Pharmaceutical New Jinxi Factory Organized FDA Simulation Inspection
Release time:
2023-05-04
In order to meet the FDA inspection, from April 17 to 19, Jianfeng Pharmaceutical Company's Xinjinxi Factory commissioned a business consulting company to conduct a simulation inspection of G01, G02 workshops, warehouses, QA, QC, engineering and other systems, and conducted a gap analysis according to China and cGMP quality system management, in order to evaluate the cGMP compliance level of Xinjinxi Factory as a QMS supplier of NMPA and OSD products in the US market. The
expert group is divided into three groups to audit the warehouse sampling room, G01 and G02 workshops, material management system related documents, production system related documents, material supplier management, public system site and related documents, QC laboratory site and document system, QA quality assurance system, plant facilities and equipment management and measuring instrument management, equipment confirmation, etc, and the workshop clean area environment, compressed air and water system monitoring conditions for inspection. The expert group made a detailed report on the inspection, affirmed the quality management system of Jianfeng Pharmaceutical's new Jinxi plant, and put forward opinions on the deficiencies found in the inspection. Zhou Hengbin, manager of
Manufacturing Department 2, said that he would immediately analyze and rectify the causes of the deficiencies, improve the quality system management level of the new Jinxi plant, and lay the foundation for passing FDA certification. (Student Wang)
More information
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On the morning of July 1, more than 40 members of the group's party committee, party members of various branches of the group headquarters, and party members of subordinate enterprise branches went to the Shuanglong Hydropower Station, the Red Education Base of Jinhua City, to receive party spirit and revolutionary tradition education.
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On June 16 and 18, the theoretical and practical examinations for the determination of professional skill level in the peak pharmaceutical sector were held successively in Jinxi pharmaceutical factory. The independent identification of vocational skill level includes three occupations (types of work): pharmaceutical preparation worker, chemical inspector and organic synthesis worker, basically covering the main posts in the pharmaceutical sector, with a total of 125 employees signing up for the identification.
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On June 16, the Jianfeng Pharmaceutical Quality Research and Development Party Branch and the Jinhua Vocational Skills Management Service Center Party Branch held a signing ceremony in Jinxi Factory to establish a party building alliance.
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Jinhua Mayor Xing Zhihong to Peak Research
On the afternoon of June 1, Jinhua Mayor Xing Zhihong, Wucheng District Party Committee Secretary Gao Feng, District Mayor Hu Yuxian, and heads of the Municipal Economic and Information Bureau, Development and Reform Bureau and other departments went to the group headquarters to discuss and exchange with the leaders of the group company to understand the development of the enterprise. Solicit opinions and suggestions from enterprises on government work. After understanding the current business situation of the peak, Xing Zhihong pointed out that focus, follow the right path, frontier, steady, is the peak to long-term prosperity of the magic weapon, must continue to adhere.
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