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The parent company, Kangtai Biological, has passed the EU QP audit, and its quality management system meets EU GMP standards.

Release date:

2022-05-09

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Abstract

On May 6, 2022, the adenovirus‑vector COVID‑19 vaccine production facility of Shenzhen Kangtai Biological Products Co., Ltd., the parent company of Beijing Minhai Biotechnology Co., Ltd., located in Shenzhen, received a Certificate of Conformity issued by the European Union Qualified Person (QP). The EU QP audit focused on various aspects of Kangtai’s vaccine production line, including utility systems, the manufacturing management system, the quality assurance system, the warehousing and logistics system, as well as process and cleaning validation. Following the audit, a QP audit report was prepared to confirm compliance with EU standards, and a declaration of QP qualification was issued. This milestone marks that Kangtai’s adenovirus‑vector COVID‑19 vaccine is now ready for production.

On May 6, 2022, the adenovirus-vector COVID‑19 vaccine production facility of Shenzhen Kangtai Biological Products Co., Ltd., the parent company of Beijing Minhai Biotechnology Co., Ltd., located in Shenzhen, received a Certificate of Conformity issued by an EU Qualified Person (QP).

This EU QP audit focused on Kangtai Biological’s vaccine production line, examining its utility systems, manufacturing management system, QA system, warehousing and logistics system, as well as product process validation and cleaning validation. The audit culminated in the issuance of a QP audit report, confirming compliance with EU standards and providing a formal declaration of QP qualification.

This marks that Kangtai Biological’s adenovirus‑vector COVID‑19 vaccine production facility and quality management system have met EU GMP standards, ensuring the high‑quality development and commercial-scale manufacturing of the vaccine. It also represents a significant milestone in the company’s internationalization strategy, which will help further expand into overseas markets and support the global rollout of additional vaccine products.

Keywords:

Chairman Du Weimin inspected the construction progress of the Kangtai Group Headquarters Building project.

Conduct pre-holiday safety inspections to safeguard and fortify the safety defense line.

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