Quality Management and Control Strategies in the Development Stage of Biologic Drugs

Xiang Liu （ Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Nanjing, Jiangsu, 211100, China ）

Abstract

Although the development of biological drugs brings new hope to human health, it also presents certain challenges, requiring strengthened quality management and control. Key aspects during the research and development phase include: controlling raw materials and equipment; ensuring proper sample management and analysis; safeguarding data recording and security. Control strategies involve establishing a comprehensive quality management system, conducting risk assessment and response, utilizing technical tools, and enhancing personnel training and communication. These elements are critical stages and strategies for ensuring the safety, efficacy, and quality controllability in the development of biological drugs, ultimately providing patients with high-quality medications.

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