The company implements the quality management system where the general managers are directly responsible for the production. Advanced equipment and scientific management create high-quality products.
According to the requirements from the international organization for standardization and management of production, the company, since 1998, has invested a lot of money for the improvement of GMP facilities, machinery and equipment, sanitation, and has built production areas in garden style. The company introduced advanced equipment, instruments, and built a testing center with the world's advanced testing instrument.
According to the requirements of GMP management, the company established and improved hundreds of standard operating procedures (SOP) including QA, QC, raw materials procurement, production and operation of equipment, metering, warehousing, sales management, as well as improved the standard management procedures (SMP) and standard technology program (STP). By strengthening the training and education, the company improved the employee skills assessment to enhance staffs’ consciousness of the quality of products.
The perfect management system and high-quality product quality satisfy domestic and international official audit institutions and customer quality audit departments, and also let the Chengyi pharmaceutical products sell well at home and abroad.
In December 1998, the company’s leading product – Ribavirin APIs – certified by TGA Australia and the European Union, Canada and other relevant agencies. With its exquisite manufacturing technology, advanced production management, excellent product quality, it became the famous-brand products in Zhejiang province and won the gold prize in the fourth session of the China New Product Exposition. Antiviral drugs acyclovir, Amikacin injection, Lincomycin Hydrochloride Injection were rated as high-quality pharmaceutical products in Zhejiang province. Shaweiluo (acyclovir) capsule got the outstanding achievement award in the 99 International Medical Instruments, Pharmaceutical Machinery Expo. The company of Li Shan brand trademark was named as the famous trademark of Zhejiang province.
Chengyi Pharmaceutical Company built up advanced modern pharmaceutical analysis laboratories, with experienced experts and advanced analytical equipment for the imports. According to the requirements of GMP, the company can inspect and analysis drug production. That supports the company’s production, research and development. We have a set of strict rules of management, and we attach great importance to the stability of experimental products, validation of analytical methods, transference of analysis method and super gauge (OOS) survey. In order to ensure the accuracy and scientificity of each data analysis, our main analytical facilities are:
● High performance liquid chromatograph
● Gas chromatograph (with headspace sampling)
● The Fourier transform infrared spectrophotometer
● UV VIS spectrophotometer
● Automatic polarimeter
● Differential scanning calorimetry, DSC
● Thin layer analyzer
● Malvin particle size analyzer
● Carbon analyzer
● DL53 automatic potentiometric titration apparatus
● DL38 cassette moisture meter
● Dissolution tester
● Constant temperature and humidity stability test box
● Microbiological testing room