AN OVERVIEW ON QUALITY BY DESIGN IN PHARMACEUTICAL PRODUCT DEVELOPMENT

The concept of Quality by Design reflects current global regulatory thinking related to pharmaceutical products. The pharmaceutical industry needs to improve its performance. Newer technologies need to be implemented that can effectively reduce the cost and, at the same time, improves product quality. Quality by design (QbD) is the best solution to build quality in all pharmaceutical products. The main objective of QbD is to ensure the quality product resulting from a combination of prior knowledge and new estimation during development. QbD is being widely promoted by the food and drug administration (FDA) and the international conference on Harmony (ICH). Quality by design (QbD) in the pharmacy field is mainly based on the understanding of how materials and process parameters affect the quality profile of final products. In this article, the key elements of QbD viz., Target product quality profile, Critical quality attributes, Risk assessment, Design space, and Control strategy are discussed to understand the performance of dosage forms within the design space. Tools of QbD (DoE, Quality risk management, and process analytical technology) are also discussed in QbD. These reviews underline the importance of QbD in inculcating a science-based approach in pharmaceutical product development.