Quality control management in the production of radiopharmaceuticals at the A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies
- Authors: Nepochatov I.O.1
-
Affiliations:
- A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies of the Ministry of Health of the Russian Federation
- Issue: Vol 3, No 1S (2021): Supplement
- Pages: 48-49
- Section: Пленарное заседание
- URL: https://journals.eco-vector.com/PharmForm/article/view/71775
- ID: 71775
Cite item
Full Text
Abstract
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., 70References
