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International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544 | Issues per year: Monthly | Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

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Analytical Quality by Design (AQbD): A Comprehensive Review with Emphasis on Risk Assessment Approaches

Author(s): Palak Jethava*1¹, Dr. Nilesh Patel2²

Email(s): ¹jethawapalak@gmail.com

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1 Research Scholar, Gujarat Technological University, Nr.Vishwakarma Government Engineering College Nr. Visat Three Roads, Visat - Gandhinagar Highway, Chandkheda, Ahmedabad – 382424 - Gujarat 2 Department of Pharmaceutical Quality Assurance, B. K. Mody Government Pharmacy College, Polytechnic Campus, Bhavnagar Rd, Near Aji Dam Road, GIDC, Rajkot, Gujarat 360003

Published In: Volume - 4, Issue - 8, Year - 2025

DOI: https://doi.org/10.71431/IJRPAS.2025.4801

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ABSTRACT:
Analytical Quality by Design (AQbD) is an innovative framework that enhances the robustness, reliability, and regulatory compliance of analytical methods through a systematic, science- and risk-based approach. This review article provides a comprehensive overview of the AQbD paradigm, with a particular emphasis on the integration and application of risk assessment tools. Key elements of AQbD, including Analytical Target Profile (ATP), method scouting, Design of Experiments (DoE), and control strategies, are discussed in detail. The article explores the role of risk assessment in identifying critical method parameters (CMPs) and critical quality attributes (CQAs), enabling more informed decision-making throughout method development and lifecycle management. Various risk assessment tools—such as Ishikawa diagrams, Failure Mode and Effects Analysis (FMEA), and Risk Ranking and Filtering (RRF)—are examined for their practical utility and effectiveness. Case studies and regulatory perspectives are also highlighted to illustrate the implementation of AQbD principles in real-world settings. By focusing on risk-based thinking, AQbD not only improves method performance and lifecycle sustainability but also aligns with global regulatory expectations. This review aims to provide researchers and professionals with a clear understanding of AQbD’s benefits and challenges, particularly in the context of method risk management.

Keywords:

Cite this article:
Palak Jethava, Dr. Nilesh Patel. Analytical Quality by Design (AQbD): A Comprehensive Review with Emphasis on Risk Assessment Approaches. IJRPAS, August 2025; 4 (8): 1-16.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4801

