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This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
About a decade ago, FDA and other regulatory agencies introduced a series of pharmaceutical guidance documents that included risk management and quality by design (QbD). These initiatives were aimed at modernizing the manufacturing of small-molecule drugs and biologics. The topics on risk management and QbD were published as International Council for Harmonization (ICH) guidance Q9 (1) and ICH guidance Q8 (2), respectively. Both concepts have
been widely accepted by the industry within the manufacturing space and have been applied effectively to minimize production failure risks and define a design space where quality target product profiles can be managed and maintained.
The pharmaceutical analytical community, unfortunately, has been rather slow in adapting these concepts, as well as design of experiment (DoE) (3), for in-process testing or release and stability assessment of drug substance and drug product. In this paper, the author outlines the reasons why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
Mario Dipaola is senior scientific director at Charles River Laboratories, Woburn, MA.
eBook: Biopharma Laboratory Best Practices 2018
When referring to this article, please cite it as M. DiPaola, "Best Practices in Analytical Method Development and Testing," BioPharm International Biopharma Laboratory Best Practices eBook (October 2018).