Research Journal of Pharmacy and Technology

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Implementation of Quality by Design Approach for Method Development and Validation: A Review


Affiliations
1 Research Scholar, College Of Pharmaceutical Sciences, Dayananda Sagar University, Bangalore-560078,, India
2 Associate Professor, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078, India
3 Professor and Dean, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078,, India
     

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QbD is the heart of recent pharmaceutical development. The implementation of QbD principles delivers a cost efficient methodology for delivering quality medicines for users. Regulatory agencies like USFDA and the European medicines agency (EMA) are placing the greater importance on a part of filing. QbD is efficient advances toward progress so as to commence through pre-defined aim and emphasizes manufacturing product and quality process understanding and method control depending on resonance knowledge and quality hazard supervision. Quality cannot be tested in the products but quality should be built by design, it is an essential part of modern approaches to pharmaceutical quality.under this concept of QbD throughout designing and development of a product. It is important to define the performance profile of the desired product, the quality profile of the target product, and identify critical quality attributes.

Keywords

Quality by design, Analytical method validation.
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  • Bhusnure OG, Gholve SB, Bawage M, Vinod T. Analytical method development and validation of prednisolone sodium phosphate by QbD approach. IOSR Journal of Pharmacy and Biological Sciences 2015; 10(6): 64-75.

  • Hasnain MS, Siddiqui S, Rao S. QbD driven development and validation of a bioanalytical LC-MS method for quantification of Fluoxetine in human plasma. Journal of chromatographic sciences. 2016; 54(5); 736-743.

  • Shah AD, Patel CN. Implementation of QbD approach to the RP-HPLC method development and validation of Roflumilast in bulk and tablet dosage form: an application in degradation study. World Journal of Pharmacy and Pharmaceutical Sciences 2014; 3(6); 2281-2307.

  • Chaphekar MM, Hamrapurkar PD. Development and validation of RP- HPLC assay method for Vildagliptin using QbD approach and its application to forced degradation studies. International Journal of Pharmaceutical Sciences and Drug Research 2016; 8(3): 157-165.

  • Bhusnure OG, Gandge NV, Gholve SB. QbD approach for analytical method development and validation of melatonin by spectroscopic method. Journal of Pharmacy Research 2017; 11(5): 464-471.

  • Sahoo CK, Sudhakar M, Sahoo NK, Rao SRM. Validation of Analytical Methods: A Review. Journal of Innovation in Pharmaceutical Sciences 2017; 1(3): 8-13.

  • Sandhu PS, Beg S, Singh B. QbD- driven development and validation of a HPLC method for estimation of Tamoxifen citrate with improved performance. Journal of Chromatographic Science 2016; 54(8); 1373-1384.

  • Sachin B. Gholve, Rani R. Ajfunde, Omprakash G.Bhusnure and sanjay S. Thonte. Analytical method development and validation by QbD approach. Pelagia Research Library, 2015; 6(8); 18-24.

  • ICH Technical requirements for the registration of pharmaceutical human use, Pharmaceutical development Q8 (R2). Harmonised Tripartite Guideline, 2009; 1-28 10. USFDA FDA’s Pharmaceutical current Good Manufacturing Practices for the 21st century A risk based Approach: Final report.2003

  • Singh B, Kumari N, Saini G et. al. Quality by Design: A systematic approach for the analytical method.Journal of Drug Delivery and Therapeutics, 2019; 9(3); 1006-1012.

  • 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; 1-8.

  • Panda SS, Beg S, Venkata RK et. al. Implementation of Quality by Design Approach for developing chromatographic methods with enhanced performance.Journal of Analytical and Pharmaceutical Research 2016; 2(6).

  • Shishir KP, Kalpana D, Anita A. Review on comprehensive understanding of building an analytical quality by design for drug manufacturing process. Asian Journal of Biomedical and Pharmaceutical Sciences 2020; 10(7):10-15

  • ICH Topic Q8 (R2). ICH Harmonised tripartite guideline. In proceedings of the international Conference on Harmonization of Technical requirements for registration of pharmaceuticals for human use (ICH 09), Pharmaceutical Development. 2009

  • Garg LK, Sait SS, Krishnamurty T et. al. Quality by design: A practical experimental design approach by blocking and varying certain factors of a stability indicating HPLC method for simultaneous estimation of omeoprazole and ketoprofen Journal of Liquid Chromatography Related Technologies 2015; 38(6): 677-686.

  • Yeram P, Hamrapurkar PD, Mukhedkar P. Implementation of quality by design approach to develop and validate stability indicating assay method for the simultaneous estimation of sofosbuvir and ledipasvir in bulk drugs and tablet formulation.International Journal of Pharmaceutical Sciences and Research 2019; 10(1): 180-188.

  • Yadav NK, Raghuvanshi A, Sharma G. QbD based development and validation of stability indicating HPLC method for estimating Ketoprofen In bulk drug and proniosomal vesicular system J Chromatogr Sci 2016; 54(3): 377-89.

  • Khurana RK, Beg S, Lal D et al., Analytical quality by design approach for development of a validated bioanalytical UPLC method for docetaxel trihydrate. Current Pharmaceutical Analysis 2015; 11(3): 180-192.

  • Hasnain MS, Siddiqui S, Rao S et al. QbD- Driven development and validation of a bioanalytical LC-MS method for quantification of fluoxetine in human plasma.Journal of Chromatographic Sciences. 2016; 54(5): 736-743.

  • Beg S, Chaudhary V, Sharma G et al. QbD oriented development and validation of a bioanalytical method for nevirapine with enhanced liquid- liquid extraction and chromatographic separation. Biomedical Chromatography 2016; 30(6): 818-828.

  • Taevernier L, Wynedaele E, Hondt MD et. al. Analytical quality by design approach for sample treatment of BSA- containing solutions. Journal of Pharmaceutical Analysis 2015; 5(1): 27-32.

  • Palakurthi AK, Dongala T,.Katakam LNR. QbD based development of HPLC method for simultaneous quantification of Telmisaratan and Hydrochlororhiazide impurities in tablets dosage form.practical Laboratory Medicine. 2020

  • Karmarkar S, Yang X, Garber R et. al., Quality by design based method development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance. Journal of Pharmacy and Biomedical Analysis 2014; 100: 167-174.


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  • Implementation of Quality by Design Approach for Method Development and Validation: A Review

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Authors

Sowmya HG
Research Scholar, College Of Pharmaceutical Sciences, Dayananda Sagar University, Bangalore-560078,, India
M. Gnana Ruba Priya
Associate Professor, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078, India
V. Murugan
Professor and Dean, College of Pharmaceutical Sciences, Dayanandasagar University, Bengaluru-560078,, India

Abstract


QbD is the heart of recent pharmaceutical development. The implementation of QbD principles delivers a cost efficient methodology for delivering quality medicines for users. Regulatory agencies like USFDA and the European medicines agency (EMA) are placing the greater importance on a part of filing. QbD is efficient advances toward progress so as to commence through pre-defined aim and emphasizes manufacturing product and quality process understanding and method control depending on resonance knowledge and quality hazard supervision. Quality cannot be tested in the products but quality should be built by design, it is an essential part of modern approaches to pharmaceutical quality.under this concept of QbD throughout designing and development of a product. It is important to define the performance profile of the desired product, the quality profile of the target product, and identify critical quality attributes.

Keywords


Quality by design, Analytical method validation.

References