1.      Volta e Sousa L, Gonçalves R, Menezes JC, Ramos A. Analytical method lifecycle management in pharmaceutical industry: a review. Aaps Pharmscitech. 2021 Apr 9;22(3):128.
2.      Deidda R, Orlandini S, Hubert P, Hubert C. Risk-based approach for method development in pharmaceutical quality control context: A critical review. Journal of pharmaceutical and biomedical analysis. 2018 Nov 30;161:110-21.
3.      Jayagopal B, Shivashankar M. Analytical quality by design–a legitimate paradigm for pharmaceutical analytical method development and validation. Mechanics, Materials Science & Engineering Journal. 2017 Apr 10;9.
4.      Hanna-Brown M, Ermer J, Katzenbach S, Rignall A, Gervais A, Hoffmann J, Wypych J, McLaughlin K, Borman P, Grosche O, Hamilton P. Analytical procedure lifecycle management: current status and opportunities.
5.      European Medicines Agency ICH Guideline Q9(R1) on Quality Risk Management. Step 2b, Amsterdam, The Netherlands. 2021. [(accessed on 01 August 2025)]. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals_en-1.pdf
6.      Beg S, Hasnain MS, Rahman M, Almalki WH, editors. Handbook of analytical quality by design. Academic Press; 2021 Jan 9.
7.      Zagalo DM, Silva BM, Silva C, Simoes S, Sousa JJ. A quality by design (QbD) approach in pharmaceutical development of lipid-based nanosystems: A systematic review. Journal of Drug Delivery Science and Technology. 2022 Apr 1;70:103207.
8.      Kovač L, Časar Z, Trdan Lušin T, Roškar R. Development of an analytical method for determination of related substances and degradation products of cabotegravir using analytical quality by design principles. ACS omega. 2022 Mar 4;7(10):8896-905.
9.      Yabré M, Ferey L, Somé TI, Sivadier G, Gaudin K. Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design. Journal of Pharmaceutical and Biomedical Analysis. 2020 Oct 25; 190:113507.
10. Muchakayala SK, Katari NK, Saripella KK, Schaaf H, Marisetti VM, Ettaboina SK, Rekulapally VK. Implementation of analytical quality by design and green chemistry principles to develop an ultra-high performance liquid chromatography method for the determination of Fluocinolone Acetonide impurities from its drug substance and topical oil formulations. Journal of Chromatography a. 2022 Aug 30; 1679:463380.
11. Gundecha S, Patel M, Mayur YC. An application of quality by design and analytical greenness assessment approach for the development of erlotinib stability indicating method. Chromatographia. 2022 Jul;85(7):575-88.
12. Singh B, Khurana RK, Kaur R, Beg S. Quality by design (QbD) paradigms for robust analytical method development. The Pharma Review. 2016;14:61-6.
13. Zhang L, Mao S. Application of quality by design in the current drug development. Asian journal of pharmaceutical sciences. 2017 Jan 1;12(1):1-8.
14. Holm P, Allesø M, Bryder MC, Holm R. ICH Quality Guidelines: An Implementation Guide. E. Teasdale, D. Elder, & RW Niims (Eds.) Q. 2017;8.
15. Borman P, Chatfield M, Nethercote P, Thompson D, Truman K. The application of quality by design to analytical methods. Pharmaceutical Technology. 2007 Oct 1;31(10):142-8.
16. Tang Y, Aaps O. Quality by design approaches to analytical methods-FDA perspective. FDA/CDER. 2011.
17. Hanna-Brown M, Ermer J, Katzenbach S, Rignall A, Gervais A, Hoffmann J, Wypych J, McLaughlin K, Borman P, Grosche O, Hamilton P. Analytical procedure lifecycle management: current status and opportunities.
18. Peraman R, Bhadraya K, Padmanabha Reddy Y. Analytical quality by design: a tool for regulatory flexibility and robust analytics. International journal of Analytical chemistry. 2015;2015(1):868727.
19. Rozet E, Lebrun P, Hubert P, Debrus B, Boulanger B. Design spaces for analytical methods. TrAC Trends in Analytical Chemistry. 2013 Jan 1; 42:157-67.
20. Deepa M, Reddy KR, Satyanarayana SV. A review on quality by design approach for analytical method development. J. Pharm. Res. 2017;11(4):272-7.
21. Ganorkar A, Gupta K. Analytical quality by design: a mini review. Biomed. J. Sci. Tech. Res. 2017;1(6):1555-8.
22. Pande PP, Sayyad SF, Chavan MJ, Chaudhari SR. Quality by design in analytical method development and validation. J Environ Life Sci. 2017 Jun;2(2):39-45.
23. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of chemistry. 2017 May 1;10:S3412-25.
24. Gaudin K, Ferey L. Quality by design: a tool for separation method development in pharmaceutical laboratories. LC-GC, 201; 29(10):16–25.
25. Peraman R, Bhadraya K, Padmanabha Reddy Y. Analytical quality by design: a tool for regulatory flexibility and robust analytics. International journal of Analytical chemistry. 2015;2015(1):868727.
26. Rozet E, Lebrun P, Hubert P, Debrus B, Boulanger B. Design spaces for analytical methods. TrAC Trends in Analytical Chemistry. 2013 Jan 1;42:157-67.
27. Mogal V, Dusane J, Borase P, Thakare P, Kshirsagar S. A review on quality by design. Pharm Biol Eval. 2016;3:313-9.

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