QYUNS-B (02509): Subsidiary Successfully Passes EU Qualified Person Audit for Manufacturing Base

Stock News

Oct 10

QYUNS-B (02509) announced that its subsidiary, Jiangsu Saifusi Biotechnology Co., Ltd. ("Saifusi"), has successfully passed the European Union Qualified Person (QP) audit and officially received a compliance audit report issued by the QP. The successful completion of this QP audit signifies that the Group's industrialization base quality management system and production capabilities have met EU GMP standards.

The audit was conducted by a senior QP in accordance with EudraLex Volume 4 (EU pharmaceutical GMP regulations) and related guidelines. The audit team conducted a comprehensive 3-day review of Saifusi and gave full recognition to the company's high-standard quality management system, advanced facilities and equipment, and professional technical team. The audit confirmed that both the software and hardware management of the production base comply with EU GMP requirements.

Companies that pass QP inspection will receive a compliance statement issued by the QP, which serves as strong evidence that the enterprise meets international GMP requirements and is a prerequisite for products to enter the EU market. Obtaining QP certification represents an important milestone in the Group's overseas expansion strategy, laying a solid foundation for the company's future innovative product overseas expansion and global strategic layout.

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