Method Transfer
Methodology transfer is the documented evidence that a method can be replicated at another site while meeting pre-defined specifications.
Every batch entering the country is approved for quality control by the manufacturing plant. However, Mexican regulations require local quality control testing for all imported medications. To comply with this requirement and avoid a complete revalidation, "analytical methodology transfer" is employed.
This process qualifies a different laboratory, other than the originating one, to perform one or more methodologies, ensuring that the results obtained by the external laboratory are also reliable. In this particular case, the transfer of analytical methodologies necessary for conducting quality control tests for a product is being analyzed. The process is outlined in a transfer protocol, and upon completion, a final report is generated, approving the external laboratory for conducting the analyses, provided it meets the required parameters. One of the methods employed is the comparison of homogeneous samples, which verifies that inter-laboratory precision falls within acceptable ranges.