在中药注射剂安全性再评价工作中践行“质量源于设计”的思考

Implementation of Quality by Design in the Program of Safety Re-evaluation of TCM Injections

现代制药工业的质量控制理念从"检验放行"经历"过程控制"发展到"质量源于设计"(QbD)。但如何将QbD应用于中药研发、生产和监管,目前尚无成功案例。中药注射剂安全性再评价工作客观上为系统地践行QbD创造了有利条件。本文从中药注射剂关键质量属性的确定,关键物料属性和关键工艺参数的识别,设计空间的开发,控制策略的制定以及持续改进5个方面探讨了如何运用QbD理念和工具改进中药注射剂质量控制模式,以确保临床用药安全有效。

It has been widely accepted in modern pharmaceutical industry that quality cannot be tested into products , instead quality should be built-in by design . However , the implementation of Quality by Design （ QbD ） in development , manufacture and supervision of traditional Chinese medicine （ TCM ） still remains to be a challenge . The program of safety re-evaluation of TCM injections provides an opportunity to practice QbD approach in TCM industry . This paper discussed some potential ways that improve the quality of TCM injec-tions base on QbD related tools , including identification of critical quality attributes , critical process parameters and critical material attributes, development of design space and control strategy.