Radiopharmaceuticals and good radiopharmacy practice
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Good Manufacturing Practice (GMP) is concerned with both manufacturing and quality control procedures. Good radiopharmacy practice means GMP applied to radiopharmaceuticals by taking into account the special nature of these products. Because radioactive substances are the essential basis for the acquisition of data from nuclear medicine investigations, attention has to be paid to the control of all parameters of quality assurance. This is particularly important in those cases where quality control tests have to be performed on apost factum basis,i.e. after administration to the patient, because of the short half-life time of the radionuclide.
Radiopharmaceutical quality control is a necessity in all nuclear medicine departments. If a laboratory does not institute radiopharmaceutical quality control until the cause of a ‘poor image’ in the diagnostic process must be identified, the problem will be compounded. The quality control tests must be mastered before they can be used to resolve problems.
KeywordsTechnetium Pertechnetate Good Manufacture Practice Quality Control Test Isomeric Transition
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