Ivars Bemberis

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