TECHNOLOGY TRANSFER TO THE FACILITY FOR PRODUCTION OF MEDICINES

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Abstract


Innovation development of pharmaceutical industry is close connected to knowledge transfer going to each subsequent life cycle phase of medicinal product. Formal regulation of technology and knowledge transfer is essential for achievement high quality during production of medicines designed during development phase. Conceptual tools, approaches and requirements are considered that are necessary for knowledge and technology transfer across all the life cycle phases of medicines. They are based on scientific knowledge of medicinal products and take into account both international and Russian regulations in the area of development, production and distribution of medicines. Importance of taking into consideration all aspects related to quality of medicines in all steps of technology transfer is shown. An approach is described for technology transfer organization for Russian pharmaceutical manufacturers based on international guides in this area.

 


About the authors

V. V. Beregovykh

Sechenov First Moscow State Medical University, Russian Federation

Author for correspondence.
Email: beregovykh@ramn.ru

Russian Federation PhD, corresponding member of RAMS, Head of the Department of Industrial Pharmacy of SBEI HPE “I.M. Sechenov First Moscow State Medical University” of Ministry of Health, RAMS. Address: blng. 2, 8, Trubetskaya Street, Moscow, RF, 119991; tel.: +7 (495) 698-56-50

O. R. Spitskii

OOO NNE Pharmaplan, Moscow, Russian Federation

Email: olsp@nnepharmaplan.com

Russian Federation Head of Quality System Department of “NNE Pharmaplan” LLC. Address: 19, Leninskaya Sloboda Street, Moscow, RF, 115280; tel.: +7 (499) 270-09-99

References

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