چکیده (انگلیسی):

The analytical transfer is a complete process that consists in transferring an analytical procedure
from a sending laboratory to a receiving laboratory. After having experimentally demonstrated
that also masters the procedure in order to avoid problems in the future. Method of transfers is now
commonplace during the life cycle of analytical method in the pharmaceutical industry. No official
guideline exists for a transfer methodology in pharmaceutical analysis and the regulatory word of
transfer is more ambiguous than for validation. Therefore, in this study, Gauge repeatability and
reproducibility (R&R) studies associated with other multivariate statistics appropriates were successfully
applied for the transfer of the dissolution test of diclofenac sodium as a case study from a sending laboratory A (accredited laboratory) to a receiving laboratory B. The HPLC method for the determination
of the percent release of diclofenac sodium in solid pharmaceutical forms (one is the discovered
product and another generic) was validated using accuracy profile (total error) in the sender laboratory
A. The results showed that the receiver laboratory B masters the test dissolution process, using the
sameHPLC analytical procedure developed in laboratory A. In conclusion, if the sender used the total
error to validate its analytical method, dissolution test can be successfully transferred without
mastering the analytical method validation by receiving laboratory B and the pharmaceutical analysis
method state should be maintained to ensure the same reliable results in the receiving laboratory.