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Journal of Pharmaceutical Research

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Analytical QBD Approach to Redefine the Quality of Pharmaceuticals: A Review
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v22.4.81

Year: 2023, Volume: 22, Issue: 4, Pages: 178-185

Review Article

Analytical QBD Approach to Redefine the Quality of Pharmaceuticals: A Review

Shaik Ayesha Ameen1,*, Nagaraju Pappula2

1 Research scholar, Hindu college of pharmacy, Guntur, Andhra Pradesh
2 Professor and HOD, Department of pharmaceutical analysis, Hindu college of pharmacy, Guntur, Andhra Pradesh

*Corresponding author email: [email protected]

Creative Commons License

Abstract

As per the present scenario traditional techniques of quality by testing of finished pharmaceutical products have proved to be unsatisfactory, although focus on 'Total quality assurance can be attained only by in-process testing and analysis. The Quality by Design (QbD) idea has already been established and applied in all nations that adhere to the International Conference on Harmonization Guidelines. The proposed ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems offer a foundation for incorporating quality into the product. Other components are being added and integrated into the analytical method development process, including as Quality Risk Management, the Pharmaceutical Quality System, and Process Analytical Technology (PAT) guidelines. The Quality by Design (QbD) idea has already been established and applied in all nations that adhere to the International Conference on Harmonization Guidelines. The proposed ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems offer a foundation for incorporating quality into the product. Other components are being added and integrated into the analytical method development process, including as Quality Risk Management, the Pharmaceutical Quality System, and Process Analytical Technology (PAT) guidelines. They are widely acknowledged in the business as AQbD (Analytical Quality by Design) ideas. This paper attempts to summarize QbD achievements to date, regulatory perspectives on QbD, a comparative examination of conventional and analytical QbD techniques in method development, and issues about its fundamental application.

Keywords

Quality by Design, Design of Experiments, Analytical Quality, Critical Quality Attributes Analytical Target Profile, Process Control

