Abstract

QUALITY BY DESIGN A QUALITY ENHANCEMENT TOOL FOR PHARMACEUTICAL PRODUCT

Suyog Nivrutti Cheke*, Satish Shelke, Rushikesh Diware and Shirish Jain

ABSTRACT

Quality cannot be tested into product it has to be build into product. This paper gives idea about how QBD is operating as a tool for significant rise in quality of pharmaceutical product. Product design is a integral part of QBD. Implementing quality by design in our practices by designing the target product drug profile gives brief idea about quality by design elements. The advantages, possibilities, and stages involved in Pharmaceutical Quality by Design are discussed. Pharmaceutical industry ensures quality of final product by imposing QBD as a tool. Suitable acknowledgement of role of ICH and FDA in establishing quality by design The focus of the pharmaceutical development is to outline a quality product and its manufacturing process to inevitably deliver the intended performance of the product.

Keywords: Quality by design, Design space, Pharmaceutical development, Critical quality attributes.