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System Suitability Test required for GLP work?

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  • Pauline Carr
    15/09/2020 13:03
    This is probably a mute question but should a system suitability test be run on a HPLC system for each set of samples being tested for a GLP study. I know that GMP requires SST to be run but not sure about GLP requirements.
  • RQA GLP Committee
    19/11/2020 14:04
    Dear Pauline, You would need to be able to prove that the equipment and reagents were fit for purpose, and along with other factors (appropriate service and calibration, running standards with samples etc), it would be usual to conduct system suitability testing at least each day that analysis was performed, if not every run. Consider the risk to the samples. If you only have a small amount of sample and doing a repeat run may not be feasible then it would be important to know everything was operating correctly for that run. Therefore, it may be advisable to follow GMP expectations (and your SOPs).
  • Alex Johnson
    13/12/2020 17:43
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