References

  1. Woodcock J. The concept of pharmaceutical quality. American Pharmaceutical Review. 2004;7(6):10–15. Available from: https://www.researchgate.net/publication/279577343_The_concept_of_pharmaceutical_quality
  4. Valentine EN. Quality By Design (Qbd): Manufacturing And Product Quality Of Generics Drugs Perspective. Journal of Global Trends in Pharmaceutical Sciences. 2013;4(4):1257–1262. Available from: https://www.jgtps.com/admin/uploads/T5O6mb.pdf
  5. Karmarkar S, Garber R, Genchanok Y, George S, Yang X, Hammond R. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities. Journal of Chromatographic Science. 2011;49(6):439–446. Available from: https://pubmed.ncbi.nlm.nih.gov/21682993/
  7. Raman NVVSS, Mallu UR, Bapatu HR. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry. 2015;p. 1–8. Available from: https://doi.org/10.1155/2015/435129
  9. Vogt FG, Kord AS. Development of Quality-By-Design Analytical Methods. Journal of Pharmaceutical Sciences. 2011;100(3):797–812. Available from: https://doi.org/10.1002/jps.22325
  10. SNM, Mahapatra A. Analytical Quality by Design - A review. Indian Research Journal of Pharmacy and Science. 2020;7. Available from: https://www.researchgate.net/publication/342924833_Analytical_Quality_by_Design_-_A_review
  11. Krunal Y, Patel ZR, Dedania RR, Dedania. Unnati Patel QbD approach to HPLC method development and validation of ceftriaxone sodium. Future Journal of Pharmaceutical Sciences. 2021;(7) 147. Available from: https://fjps.springeropen.com/articles/10.1186/s43094-021-00286-4
  15. Rozet E, Ziemons E, Marini RD, Boulanger B, Hubert PH. Quality by Design Compliant Analytical Method Validation. Analytical Chemistry. 2012;84(1):106–112. Available from: https://doi.org/10.1021/ac202664s
  16. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding Pharmaceutical Quality by Design. The AAPS Journal. 2014;16(4):771–783. Available from: https://doi.org/10.1208/s12248-014-9598-3
  17. Kochling J, Wu W, Hua Y, Guan Q, Castaneda-Merced J. A platform analytical quality by design (AQbD) approach for multiple UHPLC-UV and UHPLC–MS methods development for protein analysis. Journal of Pharmaceutical and Biomedical Analysis. 2016;125:130–139. Available from: https://doi.org/10.1016/j.jpba.2016.03.031
  18. Ganorkar AV, Gupta KR. Analytical Quality by Design: A Mini Review A Mini Review. Biomed J Sci & Tech Res. 2017;1(6). Available from: https://biomedres.us/pdfs/BJSTR.MS.ID.000484.pdf
  21. Martins I, Fukudacamila F, Fidelis, Pintocamila, Santos, Moreira­alessandro M, et al. Felipe Rebello Lourenço Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD), Braz. J. Pharm. Sci. 2018;54. Available from: https://doi.org/10.1590/s2175-97902018000001006
  23. Girija D, Reddy BV, Krishna CS, Kumar RK, Lakshmi G, SM. Emerging Achievements Of Quality By Design In Pharmaceutical Industry. World Journal of Pharmaceutical and Life Sciences. 2019;5(12):208–213. Available from: https://www.wjpls.org/home/article_abstract/1611
  26. Mahapatra A. Subramania Nainar Meyyanathan Analytical quality by design- A review. Indian Research Journal of Pharmacy and Science. 2022;25:2132–2140.
  27. Bhatt DA, Rane SI. QbD Approach to Analytical RP-HPLC Method Development and its Validation. Int. J. Pharm. and Pharm. Sci. 2011;3(1):179–187. Available from: https://innovareacademics.in/journal/ijpps/Vol3Issue1/1052.pdf
  30. Das V, Bhairav B, RBS. Review Article: Quality by Design approaches to Analytical Method. Development Research J. Pharm. and Tech. 2017;10(9). Available from: https://doi.org/10.5958/0974-360X.2017.00567.4
  31. Katekar V, Sangule D, Bhurbhure O, Ingle P, Dhage S, Jadhav K. A Review on Quality by Design Approach in Analytical Methods. Journal of Drug Delivery and Therapeutics . 2016. Available from: https://jddtonline.info/index.php/jddt/article/view/5386
  32. Ravisankar P, Gowthami S, Rao GD. A review on analytical method development. Indian journal of research in pharmacy and biotechnology. 2014;2(3):1183. Available from: https://www.ijrpb.com/issues/Volume%202_Issue%203/ijrpb%202(3)%209%20ravisankar%202%201183-1195.pdf
  33. Reid GL, Cheng G, Fortin DT, Harwood JW, Morgado JE, Wang J, et al. Reversed- Phase Liquid Chromatographic Method Development in an Analytical Quality by Design Framework. Journal of Liquid Chromatography & Related Technologies. 2013;36(18):2612–2638. Available from: https://doi.org/10.1080/10826076.2013.765457
  34. Nishendu P, Nadpara RV, Thumar, Vidhi N, Kalola, Parula B. Patel Quality By Design (Qbd) : A Complete Review. Int. J. Pharm. Sci. Rev. Res. 2012;17(2):20–28. Available from: https://globalresearchonline.net/journalcontents/v17-2/04.pdf
  35. Krull I, Swartz M, Turpin J, Lukulay PH, Verseput RA. Quality-by-Design Methodology for Rapid LC Method Development, Part I. LCGC N. Am. 2008;26:1190–1197.
  36. Ling S, Mcbrien M. A Quality by Design Approach to Chromatographic Method Development. LCGC: The Column. 2011;7(5):16–20.
  37. Nagar M, Panwar VSS, Chopra, Indubala P. Scholars Research Library Der Pharmacia Letter. 2010;2(2):111–130.
  39. Skoog DA, Holler FJ, Crouch S. Principles of Instrumental Analysis. Thomson Learning. 2006. Available from: Thomson Learning
  40. Jaiprakash N, Sangshetti M, Deshpande Z, Zaheer DB, SRA. Quality by Design Approach: Regulatory Need. Arabian Journal of Chemistry. 2014;p. 1–14.
  41. Ahuja S, Jespersen N. Modern Instrumental Analysis. Elsevier. 2006.

Copyright

© 2023 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

  • 04 March 2024

Year: 2023, Volume: 22, Issue: 4


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