Standard Operating Procedure

The FDA requires that all PET drug manufacturing and imaging facilities follow explicit and accepted Standard Operating Procedures (SOPs). These procedures cover not only drug production, but also distribution, administration, equipment use and qualification, and facility regulatory procedures.  The purpose is to ensure that your processes are under strict control at all times.

Let Cyclomedical’s experience aid you here. As part of the original consortium submitting PET production to the FDA for a New Drug Application, we developed the SOPs for 18F FDG and have continued to upgrade and improve them. For you, the result will be a catered set of documents guiding:  

  • Administration  
  • Equipment  
  • Quality Assurance  
  • Radiation Safety  
  • Aseptic processing area (clean room)
  • Staff training
  • Drug acceptance/distribution  

Cyclomedical’s expertise will work for you.