期刊
ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES
卷 12, 期 1, 页码 1-8出版社
HONG KONG ASIAMED PUBLISH HOUSE
DOI: 10.1016/j.ajps.2016.07.006
关键词
Quality by design (QbD); Process analytical technology (PAT); Critical quality attributes (CQA); Design of experiment (DoE); Risk assessment; Near infrared (NIR) spectroscopy
资金
- Talents Project of Liaoning Province, China [LR2013047]
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. (C) 2017 Shenyang Pharmaceutical University. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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