新型的药品质量管理理念“质量源于设计”

被引：88

作者：

王明娟

胡晓茹

戴忠

马双成

机构：

[1] 中国食品药品检定研究院

来源：

中国新药杂志 | 2014年 / 23卷 / 08期

关键词：

质量源于设计; 药品质量管理; 风险控制; 控制策略;

D O I：

暂无

中图分类号：

R95 [药事组织];

学科分类号：

100406 [军事预防医学];

摘要：

新型的药品管理理念"质量源于设计"(quality-by-design,QbD),与现行的"质量源于检验"(quality-by-testing,QbT)理念目的相同,均是为了保障药品的安全、有效及质量可控,但是采取的策略则有明显的差异:传统的QbT主要通过终产品的检验和限制生产工艺变化等方式控制药品质量和工艺性能,类似水灾治理中的"堵"法;新型的QbD则将质量控制提前至上游,由决策部门组织成立由不同领域专家(研发、生产、管理、统计分析等)组成的风险管理评估小组,在基于对产品及其生产工艺充分理解的基础上,采用风险管理工具识别出影响终产品质量的关键原材料属性和关键工艺参数,制订有针对性的控制策略使产品质量始终介于可接受范围内,并结合药品质量系统的运行情况(外部反馈和内部回顾)对产品质量进行持续改进,类似水灾治理中的"疏"法。本综述重点解读了ICH Q8(药物研发)、Q9(质量风险管理)和Q10(药品质量系统)指南的核心内容、比较了QbD与传统QbT系统在质量控制策略等方面的差异,并结合文献报道,以示例方式阐述了如何采用QbD理念完善现行的药品质量管理系统,以期对国内的药品质量管理工作起有益借鉴作用。

引用

页码：948 / 954

页数：7

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