Radiopharmaceutical Production Personnel STOP

Staffing Requirements for an FDG facility The facility for production of PET radioisotopes and radiopharmaceuticals/radiotracers will require staff representing a wide range of qualifications. The number as well as the qualification level of personnel that will be needed in order to maintain smooth operation of the facility will be determined by the size and scope of the facility. In general, the staff should have the formal education, training and experience that are relevant to the assigned tasks. In a small facility, a single person may take on several of the jobs. More about key personnel and job responsibilities can be found by following the arrow. Contents Introduction Production Staff Support Staff Conclusions Additional Resources More Job Responsibilities STOP

Introduction The number of people working at a facility, their qualification and experience are a very important, if not the most important issue, for the efficient running of a PET facility. Many times, while designing a PET facility, It may be difficult to find the right people. It is very important that the people who will be responsible for the day to day operations of the facility be identified early and have training for their area of responsibilities. The technical supervisors and scientists should possess sufficient experience in their respective fields to guide and train the junior technical staff. The facility management should ensure that ample continuing education opportunities are provided for staff training to maintain and enhance performance. The functions involved in the workflow process are listed in the following slides and are divided into the production staff and the support staff. It must be emphasized that the staff are qualified personnel and with specialized training.

Staffing – Primary Production The first classification of people will be those involved in production Primary Job Function Minimum Education Specialized Training Cyclotron Operator(s) Two year technical degree or equivalent Specialized Training which may include: Factory training On the job training Supervised training Extensive mechanical and electrical repairs Radionuclide production Targetry Radiation safety Production Chemist(s) (Radiochemists) Diploma or Degree in Chemistry or equivalent Experience in GMP Synthesis of radiotracers Courses in laboratory operations Board certified or as required by local regulations

Staffing – Primary Production Primary Job Function Minimum Education Specialized Training QC Chemist Diploma or Degree in Chemistry, Pharmacy or Biological Sciences Analytical chemistry and instrumentation Quality assurance and management Experience in GMP Synthesis of radiotracers Courses in laboratory operations Radiation safety Qualified Person Formal training in GMP 2 years practical experience working under GMP licenseAuthorized by the facility to release radiopharmaceuticals*

Staffing - Support Personnel Primary Job Function Minimum Education Specialized Training Radiation Protection Officer Degree in Medical Physics, Health Physics or Radiation Physics Supervised training Radiation safety Engineer Experience in electronics, electromechanical engineering or equivalent Experience in electronic diagnosis and repair Laboratory operations Manager Advanced degree in physical or biological sciences Quality Management Supervision and management Experience in GMP Experience in laboratory operations

Conclusions The size and scope of the facility, in general, will determine the number as well as the qualification level of personnel that will be needed to maintain efficient operation. The staff should have the formal education, training and experience that are relevant to the assigned tasks. While most of these employees would be required to be regular employees, some may be contracted from outside sources (e.g., radiation protection officer and pharmacist).

Additional Resources Cyclotron Produced Radionuclides: Production and Quality Control of FDG [Link Under Construction] Cyclotron Produced Radionuclides: Guidelines for Setting Up a Facility TRS 471. IAEA Human Health Series no. 11 Planning a PET Center

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