Quality By Design: A Systematic Approach for the Analytical Method Validation
Abstract
The scientific way to develop an easy and robust analytical technique for critical analysis is a QbD approach. QbD is a systematic approach to product or method development that begins with predefined objectives and uses science and risk management approaches to achieve product and method understanding and ultimately method control. The aim of the analytical QbD is to achieve quality in measurement. The main objective of this review to explain different steps involved in method development by the QbD approach for analytical method development and describes the implementation of QbD in analytical procedure validation. The advantages of applying QbD principles to analytical technique include discovering and minimizing the source of variability that may lead to poor method robustness and ensuring that the method meets its intended performance need throughout the product and method lifecycle.
Keywords: Quality by design (QbD), Risk Analysis, Analytical method validation
DOI
https://doi.org/10.22270/jddt.v9i3-s.3114References
Das V, Bhairav B, Saudagar RB. Quality by design approaches to analytical method development. Res J Pharm Technol. 2017;10(9):3188–94.
Jayagopal B, Shivashankar M. Analytical Quality by Design – A Legitimate Paradigm for Pharmaceutical Analytical Method Development and Validation . Mech Mater Sci Eng J. 2017;9:10.
Mogal V, Dusane J, Borase P, Thakare P, Kshirsagar S. Review Article A review on quality by design. Pharm Biol Eval. 2016;3(3):313–9.
Nadpara NP, Thumar R V., Kalola VN, Patel PB. Quality by design (QBD): A complete review. Int J Pharm Sci Rev Res. 2012;17(2):20–8.
Peraman R, Bhadraya K, Reddy YP. 868727. 2015;2015.
Gaykar D, Khadse SC. A Review on Analytical Quality by Design. Int J Pharm Sci Rev Res. 2017;44(2):96–102.
Gandhi A, Roy C. Quality by Design ( QbD ) in Pharmaceutical Industry : Tools , Perspectives and Challenges. 2016;4(11):12–20.
Rozet E, Lebrun P, Hubert P, Debrus B, Boulanger B. Design Spaces for analytical methods. TrAC - Trends Anal Chem [Internet]. 2013;42:157–67. Available from: http://dx.doi.org/10.1016/j.trac.2012.09.007
Reddy KR, Deepa M, Ravindra Reddy K, Satyanarayana S V. A Review on Quality by Design Approach for Analytical Method Development. J Pharm Res [Internet]. 2017;11(4):272–7.
Bhusnure OG, Shinde NG, Gholve SB, Giram PS. QbD approach for analytical method development of anti-pschotic drug. Der Pharm Lett. 2015;7(12):62–70.
Gupta K. Analytical Quality by Design: A Mini Review. Biomed J Sci Tech Res. 2017;1(6):1–5.
Pande PP, Sayyad SF, Chavan MJ, Chaudhari SR. Quality by design in analytical method development and validation. J Environ Life Sci [Internet]. 2017;2(2):39–45.
Jadhav JB, Namdeogirawale N, Chaudhari RA. Quality by Design (QBD) Approach used in Development of Pharmaceuticals. Int J Pure Appl Biosci. 2014;2(5):214–23.
Gholve SB, Ajgunde RR, Bhusnure OG, Thonte SS. Pelagia Research Library Analytical method development and validation by QbD approach – A review. Der Pharm Sin. 2015;6(8):18–24.
Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arab J Chem [Internet]. 2014;10:S3412–25.
Tang Y. Quality by Design Approaches to Analytical Methods. 2011;
Raman NVVSS, Mallu UR, Bapatu HR. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. J Chem. 2015;2015:1–8.
Published
Abstract Display: 2224 
PDF Downloads: 1374 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.