility, the review was completed solely through the evaluation of submitted documentation. WHO´s decision to confirm GMP compliance without an on-site inspection reflects its high level of confidence in the operational management and quality systems of the L HOUSE facility.

The documentary assessment also reflects the enhanced international credibility of Korea´s pharmaceutical regulatory system following the designation of the Ministry of Food and Drug Safety (MFDS) as a WHO Listed Authority (WLA). Under WHO´s Regulatory Reliance policy, WHO recognizes the regulatory capabilities of WLA-designated authorities and may utilize their GMP inspection outcomes and assessment reports to replace certain on-site inspection procedures with documentary reviews.

Throughout the review process, the MFDS supported the timely submission of the requested documentation to WHO and facilitated the overall review procedure. As a result, SK bioscience was able to obtain GMP compliance confirmation in accordance with international standards while significantly improving operational efficiency by reducing the preparation time and resources typically required for an on-site inspection.

SK bioscience has consistently demonstrated its manufacturing and quality management excellence through approvals and inspections by leading global regulatory authorities. The company´s Andong L HOUSE facility obtained EU-GMP certification in 2021 and has successfully passed GMP inspections conducted by multiple international regulatory authorities and global health organizations. Most recently, SK bioscience also secured its first international procurement supply contract for its proprietary influenza vaccine, SKYCellflu, further reinforcing global confidence in the company´s manufacturing quality and supply capabilities.

Sang-yoon Lee, Head of Manufacturing at SK bioscience, said, "The successful completion of this WHO documentary GMP review demonstrates that the GMP operations and quality management systems at our Andong L HOUSE facility meet internationally recognized standards. We will continue to further strengthen our quality systems to ensure they consistently meet and exceed global regulatory expectations."