An analytical transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The experiments performed in such a transfer and the methodology used to accept or reject it should be fitted for purpose. Indeed, the process could take months and it is not realistic to perform such a long transfer in research or in an early development. However, when the method is transferred from development to production or when the quality control of a production is outsourced, it is highly critical to have all the guarantees that the method is mastered by the receiver in order to avoid problems in the future.
To corroborate the importance of this process, the Food and Drug Administration (FDA) mentions that analytical transfers appeared frequently in their 483 observations in the last years. Unfortunately, there is no regulatory guidance on this topic. However, the FDA collaborated with the International Society for Pharmaceutical Engineering (ISPE) to publish a guideline on transferring expertise and technology associated with analytical methods.
As it is for method validation, total error-based approach should be also considered in method transfer. The β-expectation tolerance interval similar to the one used in method validation is calculated and then compared to acceptance limits around the estimate of the true value.
This approach is about checking whether most of the results produced by the receiver are close to the average result of the sender.
TRANSVAL is dedicated to the transfer of quantitative analytical methods in these highly critical situations.
Login - Minimal Requirements - Features - References.
