columns

[hmelnickis]

Dear Collegues,

I am working for pharmaceutical company. I have one big problem with
inspector (auditor), and always asks me why we don't test new chromatographic columns before starting using them? I think it is not necessary, if we make system suitability test when we do analysis. What do you think? How does your laboratory test chromatographic columns? How often? Thanky you very much in advance.


Best regards,

Juris

[Elixirchen]

Dear Juris,

In our company, we always check column specification when we receive it at first time. We need make sure the condition of column to be suitable to use. I think that it is very necessary to do/check it .

How to do ?
==> We repeat and test specification and method from vendor such as Waters or Vercopak.

How often?
==> We always repeat column validation every six monthes.

Best regards.

[Uwe Neue]

Your columns come with a chromatogram that is a Certificate of Analysis by the column manufacturer. I would think that this is sufficient to accept the column. After all, you qualify the column beyond this Certificate for your assay afterwards in the system suitability test, and this is the thing that really counts.

Have you shown the inspector the Certificate of Analysis by the column manufacturer? You could write it into your procedure that the column needs to have passed the specifications of the manufacturer, which may be obvious, but it would cover you.

[tom jupille]

If you meet system suitability, the column is suitable. End of story.

If you don't meet system suitability, the column is not suitable, regardless of whether it passed the manufacturer's spec or not. The column manufacturer's test may or may not respond to factors that are important for your analysis.

As a matter of personal opinion, I think that the only meaningful test for an incoming column is an abbreviated form of system suitability (I usually focus on the retention/resolution/efficiency part rather than repeatability).

If you have been experiencing a significant number of failed columns on startup (columns that looked OK on the manufacturer's test but failed your system suitability), then doing this incoming test is a good idea (better to get early warning that your new column is a dud!). If you have not had a bad column problem, then the extra effort is probably not cost-effective, and relying on the manufacturer's test would be just fine.