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.


About the authors

Anna Bacevich

Saint-Petersburg Chemical and Pharmaceutical University, Saint Petersburg, Russia

Author for correspondence.
Email: anna.basevich@pharminnotech.com
SPIN-code: 8189-3806

Russian Federation, 197376, St. Petersburg, Professora Popova st., 14

Associate Professor, Ph.D. in Pharmaceutical Sciences, Deputy head of the Department of Industrial technology of medicines

Anatoliy S. Dzjuba

Pharmproject JSC, St. Petersburg

Email: anatoly.dzuba@pharminnotech.com

Russian Federation, 192236, Россия, Санкт-Петербург, ул. Софийская, 14

PhD of Pharmaceutical Sciences, Head of development Department, JSC «Farmproekt»

Irina E. Kaukhova

Saint-Petersburg Chemical and Pharmaceutical University, Saint Petersburg, Russia

Email: irina.kaukhova@pharminnotech.com
SPIN-code: 2931-5790
Scopus Author ID: 736701

Russian Federation, 197376, St. Petersburg, Professora Popova st., 14

D.Sc. of Pharmaceutical Sciences, Professor, Head of the Industrial technology of medicines Department,

Alexandra Tretiakov

Saint Petersburg State Chemical and Pharmaceutical University, Saint-Petersburg, Russia

Email: arina.tretjakova@pharminnotech.com

Russian Federation, 197376, St. Petersburg, Professora Popova st., 14

master student of the faculty of industrial medicine technology, Department of Economics and management

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Copyright (c) Bacevich A., Dzjuba A.S., Kaukhova I.E., Tretiakov A.

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