The company has a quality assurance department directly under the leadership of the general manager, which is fully responsible for the quality supervision and inspection of drugs. It consists of Quality Assurance Department (QA) and Quality Control Department (QC). The quality inspection department has biological inspection room, chemical inspection room, animal room and sample observation room. Equipped with instruments that meet the inspection needs, such as liquid chromatograph, gas chromatograph, infrared spectrometer, dissolution instrument, ultraviolet spectrophotometer, thin layer chromatograph, etc. Review the release of materials, intermediates and finished products.
Review the handling procedures of nonconforming products.
Monitoring of the whole production process and environmental monitoring
Evaluation of supplier quality system
Responsible for organizing and implementing the quality training of the whole company, and formulating quality standards and operating procedures.
Sampling and inspection of materials, intermediate products and finished products
Stability inspection (raw materials, intermediate products and finished products)
Formulate the responsibilities of quality management and inspection personnel, and formulate management measures for inspection equipment, instruments, reagents, standards, culture media, verification bacteria and experimental animals.