Analytical method transfer

Abstract The transfer of an analytical procedure is the documented process that qualifies a laboratory to use the method that originated in another laboratory, therefore ensuring that the receiving unit has the procedural knowledge and ability to perform the procedure as intended. Analytical methods are commonly transferred from the originating (transferring) site to other laboratories during the clinical, scale-up, or commercialization phases of product development. These receiving laboratories could be within the same company, to another company (when a product is sold), or to an external contract laboratory. The methods may be transferred several times to more than one laboratory across the globe over the lifecycle of the product. It is imperative that the knowledge associated with the routine and successful operation of a method be provided to each site. Also, it must be clearly demonstrated and documented that the receiving laboratories are capable of running the methods and obtaining results with the same accuracy and precision as the laboratory that originally developed that method.