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
Tianjin Flemish Company Donates Anti-epidemic Materials
On the morning of July 13, Tianjin Jianfeng Flanders Pharmaceutical Technology Development Co., Ltd. donated materials to the Tianjin Development Zone Charity Association to help the development zone community fight the epidemic.
2020
08-05
In late July, leaders of the group company Jiang Xiaomeng, Yu Jianhong, Chen Tianci and Qin Xuping visited subordinate enterprises separately and sent heatstroke prevention and cooling supplies to employees working under high temperature, urging everyone to pay attention to heatstroke prevention and cooling and safe production work to ensure good physical condition.
2020
08-05
On July 17 and 18, the Group's work analysis meeting for the first half of 2020 was held at the Peak Building of the Group's headquarters to summarize and review the work in the first half of the year and make arrangements for the work in the second half of the year.
2020
08-05
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer.
2020
08-05
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
07-22
The company requires to do a good job in summer safety production
The high temperature season is approaching, and the group company issued a notice a few days ago to make arrangements for safe production in summer. The notice requires all subordinate units of the company to attach great importance to the work of production safety in summer, and all production and business units should hold a special meeting on production safety in summer. According to the characteristics of production in summer, they should focus on safety risk analysis for mines, outdoor operations and high-temperature posts, and implement control measures to avoid the occurrence of safety accidents such as scalding, heatstroke and electric shock. In order to further strengthen the safety production management in the high temperature season, the notice requires the main person in charge of each production and business unit to lead a team to conduct a comprehensive inspection of the production and business premises according to the characteristics of summer production; strengthen the daily safety production inspection of key posts and special posts; timely rectify the found unsafe behaviors and hidden dangers; Strengthen the management of the storage and use of flammable, explosive, dangerous chemicals and drugs; cooling measures shall be taken for the space exceeding the storage temperature limit of articles. If it is found that the electrical equipment circuit and exhaust fan circuit are aged and damaged, replace them in time and keep the grounding wire in good condition. Do a good job in checking the fire pool, pipeline water pressure and fire extinguishing equipment to ensure that the fire fighting facilities are sensitive, intact and reliable. The high temperature in summer is also a period of frequent occurrence of heatstroke and other diseases. The notice requires all units to do a good job in heatstroke prevention and cooling, implement various relevant measures, and equip necessary cooling facilities or materials such as fans, air conditioners, ice cubes and other cooling facilities or materials according to the conditions of the production site; do a good job in the distribution of heatstroke prevention drugs, supplies and cool drinks in workshops, warehouses, construction sites and other production lines; strengthen canteen management to prevent food poisoning. (this newspaper reporter)
2020
07-31
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