1. Radiopharmaceutical Production
Personnel
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2. 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
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3. 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.

4. 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

5. 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*

6. 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

7. 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).

8. 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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