Application of modern GRPP principles in quality control of radiopharmaceuticals obtained from licensed radionuclide generators in conditions of limited production volumes

Abstract

Relevance. The production of radiopharmaceutical drugs (RPhD) in conditions of limited volume and work with short-lived isotopes is associated with special difficulties. Traditional GMP (Good Manufacturing Practice) standards, focused on large-scale production, are not always applicable in radiopharmaceutical laboratories. Therefore, the principles of GRPP (Good Radiopharmacy Practice), which adapt GMP requirements to the real conditions of RFLP production in small volumes, while maintaining high quality and safety standards, are of particular importance. Purpose of the study. To evaluate the effectiveness of applying the GRPP principles in quality control of radiopharmaceutical drugs produced using radionuclide generators in conditions of limited production, using the example of the practice of the RSE "BMC UDP RK" on the PVC. Materials and methods. An analysis of the GMP and GRPP regulatory framework was carried out, and technological processes for the production of RFLP using generator systems were considered. The experience of synthesizing ⁶⁸Ga-DOTA-TOC, ⁶⁸Ga-PSMA-11, ⁶⁸Ga-FAPI-46 and the planned ⁶⁸Ga-Pentixafor preparations was studied. Quality control methods and adaptation of production processes to limited production volumes were assessed. Results and discussion. The application of GRPP principles allows for the effective adaptation of GMP requirements to the specific features of radiopharmaceutical preparations (RPhLP) production under limited production volume conditions. This approach provides a reliable quality control system optimized for small-scale production without compromising safety and compliance with international standards. In our laboratory, GRPP principles were implemented in the processes of production and quality control of radiopharmaceutical preparations obtained using licensed radionuclide generators. This allowed us to adapt international GMP requirements to the specific features of small-scale production and ensure full compliance with modern standards in the field of radiopharmaceuticals. Conclusion. The application of modern GRPP principles in quality control of radiopharmaceuticals obtained using licensed radionuclide generators is a key factor in ensuring the safety and efficacy of products in conditions of limited production volumes. This approach helps to optimize production processes, increase the reliability of manufactured drugs and ensures compliance with high quality standards. The implementation of these principles plays an important role in the development of radiopharmaceuticals, supporting innovative areas in molecular imaging and personalized medicine.

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