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.

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 / S. Furlanetto, S. Orlandini, B. Pasquini, C. Caprini, M. Del Bubba, G. Pieraccini, S. Pinzauti. - ELETTRONICO. - (2019), pp. 28-28. (Intervento presentato al convegno 30th International Symposium on Pharmaceutical and Biomedical Analysis-PBA 2019 tenutosi a Tel-Aviv, Israel nel 15-18 Settembre 2019).

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

S. Furlanetto
;
S. Orlandini;B. Pasquini;C. Caprini;M. Del Bubba;G. Pieraccini;S. Pinzauti
2019

Abstract

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.
2019
PBA 2019-Abstracts Book
30th International Symposium on Pharmaceutical and Biomedical Analysis-PBA 2019
Tel-Aviv, Israel
S. Furlanetto, S. Orlandini, B. Pasquini, C. Caprini, M. Del Bubba, G. Pieraccini, S. Pinzauti
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1172271
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact