03.05.02. Radiopharmaceutical quality control
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.1–3
- A poor quality diagnostic radiopharmaceutical may result in1:
- inaccurate diagnostic information about the patient resulting in the inappropriate choice of therapy or intervention,
- increased radiation exposure to non-target tissues,
- increased radiation exposure due to repeat procedure, and/or
- reduced efficacy.
- Although radiopharmaceuticals are controlled for quality by manufacturers from the beginning of production, with the increased use of on-site radiopharmaceutical kit preparations, quality control must be performed prior to dispensing these products for administration to patients.4
- Radiopharmaceutical stability and integrity may be affected by storage conditions. For example, exposure to light and storage temperature may affect the stability of some products.4
- In practice, MRTs are not always the team members responsible for carrying out quality control (e.g., some facilities may have a central radiopharmacy, or a facility may order unit doses from radiopharmaceutical suppliers).
- MRTs should be aware of the acceptable limits (pass/fail) per the product monographs for the radiopharmaceuticals they employ.
- In addition, MRTs should be aware of factors that can affect the quality of radiopharmaceuticals (e.g., storage, temperature) and take care to heed expiry dates/times.
- Parameters to be assessed on radiopharmaceuticals prior to release include:
- Radiochemical purity
- Total radioactivity and volume
- Appearance
- Absence of foreign particulate
- A correct and complete label should be applied to remain legible and affixed during the processing, storage, handling, and distribution of the radiopharmacutical.6
- Radiopharmaceutical quality control is product dependent and may include3:
- Chemical purity – chemical impurities are caused by the breakdown of the material before or after labelling, or their inadvertent addition during labelling. An example of chemical impurity is excessive aluminum in a 99mTc eluate.
- Radiochemical purity – radiochemical impurities arise from decomposition of the radiopharmaceutical due to action of the solvent, temperature, pH, light, the presence of oxidizing or reducing agents, incomplete reaction or radiolysis. An example of radiochemical impurity is free 99mTcO4-.
- Radionuclidic purity- the fraction of the total radioactivity in the desired radionuclide form present in radiopharmaceutical should be checked to prevent undue radiation dose to the patient and prevent degradation of the scintigraphic images. An example of radionuclide impurity is 99Mo breakthrough.
- Sterility – radiopharmaceuticals should be tested to ensure they are free of viable microorganisms. For most radiopharmaceuticals it is not possible to obtain the results of sterility testing prior to release of the product, however, it can be released for human use if the sterility and apyrogenicity has been established by the manufacturer at the production level.
- Apyrogenicity – radiopharmaceuticals should be checked for pyrogens which are polysaccharides or proteins from the metabolism of microorganisms. The use of sterile equipment and aseptic techniques should be used when preparing radiopharmaceuticals.
- pH – all radiopharmaceuticals should have an appropriate pH to maintain their stability and integrity.
- Particle size and count – the particle size and count should be evaluated using a hemocytometer to ensure the correct number of particles is being injected according to the patient’s condition.
- Absence of foreign particulate matter.
- Colour and clarity.
- The MRT should document and confirm the successful completion of quality control tests before a product is used.6
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 confirmation of the acceptability of the quality control techniques and equipment, the quality control procedures are repeated.
- If the radiopharmaceutical fails quality control on the repeat procedure, the radiopharmaceutical is discarded.
- The MRT should check the lot number and must notify 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.6
References
- Kowalsky RJ, Falen SW. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine. 3rd ed. American Pharmacists Association; 2011.
- International Atomic Energy Agency. Quality Control in the Production of Radiopharmaceuticals. International Atomic Energy Agency; 2018. https://www.iaea.org/publications/13422/quality-control-in-the-production-of-radiopharmaceuticals
- International Atomic Energy Agency. Trends in Radiopharmaceuticals (ISTR-2019): Proceedings of an International Symposium Held in Vienna, Austria, 28 October–1 November 2019. International Atomic Energy Agency; 2019. Accessed April 7, 2021. https://www.iaea.org/publications/14736/trends-in-radiopharmaceuticals-istr-2019
- Saha GB. Fundamentals of Nuclear Pharmacy.; 2017. https://www.springer.com/gp/book/9783319575797
- Callahan RJ, Chilton HM, Ponto JA, Swanson DP, Royal HD, Bruce AD. Procedure guideline for the use of radiopharmaceuticals 4.0. J Nucl Med Technol. 2007;35(4):272-275. doi:10.2967/jnmt.107.044156
- Gillings N, Hjelstuen O, Ballinger J, et al. Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. EJNMMI Radiopharm Chem. 2021;6(1):8. doi:10.1186/s41181-021-00123-2
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