Abstract

A REVIEW ON IMPLEMENTATION OF QUALITY BY DESIGN IN FORMULATION DEVELOPMENT OF PHARMACEUTICAL PRODUCT

Bhavin D. Pandya*, Shreyash A. Diwakar and Ajay K. Saluja

ABSTRACT

The objective of this review is to provide brief overview about Quality by design (QbD) approach. The Quality by design (QbD) is a concept was first developed by Dr. Joseph M. Juran. It is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH Q8 guideline. Quality by design (QbD) is a quality system for managing a product‟s lifecycle which is emerging to enhance the assurance of safe and effective drug supply to the patient and also offers promise to significantly improve manufacturing quality performance. Some of the elements of QbD include defining quality target product profile, identifying critical quality attributes, process parameters, sources of variability, risk assessment and controlling manufacturing process to produce consistent quality over time. The application of QbD in Pharmaceutical product development is systematic and helps to ensure pharmaceutical quality and drug development by involving multivariate experiments utilizing process analytical technology (PAT) and other test to identify critical quality attributes (CQAs) based on risk assessments (RAs).

Keywords: Quality, Quality by Design, ICH, Quality Target Product Profile, Lifecycle Management, Change Control, FMEA, PAT, Multivariate Analysis.