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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
2019-03-26
Source PublicationFRONTIERS IN CHEMISTRY
ISSN2296-2646
Volume7Pages:7
AbstractHerein, 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.
Keywordquality consistency critical quality attribute quality standard process variation assessment strategy drug product
DOI10.3389/fchem.2019.00171
Language英语
Funding ProjectNational Major Scientific and Technological Special Project for Significant New Drugs Development[2017ZX09101001-007]
WOS Research AreaChemistry
WOS SubjectChemistry, Multidisciplinary
Funding OrganizationNational Major Scientific and Technological Special Project for Significant New Drugs Development
WOS IDWOS:000462486200001
PublisherFRONTIERS MEDIA SA
Citation statistics
Document Type期刊论文
Identifierhttp://ir.ipe.ac.cn/handle/122111/28276
Collection中国科学院过程工程研究所
Corresponding AuthorHu, Chang Q.
Affiliation1.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
Recommended Citation
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.
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