Zhang Lan, Mao Shirui
Shenyang Pharmaceutical University, No.103, Wenhua Road, Shenyang 110016, China.
Asian J Pharm Sci. 2017 Jan;12(1):1-8. doi: 10.1016/j.ajps.2016.07.006. Epub 2016 Aug 4.
Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design (QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. The application of QbD in drug formulation and process design is based on a good understanding of the sources of variability and the manufacture process. In this paper, the basic knowledge of QbD, the elements of QbD, steps and tools for QbD implementation in pharmaceutics field, including risk assessment, design of experiment, and process analytical technology (PAT), are introduced briefly. Moreover, the concrete applications of QbD in various pharmaceutical related unit operations are summarized and presented.
在FDA推行现行药品生产质量管理规范之前，检验质量是保证药品质量的唯一途径。为了清晰地了解生产过程，FDA在制药领域推广了质量源于设计（QbD）理念，该理念基于对物料和工艺参数如何影响最终产品质量特性的透彻理解。QbD在药物制剂和工艺设计中的应用基于对变异性来源和生产过程的充分了解。本文简要介绍了QbD的基础知识、QbD的要素、在制药领域实施QbD的步骤和工具，包括风险评估、实验设计和过程分析技术（PAT）。此外，还总结并介绍了QbD在各种制药相关单元操作中的具体应用。
