Open Access Peer-reviewed Review

Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers

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Principles of QbD
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Submitted   Jun 5, 2025
Published   Oct 17, 2025
Issue    Vol 7 No 1 (2025)
DOI   10.25082/JPBR.2025.01.001

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Ritu Tiwari corresponding author
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad 201002, Uttar Pradesh, India
Gaurav Sanjay Mahalpure
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad 201002, Uttar Pradesh, India
Meenakshi Dahiya
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad 201002, Uttar Pradesh, India
Vivekanandan Kalaiselvan
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad 201002, Uttar Pradesh, India

Abstract

Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances, vaccines, immune markers, and medicinal products. This compliance not only enhances product quality but also drives continuous improvement and innovation throughout the entire product lifecycle. Developing and regulating analytical methods are vital for maintaining high standards of product quality. By employing sophisticated scientific techniques and risk-based strategies, stakeholders can use various analytical methods to ensure the consistent production of high-quality active pharmaceutical ingredients (APIs). Techniques such as size exclusion chromatography (SEC), high-performance liquid chromatography (HPLC), gel electrophoresis, Western blotting, SDS-PAGE, and enzyme-linked immunosorbent assays (ELISA) are essential for boosting industrial efficiency and reliability in the pharmaceutical sector. Each technique supports the rigorous testing and validation required for API production, ultimately facilitating the development of safe and effective medical products. Understanding the impact of variability on the performance and results of analytical methods is crucial. The QbD framework adopts a systematic approach that underscores the need to thoroughly understand and effectively manage various aspects of the product and its manufacturing processes—laying the groundwork for ongoing improvements and innovation throughout the product lifecycle. Additionally, strict development and regulation of analytical methods are key to achieving the highest standards of product quality. Fully grasping how variability influences the performance and outcomes of analytical methods is essential, as this understanding optimizes results and maintains consistent quality. Recognizing these dynamics enhances result reliability and supports the goal of delivering safer, more effective healthcare solutions.

Keywords
analytical quality by design, quality risk management, pharmaceutical quality system, critical quality attributes, experiment design

Article Details

Supporting Agencies
The authors are grateful to the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, for providing the platform to develop the manuscript.
How to Cite
Tiwari, R., Mahalpure, G. S., Dahiya, M., & Kalaiselvan, V. (2025). Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers. Journal of Pharmaceutical and Biopharmaceutical Research, 7(1), 511-524. https://doi.org/10.25082/JPBR.2025.01.001
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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