Qualification of a Chromatographic Column: Why and How to Do It

March 15, 2003

BioPharm International, BioPharm International-03-01-2003, Volume 16, Issue 3

by Anurag Rathore, Pharmacia Corporation FDA has become more knowledgeable about process chromatography ? and more demanding about column qualification. In the latest installment of BioPharm International's "Element of BioPharmaceutical Production," five industry experts share their insights on how to qualify a chromatographic column. Their advice: Write unambiguous SOPs. Focus on reproducibility of column packing. Choose appropriate metrics. And analyze your testing procedures to reduce the chance of erroneous results.