ArticleFrontiers in chemistry2019
A Strategy to Assess Quality Consistency of Drug Products.
Article in Frontiers in chemistry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Quality assessment strategy development and analytical method selection of GMP grade biological drugs for gene and cell therapy.BBA advances · 2025Review
- A strategy for population pharmaceutical quality assessment based on quality by design.Journal of pharmaceutical analysis · 2021Article
- Recent advances of novel technologies for quality consistency assessment of natural herbal medicines and preparations.Chinese medicine · 2020Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
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