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Case Study Information

  • Project name : Nuclear compliance audits of radiopharmaceutical installations (Asia)
  • Client : Confidential
  • Complete date : 2023
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Nuclear compliance audits of radiopharmaceutical installations (Asia)

NucAdvisor conducted compliance audits at various radiopharmaceutical manufacturing sites (PET, SPECT, and therapeutic) to assess regulatory status and long-term compliance with nuclear regulations. The evaluation covered:

- Licensing status, including limitations (e.g., expiry, renewal, constraints)

- Onsite and offsite radioactive waste management

- Transport/logistics risks and regulatory compliance

- Radiological protection for staff, public, and environment (e.g., dose records, ALARA strategy)

- Past incidents, mitigation actions, and emergency preparedness

- Site-specific factors (e.g., boundaries, physical security)

- Internal safety organisation and documentation

- Results of internal inspections and corrective