Review on Pharmaceutical Quality by Design (QbD)

Authors

  • Deepak Deepak Kumar Department of Pharmaceutics, Arya college of Pharmacy Jaipur, Rajasthan, India.
  • Rahul Ancheria Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India
  • Saumya Shrivastava Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India
  • Shankar Lal Soni Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India
  • Mukesh Sharma Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

DOI:

https://doi.org/10.22270/ajprd.v7i2.460

Keywords:

Quality-by-design, design space, risk management, ICH guidelines.

Abstract

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. Dinette 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.

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Author Biographies

Deepak Deepak Kumar, Department of Pharmaceutics, Arya college of Pharmacy Jaipur, Rajasthan, India.

Department of Pharmaceutics, Arya college of Pharmacy Jaipur, Rajasthan, India.

Rahul Ancheria, Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Saumya Shrivastava, Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Shankar Lal Soni, Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Mukesh Sharma, Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

Department of Pharmaceutics, Arya College of Pharmacy, Kukas, Jaipur, Rajasthan, India

References

1. https://en.wikipedia.org/wiki/Quality_by_Design
2. Chemistry/manufacturing/controls (CMC)”.Pharmatec Associates.
3. Early, John (2013); "Quality by Design, available at: https://www.qualitydigest.com/inside/quality-insider-article/quality-design-part-2.html..
4. 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.
5. Chemolab Lebrun, 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; 2008; 91(1): 4-16.
6. Juran JM, Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services Free Press Business & Economics,1992; 538.
7. Lawrence XYu, Pharmaceutical quality by design: product and process development, understanding, and control; Pharm Res,2008; 25(4):781–791
8. General Principles and Practices" (PDF). FDA Guidance. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
9. Juran, JM, Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services Free Press Business & Economics; 538.
10. Rathore AS, Roadmap for implementation of quality by design (QbD) for biotechnology products; Trends Bio technol, 1992; 27(9):546-53.
11. Department of Health and Human Services U.S. Food and Drug Administration (2007); Pharmaceutical Quality for the 21st Century: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm128080.htm.
12. Early, John (2013),"Quality by Design, available at: http://www.qualitydigest.com/inside/quality-insider-article/quality-design-part-1.html.
13. International Conference on Harmonisation (ICH) Guidelines". at:https://research.rowan.edu/officeofresearch/compliance/irb/policiesguidance/ichguidelines/index.html.
14. ICH Quality Guidelines; available at: https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.

Published

2019-04-15

How to Cite

Deepak Kumar, D., Ancheria, R., Shrivastava, S., Soni, S. L., & Sharma, M. (2019). Review on Pharmaceutical Quality by Design (QbD). Asian Journal of Pharmaceutical Research and Development, 7(2), 78–82. https://doi.org/10.22270/ajprd.v7i2.460

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