Abstract
Pharmaceutical quality assurance is an overall concept embracing the establishment of certain criteria before production begins, the control of certain factors during production and the evaluation of certain results after production (Bryant, 1989). It is recognised that the provision of radiopharmaceuticals labelled with carbon-11 (t ½ = 20.4 min, β+ = 99.8%), nitrogen-13 (t ½ = 9.96 min, β+ = 100%), oxygen-15 (t ½ = 2.03 min, β+ = 99.9%) or fluorine-18 (t ½ = 109.8 min, β+ = 96.9%) for positron emission tomography (PET) poses special problems of quality assurance (Vera Ruiz et al., 1990). First, the short half-lives of these radionuclides exclude lengthy techniques from routine analysis. Secondly, because many PET radioligands must be produced along with only small amounts of carrier and are often derived from potent drugs, traces of structurally-related contaminants can easily detract from radiopharmaceutical quality. Thirdly, rapid labelling procedures sometimes exploit reagents which themselves are potential sources of toxins. Therefore, our approach to quality assurance, in PET radiopharmaceutical production, depends on using a well-defined protocol that delivers high quality product from materials of assured grade, supported routinely by rapid quality control procedures that measure or test parameters important to efficacy and safety. This combination, in our view, is integral to ensuring ‘good manufacturing practice’ (Sharp, 1983).
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Pike, V.W. et al. (1991). Radiopharmaceutical Production for PET: Quality Assurance Practice, Experiences and Issues. In: Emran, A.M. (eds) New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-0626-7_40
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