生物药研发阶段的质量管理控制策略

Quality Management Control Strategy in the Development Stage of Biological Drugs

文章首先对生物药的定义与分类进行了简要阐述,分析了生物药研发的重要性及挑战,强调了质量控制在生物药研发中的关键作用;其次探讨了生物药研发阶段质量管理体系的建立与实施、制定与执行质量控制标准以及研发过程中的质量风险评估与防控;最后分析了生物药研发阶段的质量控制策略。

Firstly,the def inition and classif ication of biological drugs are brief ly 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.