Pharmaceutical Product Development: A Quality by Design Approach

  • Kannissery Pramod College of Pharmaceutical Sciences, Government Medical College, Kozhikode, Kerala, India
  • M. Abu Tahir Biogenero Labs Pvt Ltd., Unit No.1, Sy. No 179, C.K Palya, Hullahalli, Sakalvara Post, Bangalore, India
  • Naseem A. Charoo [3]Zayn Pharmaceuticals, Unit No. 2H-05-320, Floor No.5 Bldg No.2, Plot No. 550-554 J&G, DMCC, Dubai, United Arab Emirates; [4] AlFalah Life Sciences Pvt. Ltd. 27-Wathora, Budgam-191113, Jammu and Kashmir, India.
  • Shahid H. Ansari Department of Pharmacognosy and Phytochemistry, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi, India
  • Javed Ali Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi, India
Keywords: Design of experiments, Design space, Process analytical technology, Risk assessment, Quality by Design, QbD


The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.


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Quality by design system
How to Cite
Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J. Pharmaceutical Product Development: A Quality by Design Approach. ijpi [Internet]. 1Aug.2016 [cited 9Dec.2021];6(3):129-38. Available from: