Organizing Technology Transfer from Research to Production

An overview of issues to be considered when organizing the transfer of technology from the research arena to the production environment will be presented. The discussion will focus on the coordination and implementation of a transfer program for a product with emphasis being given to those factors peculiar to the pharmaceutical industry. The success of any program is highly dependent on the effectiveness of the communication preceding its implementation. Therefore, the preparation and distribution of a complete document summarizing raw material and equipment requirements, manufacturing and packaging processses, process validation parameters, quality control procedures, as well as a detailed plan of action outlining expected results and time frames, must be disseminated prior to the scale-up experience. Input from the marketing and manufacturing centers must also be integrated into the plan to ensure that the right product is developed at the right price within the desired time frame. An outline encompassing these critical aspects of a transfer program will be presented.