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Yaohai Bio-Pharma Passed EU QP Audit and Attains ISO Triple Certification
Mar 11,2024

Good news! Yaohai Bio-Pharma has recently passed the on-site audit by the European Union Qualified Person (QP) for the GMP quality system and production site. Additionally, it has cleared the initial certification audits for ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System, securing the "ISO Triple Certification" certificate.

The QP audit referred to EU regulations Eudralex Vol 4, HMR2012, and MHRA Data Integrity Guidelines. It thoroughly inspected Yaohai Bio-Pharma's GMP compliance, including production management, equipment, quality control, and utility systems. The audit confirmed the company's adherence to European GMP standards across production, testing, quality, and utilities.

The ISO audit rigorously assessed Yaohai Bio-Pharma's quality, environmental, and occupational health and safety management systems through on-site checks and document reviews. The successful completion of the audit signifies the company's ongoing enhancement of its management system and integrated services.

Yaohai Bio-Pharma is the first and largest biologics CRDMO focused on microbial expression systems in Greater China. Our comprehensive services, from DNA synthesis to GMP drug manufacturing for various modalities, cater to global needs in biological drugs, vaccines, and diagnostics for both human and veterinary use. The successful EU QP audit and "ISO Triple Certification" showcase our unwavering commitment to quality, efficiency, and compliance. We are dedicated to continuous improvement, customer satisfaction, and providing FDA, EMA, and NMPA compliant services for clinical and commercial drug production.

We are also actively seeking institutional or individual global partners. We offer the most competitive compensation in the industry. If you have any questions, please feel free to contact us:

For more details about Yaohai Bio-Pharma, please kindly refer to:



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