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Jiudian Hongyang's API Benidipine successfully passed drug registration on-site
Release time:
2025-01-22 00:00
Source:
From January 14 to 17, Jiudian Hongyang welcomed the on-site inspection for the registration of the API benidipine hydrochloride. The inspectors fully affirmed Jiudian Hongyang's production quality management and Jiudian Research Institute's research quality, announcing that the inspection was successfully passed.
During the on-site inspection, the provincial bureau inspectors strictly adhered to the "Good Manufacturing Practice for Pharmaceuticals" (revised in 2010) and other laws and regulations to conduct a comprehensive inspection of Jiudian Hongyang's production management, quality management, material management, plant facilities, and equipment management. The focus was on the inspection of the production workshop, storage and inspection instruments, with special attention paid to the co-production and risk control of the products, deviations, and the transfer of products, materials and methods between Jiudian Hongyang and Jiudian Pharmaceutical Research Institute.
The registration site inspection of the API benidipine hydrochloride is the third API registration site inspection accepted by Jiudian Pharmaceutical Research Institute since 2019. Each inspection is regarded as a learning opportunity to improve the quality of research and development. In the future, Jiudian Hongyang and Jiudian Pharmaceutical Research Institute will continue to strictly control the quality of API research and development, and make improvements based on the issues raised by the inspectors, so as to learn from each other and draw inferences from one example, and continuously improve the R&D and production quality management system and concept, and contribute to the sustainable and healthy development of the pharmaceutical industry.
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