Quality by Design - A Review

  • Manohar D Kengar Rajarambapu College of Pharmacy
  • Jameer A Tamboli Rajarambapu College of Pharmacy
  • Chandrakant S Magdum Rajarambapu College of Pharmacy
Keywords: Quality-by-design, design space, risk management, ICH guidelines


Pharmaceutical Quality by Design (QBD) is a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management. Quality purchasing design (QBD) is emerging to increase the promise of providing safe and effective medicines to customers and promises to improve the efficiency of product quality. Quality means eligibility for use. The quality of the medication means that the product provides therapeutic benefits to the label reproducible and free from contamination on the label. In vivo or in vitro performance test can be evaluated for drug production. Dietite by Quality guarantees the performance of the product in vitro and the performance of the in vitro product in the in vivo product. "So the quality design is related to the product."

Author Biographies

Manohar D Kengar, Rajarambapu College of Pharmacy

Rajarambapu College of Pharmacy,
Kasegaon, Dist – Sangli, Maharashtra, India

Jameer A Tamboli, Rajarambapu College of Pharmacy

Rajarambapu College of Pharmacy,
Kasegaon, Dist – Sangli, Maharashtra, India

Chandrakant S Magdum, Rajarambapu College of Pharmacy

Rajarambapu College of Pharmacy,
Kasegaon, Dist – Sangli, Maharashtra, India


"Chemistry/ Manufacturing/ Controls (CMC)". Pharmatech Associates. available at: https://pharmatechassociates.com/ecosystem/productprocess/chemistry-manufacturing-controls-cmc-2/

"International Conference on Harmonisation (ICH) Guidelines". Rowan University. Available at: https://research.rowan.edu/officeofresearch/compliance/irb/policiesguidance/ichguidelines/index.html.

Chemolab Lebrun (2008); Development of a new predictive modeling technique to find with confidence equivalence zone and design space of chromatographic analytical methods; Chemometrics and Intelligent Laboratory Systems; 91(1); 4-16.

Department of Health and Human Services U.S. Food and Drug Administration (2007); Pharmaceutical Quality for the 21st Century: A Risk-Based Approach. Available at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm128080.htm.

Early, John (2013),"Quality by Design, available at: http://www.qualitydigest.com/inside/quality-insider-article/quality-design-part-1.html. (Retrieved on 03/14/2019).

Early, John (2013); "Quality by Design, available at: https://www.qualitydigest.com/inside/quality-insider-article/quality-design-part-2.html. (Retrieved on 03/14/2019).

ICH Quality Guidelines; available at: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.

Joseph A. Defeo & Juran, J. M. (2010); Juran's Quality Handbook: The Complete Guide to Performance Excellence 6/e; McGraw-Hill Education; 6 edition; 1136.

Juran, J. M. (1992); Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services Free Press Business & Economics; 538.

Lawrence X. Yu (2008); Pharmaceutical quality by design: product and process development, understanding, and control; Pharm Res; 25(4); 781–791.

Rathore A.S. (2009); Roadmap for implementation of quality by design (QbD) for biotechnology products; Trends Bio technol.; 27(9):546-53.

Schweitzer, Mark. (2010); "Implications and Opportunities of Applying QbD Principles to Analytical Measurements"; Pharmaceutical Technology; 34(2); 52–59.

U.S. Department of Health and Human Services Food and Drug Administration (2011); Process Validation: General Principles and Practices" (PDF). FDA Guidance. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf.

How to Cite
Kengar, M., Tamboli, J. and Magdum, C. 2019. Quality by Design - A Review. PharmaTutor. 7, 4 (Apr. 2019), 48-51. DOI:https://doi.org/10.29161/PT.v7.i4.2019.48.