Quality Management Control Strategy in the Development Stage of Biological Drugs
Firstly,the definition and classification of biological drugs are briefly described,the importance and challenges of biological drug research and development are analyzed,and the key role of quality control is emphasized.Secondly,it discusses the establishment and implementation of quality management system,formulation and implementation of quality control standards,quality risk assessment and prevention in the process of research and development of biological drugs.Finally,the quality control strategy of biological drug development stage is analyzed.
biological drugsquality managementresearch and development managementcontrol strategybiomedicine
万方数据
维普
