The approach/criteria of setting Acceptance Limits Method Validation Parameters

[v9991]

we perform analytical-method validation as per ICH Q2 (<<Dead Link Removed>> )
This is for analyzing assay of a ingredient, with specification limits of 95-105% of label claim.
Parameters include, precision (system & method), accuracy, method linearity, ruggedness, robustness etc.,

Acceptance criteria for (system)precision is set as RSD<5% (6-measurements of single sample preparation )

Acceptance criteria for (method)Accuracy is set as +/- 5% + RSD<5% (usually equivalent to that of system-precision); (measurements form 6 sample preparations)

now the question...
1) what is the approach/criteria of setting acceptance limits method validation parameters.

2) in above case for precision and accuracy, what is does the acceptance criteria signify?

3) Accuracy is demonstrated at multiple concentrations, so, can i accept any value outisde +/-5%; (places where RSD is complying!!!)

thanks for your thoughts.

 

[v9991]

Let me bring clarity into my query.../ simplify ...
what is the influence of a (Assay) specification limits(90-110% vs 95-105%) on accpetance criteria for method validation parameters Precision & Accuracy.
Precision is usually set with accpetance criteria RSD < 6%
Accuracy is usually set with acceptance criteria of 95-105% + RSD < 5%