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- Posts: 7
- Joined: Mon Dec 04, 2017 4:33 pm
When creating a new system suitability method, how does one go about determining the acceptance criteria of critical parameters like peak area percent RSD and tailing? I've looked in the USP, EP, and JP, and none seem to list specific requirements (e.g. the JP says "The allowable limit of "System repeatability" should be set at an appropriate level based on the data when suitability of the method for the evaluation of quality of the drug was verified, and the precision necessary for the quality test.")
Agilent, for example, requires a peak area RSD of 2% to pass their annual preventative maintenance. What process would they have gone through to ultimately justify this value?
Thanks