Challenges In Designing Anda For Parenteral Products

Abstract

Pharmaceutical industry is one of the most regulated sectors as it deals with life of myriad patients. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. Quality by design (QbD)-based product development involves the following elements: (a) identification of quality target product profiles (QTPPs) followed by critical quality attributes (CQAs) for various parenteral products, (b) process design and identification of critical process parameters (CPPs), (c) design space, and (d) control strategy and continuous improvement. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. Agreement on these key concepts will allow discussion of the application of these concepts to abbreviated new drug applications to progress.