Using quality by design to develop robust chromatographic methods

Melissa Hanna-Brown; Kimber Barnett; Brent Harrington; Tim Graul; Jim Morgado; Steve Colgan; Loren Wrisley; Roman Szucs; Gregory Sluggett; Gregory Steeno; Jackson Pellett

Using quality by design to develop robust chromatographic methods

Melissa Hanna-Brown
, Kimber Barnett
, Brent Harrington
, Tim Graul
, Jim Morgado
, Steve Colgan
, Loren Wrisley
, Roman Szucs
, Gregory Sluggett
, Gregory Steeno
, Jackson Pellett

Pfizer

Research output: Contribution to journal › Review article › peer-review

Abstract

The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems because the variability in any process is partly made up of the contributions of the measurement system variability used to understand the process. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Original language	English
Pages (from-to)	70-88
Number of pages	19
Journal	Pharmaceutical Technology Europe
Volume	26
Issue number	9
Publication status	Published - 1 Sep 2014
Externally published	Yes

Cite this

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abstract = "The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems because the variability in any process is partly made up of the contributions of the measurement system variability used to understand the process. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.",

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AU - Hanna-Brown, Melissa

AU - Barnett, Kimber

AU - Harrington, Brent

AU - Graul, Tim

AU - Morgado, Jim

AU - Colgan, Steve

AU - Wrisley, Loren

AU - Szucs, Roman

AU - Sluggett, Gregory

AU - Steeno, Gregory

AU - Pellett, Jackson

PY - 2014/9/1

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N2 - The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems because the variability in any process is partly made up of the contributions of the measurement system variability used to understand the process. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

AB - The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems because the variability in any process is partly made up of the contributions of the measurement system variability used to understand the process. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

UR - https://www.scopus.com/pages/publications/84919420194

M3 - Review article

AN - SCOPUS:84919420194

SN - 0164-6826

VL - 26

SP - 70

EP - 88

JO - Pharmaceutical Technology Europe

JF - Pharmaceutical Technology Europe

IS - 9

ER -

Using quality by design to develop robust chromatographic methods

Abstract

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