Competency: 10

Details

Write and disseminate standard operating procedures (SOPs) for the quality management system for the preparation and quality control of radiopharmaceuticals.

Considerations

• Quality assurance, including management and organisational aspects.
• Quality risk management.
• Quality management systems.
• Quality audits: participation in internal and external audits and inspections, follow-up and reporting, including relevant aspects of clinical governances, controls assurance standards, risk management/assessment and critical point analysis
• The role of the qualified person.
• Quality system review.
• BS5750, ISO 9000.
• Laboratory of Government Chemist (LGC) and Pharmassure schemes of intra-laboratory quality assurance.
• Governance and controls assurance, risk management and critical point control analysis.
• United Kingdom Accreditation Service.
• EU Good Manufacturing Practice (GMP).
• International Good Manufacturing Practice (GMP) guidelines and standards.
• Quality assurance and technical information database.
• Defective products, complaints and recall procedure.
• Inter-relationships between disciplines involved in quality assurance.
• Royal Pharmaceutical Society hospital standards.
• Documentation.
• Authorisation, control and indexing the documentation.
• Updating and version control.
• Pharmaceutical formulation and processes.
• Properties of excipients and ingredients in pharmaceutical products.
• Key chemical and physical reactions involved in the preparation, stabilisation and degradation of medicinal products.
• Mathematical principles and calculations for pharmaceutical sciences.
• Radionuclides used in nuclear medicine:
  • the relationships between their physical properties, their clinical applications, and their strengths and weaknesses;
  • the radiopharmaceutical chemistry of these radionuclides;
  • the influence of these chemical properties on the biodistribution of their radiopharmaceuticals;
  • the different formulations used in nuclear medicine; properties and preparation;
  • radiopharmaceutical kits and reagents used therein.
• Radiation safety in radiopharmacy.

Relevant learning outcomes