ABSTRACT

Analytical techniques must be created for different phases of the P’ceutical product life cycle. If these processes are not effectively organized using scientific knowledge and process understanding, they can lead to an expensive and time-intensive procedure. The pharmaceutical industry is actively exploring novel policies or elements that can be incorporated into or substituted for existing components in their quality and risk management systems. The concept of Quality by Design was initially outlined by the renowned quality expert Joseph M. Juran. This concept can also be extended to analytical method development, referred to as Analytical Quality by Design. Quality by Design is a systematic approach to development that begins with predefined objects and emphasises product and process understanding and process control. AQbD is essential in modern method development, contributing to a systematic approach to drug development. This review article's main objective is to delineate the steps in method development with Analytical quality by design, addressing implementation concerns. The analytical method development process includes Critical Performance Attributes (CPAs), MODR, Analytical Method Validation, Control Strategy, and Continuous Method Improvement. Keywords: Analytical Quality by Design, Analytical Target Profile, Critical Performance Attributes, MODR
Publication date: 01/12/2024

https://ijbpas.com/pdf/2024/December/MS_IJBPAS_2024_8504.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.12.8504