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

1★, 2, 3★ Corresponding author

  1. 1Research and Development, Centaur Pharmaceuticals Pvt. Ltd., Plot No. 4, Phase II, ITBT park, Hinjewadi, Pune, Maharashtra, INDIA.
  2. 2Department of Pharmaceutical Sciences, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, INDIA.
  3. 3Department of Pharmaceutical Sciences, Dr. R. G. Bhoyar Institute of Pharmaceutical Education and Research, Wardha, Maharashtra, INDIA.

CORRESPONDENCE

Pramod Parshuramkar

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

pramodudps@yahoo.co.in

Received: 12-11-2022; Revised: 27-02-2023; Accepted: 30-03-2023.

Volume 15, Issue 3 · pp. 406-418 · 2023 · DOI: 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.

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    Parshuramkar, P., Khobragade, D., & Kashyap, P. (2023). Comprehension of Quality by Design in the Development of Oral Solid Dosage Forms. Journal of Young Pharmacists, 15(3), 406-418. https://doi.org/10.5530/jyp.2023.15.56

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    © 2023 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0