Abstract

A REVIEW ON QUALITY BY DESIGN APPROACH (QBD) FOR PHARMACEUTICAL DEVELOPMENT

*Arjun Joshi, Anil G. Raval, Dr. Yogesh K. Patel and Kanchan M. Mandal

ABSTRACT

Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines.

Keywords: Quality by Design (QbD), Process Analytical Technology (PAT), Quality target product profile, Critical quality attributes.