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 › 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)	48-64
Number of pages	17
Journal	Pharmaceutical Technology
Volume	38
Issue number	9
Publication status	Published - 2015
Externally published	Yes

Cite this

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AU - Hanna-Brown, Melissa

AU - Barnett, Kimber

AU - Harrington, Brent

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AU - Morgado, Jim

AU - Colgan, Steve

AU - Wrisley, Loren

AU - Szucs, Roman

AU - Sluggett, Gregory

AU - Steeno, Gregory

AU - Pellett, Jackson

PY - 2015

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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/84944224247

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SN - 1543-2521

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SP - 48

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JO - Pharmaceutical Technology

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Using quality by design to develop robust chromatographic methods

Abstract

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