Review Article

The AAPS Journal

, Volume 10, Issue 2, pp 268-276

Quality by Design: Concepts for ANDAs

  • Robert A. LionbergerAffiliated withFood and Drug Administration, Office of Generic Drugs
  • , Sau Lawrence LeeAffiliated withFood and Drug Administration, Office of Generic Drugs
  • , LaiMing LeeAffiliated withFood and Drug Administration, Office of Generic Drugs
  • , Andre RawAffiliated withFood and Drug Administration, Office of Generic Drugs
  • , Lawrence X. YuAffiliated withFood and Drug Administration, Office of Generic Drugs Email author 

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.

Key words

control strategy critical material attributes critical process parameters design space quality by design