SK Bioscience passed a routine World Health Organization (WHO) Good Manufacturing Practice (GMP) review through a document-based assessment alone, without an on-site inspection. The outcome is seen as reflecting international trust in the manufacturing and quality-control capabilities of its Andong vaccine plant "L HOUSE" and in Korea's pharmaceutical regulatory system.
SK Bioscience said on the 9th that it completed the routine WHO GMP review through a document-based assessment for its flu vaccines "SKYCellflu" and "SKYCellflu Quadrivalent," its chickenpox vaccine "SKYVaricella," and its typhoid vaccine "SKYTyphoid," all of which have received WHO Prequalification (PQ) certification.
The WHO typically visits production facilities in person every three years to inspect manufacturing and quality-control systems. In this review, however, it recognized GMP compliance based solely on a review of documents submitted by L HOUSE. SK Bioscience explained that this confirmed trust in L HOUSE's production facility operations and quality system.
The Ministry of Food and Drug Safety's designation as a WHO Listed Authority (WLA) also influenced this document-based review. The WHO operates a "regulatory reliance" policy that uses GMP assessment results conducted by regulatory agencies in WLA countries to replace some on-site inspections with document-based reviews. The ministry supported the submission of materials requested by the WHO during this review process.
L HOUSE obtained European Union Good Manufacturing Practice (EU-GMP) certification in 2021, and has since passed quality verification by numerous global regulatory agencies and international organizations. Recently, it signed a contract to supply its in-house-developed flu vaccine SKYCellflu to an international organization, expanding its global supply.
"The completion of this document-based review is a result of L HOUSE's GMP operating capabilities and quality system being recognized internationally," said Lee Sang-yoon, plant manager at SK Bioscience. "We will continue to advance a quality-control system that meets global standards."
