The implementation of a Contamination Control Strategy (CCS) according to Annex 1 also provides significant added value for radiopharmaceutical products while at the same time defining clear regulatory requirements. The CCS ensures consistent control throughout the entire manufacturing process, resulting in increased safety and product quality and ensuring compliance with regulatory standards.
In radiopharmaceutical manufacturing processes, the execution of classical GMP controls is made more difficult by radiation-protection-related constraints as well as the use of automated, closed systems. The short half-lives of radionuclides allow for only limited controls, which makes preventive CCS measures particularly important. Despite shielded working environments, risks remain due to limited maintenance and cleaning possibilities and the need for remote interventions. Regulatory expectations for barrier technology, cleanroom management, and environmental monitoring require a documented overall concept—from target preparation to product release.
The application of Quality Risk Management (QRM) principles is a key element throughout all lifecycle phases. Through systematic risk assessments, potential contamination risks in radiopharmaceutical manufacturing are identified and appropriate control measures are established.