Volume : 12, Issue : 12, December- 2025
Title:
A REVIEW ON RECENT STRATEGIES IN AQbD APPROACH
Authors :
Shubham Santosh Shinde, Vaishnavi Devidas Jaybhaye, Sakshi Suryakant Tipale, Mr. Swapnil P.Kulthe
Abstract :
Recent strategies in the Analytical Quality by Design (AQbD) approach have transformed the way analytical methods are developed, optimized, and controlled in pharmaceutical and regulatory environments. AQbD integrates scientific knowledge and risk-based strategies to ensure the consistent performance and quality of analytical methods throughout their lifecycle. This article explores the latest advancements in AQbD, focusing on key strategies such as method understanding, risk assessment, and the application of experimental designs like Design of Experiments (DoE) to optimize method parameters. Emphasizing the importance of system suitability criteria, monitoring, and trending of method outputs, the article highlights how these strategies can enhance method robustness, reduce variability, and ensure product quality. Case studies from regulatory agencies, including the MHRA and British Pharmacopoeia, illustrate the practical application of AQbD concepts in the development of compendial methods, such as the Atorvastatin Assay method. By leveraging these innovative approaches, pharmaceutical industries can improve method performance, ensure compliance, and meet evolving quality standards.
Keywords: Analytical Quality by Design (AQbD), Quality by Design (QbD), Critical Quality Attributes (CQAs)
Cite This Article:
Please cite this article in press Shubham Santosh Shinde et al., A Review On Recent Strategies In AQbD Approach , Indo Am. J. P. Sci, 2025; 12(12).
Number of Downloads : 10
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