ABSTRACT:
The methodical strategy known as Quality by Design or QbD has transformed the pharmaceutical sector by emphasising product quality, safety, and efficacy. This method, which is supported by regulatory organisations such as the USFDA and ICH, emphasises the importance of risk management, understanding processes and goods, and predetermined targets. Important elements such the Quality Target Product Profile, Critical Process Parameters, Critical Quality Attributes, control techniques, or knowledge regarding processes all are included in QbD concepts. SThe increasing acceptance of Analytical Quality by Design (AQbD) in the development of methods ensures robust analytical procedures. The regulatory view highlights the significance of QbD in securing product quality through systematic risk-based methods, continuous improvement, and modern technologies like Process Analytical Technology (PAT). This is especially true for the USFDA and ICH.The use of QbD has expanded to a number of industries, such as the food, pharmaceutical, and herbal sectors, proving its adaptability and efficacy in improving product development, production, and quality control. This Review also illustrates certain Case studies that demonstrate the effective use of QbD in fields including the creation of analytical methods, the formulation of polyherbal tablets, and the assessment of food quality. As the pharmaceutical sector moves towards continuous manufacturing, quality by design (QbD) becomes increasingly important for increasing production effectiveness, cutting expenses, and preserving regulatory compliance. All things considered, QbD presents a bright future for producing pharmaceutical items of the highest standard while reducing mistakes and uncertainty in the production process.