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Zhifei Longcom Passes EU QP Audit, An Acceleration in Zhifei’s International Strategic Layout

Release time:2022-11-09  |  Click rate:

On November 8, 2022, the Recombinant COVID-19 Vaccine (CHO Cell) and the Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell) of Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zhifei Longcom"), the wholly-owned subsidiary of Chongqing Zhifei Biological Products Co., Ltd. (hereinafter referred to as "Zhifei"), obtained the GMP Compliance Statement issued by the European Union (EU) Qualified Person (QP).

From September 26 to 29, 2022, the EU QP conducted a comprehensive and systematic review on the bulk, preparation production line and quality management system of the Recombinant COVID-19 Vaccine (CHO Cell) and the Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell), resulting in the QP Audit Report and the GMP Compliance Statement.

Passing the EU QP audit indicates that the production facility and quality management system of the Recombinant COVID-19 Vaccine (CHO Cell) and the Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell) are in line with EU GMP Guidelines and US cGMP Regulations. Meanwhile, it marks that Zhifei’s international strategic layout has reached a new level.

As the wholly-owned subsidiary of Zhifei, Zhifei Longcom adheres to the development mode of "innovation and sharing" and the development concept of sustainability, actively exploring the international market, striving to build the "Zhifei" path and establish the "Zhifei" brand, to contribute more "Zhifei" strength to the popularization of high-quality innovative vaccines worldwide.