Quality Control for 11C and 18F Radiopharmaceuticals in the Research Environment
There are two general approaches to regulating the production of radiopharmaceuticals. One is based on performance standards and the other is through prescriptive regulations. With performance standards, the general requirements are defined that describe the production and quality control of a radiopharmaceutical. This approach allows for the institution to arrive at a suitable protocol as long as it meets the specified goal of applicability for human use. Thus, a system based on performance standards must have highly trained personnel.
KeywordsShelf Life Performance Standard Test Paper Radiochemical Purity Prescriptive Regulation
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- 1.Vera-Ruiz, H., Marcus, C.S., Pike, V.W., Coenen, H.H., Fowler, J.S., Meyer, G.J., Cox, P.H., Vaalburg, W., Cantineau, R., Helus, F., and Lambrecht, R.M., 1990, Report of an International Atomic Energy Agency’s Advisory Group Meeting on “Quality Control of Cyclotron-produced Radiopharmaceuticals.”, Nucl. Med. Biol. 17:445–456.Google Scholar
- 2.Pike, V.W., Waters, S.L., Kensett, M.J., Bateman, D., Considine, D., Turton, D.R., Luthra, S.K., Brady, F., Shah, A., Shah, F., and Silvester, D.J., 1991, Radiopharmaceutical production for PET: Quality assurance practice, experience and issues, in: “New Trends in Radiopharmaceutical Synthesis, Quality Assurance and Regulatory Control,” A.M. Emran, ed. Plenum Press, New York.Google Scholar
- 3.Ruth, T.J., Adam, M.J., Morris, D., and Jivan, S., 1986, Microprocessor controlled system for automatic and semi-automatic syntheses of radiopharmaceuticals. J. Labelled Compd. Radiopharm. 23:1185–1186.Google Scholar
- 4.United States Pharmacopeial Convention, 1989, Flu-deoxyglucose F-18 Injection Monograph, in: “United States Pharmacopeia/National Formulary XXI, Suppl. 9” 3190.Google Scholar