Verification test to assess the analytical performance

[frasmx]

Hi all

Hope can somebody help. I work for a company that develops personal care products, we have liquid and gas chromatographs, by regulations must make a monthly verification test to assess the analytical performance of the aparratus, someone I can recommend a simple test to achieve this goal ?. which standards to use? etc.

thank a lot

[Bluesman75]

For a monthly check I would do no more than checking flow rate, column temperature and lamp intensity for the HPLC and gas flow rate for the GC.

[tom jupille]

This may not help, but a validated regulatory method should include system suitability criteria which must be checked every time an analysis is run. If you meet those criteria, then the system is suitable for the analysis. Doing additional test is redundant.

That said, I would concur with Bluesman75's comment (just to keep the regulators happy). One way of accomplishing this is to run a "mini system suitability" on one of your simpler assays once a month. If the retention times are correct, then your flow rates and temperature must be correct. If you get the expected peak area from a standard, then your detector must be functioning OK.

[frasmx]

Thanks a lot,