Quality management of Kunming Baker Norton Pharmaceutical Co., Ltd.

It has a clean workshop of more than 5,000 square meters, including three GMP oral preparation workshops and nine production lines for amoxicillin, cephalosporin and comprehensive preparations. Production dosage forms include capsules (containing penicillin and cephalosporins), suspensions (containing penicillin and cephalosporins), tablets, granules and imported soft capsules. There are also modern raw and auxiliary materials warehouses, packaging materials warehouses, finished products warehouses and GSP warehouses. KBN Quality Control Center adopts domestic first-class inspection and testing equipment. KBN organizes production and business activities in strict accordance with GMP and GSP specifications, and the product market sampling pass rate reaches 100%.

Ahead of GMP in China

KBN is the first batch of enterprises in China that have passed the national GMP certification. For more than ten years, KBN has been aiming at international standards and has maintained its leading position in the domestic GMP field through continuous GMP implementation and upgrading. As early as 1998, KBN passed the first batch of national drug GMP certification in China. After 1998, KBN continuously strengthened GMP management and increased investment in software and hardware according to the new national GMP standards and international standards. ERP is used in logistics management, production management and sales management, which realizes the whole process quality control from material procurement to production to sales, and makes the GMP management of KBN always at the leading level in the same industry in China.

The internal control standard is higher than the national standard.

In terms of quality management system, KBN produces products imported from the United States, Europe and Japan, and is a joint venture company of TEVA in China. According to the requirements of global management of TEVA, KBN is subject to the quality audit of EU standards implemented by TEVA for its global subsidiaries every year. Therefore, KBN should not only implement the quality control of China standards, but also implement the quality standards of the European Union, which makes the internal control index of KBN higher than the national index.