, Volume 10, Issue 2, pp 268-276

Quality by Design: Concepts for ANDAs

Abstract

Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. 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.

Opinions expressed in this manuscript are those of the authors and do not necessarily reflect the views or policies of the FDA.
The PAR is the range of experimental observations that lead to acceptable quality. A sponsor has the option of conducting experimental observations over the entire POS; in this case the POS could be equivalent to the PAR. Alternatively a sponsor may use prior knowledge, mechanistic models and trends from the PAR to draw conclusions about sensitivity over a POS that is larger than the PAR.