Paper Contents
Abstract
The implementation of Analytical Quality by Design (AQbD) marks a significant advancement in the systematic development, validation, and lifecycle management of analytical methods, particularly for complex pharmaceutical formulations. AQbD principles are thoroughly reviewed in this article, with particular focus focused on key components like the Method Operable Design Region (MODR), Critical Method Parameters (CMPs), Design of Experiments (DoE), and Analytical Target Profile (ATP). The AQbD framework enhances technique robustness, adaptability, and consistency with the aim to overcome the inherent challenges in assessing complex drug delivery systems, including biologics, nanoparticles, and sustained-release formulations. Process Analytical Technology (PAT), chemometrics, artificial intelligence (AI), machine learning (ML), and green analytical practices are a few of emerging technologies that are easily incorporated into AQbD strategies to improve regulatory compliance, sustainability, and analytical performance. ICH Q14 and the revised Q2(R2) guidelines have caused regulatory expectations to evolve towards the use of analytical submissions that are risk- and science-based. The case studies that accompany reveal how AQbD has been effectively used in real-world scenarios, and the outlook for the future shows how it is becoming increasingly essential to digital transformation and sustainable pharmaceutical analysis.
Copyright
Copyright © 2025 Dr.A.Krishnamanjari Pawar. This is an open access article distributed under the Creative Commons Attribution License.
