Abstract

QUALITY BY DESIGN (QBD): A COMPREHENSIVE REVIEW

Pranita Kalidas Pawar*, Anuradha Kameshwar Salunkhe, Meena Kiran Jagtap, Payal Sudhakar Katkar, Shubham Ganeshrao Bhosle and Shantanu Anil Dhobale

ABSTRACT

Quality by Design is the modern approach for quality of pharmaceuticals. Quality means customer satisfaction in terms of services, product and process. QbD is best key to build a Quality in pharmaceutical products. This paper discusses pharmaceutical Quality by Design (QbD) as a way to generate high quality pharmaceuticals. Details about Quality by Design are given in addition to a list of components and tools of Quality by Design. It is based on the ICH Guidelines Q8 for Pharmaceutical development, Q9 for Quality risk management, Q10 for Pharmaceutical Quality system. Quality by Design (QbD) and describes use of Quality by Design to ensure quality of pharmaceutical analysis. Under this concepts of be throughoutdesign and growth of products, it is important to identify desire product performance report Target Product Profile (TPP), Quality Target Product Profile (QTPP), and identify Critical Quality Attributes (CQA). QbD (Quality by Design) was one of design experiment approved by the FDA to maintain the quality of drug product before reaching to market.

Keywords: CQA, CS, DS, DoE, QbD, QRM.