Quality by Design: Concepts for ANDAs

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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.

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Understanding critical material properties for solid dosage form design

Anthony Hlinak, Kamal Kuriyan, Kenneth R. Morris … (2006)

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Commentary on AAPS Workshop: dissolution testing for the twenty-first century: linking critical quality attributes and critical process parameters to clinically relevant dissolution.

Manoranjan S. D’Souza, T Mirza, David Tong … (2007)

This is a summary report of the workshop entitled "Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," organized by the In Vitro Release and Dissolution Testing Focus Group of the American Association of Pharmaceutical Scientists. Participants from the pharmaceutical industry, regulatory authorities, and academia in the US, Europe, and Japan attended this workshop to review, discuss, and explore the role of traditional dissolution testing in the new arena of Quality by Design (QbD) and Process Analytical Technology (PAT). Other areas of discussion were the use of the dissolution test to evaluate drug release from novel dosage forms, challenges in dissolution testing and specification setting, and dissolution apparatus calibration using performance verification tablets versus mechanical calibration. The workshop identified areas where further research and collaboration are needed to advance knowledge and understanding of the science of dissolution. Views expressed in this report are those of the authors and do not necessarily reflect those of the FDA and USP.