Qualification of a Chromotographic Column

May 1, 2003
J. Kevin O'Donnell
J. Kevin O'Donnell

,
Robert M. Kennedy
Robert M. Kennedy

,
Oliver Kaltenbrunner
Oliver Kaltenbrunner

,
Ivars Bemberis
Ivars Bemberis

,
Anurag S. Rathore

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi, Tel. +91.9650770650, asrathore@biotechcmz.com.

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-05-01-2003, Volume 15, Issue 5

In this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.

The US Food and Drug Administration (FDA) has become more knowledgeable regarding process chromatography - and more demanding concerning column qualification. In this article, five industry experts share their insights on how to qualify a chromatographic column. Their advice: write unambiguous standard operating procedures (SOPs); focus on the reproducibility of column packing; choose appropriate metrics; and analyse your testing procedures to reduce the chance of erroneous results.

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