Abstract

REVIEW ON: INTEGRATING QUALITY BY DESIGN IN ANALYTICAL METHOD DEVELOPMENT: PRINCIPLES AND BENEFITS

Rushikesh Bodre*, Dr. Sushma Vaishnav, Dr. Pravin Wakte, Dr. Sachin Bhusari and Dr. Gajanan Vaishnav

ABSTRACT

Quality by Design (QbD) is a comprehensive approach employed in the pharmaceutical production sector to ensure the consistent efficacy of analytical procedures. This methodology involves the development of a Control Strategy and the establishment of the Method Operable Design Region (MODR) for the validation of analytical techniques for various batches of Active Pharmaceutical Ingredients (API). Quality by Design emphasizes the incorporation of quality into the product through a systematic design approach rather than relying solely on inspection and review. This manuscript delves into the fundamentals and execution of Analytical Quality by Design (AQbD), encompassing the Analytical Target Profile (ATP), Critical Quality Attributes (CQA), risk evaluation, and experimental design for MODR advancement. By contrasting conventional analytical approaches with the QbD strategy, the advantages of AQbD, like sturdy method formulation, regulatory adaptability, and steady method enhancement, are underscored. The assimilation of AQbD into pharmaceutical advancement ensures that analytical techniques are dependable, precise, and proficient in preserving the anticipated performance over their lifecycle.

Keywords: Quality by Design (QbD), analytical procedures, Control Strategy, Method Operable Design Region (MODR), systematic design, Analytical Quality by Design (AQbD), Analytical Target Profile (ATP), Critical Quality Attributes (CQA), risk evaluation.