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

Shaik Ayesha Ameen; Nagaraju Pappula

doi:10.18579/jopcr/v22.4.81

Article

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 Ameen^1,*, 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]

This work is licensed under a Creative Commons Attribution 4.0 International 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

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
SB, Hasnain S, Rahman M, Swain S. Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications. 2002. Available from: https://www.perlego.com/book/1810304/pharmaceutical-quality-by-design-principles-and-applications-pdf
Sachin B. Gholve et al Analytical method development and validation by QbD approach - A review. Der Pharmacia Sinica. 2015;6(8):18–24. Available from: https://www.researchgate.net/publication/281742946_Analytical_method_development_and_validation_by_QbD_approach_-_A_review
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
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/
Morgado J, Barnett K, Harrington B, Wang J, Harwood J, DF. Analytical Quality by Design (AQbD) in Pharmaceutical Development. 2013. Available from: https://www.americanpharmaceuticalreview.com/Featured-Articles/144191-Analytical-Quality-by-Design-AQbD-in-Pharmaceutical-Development/#:~:text=These%20same%20QbD%20principles%20have,intended%20performance%20throughout%20its%20lifecycle.
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
Lawrence X. Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical Research. 2008;25(4):781–791. Available from: https://pubmed.ncbi.nlm.nih.gov/18185986/
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
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
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
International Conference on Harmonization (ICH), Tripartite guidelines ICH Q8 (R2): Pharmaceutical Development. 2009.
ICH Q9 Guidelines: Quality Risk Assessment'' Food and Drug Administration. In: International Conference on Harmonization (ICH). 2006.
Ramalingam P, BJ. QbD Considerations for Analytical Development. 2019.
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
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
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
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
Bhutani H, Kurmi M, Singh S. Sarwar Beg and Bhupinder Singh Quality by Design (QbD) in Analytical Sciences: An Overview. Pharma Times. 2014;46(8):71–75. Available from: https://www.researchgate.net/publication/267034239_Quality_by_Design_QbD_in_Analytical_Sciences_An_Overview
MB, SN. Analytical Quality by Design (Aqbd): New Paradigm for Analytical Method Development. International Journal of Development Research. 2015;5(2):3589–3599. Available from: https://www.journalijdr.com/analytical-quality-design-aqbd-new-paradigm-analytical-method-development
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
Peraman R. Kalva Bhadraya and Yiragamreddy Padmanabha Reddy Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics . 2015. Available from: https://doi.org/10.1155/2015/868727
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
Beg S, Hasnain MS, Rahman M, Almaki WH. Handbook of analytical quality by design. 2011. Available from: https://shop.elsevier.com/books/handbook-of-analytical-quality-by-design/beg/978-0-12-820332-3
Das V, Bhairav B, RS. Quality by Design approaches to Analytical Method Development. J. Pharm. and Tech. 2017;10(9). Available from: https://www.researchgate.net/publication/322790769_Quality_by_Design_approaches_to_Analytical_Method_Development
Mahapatra A. Subramania Nainar Meyyanathan Analytical quality by design- A review. Indian Research Journal of Pharmacy and Science. 2022;25:2132–2140.
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
Q10:Pharmaceutical Quality System, ICH Tripartite Guidelines. 2007.
Food and Drug Administration CDER Guidance for industry, Q8 pharmaceutical development. 2006.
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
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
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
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
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
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.
Ling S, Mcbrien M. A Quality by Design Approach to Chromatographic Method Development. LCGC: The Column. 2011;7(5):16–20.
Nagar M, Panwar VSS, Chopra, Indubala P. Scholars Research Library Der Pharmacia Letter. 2010;2(2):111–130.
McPolin O. Validation of analytical method for pharmaceutical analysis. 2009.
Skoog DA, Holler FJ, Crouch S. Principles of Instrumental Analysis. Thomson Learning. 2006. Available from: Thomson Learning
Jaiprakash N, Sangshetti M, Deshpande Z, Zaheer DB, SRA. Quality by Design Approach: Regulatory Need. Arabian Journal of Chemistry. 2014;p. 1–14.
Ahuja S, Jespersen N. Modern Instrumental Analysis. Elsevier. 2006.
Musters J, Bos LVD, Kellenbach E. Applying QbD Principles To Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for a Commercial API. Organic Process Research & Development. 2013;17(1):87–96. Available from: https://doi.org/10.1021/op300292a

