Opportunities and challenges to implementing Quality by Design approach in generic drug development.

This article presents an overview of the implementation of key elements (Target Product Profile, Critical Quality Attributes, design space and control strategy) of Quality by Design (QbD) – a systemic approach in the case of generic drugs. The basis for this concept is that advanced understanding of variables affecting generic drug (product) quality, either obtained through historical operation or demonstrated through process modelling, justifies the replacement of the traditional process targets with acceptable operational ranges. This article also describes the steps involved in the development of generic drugs, steps through which the QbD concept can be applied, and the opportunities for and challenges to implementing QbD in generic drug development. [ABSTRACT FROM AUTHOR]