Monika Jadhav
Assistant Professor
Title: Implementation of Quality by Design approach to analytical method development and validation
Biography
Biography: Monika Jadhav
Abstract
A QbD and lifecycle management approach to analytical method development and qualification results in a better understandingrnand fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughoutrnthe lifecycle. This, in turn, leads to less method transfer failures and method “incidents†when used in the routine environment. Asrnthe MNC’s are now applying Quality by Design (QbD) to process development, it is now being recognized that this is also the wayrnforward to improve and standardize approach to analytical procedures. The recent focus within the pharmaceutical industry andrnassociated regulatory bodies on QbD approaches to analytical method development are a positive sign that both the industry andrnregulators are acknowledging the importance of understanding the contribution of measurement uncertainty to drug processes andrnproducts. The benefits of applying QbD principles to analytical methods include identifying and minimizing sources of variabilityrnthat may lead to poor method robustness and ensuring that the method meets its intended performance requirements throughoutrnthe product and method lifecycle. The ultimate goal is to highlight that QbD concepts and terminology can be applied to analyticalrnmethods and to suggest how adoption of a QbD approach might be used to develop more robust analytical methods and effectiverncontrol systems. At the same time, these efforts aim to support more advanced regulatory approaches to change management