TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY: TRANSFER OF PROCESS FROM DEVELOPMENT TO COMMERCIALIZATIONAbstract
Appropriate technology transfer is both integral and critical to drug discovery and development for new medicinal products and is also important to upgrade drug quality designed during research and development and to final product during manufacturing as well as to assure stable quality transferred. Successful development and commercialization of innovative technologies is always fraught with difficulties, multifaceted endeavour, and a variety of development tools exist to promote this activity, by far the most popular approach to directly promoting successful innovation is through technology transfer. To successfully and simultaneously develop appropriate clinical good manufacturing practice facilities, specify and design specialized process equipment, finalize process details, and correctly determine scale-up parameters requires the integrated efforts of a highly skilled technology transfer team. Successful technology transfer requires carefully studying numerous situations like careful evaluation of ultimate manufacturing requirements early in research and development and the consequent development of robust processes that withstand large-scale operation, the assembly of a detailed technology transfer document that provides manufacturing with both “know how” and “know why,” and will serve as the basis for facilities and equipment design as well as operator training and standard operating procedure generation and the management of a closely integrated and cooperative technology transfer team with membership from development, manufacturing, engineering, quality, validation, and management to ensure that the new process is carefully and thoroughly taught to all involved, that fine details as well as broad objectives are clearly in focus until the new process is through consistency lots and in successful manufacturing.
Rahul Dogra*, Rajeev Garg and Prabhash Jatav
Department of Pharmaceutics, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy, Punjab, India
12 January, 2013
28 February, 2013
29 April, 2013
01 May, 2013