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The development of analytical procedures in a methodical manner is of the utmost significance in the pharmaceutical sector. It is of the utmost importance to strictly adhere to the norms and standards that have been created, such as those that have been developed by respectable organisations such as the International Council for Harmonisation (ICH) and the Food Development Administration (FDA). The concept of Quality by Design (QbD) is a fundamental idea that emphasises having a full understanding of both the product and the process, as well as including control and risk management. When compared to the conventional empirical method development, the science-based approach of Analytical Quality by Design (AQbD) offers a number of significant benefits. These advantages include the ability to get consistent results, the concentration on essential factors, and an increase in cost-effectiveness. In addition, the book digs into the primary factors that were reviewed throughout the process of method development. These criteria include specificity, linearity, limits of detection and quantitation, range, accuracy, and precision that was considered. In addition, it highlights the crucial role that regulatory organisations play in enhancing the quality of pharmaceuticals and in standardising the methods that are used for drug regulation on a global scale. Last but not least, it emphasises the value of AQbD in terms of facilitating regulatory communication, accelerating approval procedures, and monitoring alterations to analytical techniques once approval processes have been completed.