Radiopharmaceutical quality control is performed and evaluated prior to release for administration
- Radiopharmaceutical quality control is vital to ensure the safety and effectiveness of a nuclear medicine procedure1.
- The safe and effective use of radiopharmaceuticals requires that they be of the highest quality with regard to their radionuclide and radiochemical purity
- Although radiopharmaceuticals are controlled for quality by manufacturers, they still require testing before administration.
- Radiopharmaceutical integrity may be affected by storage conditions:
- Exposure to light, storage temperature, etc. may affect the stability of some products2
- The presence of impurities, such as different radionuclides or unwanted chemical forms of the desired radionuclide, may affect the diagnostic information or result in unnecessary radiation to the patient1.
- In practice, MRTs are not always the team members responsible for carrying out quality control (e.g., in a facility with a central radiopharmacy).
- MRTs should be aware of the acceptable limits (pass/fail) for the radiopharmaceuticals they employ.
- Acceptable limits can be found in product monographs
- In addition, MRTs are aware of factors that can affect the quality of radiopharmaceuticals (e.g., storage) and take care to heed expiry dates/times.
- A comprehensive radiopharmaceutical quality control program is developed and implemented3.
- Parameters to be assessed on radiopharmaceuticals prior to release include:
- Correct and complete label
- Total radioactivity and volume
- Absence of foreign particulate
- Radiopharmaceutical quality control is product dependent and may include3:
- Chemical purity
- Radiochemical purity
- Radionuclidic purity
- Particle size and count
- Absence of foreign particulate matter
- Colour and clarity
- The MRT documents or confirms the successful completion of quality control tests before a product is used4
- If a radiopharmaceutical fails the quality control tests, the first step is to confirm and evaluate all aspects of the quality control itself, including:
- Materials used
- Equipment used
- After this confirmation, the quality control procedures are repeated.
- If the radiopharmaceutical fails quality control on the repeat procedure, the radiopharmaceutical is discarded.
- The MRT checks the lot number and notifies a person of authority (e.g., radiopharmacist, manager) of the problem with radiopharmaceutical quality
- Quality control failures are documented and investigated, with measures taken to prevent future events4.
Kowalsky RJ, Falen SW. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine. 3rd ed. Washington, DC: American Pharmacists Association, 2011.
Saha GB. Fundamentals of Nuclear Pharmacy. New York, NY: Springer, 2010.
Callahan RJ, Chilton HM, Ponto JA, et al. Procedure Guideline for the Use of Radiopharmaceuticals 4.0. J Nucl Med Technol 2007;35(4):272-275.
European Association of Nuclear Medicine. Guidelines on current good radiopharmacy practice (CGRPP) in the preparation of radiopharmaceuticals. Available from: http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf. [Accessed 20 Mar 2013]