Abstract

Technology transfer for pharmaceutical products is a program that has been followed for some time (1–9). Issues to be considered when organizing the transfer of technology from the research arena to the production and quality assurance (QA) environments are reviewed in this article. The discussion focuses on the coordination and implementation of a technology transfer program for a product, with emphasis on factors unique 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 processes, process validation parameters, quality control (QC) procedures, and safe handling procedures—as well as a detailed plan of action outlining expected results and time frames—must be distributed before the technology transfer and scale-up experience. Input from the marketing and manufacturing centers must 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 is presented.