Recently, the commercial manufacturing base of Guangzhou Canton Biologics Technology Co., Ltd. in Foshan successfully passed a rigorous on‑site audit by a European Union Qualified Person (EU QP) and obtained the QP Declaration (QPD) certification. This marks that the quality management system of Canton Biologics’ commercial manufacturing has met EU GMP requirements.

As an internationally leading biologics CDMO company, Canton Biologics has quality and technical experts with international backgrounds. Its quality team has deep experience in the biologics industry, is familiar with GMP and regulatory filing requirements in various countries, and has dozens of successful IND and BLA filing experiences both domestically and internationally. Canton Biologics has established a comprehensive GMP management system, including the operation and maintenance of plant and equipment, personnel training, production and quality assurance operations, and the testing and release of materials and products, to ensure product quality and compliance.

The QPD certification for the Foshan site is a milestone in Canton Biologics’ development, signifying that the company can now provide EU GMP‑compliant, high‑quality large‑molecule CDMO manufacturing services to clients in the European Union and around the world.

The on‑site audit was conducted by Edward Balbirni, an experienced Irish QP with over 30 years of experience in biopharmaceutical manufacturing. The audit evaluated systems including quality assurance, quality control, production management, material management, and facility and equipment management against international standards such as EU GMP and ICH. The audit lasted three days and concluded that the Foshan site met the requirements of EU GMP regulations, possesses CMC services and commercial manufacturing capabilities aligned with EU standards, and is capable of providing high‑quality large‑molecule commercial manufacturing services to clients in the EU and globally.

This success would not have been possible without the foresight, correct decisions, and strong support of the company’s senior management in the early stages of establishing the Foshan site, as well as the tireless, around‑the‑clock efforts of all employees. It is through their collaborative hard work and selfless dedication that this important corporate milestone has been achieved.

Looking ahead, Canton Biologics will continue to uphold its philosophy of “Reliable, Efficient, Innovative,” earnestly implement its quality policy of “Driven by technology, sustained by quality, winning the market through service,” and strive to become a high‑quality, high‑efficiency global CDMO enterprise, providing fast and efficient services to clients worldwide.