This guide discusses the principles behind the technology transfer process, which can be applied in full or in part, dependent on the nature and complexity of the products involved in the transfer. The requirement to perform a formal technology transfer is prescribed - directly and indirectly - by the regulatory authorities within the European Union (EU). For those markets regulated by the Food and Drag Administration (FDA) in the United States, there are veiy specific requirements for transfer. Whilst this guideline is focused on the EU, the principles, if applied in full, would be expected to meet FDA requirements also.