Hongjitang Pharmaceutical is a major domestic manufacturer of diosmectite, possessing a leading-edge diosmectite production base. Hongjitang’s diosmectite are exported to numerous countries worldwide, including South Korea, Germany, the Netherlands, Brazil, and Russia.
Recently, the diosmectite workshop of Shandong Hongjitang Pharmaceutical Group Co., Ltd. underwent a three-day comprehensive on-site audit by officials from the Korean Food and Drug Administration. The successful completion of this audit with zero defects signifies that Hongjitang Pharmaceutical’s quality management system and production standards have gained recognition from major international drug regulatory agencies, laying a solid foundation for Hongjitang’s continued expansion in the international market, particularly in the high-end market.
The audit team was highly authoritative, comprised of Ms. Kam Hyunhee and Ms. Park Jeehye, auditors from MFDS Korea, and Mr. Keum Dosoo, Product Development Director, and Ms. Kang Mi Hyun, Senior QA Manager, from partner Daewon Pharmaceutical Korea. Based on international Good Manufacturing Practice (GMP) standards, the auditors conducted a thorough and comprehensive assessment of Hongjitang’s diosmectite API production quality management system, covering the entire process from material receiving to product release.
Jiang Hongsheng, Chairman and President of Hongjitang Pharmaceutical Group, received and attended the first meeting, warmly welcoming the auditors. He emphasized, “Meeting the highest global quality standards is our eternal commitment to our clients. We view every audit as a valuable opportunity to improve ourselves and are committed to providing our global clients with the safest and most reliable pharmaceutical raw materials.”
Liu Cejia, Vice President and Quality Manager of Hongjitang Pharmaceutical, who led the entire inspection process, stated, “This audit was a major test of our daily quality management. The team’s thorough preparation and strict adherence to SOPs (Standard Operating Procedures) gave us the confidence to handle it with ease. We will quickly incorporate the valuable suggestions from the auditors into our continuous improvement plan.” After three days of rigorous and efficient inspection, the Korean auditors announced at the closing meeting that the audit had concluded successfully with zero defects, and highly praised Hongjitang Pharmaceutical’s high-standard production environment, advanced quality control system, and the high level of professionalism of its employees.
This audit by the Korean MFDS is not only strong proof of Hongjitang Pharmaceutical’s quality strength, but also a significant milestone in the company’s internationalization strategy. In the future, Hongjitang Pharmaceutical will continue to uphold its motto of “Though the processing is complex, we dare not reduce manpower; though the ingredients are expensive, we dare not reduce the quality,” striving to produce the most cost-effective innovative, effective, safe, and reliable medicines, actively participating in international competition, and showcasing the superior quality of “Made in China” to the world.


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