Quality Management System
Since 2001 the company has established quality management system. And we passed certification of ISO9001 at the same year. In 2007, food safety management system was introduced, then certified for ISO22000 and passed it at last. In 2013, the company improved the originally existing food safety management system and passed the certification of FSSC22000 system, which is of the highest requirements for the food safety management system. With the development of the company, we got drug production license from SFDA. The overall quality management system was further improved and perfected by integrating requirements of cGMP, Q7 and ISO9001. Moreover, the company as one of the APIs suppliers, successfully passed the USA FDA on site inspection without defect reporting in March, 2013. And later in August, FDA sent a letter to the company, where it said “your facility as acceptable”.
The vice president for OA, representative of quality management, is responsible for the overall quality management system, which is under the leadership of the general manager.
The job responsibility of the vice president is to organize and implement the quality guidelines, goals and quality responsibilities of the company, as well as to organize and prepare quality plans, so that the quality requirement could be satisfied and the overall activities planned as schedule could be carried out.
The QA department in the company is responsible for the whole production process of products, which includes assessment of raw materials for suppliers, monitoring the manufacturing process, release of the finished products, as well as after-sale services. Furthermore, its responsibility extends to supervision and guidance of quality activities related with purchasing, warehouse, production, equipment, technical, QC, sales and R&D department in order to be sure of finished products with sound quality.
The QC department in the company is responsible for daily material acceptance, monitoring the whole production process, release testing of finished products, supervision of facilities for purified water system, deionized water system and HAVC system. The QC lab is equipped with some advanced instruments such as over 10 sets of HPLC, GC, FTIR, UV, AAS as well as a Microbial lab. It could offer perfect and advanced testing methods to monitor and ensure the quality of products.