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

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.

Keywords

radiopharmaceutical preparations / PET / validation / beyond specification limits / Media Fill Test

RIGHTS & PERMISSIONS

Nepochatov I.O.