GC Biopharma clears WHO vaccine audit without site visit

(GC Biopharma)

GC Biopharma said Tuesday it became the first South Korean pharmaceutical company to pass a regular World Health Organization vaccine manufacturing audit through a document-only assessment without an on-site inspection.

The company said the WHO approved Good Manufacturing Practice (GMP) compliance for its influenza vaccine GC Flu and varicella vaccine Barycela, both of which already hold WHO prequalification status.

GC Biopharma applied for the audit in September last year and completed the process through document submissions and written evaluations without hosting in-person inspections by WHO officials.

The approval is being viewed as an early example of how South Korea’s upgraded regulatory standing is helping simplify global pharmaceutical certification procedures.

Last year, South Korea’s Ministry of Food and Drug Safety secured full listing status in the WHO’s Listed Authorities framework for pharmaceuticals and vaccines, a designation recognizing advanced regulatory capabilities.

Industry officials expect the stronger credibility of South Korea’s regulatory system to support overseas approvals and international procurement opportunities for WHO prequalified products in the future.

GC Biopharma said the desk assessment reduced audit-related costs by more than half compared with conventional on-site inspections. The company also expects lower administrative burdens tied to scheduling and preparing for visits by overseas inspection teams.

“The result reflects recognition of both our quality management system and the regulatory capabilities of South Korea’s drug authority,” said Lee Jae-woo, head of development at GC Biopharma. “We will continue operating a quality system aligned with global standards.”