BioKangtai passed the EU QP audit quality management system and reached the EU GMP standard

2022-05-08

On May 6, 2022, Shenzhen Kangtai Biological Products Co., Ltd.'s adenovirus-vectored COVID-19 vaccine production base in Shenzhen obtained a Declaration of Conformity issued by an EU Quality Authorized Person (QP).


The EU QP audit is mainly carried out on the public system, production management system, QA system, warehousing and logistics system, product process verification and cleaning verification of Kangtai Bio's vaccine production line, and finally a QP audit report is formed to ensure that the relevant requirements meet EU standards. And issue a statement of QP qualification.


This indicates that Kangtai Bio's production base and quality management system of the adenovirus vector new crown vaccine have reached the EU GMP standard, which can ensure the high-quality development and commercial production of the vaccine. This is also an important achievement of the company's internationalization strategy, which will help to further open up overseas markets in the future and facilitate the global distribution of more vaccine products.