August 28 to September 12, 2015. Accompanied by the director of the Municipal Food and Drug Administration Bureau, the provincial expert group and the three companies conducted a nearly half-month on-site inspection of the new products declared by our company: cephalosulfuron sodium and clavulanic acid (clavulanic acid) products. . The on-site verification work lasted for the longest time and the product process created more than any previous verification work.
The clavulanic potassium product has a complex process: mainly by biological fermentation, filtration, ion exchange, analysis, extraction, tert-butylamine clavulanate, and finished potassium clavulanate. Cefotaxime sodium is a sterile freeze-dried bulk drug, which was independently developed by our company. The expert group listened carefully to the report of the small-scale R&D personnel and detailedly reviewed the small-scale production records, and detailed traced the raw and auxiliary materials of fluoxetine sodium. The verification contents include: registration declaration materials, process specifications, inspection records, batch production records, equipment performance confirmation, workshop production site, dissolution, freeze-drying, packaging, product stability, product testing, sample retention and storage.
Yang Linqing, manager of the Quality Research Center, Gao Weixia, manager of the Quality Management Center, Zhu Ruiqing, director of the No. 1 plant, Wang Fengwen, the climatic acid project manager, and Zhao Zuozheng, deputy manager of the plant, accompanied the expert group and submitted the relevant crafts, processes, and inspection reports. And escorted to the scene to view the work.
Since the release of the new version of GMP, all audits and inspections have been stricter than before. The on-site verification review experts pay more attention to the authenticity of the site, the accuracy of the data, the safety of the product and the standardization of the operation. The entire inspection process requires photographing records for each process, and the operation posts and operation locations are marked on the photographs. Special positions, such as electronic platform scales with separate posts, require qualified and officially approved equipment verification materials. In terms of document records, opinions and suggestions on the accuracy and completeness of language descriptions are also proposed. The expert team fully affirmed and recognized the company's hardware facilities, production capabilities, and site preparations.
During this on-site inspection, leaders of each Ruiying Pioneer production plant actively communicated and cooperated with each other. All factory employees work overtime and work together. Complete the preparation of the workshop production site and documents. During the site visit of the Group of Experts, the serious and careful, rigorous and skillful responses of the main leaders and department heads of each factory area left a good impression on the experts.
The on-the-spot inspections of the two major products, fluoxetine sodium and clavulanic acid (clavulanic acid), not only marked an increase in the selling points of our company's products, but also demonstrated the strength of Ruiying's step by step progress. Let us continue to work hard from excellence to excellence!