SK Bioscience Passes WHO GMP Regular Inspection Through Document-Based Review

SK Bioscience has passed the regular Good Manufacturing Practice (GMP) inspection for three World Health Organization (WHO) prequalified vaccines through a document-based review, without an on-site inspection.

SK Bioscience Andong L HOUSE exterior view. SK Bioscience

On July 9, SK Bioscience announced that it had completed the triennial WHO GMP inspection for its three vaccines—Skycellflu and Skycellflu Quadrivalent (influenza vaccines), Skyvaricella (varicella vaccine), and SkytTyphoid (typhoid vaccine)—using only a document-based review process.

Normally, a WHO GMP inspection involves an on-site visit to production facilities to assess manufacturing and quality management systems. However, for this round, the inspection of the Andong L HOUSE, where the vaccines are produced, was completed solely through the review of submitted documentation.

This document-based review is related to the increased international trust in Korea's pharmaceutical regulatory system, following the designation of the Ministry of Food and Drug Safety as a WHO Listed Authority (WLA). The WHO operates a 'regulatory reliance' policy, which recognizes the regulatory capabilities of WLA-designated countries. As a result, certain procedures, such as GMP inspections, may be substituted with document reviews based on the outcomes and evaluation materials from the Ministry of Food and Drug Safety.

During this process, the Ministry of Food and Drug Safety supported the submission of materials requested by the WHO. This allowed SK Bioscience to streamline the preparation time and workforce required compared to an on-site inspection, while still successfully obtaining a GMP compliance determination that meets international standards.

SK Bioscience has consistently received recognition for its manufacturing and quality management capabilities from major global regulatory agencies. The Andong L HOUSE obtained EU-GMP certification in 2021 and has successfully passed GMP verifications from numerous global regulatory bodies and international organizations. Additionally, the company recently secured a supply contract with an international organization for its independently developed influenza vaccine, Skycellflu.

Lee Sangyoon, Plant Manager at SK Bioscience, stated, "The completion of the WHO GMP document-based review is a testament to the GMP operation capabilities and quality systems at Andong L HOUSE being recognized internationally," adding, "We will continue to further enhance our quality management systems to meet global standards."

This content was produced with the assistance of AI translation services.