SPDS Set 1 ERP Book

CHON-002

tablet used. Inter-day Precision was reported at 1.94% RSD and Intra-day precision was reported at 1.53%, which meets the SMPR of less than or equal to 2%. Assessed using the combined %RSD of the analysis of two samples over two days. This was done within the same laboratory rather than a multi-laboratory validation as stated in the SMPR. No system suitability results were reported for the validation nor are there any stated requirements in the method to ensure the system is operating as intended prior to analysis.

Reproducibility (RSDR)

System Suitability

Is the method safe to use as written? Are there any safety concerns with any component, instrument, reagent or instruction of the method? If yes, please clearly state the concerns. Does the method include all necessary safety precautions and/or warning statements? Yes or No. If No, please suggest potential precautions or warnings that can be added to the method for users or recommend safer option(s) if warranted.

Yes

No

There is no mention of any safety precautions in the method.

Recommendations

I do not recommend the method be adopted for First Action status. The method uses instrumentation that is not widely used in commercial testing laboratories. The methodology lacks specificity and robustness. There are far too many parameters that require strict controls thus making this method undesirable for routine QC testing.

Final Recommendation: