Critical evaluation of quality by design software

Daram Sushma Reddy; Vadla Pranay Kumar; Thalaari Shyam; Vadagam Chandana; Tenugu Sai Priya; Vankunavath Sandeep

doi:10.30574/ijsra.2025.14.2.0343

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Critical evaluation of quality by design software

Daram Sushma Reddy ^*, Vadla Pranay Kumar, Thalaari Shyam, Vadagam Chandana, Tenugu Sai Priya and Vankunavath Sandeep

Department of Pharmaceutical Analysis, Malla Reddy Institute of Pharmaceutical Sciences, Maisammaguda, Dhulappaly, Post via kompally, Secunderabad-500100.

Review Article

International Journal of Science and Research Archive, 2025, 14(02), 1548-1559

Article DOI: 10.30574/ijsra.2025.14.2.0343

DOI url: https://doi.org/10.30574/ijsra.2025.14.2.0343

Publication history

Received on 23 December 2024; revised on 21 February 2025; accepted on 24 February 2025

Abstract

Quality by design (QbD) represents the modern approach to ensuring pharmaceutical quality. This concept has significantly influenced the progress of pharmaceutical sciences, having been established and applied globally in accordance with the International Conference on Harmonization (ICH) Guidelines. The proposed ICH guidelines—Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems—provide a foundation for integrating quality into products.

In the QbD framework, it is crucial to define the desired product performance profile, known as the Target Product Profile (TPP), and the Target Product Quality Profile (TPQP), as well as to identify Critical Quality Attributes (CQA). Based on this, we can design both the product formulation and the process to meet these attributes. This leads to recognizing the impact of raw material Critical Material Attributes (CMA) and Critical Process Parameters (CPP) on the CQAs, and identifying sources of variability

Keywords

Quality By Design; Design of Experiments; Target Product Profile (TPP); Target Product Quality Profile (TPQP); Critical Process Parameter (CPP)

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How to cite this article

Daram Sushma Reddy, Vadla Pranay Kumar, Thalaari Shyam, Vadagam Chandana, Tenugu Sai Priya and Vankunavath Sandeep. Critical evaluation of quality by design software. International Journal of Science and Research Archive, 2025, 14(02), 1548-1559. Article DOI: https://doi.org/10.30574/ijsra.2025.14.2.0343.

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