Comprehension of Quality by Design in the Development of Oral Solid Dosage Forms

1Research and Development, Centaur Pharmaceuticals Pvt. Ltd., Plot No. 4, Phase II, ITBT park, Hinjewadi, Pune, Maharashtra, INDIA

2Department of Pharmaceutical Sciences, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, INDIA

3Department of Pharmaceutical Sciences, Dr. R. G. Bhoyar Institute of Pharmaceutical Education and Research, Wardha, Maharashtra, INDIA

Corresponding author.

Correspondence: Mr. Pramod Parshuramkar Centaur Pharmaceuticals Pvt. Ltd., Plot No. 4, Phase II, ITBT Park, Hinjewadi, Pune, Maharashtra, INDIA. Email: pramodudps@yahoo.co.in
Received November 12, 2023; Revised February 27, 2023; Accepted March 30, 2023.
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Citation

1.Parshuramkar P, Khobragade D, Kashyap P. Comprehension of Quality by Design in the Development of Oral Solid Dosage Forms. Journal of Young Pharmacists [Internet]. 2023 Aug 25;15(3):406–18. Available from: http://dx.doi.org/10.5530/jyp.2023.15.56
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Published in: Journal of Young Pharmacists, 2023; 15(3): 406-418. Published online: 22 August 2023DOI: 10.5530/jyp.2023.15.56

ABSTRACT

The Quality by Design (QbD) concept has been appreciated and expected by the regulatory agencies, especially the “United States Food and Drug Administration” (USFDA), the “European Medicines Agency” (EMA), and other agencies that have adopted the “International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use” (ICH) around the globe. This paper describes the application of QbD principles in the pharmaceutical development of Oral Solid Dosage forms (OSDs). It encourages the implementation of risk-based approaches when designing pharmaceutical products. It provides a thorough understanding of formulation variables, Critical Material Attributes (CMAs), process variables, and Critical Process Parameters (CPPs) based on industrial experience that can be considered for risk assessment during the development of OSDs. It provides handy guidance to academics, research scholars, and industry scientists for implementing QbD in developing the OSDs.

Keywords: Control strategy, Critical process parameters, Critical material attributes, Quality by design, Risk assessment