QUALITY BY DESIGN: THE TOOL FOR REGULATORY COMPLIANCEAbstract
QbD decrees the definition of a goal for the method and accentuates thorough evaluation and scouting of alternative methods systematically to obtain ideal method performance. QbD tools like risk assessment and design of the experiment, empowers better quality to be instilled into the analytical method and facilitate prior understanding and identification of variables affecting the method performance. Analytical quality by design (AQbD) permits the analytical method for movement within a method operable design region. Unlike current methods, analytical method development using AQbD approaches diminishes the number of out of trend results and out of specification results due to the robustness of the method. It is a current inclination among pharmaceutical industry to implement AQbD in method development processes as a part of risk management, pharmaceutical development and pharmaceutical quality systems (ICHQ10). It owes to the lack of explanatory reviews. The objective of this review article is to provide a comprehensive understanding of various aspect of QbD.
M. P. Venkatesh *, A. Philip and H. V. Gangadharappa
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
14 June 2018
25 August 2018
06 February 2019
01 March 2019