Abstract

APPLICATION OF QUALITY BY DESIGN APPROACH IN ANALYTICAL METHOD DEVELOPMENT

*Suvarna Sharad Vanjari, Tushar Atmaram Deshmukh and Vijay Raghunath Patil

ABSTRACT

The concept of Quality by Design was first defined by the quality guru Joseph M. Juran, according to Juran quality cannot be tested into the product; quality should be built in by design. The aim of pharmaceutical development is to design a quality product and its manufacturing process consistently delivers the intended performance of the product. The quality, safety and efficacy of a pharmaceutical product must be designed significantly by thoroughly understanding the role of each component of a product(critical quality attributes) and systematic understanding and control of all the process steps (Unit operations) involved in the manufacturing (Critical Process Parameter). The key objective of adopting the concept of Quality by Design (QBD) is to achieve process and product robustness, to achieve better patient care. Quality by Design it is a systematic approach to development; product or analytical method development that begins with predetermined objective and emphasizes product and process understanding and process control, based on sound science and quality risk management. It is an essential part of the modern approach to build quality in the product by design. Quality has been given an importance by all regulatory body for pharmaceutical products. Quality means customer satisfication in terms of services, product and process. Customer demands perfection in quality, reliability, low cost and performance. The features like performance, trustworthiness, robustness, ease of use serviceability has to be built in the product and such product should be free from deficiencies.

Keywords: Quality by Design, Quality Risk Management Analytical Method Development.