An exterior view of SK Bioscience's Andong L HOUSE facility. [SK Bioscience]
An exterior view of SK Bioscience's Andong L HOUSE facility. [SK Bioscience]

SK Bioscience has passed a World Health Organization (WHO) Good Manufacturing Practice (GMP) periodic inspection through document review alone — without an on-site audit — demonstrating its manufacturing and quality management capabilities at a global level.

SK Bioscience announced Thursday that it had completed the triennial WHO GMP periodic inspection via document review for three WHO Prequalification (PQ)-certified vaccines: the influenza vaccines Skycelflu and Skycelflu Quadrivalent, the varicella vaccine Skyvaricella, and the typhoid vaccine Skytyphoid.

WHO GMP inspections are typically conducted as on-site audits, with inspectors visiting production facilities directly to verify manufacturing and quality management systems. However, the Andong L HOUSE factory — where the vaccines are produced — completed the review process through document submission alone, reflecting the high level of confidence WHO has in the facility's operations and quality management framework.

The successful document-only review reflects both SK Bioscience's GMP operational capabilities and the elevated international standing of South Korea's pharmaceutical regulatory system, following the Ministry of Food and Drug Safety's designation as a WHO Listed Authority (WLA). Under WHO's Regulatory Reliance policy, which recognizes the regulatory competence of WLA-designated countries, WHO substituted the on-site audit with a document review by drawing on the ministry's GMP oversight results and assessment materials. The ministry also provided support to ensure the documents WHO requested were submitted smoothly.

SK Bioscience's Andong L HOUSE has a strong track record with major global regulators and international bodies, having obtained EU GMP certification in 2021, among other successful inspections. More recently, the company signed an international supply contract for Skycelflu, its proprietary influenza vaccine, further expanding confidence in its quality and supply capabilities in global markets.

"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 systems," said Lee Sang-yun, factory manager at SK Bioscience. "We will continue to advance our quality management framework to meet the highest global standards."


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