Boryeong and Yesan Plants Obtain EU-GMP Certification for Anticancer Injection Production Facilities

[Asia Economy Reporter Myung-hwan Lee] On the 6th, Boryung announced that it has obtained EU-GMP (European Union Good Manufacturing Practice) certification for its anticancer injection production facility at the Yesan plant.

GMP (Good Manufacturing Practice) is a system that sets management standards required for all production processes in a factory, from raw material procurement to manufacturing, quality control, and shipment, to manufacture pharmaceuticals. Among them, EU-GMP, approved by the European Medicines Agency (EMA), is classified as one of the highest-level certifications in the world along with the US Food and Drug Administration (FDA)'s cGMP.

This certification was conducted after an inspection by the pharmaceutical licensing authority of the Hamburg state government in Germany. A four-day on-site audit was also conducted from September 28 to October 1 last year to determine compliance with the certification requirements.

With this certification, Boryung has established an environment to promote the export of anticancer drugs and CDMO business not only to Europe but also overseas markets in general.

The cytotoxic anticancer injection production facility within the Boryung Yesan campus, completed in 2019, can produce at least 6 million vials annually. It is equipped with the latest 'isolator system' in most manufacturing process stages, enabling the safe production of highly pharmacologically active pharmaceuticals.

Domestically, after receiving GMP approval from the Ministry of Food and Drug Safety in November 2020, anticancer injection production began in earnest starting at the end of December of the same year with the production of 'Belkinju' (generic name Bortezomib), a treatment for multiple myeloma.

Kyung-sook Park, Head of Production Quality Division at Boryung, stated, "Through this EU-GMP certification, Boryung's manufacturing competitiveness has been recognized as world-class," and added, "We will do our best to make the Yesan campus a springboard for Boryung's global expansion through continuous efforts in manufacturing and quality control."