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Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full-scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factor for risk analysis having the most impact on quality attributes of a medicinal product. Further important factors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.


About the authors

V. V. Beregovykh

I.M. Sechenov First Moscow State Medical University, Russian Federation

Author for correspondence.
доктор технических наук, член-корреспондент РАМН, заведующий кафедрой про- мышленной фармации Первого МГМУ им. И.М.Сеченова Адрес: 119991, Москва, ул. Трубецкая, д. 8, стр. 2, тел.: +7 (495) 698-56-50 Russian Federation

O. R. Spitskii

«NNE Pharmaplan», Moscow, Russian Federation

руководитель системы качества ООО «ННЕ Фармаплан» Адрес: 115280, Москва, ул. Ленинская Слобода, д. 19, тел.: +7 (499) 270-09-99 Russian Federation


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