Management Control
The company implements a quality management system under the direct responsibility of the general manager, with advanced equipment and scientific management to create high-quality product quality.
According to the requirements of the International Organization for Standardization and management production, since 1998, the company has invested a lot of money in GMP transformation of plant facilities, machinery equipment and sanitary environment to build a garden like production plant; And introduce advanced equipment and instruments, and build a testing center equipped with world-class testing instruments.
According to the requirements of GMP management, the company has developed and improved hundreds of standard operating procedures (SOPs), standard management procedures (SMPs), and standard technical procedures (STPs), including QA, QC, raw material procurement, production operations and equipment, measurement, warehousing, and sales management; And by strengthening training and education, strengthening employee skill assessment, and enhancing the quality awareness of all employees, the production management level is significantly improved, and the product quality reaches the top level.
The sound management system and excellent product quality have made both domestic and foreign official audit institutions and customer quality audit departments deeply satisfied with Chengyi Pharmaceutical, and have also made Chengyi Pharmaceutical's products widely sold both domestically and internationally.
In December 1998, the company's main product, Ribavirin API, passed the GMP certification of relevant institutions such as the Australian TGA and the European Union and Canada. With its exquisite manufacturing process, scientific and advanced production management, and excellent product quality, it became a famous brand product in Zhejiang Province and a high-quality pharmaceutical product in Zhejiang Province. It won the gold medal at the 4th China New Product Expo; The antiviral drugs acyclovir raw material, amikacin injection, and lincomycin hydrochloride injection have been rated as high-quality pharmaceutical products in Zhejiang Province and high-quality products in Zhejiang Province, respectively; Xavirol (Acyclovir) capsules were awarded the Gold Award for Excellent Achievements at the '99 International Exhibition and Academic Exchange Seminar on Pharmaceutical and Mechanical Achievements in Medicine and Medical Devices'. The company's "Lishan" brand trademark has been rated as a famous trademark in Zhejiang Province.
Return To Society
Cheng Yi Pharmaceutical has established an advanced modern analysis laboratory, equipped with experienced analysis experts and advanced imported analysis equipment. It can conduct strict quality analysis and testing of drug production according to GMP requirements, effectively supporting the production and research and development of all products of Chengyi Pharmaceutical. We have a complete set of strict analysis and management procedures, which attach great importance to product stability experiments, validation of analysis methods, transfer of analysis methods, and investigation of analysis violations (i.e. OOS), ensuring the accuracy and scientificity of each analysis data. Our main analysis facilities include:
● hpLC
● Gas chromatograph (with headspace injection)
● Infrared spectrophotometer
● UV visible spectrophotometer
● Automatic polarimeter
● DSC
● Thin layer analyzer
● Marvin particle size analyzer
● Carbon analyzer
● DL53 Full automatic potentiometric titration
● DL38 Card type moisture titrator
● Dissolution tester
● Constant temperature humidity stability test chamber
● Microbial testing room