QbD (Quality by Design): A systematic approach for evaluating and improving a (production) process or marketing of statistical expertise in disguise?

QbD is often promoted as an approach for improving quality, enhancing efficiencies and reducing cost of the manufacturing of pharmaceutical products such as tablets and products. This article provides a critical assessment of this view. It is argued that the promotion appears to be an attempt to market of the expertise in statistical analyses. This distorted view in fact appears to be causing confusion and hindrance in accepting the QbD approach. A discussion is provided highlighting the underlying issues in this regard. Link for the article Please click here for complete article

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