Quality & Compliance
RMC maintains a quality management framework to ensure that radiopharmaceutical production meets applicable regulatory and clinical standards. Quality practices focus on documentation, traceability, and controlled processes.
Quality Management
- Documented procedures covering production and quality control.
- Batch records and traceability for each production run.
- Deviation management and corrective actions when needed.
Regulatory Alignment
- Compliance with Croatian regulatory requirements for radiopharmaceutical production.
- Alignment with relevant EU guidelines and standards applicable to nuclear medicine.
Audits and Reviews
Internal reviews and external inspections support ongoing compliance and improvement.