A Review on Quality by Design Approach (QBD) for Pharmaceuticals

  • Jayashri J. Bhise
  • Omprakash G. Bhusnure
  • Shrikrishna T. Mule
  • Imran N. Mujewar
  • Sachin B. Gholve
  • Pallavi U. Jadhav


Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines.

Keywords: QbD design, ICH, QTPP, CQA, PAT.


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How to Cite
Bhise JJ, Bhusnure OG, Mule ST, Mujewar IN, Gholve SB, Jadhav PU. A Review on Quality by Design Approach (QBD) for Pharmaceuticals. JDDT [Internet]. 30Jun.2019 [cited 23May2022];9(3-s):1137-46. Available from: http://www.jddtonline.info/index.php/jddt/article/view/3014

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