The AAPS Journal

, Volume 10, Issue 2, pp 268–276

Quality by Design: Concepts for ANDAs

Authors

  • Robert A. Lionberger
    • Food and Drug AdministrationOffice of Generic Drugs
  • Sau Lawrence Lee
    • Food and Drug AdministrationOffice of Generic Drugs
  • LaiMing Lee
    • Food and Drug AdministrationOffice of Generic Drugs
  • Andre Raw
    • Food and Drug AdministrationOffice of Generic Drugs
    • Food and Drug AdministrationOffice of Generic Drugs
Review Article

DOI: 10.1208/s12248-008-9026-7

Cite this article as:
Lionberger, R.A., Lee, S.L., Lee, L. et al. AAPS J (2008) 10: 268. doi:10.1208/s12248-008-9026-7

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

Copyright information

© American Association of Pharmaceutical Scientists 2008