Copyright

Year: 2023, Volume: 22, Issue: 4

[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

[2] SB, Hasnain S, Rahman M, Swain S. Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications. 2002. Available from: https://www.perlego.com/book/1810304/pharmaceutical-quality-by-design-principles-and-applications-pdf

[3] Sachin B. Gholve et al Analytical method development and validation by QbD approach - A review. Der Pharmacia Sinica. 2015;6(8):18–24. Available from: https://www.researchgate.net/publication/281742946_Analytical_method_development_and_validation_by_QbD_approach_-_A_review

[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/

[6] Morgado J, Barnett K, Harrington B, Wang J, Harwood J, DF. Analytical Quality by Design (AQbD) in Pharmaceutical Development. 2013. Available from: https://www.americanpharmaceuticalreview.com/Featured-Articles/144191-Analytical-Quality-by-Design-AQbD-in-Pharmaceutical-Development/#:~:text=These%20same%20QbD%20principles%20have,intended%20performance%20throughout%20its%20lifecycle.

[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

[8] Lawrence X. Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical Research. 2008;25(4):781–791. Available from: https://pubmed.ncbi.nlm.nih.gov/18185986/

[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

[12] International Conference on Harmonization (ICH), Tripartite guidelines ICH Q8 (R2): Pharmaceutical Development. 2009.

[13] ICH Q9 Guidelines: Quality Risk Assessment'' Food and Drug Administration. In: International Conference on Harmonization (ICH). 2006.

[14] Ramalingam P, BJ. QbD Considerations for Analytical Development. 2019.

[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

[19] Bhutani H, Kurmi M, Singh S. Sarwar Beg and Bhupinder Singh Quality by Design (QbD) in Analytical Sciences: An Overview. Pharma Times. 2014;46(8):71–75. Available from: https://www.researchgate.net/publication/267034239_Quality_by_Design_QbD_in_Analytical_Sciences_An_Overview

[20] MB, SN. Analytical Quality by Design (Aqbd): New Paradigm for Analytical Method Development. International Journal of Development Research. 2015;5(2):3589–3599. Available from: https://www.journalijdr.com/analytical-quality-design-aqbd-new-paradigm-analytical-method-development

[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

[22] Peraman R. Kalva Bhadraya and Yiragamreddy Padmanabha Reddy Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics . 2015. Available from: https://doi.org/10.1155/2015/868727

[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

[24] Beg S, Hasnain MS, Rahman M, Almaki WH. Handbook of analytical quality by design. 2011. Available from: https://shop.elsevier.com/books/handbook-of-analytical-quality-by-design/beg/978-0-12-820332-3

[25] Das V, Bhairav B, RS. Quality by Design approaches to Analytical Method Development. J. Pharm. and Tech. 2017;10(9). Available from: https://www.researchgate.net/publication/322790769_Quality_by_Design_approaches_to_Analytical_Method_Development

[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

[28] Q10:Pharmaceutical Quality System, ICH Tripartite Guidelines. 2007.

[29] Food and Drug Administration CDER Guidance for industry, Q8 pharmaceutical development. 2006.

[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.

[38] McPolin O. Validation of analytical method for pharmaceutical analysis. 2009.

[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.

[42] Musters J, Bos LVD, Kellenbach E. Applying QbD Principles To Develop a Generic UHPLC Method Which Facilitates Continual Improvement and Innovation Throughout the Product Lifecycle for a Commercial API. Organic Process Research & Development. 2013;17(1):87–96. Available from: https://doi.org/10.1021/op300292a

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

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