Quality Control

Our clean factory buildings occupy an area of more than 5000 m2, including three workshops for GMP oral medication preparation (amoxicillin, cephalosporin and comprehensive preparations) and nine production lines. The drugs produced include capsules (including penicillin and cephalosporins), suspensions (including penicillin and cephalosporins), tablets, granules and soft gelatin capsules. Additionally, we have modern raw and auxiliary materials warehouses, packaging materials warehouses, finished products warehouses and GSP warehouses. In our Quality Control Center we make use of domestic first-class checking and testing equipment. We organize our production and operation activities in strict compliance with GMP and GSP specifications, and the qualification rate of products taken out of the market for sampling is 100%.

Taking the lead in the GMP field

KBN was among the earliest group in China to achieve national GMP certification. For over ten years, KBN, aiming at international standards, has continuously implemented and upgraded its GMP, thus keeping its leading position in the domestic field in terms of GMP. As early as 1998, KBN was among the earliest group in China to achieve national GMP certification. After 1998, according to the new GMP specifications and international standards, KBN has continuously strengthened its GMP management, increased investments in software and hardware. It has also used ERP for logistics management, production management and sales management, thus realizing total quality control from raw material purchasing to production and sales. So, our GMP management has consistently been in a leading position among the competitors of the same industry in China.

Set up internal control standards that are higher than the national ones

In terms of quality control, since we not only produce the products introduced from the USA, Europe and Japan, but are also a joint venture company of TEVA in China, in line with the global management requirements of TEVA, we receive annual quality audits of EU standards from TEVA; therefore, we must not only implement Chinese standards, but also EU quality standards. This makes our internal quality control standards higher than the national ones.