SK bioscience said on the 9th that it passed the World Health Organization (WHO) good manufacturing practice (GMP) regular inspection through a document review without an on-site audit.
The review covered the influenza vaccines "Skycellflu" and "Skycellflu Quadrivalent," the varicella vaccine "Skyvaricella," and the typhoid vaccine "Skytyphoid," which have WHO prequalification (PQ) certification. WHO conducts a GMP regular inspection of these vaccines every three years.
Usually, a WHO GMP inspection is conducted as an on-site audit that visits the manufacturing facility to verify the manufacturing and quality management systems.
This document review is also a case where the regulatory reliance policy was applied after the Ministery of Food and Drug Safety was designated as a WHO listed authority (WLA). WHO recognizes the regulatory capacity of countries designated as WLAs and uses the Ministery of Food and Drug Safety's GMP oversight results and evaluation materials, replacing on-site audits with document reviews in some procedures.
Lee Sang-yoon, SK bioscience's plant manager, said, "The completion of this WHO GMP document review is a result that internationally recognizes the GMP operational capability and quality system of the Andong L HOUSE," and added, "We will continue to advance a quality management system that meets global standards."
Andong L HOUSE obtained European Union (EU) GMP certification in 2021 and has passed GMP verifications by global regulatory authorities and international organizations. Recently, it also signed a supply contract with an international organization for its in-house developed influenza vaccine "Skycellflu."