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.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.10.6424