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, α-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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.