Abstract: Quality by Design (QbD) has been widely applied to pharmaceutical manufacturing to enhance process robustness, and improve product quality and manufacturing productivity. Recently, there arose tremendous interests from both the pharmaceutical industry and regulatory agents to expand it to analytical methodology. Similar to process QbD, analytical QbD offers the benefits of more thorough understanding of both the measurement requirements and analytical methods, thus delivers more robust methods. In addition, analytical QbD could significantly reduce the efforts relating to post approval variation. However, the approach would also mean significantly more experimentation to assess and understand the analytical method. This paper describes our attempts to apply some informatics tools to streamline the QbD method development to alleviate the increased resource burden.Summary: Quality by Design (QbD) has been widely applied to pharmaceutical manufacturing to enhance process robustness, and improve product quality and manufacturing productivity. Recently, there arose tremendous interests from both the pharmaceutical industry and regulatory agents to expand it to analytical methodology.
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