Method Transfer

Analytical methods are a major tool in the 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 as well in the receiving laboratory as in the originator's laboratory, or the transferring laboratory, is called analytical method transfer (MT). The most common approach for MT is comparative testing, where well characterized samples are analyzed in the transferring and receiving lab following a standard operating procedure. The whole MT process is written down in a Method Transfer Protocol - also the acceptable values are specified in this document.

Vela is experienced in MT and has performed such activities within the EU and from India.