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

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。

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

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 injections 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.