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TECHNOLOGY TRANSFER TO THE FACILITY FOR PRODUCTION OF MEDICINES
- Authors: Beregovykh V.V.1, Spitskii O.R.2
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Affiliations:
- Sechenov First Moscow State Medical University, Russian Federation
- OOO NNE Pharmaplan, Moscow, Russian Federation
- Issue: Vol 68, No 12 (2013)
- Pages: 49-57
- Section: PHARMACEUTICALS: CURRENT ISSUES
- Published:
- URL: https://vestnikramn.spr-journal.ru/jour/article/view/108
- DOI: https://doi.org/10.15690/vramn.v68i12.860
- ID: 108
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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.
Keywords
About the authors
V. V. Beregovykh
Sechenov First Moscow State Medical University, Russian Federation
Author for correspondence.
Email: beregovykh@ramn.ru
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 Россия
O. R. Spitskii
OOO NNE Pharmaplan, Moscow, Russian Federation
Email: olsp@nnepharmaplan.com
Head of Quality System Department of “NNE Pharmaplan” LLC. Address: 19, Leninskaya Sloboda Street, Moscow, RF, 115280; tel.: +7 (499) 270-09-99 Россия
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