Quality by Design Strategy as a Risk-Based Framework for the Optimization of Fast and Selective Chromatographic Methods for the Analysis of Bioactive Mixtures: Potentiality and Critical Issues

Sandra Furlanetto, Department of Chemistry “Ugo Schiff”, University of Florence, Italy (furlanettos@unifi.it)
S. Orlandini, Department of Chemistry “Ugo Schiff”, University of Florence, Italy
B. Pasquini, Department of Chemistry “Ugo Schiff”, University of Florence, Italy
C. Caprini, Department of Chemistry “Ugo Schiff”, University of Florence, Italy
M. Del Bubba, Department of Chemistry “Ugo Schiff”, University of Florence, Italy
G. Pieraccini, Mass Spectrometry Center (CISM), Department of Health Sciences, University of Florence, Italy
S. Pinzauti, Department of Chemistry “Ugo Schiff”, University of Florence, Italy

Quality assurance (QA) is a process that ensures the customer that the final product meets predefined requirements. It has a key role in the pharmaceutical field to ensure efficacy and safety of drugs. Quality control, within the QA process, requires a series of investigations aimed at identifying any non-conformances in the deliverables. However, it is increasingly important, in the face of a rising culture of quality, to develop analytical methods and processes according to the principles of Quality by Design (QbD), that envisages the definition of all the factors potentially critical for the process and the definition of an experimental space where the quality of the process is assured at a predefined level of probability.

In the last years, US Food and Drug Administration documents have underlined the importance to adopt risk management strategies to ensure the quality of pharmaceutical processes. QbD framework has been outlined in International Council for Harmonization guidelines, ICH Q8-Q11, focusing on pharmaceutical product and process control. Even if the adoption of analytical QbD concept has been significantly rising over the years, it still needs to be effectively encouraged within both the academic and the industrial research. In this context, the development of new ICH Q14 guideline on Analytical Procedure Development will represent an opportunity to further spread this risk-based strategy, which also enables to lay scientific basis for flexible regulatory approaches to post-approval Analytical Procedure changes. In this presentation, examples of QbD applied to the development of chromatographic methods will be presented. Attention will also be paid, in a critical way, to how the research in this field can be useful in sectors where controllable variables are difficult to be established.

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Abstract Reference & Short Personal Biography of Presenting Author

Sandra Furlanetto is an Editor of the Journalof Pharmaceutical and Biomedical Analysis (Elsevier).
She is Associate Professor of Analytical Chemistry at the Department of Chemistry of the University of Florence, Italy.
She is Rector's Delegate for Students Orientation at the above University.
The current research of her group is focused on the development and validation of separative analytical methods and on the application of chemometrics for their optimization.