A Strategy to Assess Quality Consistency of Drug Products

doi:10.3389/fchem.2019.00171

	A Strategy to Assess Quality Consistency of Drug Products
	Qi, Shu Y.1,2; Yao, Shang C.1; Yin, Li H.1; Hu, Chang Q.1
刊名	FRONTIERS IN CHEMISTRY
	2019-03-26
卷号	7 页码:7
关键词	quality consistency critical quality attribute quality standard process variation assessment strategy drug product
ISSN号	2296-2646
DOI	10.3389/fchem.2019.00171
英文摘要	Herein, we aimed to develop a strategy to assess quality consistency of a drug product, with a focus on two typical cases of injection. Multi-variable analysis using a sequencing combination of factor analysis, one-way analysis of variance and cluster analysis identified all potential Critical Quality Attributes (CQAs) for each manufacturing process, which were identified from the attributes of quality standard (QAs) using supervised (cefazolin sodium pentahydrate, alpha-CEZ-Na) or unsupervised (cephathiamidine, CETD) analysis. All CQAs from QAs were applied to set up an integrated index, quality consistency attribute (QCA), to evaluate product quality consistency in a specific aspect. Meanwhile, real-time analysis by chemometrics-assisted near-infrared spectroscopy (NIR) was used to obtain useful information corresponding to the CQAs from the process attributes (PAs) of some of the critical processes. The quantitative results of characteristic signals of NIR by multiple linear regression was defined as the process consistency attribute (PrCA), and was used to assess the product quality consistency in another aspect. Therefore, either values of QCA or PrCA displayed sensitivity to changes in product quality, allowing us to establish a strategy with strong practicality, comprehensiveness and visualization to demonstrate the quality consistency of a specific product. Such strategy is not only conducive to the improvement of quality standards, but to the retrospective investigation of manufacturing processes which ultimately allowed maintenance of product consistency.
资助项目	National Major Scientific and Technological Special Project for Significant New Drugs Development[2017ZX09101001-007]
WOS研究方向	Chemistry
语种	英语
出版者	FRONTIERS MEDIA SA
WOS记录号	WOS:000462486200001
资助机构	National Major Scientific and Technological Special Project for Significant New Drugs Development
内容类型	期刊论文
源URL	[http://ir.ipe.ac.cn/handle/122111/28276]
专题	中国科学院过程工程研究所
通讯作者	Hu, Chang Q.
作者单位	1.Natl Inst Food & Drug Control, Inst Chem Drug Control, Div Antibiot, Beijing, Peoples R China 2.Chinese Acad Sci, Inst Proc Engn, State Key Lab Biochem Engn, Beijing, Peoples R China
推荐引用方式 GB/T 7714	Qi, Shu Y.,Yao, Shang C.,Yin, Li H.,et al. A Strategy to Assess Quality Consistency of Drug Products[J]. FRONTIERS IN CHEMISTRY,2019,7:7.
APA	Qi, Shu Y.,Yao, Shang C.,Yin, Li H.,&Hu, Chang Q..(2019).A Strategy to Assess Quality Consistency of Drug Products.FRONTIERS IN CHEMISTRY,7,7.
MLA	Qi, Shu Y.,et al."A Strategy to Assess Quality Consistency of Drug Products".FRONTIERS IN CHEMISTRY 7(2019):7.