Best Practices in Analytical Method Development and Testing

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.

Read this article in Pharmaceutical Technology's Bio/Pharma Laboratory Best Practices 2018 eBook.

About the Author

Mario DiPaola is senior scientific director at Charles River Laboratories, Woburn, MA.

Article Details

Pharmaceutical Technology
eBook: Bio/Pharma Laboratory Best Practices 2018
Vol. 42
November 2018
Pages: 16–23

Citation

When referring to this article, please cite it as M. DiPaola, "Best Practices in Analytical Method Development and Testing," Pharmaceutical Technology Bio/Pharma Laboratory Best Practices eBook (November 2018).