Role of Current Good Manufacturing Practices in Establishment of Quality Assurance for in-House Radiopharmaceuticals

  • Thomas E. Boothe
  • Ali M. Emran

Abstract

The ultimate goal of any facility involved in the preparation of radiopharmaceuticals should be the generation of products that are safe and effective. Although this is a fairly obvious statement and almost all nuclear medicine personnel and radiopharmaceutical chemists would affirm that they do this, they cannot always prove their assertion; the failure is evidenced by a lack of sufficient data, lack of proper validation, or lack of documentation.

Keywords

Good Manufacturing Practice United States Pharmacopeia Positron Emission Tomographic Plastic Test Tube Radiopharmaceutical Preparation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Alexoff, D.L., Fowler, J.S., and Gatley, S.J., 1991, Removal of the 2.2.2. cryptand (kryptofix 2.2.2.™) from 18FDG by cation exchange, Appl. Radiat. Isot. 42:1189.CrossRefGoogle Scholar
  2. Alexoff, D.L., Casati, R., Fowler, J.S., Wolf, A.P., Shea, C., Schlyer, D.J., and Shuie, C-Y., 1992, Appl. Radiat. hot. 43:1313.CrossRefGoogle Scholar
  3. Boothe, T.E. and Emran, A.M., 1991, The Role of High Performance Liquid Chromatography in Radiochemical/Radiopharmaceutical Synthesis and Quality Assurance, in: Radiopharmaceutical synthesis, quality assurance and regulatory control, A.M. Emran, ed. Plenum, New York.Google Scholar
  4. Chaly, T. and Dahl J. Robert, 1989, Thin layer chromatographic detection of kryptofix 2.2.2 in the routine synthesis of [18F]2-fluoro-2-deoxy-D-glucose, Nucl. Med. Biol. 16:385.Google Scholar
  5. Coenen, H.H., Pike, V., W. Stöcklin, and Wagner, R., 1987, Recommendation for practical production of [2–18F]fluoro-2-deoxy-D-glucose, Appl. Radiat. hot. 38:605.CrossRefGoogle Scholar
  6. DeSain, S., 1991, Drug, Devise, and Diagnostic Manufacturing, Interpharm Press, Inc., Buffalo Grove.Google Scholar
  7. FDA Public Hearing, March, 1993, Regulatory approach to positron emission tomographic (PET) radiopharmaceuticals, Rockville, MD, Institute of Clinical PET, Arlington.Google Scholar
  8. FDA, 1984, Nuclear Pharmacy Guidelines: Criteria for Determining When to Register as a Drug Establishment, Office of Compliance, Washington, D.C.Google Scholar
  9. Ferrieri, R.A., Schlyer, D.J., Alexoff, D.L., Fowler, and Wolf, A.P, 1993, Direct analysis of kryptofix 2.2.2.in 18FDG by ga chromatography using a nitrogen-selective detector, Nucl. Med. Biol. 20:367.PubMedCrossRefGoogle Scholar
  10. Finn, R. and Boothe, T., 1991, Quality assurance considerations related to “in-house” radiopharmaceutical preparations utilizing positron emitting radionuclides, in: Radiopharmaceutical synthesis, quality assurance and regulatory control, A.M. Emran, ed., Plenum, New York.Google Scholar
  11. Hamacher, K., Coenen, H.H., and Stöcklin, 1986, Efficient stereospecific synthesis of no-carrier-added [2–18F]fluoro-2-deoxy-D-glucose using aminopropylether supported nucleophilic substitution, J. Nucl. Med. 27:235.PubMedGoogle Scholar
  12. International Organization for Standardization, ISO 9000: International Standards for Quality Management, 2nd, ed., Geneva, Switzerland.Google Scholar
  13. Johnson, B.F., Sabourin, C.L., and Finn, R.D., 1993, Improving the purity of [F-18]2FDG preparations, J. Nucl. Med. 34:239P.Google Scholar
  14. Namavari, M., Satyamurthy, N., and Barrio, J.R., 1993, Efficient removal of tin contaminants from the preparation of 6-[F-18]fluoro-L-DOPA and analogs, J. Nucl. Med. 34:238P.Google Scholar
  15. Padgett, H.C., Schmidt D.G., Luxen, A., Bida, G.T., Satymurthy, N., and Barrio, J.R., 1989, Computer-controlled Radiochemical Synthesis: A Chemical Process Control Unit for the Automated Production of Radiochemicals, Appl. Radiat. hot. 40:433.CrossRefGoogle Scholar
  16. Pike, V.W., Waters, S.L., Kensett, M.J., Bateman, D., Considine, D., Turton, D.R., Luthra, S.K., Braby, F., Sha, A., 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, New York.Google Scholar
  17. Tewson, T.J., 1983, Synthesis of no-carrier-added fluorine-182-fluoro-2-deoxy-D-glucose, J. Nucl. Med. 24: 718.PubMedGoogle Scholar
  18. Tewson, T.J., 1989, Procedures, pitfalls, and solutions in the production of [18F]2-deoxy-f- fluoro-D-glucose: a paradigm in the routine synthesis of fluorine-18 radiopharmaceuticals, Nucl Med. Biol 16:533.Google Scholar
  19. USP XXII, Supplement 1, p.2129, 1989, United States Pharmacopeial Convention, Inc., Rockville, MD.Google Scholar
  20. 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, 1990, Report of an international atomic energy agency’s advisory group meeting on “quality control of cyclotron-produced radiopharmaceuticals”. Nucl Med. Biol 17:445.Google Scholar
  21. Vora, M., Boothe, T., Finn, R., Kothari, P., Emran, A., Carroll, S. and Gilson, A., 1985, Multimillicurie preparation of 2-[18F]fluoro-2-deoxy-D-glucose via nucleophilic Displacement with fluoride-18 labelled fluoride, J. Labelled Compd. Radiopharm. 22:953.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 1995

Authors and Affiliations

  • Thomas E. Boothe
    • 1
  • Ali M. Emran
    • 2
  1. 1.Cyclotron/Radiochemistry and Nuclear Pharmacy, Division of Nuclear MedicineMount Sinai Medical CenterMiami BeachUSA
  2. 2.Positron Diagnostic and Research CenterThe University of Texas Houston Health Science CenterHoustonUSA

Personalised recommendations