Chromatography Forum

We are reviewing our current paper based HPLC Column tracking system due to issues with keeping all the data consistent. How are others on the forum tracking column useage - "paper" based system, CDS, 3rd party system, etc.? We were considering going with the CDS, but while ChemStation Plus could do this, Cerity can not (or at least does not let you query on column information).

What do you do with the information if you do record it - review before next use, review when disposing of column, etc.?

Has anyone who works in a regulated environment (especially FDA, MHRA) been challenged on their system, or lack of? I'm trying to see if there is a reulatory requirement to track column performance, or if it is just seen as "good practice".

On the second point, do you dedicate columns to particular analytical methods, or do you use the same column for different methods? If the latter, do you have any criteria on what methods the column can be used, e.g. similar composition of mobile phase.

Thanks
Tim

Re dedicating columns:
- columns are cheap
- your time is valuable
- OOS investigations are expensive.

Tim,

Column performance in routine tasks in a regulated environment should be addressed by the system suitability test. This IS required and I am not aware of any reqirements for further affords on column tracking.
What is the use of a column tracking system if it is unclear how the gained information is used? If collecting column use information it should be reviewed before next use. What happens if you review it just before disposal and find that some thing is wrong?
It makes less problems if a column is dedicated to a special method.

Alex