Abstract

QUALITY BY DESIGN APPROACH FOR PHARMACEUTICALS: IMPLEMENTATION, APPLICATIONS AND CHALLENGES

Dipali S. Doifode*, Akanksha S. Ghatare, Ab Ahesan Ab Faruk, Sonali A. Kantale, Shyamkumar M. Dabhade, Prashil S. Dhumale and Anuja M. Rekhate

ABSTRACT

A crucial component of the contemporary advancement in pharmaceutical quality is quality by design, or QbD. This review identifies some of the components of quality by design and describes them. The advantages, prospects, and procedures associated with pharmaceutical product quality by design are explained. The goal of pharmaceutical development is to create high-quality products and manufacturing processes that reliably produce the desired results. Products cannot be assessed for quality; instead, quality should be included in the design. Key components of Quality by Design, as well as the Quality Goal product profile and essential quality criteria, are included. The ICH Guidelines serve as the cornerstone of Quality by Design. It is predicated on the ICH Guidelines Q8 for pharmaceutical development and Q9 for pharmaceutical quality systems quality risk management. It also outlines the problems and applications of qualityby design in the research and production of pharmaceuticals.

Keywords: Quality by Design (QbD), ICH Guidelines Q8, Quality target product profile, Critical quality attributes, Risk Assessment.