A Comprehensive Review on the Emerging Concept: QBD Approach to Analytical Method Development and Validation With Regulatory Importance

Abstract

The administration of the pharmaceutical sector is carefully regulated by a quality policy. Regulatory organizations like the USFDA propose the scientific pharmaceutical development process known as Quality by Design (QbD). Due to the increase in the number of quality issues with pharmaceutical items, it has recently become more important. QbD can be used to create quick and reliable analytical methods for critical analysis. A scientific and risk-management strategy is used to achieve method and product understanding in the QbD approach to product and method development, which begins with predetermined targets. Regulatory bodies receive additional assurance from QbD-based product development. The analytical techniques that are used to analyze pharmaceutical drug items are equally vital, and any problems with the analytical technique's design could put patients at risk for poor quality care. As of now, none of the regulatory bodies have any explicit requirements for AQbD (Analytical Quality by Design) in analytical development. Despite the fact that there isn't a formal regulatory agency directive on AQbD, a lot of effort has recently been done in this area. The goal of AQbD is to attain measurement quality. Recently, other regulatory agencies, particularly the EMA (European Medicines Agency) and other ICH countries authorities throughout the world, have shown appreciation for the idea. They are widely acknowledged by the industry as AQbD (Analytical Quality by Design) concepts. The major goal of this review is to clarify the many phases involved in creating an analytical method using a QbD approach, as well as the application of QbD to the validation of analytical procedures and the regulatory significance of applying AQbD.