Ludivine Ferey
University of Bordeaux, France
Title: Using innovative combination of Quality by Design and green analytical chemistry approaches for the development of analytical methods in pharmaceutical sciences
Biography
Biography: Ludivine Ferey
Abstract
Recent pharmaceutical regulatory documents have emphasized the importance of applying Quality by Design (QbD) concept for in-depth product and process understanding to ensure product quality by the design. QbD concept has been supported by the International Conference on Harmonization guideline Q8 (R2). The goal of this present study is to demonstrate the usefulness of the QbD approach when applied to the development of separation methods in green analytical chemistry. The relevance of QbD and green analytical chemistry combination was emphasized by the case study of Active Principle Ingredient and its related substance analysis by UHPLC. Following a QbD approach, green chemistry principles were included in the analytical target profile to reduce environmental impact and minimize analyst exposure during a future routine use after the implementation of the method in pharmaceutical industry. First, a scouting phase enabled to select the stationary phase and the type of organic solvent. After applying quality risk assessment, the effects of selected critical process parameters on Critical Quality Attributes (CQAs) were evaluated through a screening design. A response surface methodology was then carried out to model CQAs as function of the retained factors and the optimal separation conditions were determined by applying desirability functions to the modeled responses. Finally, focusing at quality risk management, the design space was computed as the multidimensional subspace where the CQAs fulfilled the requirements. The method was successfully validated by the accuracy profile approach and applied to a pharmaceutical product.