[Edaily Reporter Kim Seung-kwon ] SK BIOSCIENCE(302440)has demonstrated its global-level manufacturing and quality control capabilities by passing the World Health Organization’s (WHO) GMP (Good Manufacturing Practice) periodic inspection through a written review alone, without an on-site audit.

SK BIOSCIENCE announced on the 9th that it had completed the WHO’s regular GMP inspection—conducted every three years—via a written review for its WHO Prequalification (PQ)-certified vaccines: △ the influenza vaccines SkyCellFlu and SkyCellFlu4, △ the varicella vaccine SkyVaricella, and △ the typhoid vaccine SkyTyphoid.

Typically, WHO GMP inspections are conducted through on-site audits, where inspectors visit production facilities to verify manufacturing and quality control systems. However, for the Andong L HOUSE plant—the manufacturing site for these vaccines—the review process was completed solely through a review of submitted documents. The fact that the WHO confirmed GMP compliance without an on-site visit demonstrates a high level of confidence in the production facility operations and quality control systems at Andong L HOUSE.

This document-based review is linked not only to SK BIOSCIENCE’s GMP operational capabilities but also to the increased international confidence in South Korea’s pharmaceutical regulatory system following the Ministry of Food and Drug Safety’s designation as a WHO World-Class Regulatory Authority (WLA). The WHO operates a “Regulatory Reliance” policy that places trust in the regulatory capabilities of countries designated as WLAs; accordingly, it replaces on-site inspections with document reviews for certain procedures by utilizing the MFDS’s GMP management results and evaluation data.

During this review process as well, the MFDS provided support to ensure that the data requested by the WHO was submitted smoothly and facilitated the proceedings. As a result, SK BIOSCIENCE was able to optimize the preparation time and personnel required for the on-site inspection while still receiving 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 facility obtained EU-GMP certification in 2021 and has successfully passed GMP audits by numerous global regulatory agencies and international organizations. Furthermore, the company continues to build trust in its quality and supply capabilities in the global market, as evidenced by its recent signing of a supply contract with an international organization for its in-house developed influenza vaccine, “SkyCellFlu.”

Lee Sang-yoon, Plant Manager at SK BIOSCIENCE, stated, “The completion of this WHO GMP document review is a testament to the international recognition of Andong L HOUSE’s GMP operational capabilities and quality system,” adding, “We will continue to enhance our quality management system to meet global standards.”