GC Green Cross Receives Final Approval for WHO GMP Document-Based Inspection

GC Green Cross announced on May 19 that it has received final approval to substitute the regular, on-site GMP inspections—conducted every three years for World Health Organization (WHO) PQ (prequalification) products—with a document-based review process.

GC Green Cross Headquarters. GC Green Cross

After applying for inspection in September last year, GC Green Cross obtained WHO GMP conformity certification for its influenza vaccine "GC Flu" and varicella vaccine "Varicella" through a document-based assessment without an on-site visit. According to the company, this is the first case in Korea where WHO GMP standards were met solely through a document review, resulting in more than 50% cost savings compared to in-person inspections.

This achievement is interpreted as a tangible result of the Ministry of Food and Drug Safety being listed on the WHO list of regulatory authorities for excellence (WLA).

Last year, the Ministry of Food and Drug Safety became the first regulatory authority worldwide to be listed for all functions in the pharmaceuticals and vaccines sector on the WHO WLA, officially recognizing its global standard regulatory capabilities.

As a result, the international procurement process for pharmaceuticals and vaccines can now proceed more efficiently, which is expected to have a positive impact on expanding Korean companies' entry into the global procurement market.

Lee Jaewoo, Head of Development at GC Green Cross, stated, "This approval through a document-based review is a recognition of both GC Green Cross's outstanding quality management and the international regulatory credibility of the Ministry of Food and Drug Safety. We will continue to do our best to ensure a stable supply of vaccines based on quality systems that meet global standards."

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