Competency: 2

Details

Perform successful broth transfer test

Considerations

• UK regulatory requirements that apply to the design and operation of radiopharmacies.
• Activities normally undertaken in a hospital radiopharmacy.
• Consolidated Human Medicines Regulations 2012
• The Medicines Act 1968 and its implication to medicines preparation activities, with particular attention on hospital-based work.
• EU Good Manufacturing Practice (GMP).
• Pharmaceutical microbiology:
  • microorganisms, microbial growth (form and actions of microbes)
  • sources of microbiological contamination
  • potential risks from microbial contamination (pathogens and infection risks)
  • spoilage and control/preservation.
• Quality assurance in radiopharmacy in particular and describe the most important means of control of aseptic preparation and how the principles of quality assurance are routinely applied in a radiopharmaceutical production system.

Relevant learning outcomes