ABSTRACT
Technology transfer for pharmaceutical products is a program that has been followed for some time. This chapter reviews the issues to be considered when organizing the transfer of technology from the research arena to the production and quality assurance environments. It focuses on the coordination and implementation of a transfer program for a product, with emphasis given to those factors special to the pharmaceutical industry. The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process. Personnel training must also be considered if the technology is new to the site. Return on involvement encompasses the philosophy that employees are a key element in the successful introduction of any technology or product approval. Any development and technology transfer program should be reduced to a written document. Critical areas affecting the manufacture, packaging, safety, and quality of pharmaceutical products are discussed in relationship to their impact by the technology transfer process.
