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.