System Suitability during validation/verification
Posted: Wed Sep 10, 2014 10:38 am
As per USP 37 NF 32. What does it mean for their System Suitability Guideline as mentioned below:
"Whenever, there is a significant change in the chromatographic system (equipment, mobile phase component, or other components) or in a critical reagent, System Suitability is to be reestablished."
During validation we have, Precision, Day 2 (Intermediate Precision), Solution Stability (24 hours standing of day 1 sample with fresh standard), Robustness. Do I still need to perform suitability test if.
1. I'm injecting same sample preparation again the next day with new standard preparation but still the same HPLC system and mobile phase?
2. I'm injecting new sample and standard preparation but still the same HPLC system and mobile phase?
THanks.
"Whenever, there is a significant change in the chromatographic system (equipment, mobile phase component, or other components) or in a critical reagent, System Suitability is to be reestablished."
During validation we have, Precision, Day 2 (Intermediate Precision), Solution Stability (24 hours standing of day 1 sample with fresh standard), Robustness. Do I still need to perform suitability test if.
1. I'm injecting same sample preparation again the next day with new standard preparation but still the same HPLC system and mobile phase?
2. I'm injecting new sample and standard preparation but still the same HPLC system and mobile phase?
THanks.