Method Transfer

Analytical methods are a major tool in pharmaceutical development to control the quality and integrity of the active drug substance or drug product. The process that establishes documented evidence that the analytical method works in the receiving laboratory as well as in the originator's laboratory or the transferring laboratory, is termed Analytical Method Transfer (AMT). The most common approach for an AMT is comparative testing, where well -characterized samples are analyzed in the transferring and receiving lab following a standard operating procedure. The whole AMT process is documented in a Method Transfer Protocol, where also the acceptable criteria are specified.


VelaLabs is experienced in AMTs and has performed such activities for example for companies from EU countries, India and USA.