Analytical quality by design; Design of experiments; Drug analysis; Quality control; Method operable design space region; Risk-based approach
Abstract :
[en] Pharmaceutical regulatory bodies increasingly require the implementation of systematic approaches in pharmaceutical product development. Quality control methods play a key role in the control strategy of drugs manufacturing to assure their quality. A risk-based approach in the analytical method development is strongly recommended to ensure that the method performances fit the purpose of the method during its entire life-cycle. In the last decade, analytical quality by design (AQbD), as risk management oriented methodology, has been progressively integrated with method development for fulfilling this objective. This approach has successfully allowed the quality to be designed into the analytical processes by obtaining a deep understanding of the procedures. In this paper the AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed. Recent publications regarding how AQbD has been applied in separation techniques were reviewed. The different development strategies have been also showcased, highlighting their advantages and disadvantages, in order to give a useful overview.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Deidda, Riccardo ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Orlandini, Serena
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Cédric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Language :
English
Title :
Risk-based approach for method development in pharmaceutical quality control context: A critical review
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