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Abstract
Quality by Design (QbD) is a transformative and systematic approach to developing top-tier pharmaceutical products, ushering in a departure from traditional trial-and-error methods toward a more science-based, risk-oriented, and holistic strategy. Central to QbD implementation is the meticulous development of formulations and manufacturing processes, consistently fulfilling predefined quality objectives. The core objective of QbD remains unwavering — to guarantee the steadfast alignment of the final pharmaceutical product with predetermined quality attributes, thereby mitigating batch-to-batch variations and potential recalls. This article succinctly explores the multifaceted application of QbD methodology within the pharmaceutical industry. Emphasizing its pivotal role in research and development, manufacturing, quality control, and quality assurance, the discussion navigates through the strategic deployment of QbD elements and tools. Amidst the evident advantages of QbD, challenges persist in its widespread adoption within the pharmaceutical sector and regulatory frameworks. This article sheds light on the regulatory landscape that currently governs the implementation of QbD in these crucial stages of pharmaceutical processes. For that reason, this review article aims to provide researchers, scientists, and industry professionals with a thorough introduction to QbD so they may adopt this methodical approach to developing and producing high-quality pharmaceutical products, always in compliance with the underlying regulations.Graphical
Highlights
Ensuring pharmaceutical product quality is a top priority for industries, driven by the need to safeguard patient safety and ensure the efficacy of products
DoE experiments underscored the significant influence of drug loading on the sole quality attribute—paracetamol sustained-release formulations’ dissolution rate. These findings demonstrate the valuable application of Quality by Design (QbD) in tablet manufacturing by providing crucial insights into critical parameters and their impact on essential quality attributes, thereby contributing to the optimization of sustained-release formulations [71]
The global pharmaceutical landscape is transforming with the increasing integration of QbD methodology
Summary
Ensuring pharmaceutical product quality is a top priority for industries, driven by the need to safeguard patient safety and ensure the efficacy of products. By planning and executing experiments, collecting data, and analysing results statistically, DOE allows for the systematic evaluation of process parameters [12] This structured approach helps experts identify key sources of variability and determine the optimal conditions needed to achieve the desired product quality features. Controlling these critical variables within clearly defined limits reduces the risk of product failures, inconsistencies, and batch rejections Another key element of QbD is the development of a Quality Target Product Profile (QTPP) [2, 13], which outlines the therapeutic goals, safety requirements, and intended product characteristics [14]. As regulatory agencies increasingly favor QbD-based submissions, its long-term advantages in process efficiency, regulatory flexibility, and patient safety outweigh the initial implementation challenges [20] In this comprehensive review, the objective is to thoroughly explore the significant role played by QbD in the pharmaceutical industry, focusing on its application across fundamental domains — research and development, manufacturing, quality control, and quality assurance. This review highlights how QbD principles refine and advance the pharmaceutical development processes
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