Page 16 - qp_17
P. 16

c)  Estimation Of Total Imprecision

                      1.  Calculate Total Imprecision (SDT)using the following equation :


                                                              − 1
                                                                              2
                                                                       2
                                                     =  �   ∙    + 
                                                      
                                                                              
                                                               
                          Where n= number of replicates per day
                      2.  Calculate Total CV (CVT)using this equation :
                                                                 
                                                         =    × 100
                                                           
                                                                
                      3.  Compare with
                             i.   Manufacturer’s claimed total CV (CVMT) &within run CV (CVMWR)

               d) Evaluation Of Imprecision

                   1.  Compare the calculated CVWR  and CVT with the manufacturer’s claim CV

                       •  If CVWR and CVT< manufacturer’s claim, preliminary evaluation is accepted.
                       •  If CVWR and/or CVT>manufacturer’s claim, perform verification of manufacturer’s
                          claim
   11   12   13   14   15   16   17   18   19   20   21