undefined
Jiudian Pharmaceutical successfully passed the official inspection of Hainan and Beijing Food and Drug Administration
Release time:
2025-01-13 15:49
Source:
From January 7 to January 9, Jiudian Pharmaceuticals welcomed two official inspections. The Hainan Provincial Drug Administration dispatched three inspectors to conduct a three-day GMP compliance inspection of Jiudian Production Center. At the same time, the Beijing Municipal Drug Administration also dispatched two inspectors to visit our company for an on-site inspection of the change of production site of clarithromycin granules.
The inspectors of the Hainan Provincial Drug Administration strictly followed the "Good Manufacturing Practice for Pharmaceuticals" (revised in 2010) and other laws and regulations to conduct a comprehensive inspection of the GMP compliance of the commercial production of ibuprofen suspension and ibuprofen suspension drops entrusted by Hainan Star Pharmaceutical Co., Ltd. to our company. The inspection scope includes process consistency, plant and facilities and equipment, materials and products, personnel and training, material management, production management, packaging and labeling management, confirmation and verification management, and quality management system, with special attention paid to the communication and connection mechanism between the trustee and the holder. On the other hand, the inspectors of the Beijing Municipal Drug Administration conducted an on-site inspection of the change of production site of clarithromycin granules commissioned by Beijing Boya United Pharmaceutical Research Institute Co., Ltd. to our company. The inspection focused on product technology transfer, co-production and risk control, and checked the production workshop, storage and inspection conditions.
Before the inspection, Jiudian Production Center conducted multiple rounds of document and on-site self-inspections, and promptly corrected and improved potential problems to ensure that the inspection was in the best condition. All departments also showed a high degree of cooperation during the inspection, which provided a strong guarantee for the smooth progress of the inspection. At the last meeting of the two inspections, the inspectors affirmed Jiudian Pharmaceutical's work in production quality and compliance, and recognized the production work of clarithromycin granules after the transfer of the production site. It was announced that no serious defects and major defects were found during the inspection, and the inspection was successfully passed.
Looking forward to the future, Jiudian Pharmaceutical will seriously absorb the valuable opinions and suggestions put forward by the inspectors, further optimize the document system, and improve the management level. The company will welcome every official inspection with more enthusiasm and a more rigorous attitude, ensure steady progress on the road of continuous compliance, efficiently complete various tasks, and contribute to my country's drug production.
Related news