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)
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