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.
关键词
生物药/质量管理/研发管理/控制策略/生物医药
Key words
biological drugs/quality management/research and development management/control strategy/biomedicine
维普
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