QUALITY BY DESIGN: A NOVEL APPROACH FOR THE DEVELOPMENT OF QUALITY PHARMACEUTICALS
Authors: Nikam R , BAHETI A, KUCHEKAR A, WANI M, POLSHETTIWAR S AND TAGALPALLEWAR A

ABSTRACT
Customer satisfaction and loyalty are indicators of quality. Because of the public's increased awareness of product quality, it has become a top priority for most businesses. In this review, various aspects of product quality design will be discussed. QbD is a development methodology which begins with predetermined goals & stress on product and process quality formulated on prior experience and effective control of risks. The target product profile, critical quality characteristics, risk control, creating a design room, and control methodology are all important aspects of QbD. QbD describes how composition & production process attributes affect production efficiency. With the help of some case studies, this approach is explained in the present review. QbD is an efficient tool, and with mandatory regulatory requirement to ensure that pharmaceutical products are of high quality. Keywords: Quality, critical quality Attributes, Risk assessment, predetermined goals
Publication date: 01/10/2022
    https://ijbpas.com/pdf/2022/October/MS_IJBPAS_2022_6424.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.10.6424