The U.S. Food and Drug Administration (FDA) conducted a Good Manufacturing Practice (GMP) inspection of Zhejiang Beide Pharmaceutical Co., Ltd. from September 23 to September 26, 2024. The product covered in this inspection was clarithromycin. The FDA has determined that the inspection classification for the facility is "No Action Indicated (NAI)", which confirms that the facility is in an acceptable state of compliance with current Good Manufacturing Practices (cGMP).

The scope of this inspection covered relevant systems including quality, production, facilities and equipment, materials, and laboratory controls. The inspectors affirmed the on-site production environment of Zhejiang Beide Pharmaceutical Co., Ltd. and highly praised the effective operation of its quality system. Ultimately, the company passed the on-site inspection with zero observations (no FDA Form 483 issued).

This GMP inspection marks the second time that Zhejiang Beide Pharmaceutical Co., Ltd. has passed an FDA on-site inspection, following the first one in 2017. It signifies that the company has gained recognition from an international authoritative body for its high-standard manufacturing practices, proves that the company possesses a quality system compliant with international standards, and affirms the effective operation of its quality management system. In the future, Zhejiang Beide Pharmaceutical Co., Ltd. will continue to strive for higher quality standards, make unremitting efforts to explore the international market, and commit to providing more and better pharmaceutical options for patients worldwide.

Hippocrates's Quality Compliance Management System (QMS) Provides Strong Support for Beide Pharmaceutical

To enhance its GMP quality compliance management level and ensure product quality and safety, Zhejiang Beide Pharmaceutical Co., Ltd. chose to implement Singdi's Quality Compliance Management System (QMS). This system has helped Beide Pharmaceutical establish a comprehensive quality management framework, ensuring that the entire process of pharmaceuticals—from the initiation of research and development (R&D) to the execution of production—strictly complies with regulatory standards.

Through the implementation of the QMS project, Beide Pharmaceutical has successfully built a complete quality management system, enabling efficient sharing and real-time transmission of quality documents, related records, and reports. The system has significantly streamlined approval and release processes, effectively improving the enterprise's quality management efficiency in pharmaceutical production. Meanwhile, Hippocrates's digital platform "OwlTrust" has injected strong technological impetus into Beide Pharmaceutical, ensuring the real-time performance, accuracy, and reliability of data. By leveraging online monitoring and real-time early warning functions, it has further strengthened the online control of pharmaceutical quality.

Hippocrates 's QMS solution has provided solid assurance for Beide Pharmaceutical's products to successfully pass the FDA audit. From R&D to production, and from quality control to market access, Hippocrates's professional technology and services run through the entire process, safeguarding the pharmaceutical quality of Beide Pharmaceutical.