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Jiudian successfully passed the on-site inspection for drug registration
Release time:
2025-02-24 00:00
Source:
From February 17 to 21, the expert group of the Greater Bay Area Center for Drug Review and Inspection of the NMPA visited the Jiudian Production Center to conduct on-site inspections of drug registration. After a comprehensive review, the company's R&D system and production quality management system were highly recognized by the inspection team.Two products, Simethicone Emulsion and Pentoxifylline Sustained-Release Tablets, successfully passed the inspection.
During the inspection, the inspectors of the Greater Bay Area Center strictly followed the "Good Manufacturing Practice for Pharmaceuticals" (revised in 2010) and other laws and regulations, and adopted the method of cross-conducting on-site inspections and document reviews to conduct a comprehensive GMP compliance inspection on the Simethicone Emulsion produced by a company in Zhuhai and the Pentoxifylline Sustained-Release Tablets produced by a company in Guangzhou.
The key inspection contents included process consistency, facilities and equipment, materials and products, material management, production management, validation and verification management, quality control, etc. The professional and efficient response performance of each inspected department was well received by the inspection team,.Both parties engaged in in-depth exchanges on professional and technical issues such as process, production, and inspection.
Jiudian Production Center will use this inspection as an opportunity to further enhance the company's CMO management level and lay a solid foundation for the company's sustainable and healthy development.