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    
Table 2: Four Types of Validations.