The development of an algorithm of introduction of new drug on the existing pharmaceutical production. Stage 2. Transfer of technologies

Abstract

Transfer of technologies is a logical, controllable and documented procedure of transfer of technology and control methods of medicine from the developer to the producer or from one producer to another [1]. A lot of departments of the enterprise involved in this process, their organization and coordination of work determines the character, timeliness and completeness of the transfer that has a direct influence on the quality of products. The task of the company in transfer of technologies is to preserve the quality of products and compliance with GxP rules, while material resources, time and space of the enterprise are economizing. Transfer of technologies divides into a preparatory stage and two main stages. The universal algorithm of the project of transfer of technology for the introducing a new drug at the operating enterprise is developed, the system of the organization of control and risk assessment of project activity is defined.