Jiangxi Bio has won the "WHO GMP" certification

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Company news

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2015/01/31 14:29

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[Abstract]:

　　January 30, 2015 was a special day for Jiangxi creatures. On this day, Jiangxi creatures once again welcomed several high-nose bridges and dressed up foreign guests. Oh, it turned out that three Egyptian Ministry of Health officials and foreign customers came to the company's production sites for a one-week GMP certification inspection. Yao Xiaodong, chairman and general manager of the company, and the company's management team warmly received and accompanied the inspection. General Manager Yao Xiaodong first introduced the company's production and operation situation and the development prospects of the company to the Egyptian Ministry of Health. The company's main products account for more than 70% of the total domestic sales, and external exports account for more than 90% of the total market. The product quality inspection rate is 100%, which is highly praised by customers at home and abroad. The new products developed by the company are about to enter the registration and clinical stage, and the company has bright prospects for development. Egyptian prosecutors and customers have shown great interest in the development of the company's new products, indicating that the success of new product development will continue to support the development of the company. The person in charge of production reported to them the strict implementation of the pharmaceutical production specifications, the operation according to the regulations, the strict management, and the fine-grained production management process. The quality person in charge introduced the company's strong product quality assurance system to the implementation of China's 2010 edition. Chinese Pharmacopoeia guarantees product quality.

　　According to the Egyptian Drug Administration Law, any drug that manufactures, imports and sells products that are not registered under the Act is illegal. Therefore, the General Administration of Drug Administration of the Egyptian Ministry of Health needs to confirm whether the pharmaceutical production facilities, equipment and software systems meet the requirements of WHO GMP before accepting the application for registration of export drugs. In this certification inspection, the Egyptian prosecutor went to the production workshop, warehouse, quality inspection, animal experiment and other places to carry out detailed GMP certification inspection, and conducted on-site evaluation of the removal of the A line of tetanus antitoxin products. The B-line production line has undergone a rigorous and meticulous inspection. During the inspection, they look at the employee's operation process and check it carefully against the provisions of the production operation rules. Sometimes, they continue to ask questions about the actual operation ability of the employees. The prosecutor worked seriously, and even some minor behaviors were ignored, such as the placement of on-site items, the timeliness and effectiveness of the labels, and so on. After the on-site inspection, the company's employee training and effects, employee file management, company safety management, product recall and batch production records are all detailed and evaluated.

　　The Egyptian Ministry of Health is inspecting our company in accordance with the most stringent BP Pharmacopoeia and WHO GMP requirements. After nearly a week of inspection, Egyptian Ministry of Health officials gave a high degree to our company's production and operation and product quality. Certainly, at the same time, make some suggestions on the quality of the products produced by our company. On behalf of the company, General Manager Yao Xiaodong thanked the experts of the Egyptian Ministry of Health for detailed inspection. The company will take this inspection as an opportunity to further improve management, improve quality, improve service, improve the GMP management system, and strive to provide quality products and services for the Egyptian market.

　　After the inspection, the company will pave the way for product registration and sales in Egypt and its neighboring countries. Through this inspection, the company has learned advanced foreign management concepts and management methods, and has played a greater role in improving management skills. The company's export sales have won more space, generated more benefits, and made greater contributions to the export of foreign exchange in the well-opening area.

Witness the miracle, thanks for the 2014 Jiangxi Biological 2014 Annual Work Summary and Commendation Conference was successfully held