Technology transfer

Moving a manufacturing process or an analytical method from one site, team or company to another so that the receiving side can make or test the product to the same quality. For methods, it ends with a comparison of results between the sending and receiving laboratories (analytical method transfer). Copying set points is rarely enough, because different equipment changes what the product experiences, such as mixing, heat transfer or hold times. For a product approved in Japan, a new site also has to be handled under the marketing approval: MHLW's typical examples treat adding a manufacturing site as a partial change application. Plan the transfer timeline around that filing.