Quality control management in the production of radiopharmaceuticals at the A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies

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To date, radiopharmaceutical preparations (RP) are subject to the same production and quality control requirements as non-radioactive pharmaceuticals. Although there are specific requirements for the production of RP, which complicate the fulfillment of some general requirements. For example, it is allowed to release radiopharmaceutical preparations containing some short shelf-life radionuclides for use before the completion of quality control test. This makes it difficult to work with deviations, going beyond the specification limits. There is a number of issues with validation. It is difficult to perform the Media Fill Test due to low volume production of RP. All these problems need to be addressed.

About the authors

Ilya O. Nepochatov

A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: TO_Nepochatov@zzczst.ru

Head of Quality Assurance Department

Russian Federation, 197758, Saint Petersburg, Pesochny settlement, Leningradskaya str., 70


Copyright (c) 2021 Nepochatov I.O.

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СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 76969 от 11.10.2019. 

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