| Parameter |
Early Phase |
Full |
Partial |
Transfer |
| When is it conducted? |
≤3 months
Limited API |
>3 months |
Significant change |
Between labs |
| SSTs (retention time, area, N, T, k’, Rs) |
X |
X |
|
|
| System Performance Check Standards |
|
X |
|
|
| Linearity & Range (R2 >0.99) |
X |
X |
|
|
| Number of QC Batch Runs |
1 |
≥2 |
1 |
1 |
| Carryover (1% of std. or 20% LLOQ) |
X |
X |
|
|
| LLOQ (sensitivity, S/N ≥10) |
|
X |
|
|
| Specificity / Selectivity |
X |
X |
|
|
| Accuracy (% recovery) and Precision (% RSD) |
X |
Intra-run
and
Inter-run |
X |
X |
Stability
(pre & post, storage, F/T, stock) |
|
X |
|
|
|