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Radiopharmaceutical quality control (NM specific)

 

Radiopharmaceutical quality control is performed and evaluated prior to release for administration

 

+ Importance of quality control

  • Radiopharmaceutical quality control is vital to ensure the safety and effectiveness of a nuclear medicine procedure.1
    • 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 patient.1

+ Quality control in practice

  • 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 implemented.3
  • Parameters to be assessed on radiopharmaceuticals prior to release include:
    • Correct and complete label
    • Total radioactivity and volume
    • Appearance
    • Absence of foreign particulate

 

  • Radiopharmaceutical quality control is product dependent and may include:3
    • Chemical purity
    • Radiochemical purity
    • Radionuclidic purity
    • Sterility
    • Apyrogenicity
    • pH
    • 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 used.4

+ Quality control failure

  • If a radiopharmaceutical fails the quality control tests, the first step is to confirm and evaluate all aspects of the quality control itself, including:
    • Method/technique
    • 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 events.4

+ References

  1. Kowalsky RJ, Falen SW. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine 3rd edition. Washington, DC: American Pharmacists Association, 2011.
  2. Saha GB. Fundamentals of Nuclear Pharmacy. New York, NY: Springer, 2010.
  3. 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.
  4. European Association of Nuclear Medicine. Guidelines on current good radiopharmacy practice (CGRPP) in the preparation of radiopharmaceuticals. Available at: http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf. Accessed March 20, 2013.

Related guidelines

 

Useful links

 

Validation

October 16, 2013

 

 
Canadian Association of Medical Radiation Technologists
85 Albert St, Suite 1000, Ottawa, ON, K1P 6A4
phone: 613 234-0012 / 800 463-9729
fax: 613 234-1097
www.camrt.ca