Critical evaluation of quality by design software

Reddy, Daram Sushma and Kumar, Vadla Pranay and Shyam, Thalaari and Chandana, Vadagam and Priya, Tenugu Sai and Sandeep, Vankunavath (2025) Critical evaluation of quality by design software. International Journal of Science and Research Archive, 14 (2). pp. 1548-1559. ISSN 2582-8185

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