Abstract

QBD – A NOVEL SETUP FOR THE ANALYTICAL METHOD DEVELOPMENT

Priya B. Shah*, Pruthviraj K. Chaudhry, Khushbu K. Patel and Dr. C. N. Patel

ABSTRACT

The aim of this article is to address pharmaceutical Quality by Design (QbD) and how it can be used to verify pharmaceutical quality. The modern approach to pharmaceutical quality includes quality by design. The elements of quality by design are examined, and a standard nomenclature for quality by design, critical quality attributes, critical process parameters, critical material attributes, and management strategy is established. The use of QbD was compared to the use of testing alone to assess product consistency. The QbD approach to pharmaceutical production may be a general one. It shows that product quality is maintained through the development and improvement of formulations and manufacturing processes. Defining the target product quality profile, designing product and manufacturing processes, recognising essential quality characteristics, process parameters, and sources of variability, and managing manufacturing processes to maintain consistent quality over time are just a few of the QbD activities. By knowing and monitoring formulation and manufacturing variables, pharmaceutical consistency can be ensured using QbD.

Keywords: Food and Drug Administration (FDA), Quality by Design (QbD), target product quality profile, critical quality attributes, design space, risk assessment.