Quality by Design – A Review

Abstract

At various points along the life cycle of a pharmaceutical product, analytical procedures must be established. These tasks, if not optimised using scientific knowledge and process understanding, might result in a lengthy and expensive process. In an effort to supplement or replace the current components of risk and quality management systems, the pharmaceutical industry is always looking for new policies and features. Joseph M. Juran, a renowned authority on quality, conceived up Quality by Design (QbD) first. Analytical method development, or AQbD, is an expansion of the Quality by Design idea. The Quality by Design methodology places a focus on understanding products and processes as well as controlling those processes. It starts with predetermined objects and follows a methodical approach to development.When it comes to developing new methods and drugs, analytical quality by design is an essential component of the current paradigm. In addition to addressing implementation-related issues, the primary goal of this review article is to outline the various stages of AQbD method development. Analytical Method Validation, Control Strategy, Critical Performance Attributes (CPAs), Analytical Target Profile (ATP), and Method Operable Design Region (MODR) are all parts of the analytical method development strategy.
KEY WORDS: Analytical Quality by Design, Analytical Target Profile, Critical Performance Attributes, Method Operable Design Region...