GC Green Cross Replaces WHO GMP On-site Inspection with Document-Based Review... First in Korea

GC Green Cross Undergoes First-Ever Document-Based WHO GMP Review
Streamlined Procedures Reflect Enhanced International Standing of Korean Regulators
Expected to Boost Global Trust in "Made in Korea" Pharmaceuticals

GCGreen Cross announced on September 1 that the regular on-site GMP (Good Manufacturing Practice) inspection, which is conducted every three years for WHO PQ (Prequalification·Quality Certification) products, has been replaced with a document-based review.

GC Green Cross Headquarters view. GC Green Cross

This is the first time a Korean pharmaceutical company has undergone a WHO GMP inspection through a document-based process.

Through this document-based review, GC Green Cross will undergo GMP compliance verification for its influenza vaccine "GC Flu" and varicella vaccine "Varicella." The company explained that it has thoroughly prepared all necessary materials for the review, and therefore expects to pass smoothly.

This streamlining of procedures is attributed to the enhanced international standing of Korean regulatory authorities.

The Ministry of Food and Drug Safety joined the PIC/S (Pharmaceutical Inspection Co-operation Scheme) in 2014, becoming part of the international GMP consortium. In 2023, it was listed as a WHO Listed Authority (WLA), a standard list of pharmaceutical regulatory agencies designated by the WHO. This year, it became the first in the world to be recognized for full functionality in both pharmaceuticals and vaccines under the WLA, officially acknowledging its capabilities at the level of advanced regulatory countries. As a result, Korean companies are now able to benefit from document-based inspections.

GC Green Cross emphasized that this change will bring practical benefits such as saving time and costs, while also enhancing the global credibility and brand value of "Made in Korea" pharmaceuticals.

Lee Jaewoo, Head of Development at GC Green Cross, stated, "This document-based review reflects both the expansion of GC Green Cross's WHO PQ-certified products and the strengthened international standing of the Ministry of Food and Drug Safety. It will serve as a positive precedent for other Korean companies in the future."