Pharmaceutical Manufacturing Handbook: Production and

Independent of which regulation applies at a national level to extemporaneous
or magistral preparation of radiopharmaceuticals, the patients should be entitled to
expect that these products are prepared accurately, are suitable for use, and will
meet the expected standards for quality assurance. Pharmacists involved in this kind
of production must ensure that they and any other staff involved are competent to
undertake the tasks to be performed and that the requisite facilities and equipment
are available [11] . As for other radiopharmaceutical production, systems must be in
place to ensure the operator safety due to handling of radioactive materials. All
involved staff must have suffi cient training in radiation safety issues, in addition to
training in GMP.
REFERENCES
1. Britton , K. ( 1996 ), Radiopharmaceuticals for the future , Curr. Dir. Radiopharma. Res.
Dev . (Ed. by Stephen Mather ), viii. Developments in Nuclear medicine, Vol XXX. London,
UK.
2. Saha , G. B. ( 1998 ), Fundamentals of Nuclear Pharmacy , 4th ed., Springer , Heidelberg,
Germany .
3. Alexoff , D. L. Automation for the synthesis and application of PET radiopharmaceuticals,
BNL - 68614 Offi cinal File Copy.
4. Bremer , P. O. ( 1995 ), Aseptic production of radiopharmaceuticals , in Aseptic Pharmaceutical
Manufacturing , Vol. II, Application for the 1990s , Interpharm , Michael J. Groves and
Ram Murty , pp. 153 – 180 .
5. Nordic Council on Medicines . ( 1989 ), Radiopharmacy: Preparation and Control of Radiopharmaceuticals
in Hospitals , NLN Publications No. 26 , Uppsala, Sweden .
6. European Commision ( 2003 ), EU Guide to Good Manufacturing Practice , Annex 1 and
3, Brussels, Belgium, October 8.
7. Dabbah , R. ( 1995 ), Controlled environments in the pharmaceutical and medical products
industry: A global review from regulatory, compendial, and industrial perspectives , in
Aseptic Pharmaceutical Manufacturing, Vol. II, Application for the 1990s , Interpharm ,
Michael J. Groves and Ram Murty , pp. 11 – 40 .
8. Lee , M. C. , PET and PET/CT are the fastest growing imaging modalities worldwide, paper
presented at the 5th International Conference on Isotopes (5ICI), Brussels, Belgium, Apr.
25 – 29 , 2005 .
9. Zalutsky , M. R. , Pozzi , O. , and Vaidyanatha , G. , Targeted radiotherapy with alpha particle
emitting radionuclides, paper presented at the International Symposium on Trends in
Radiopharmaceuticals (ISTR - 2005), Vienna, Austria, Nov. 14 – 18, 2005 .
10. Pharmaceutical Inspection Convention (2006, Aug.), PIC/S guide to good practices
for preparation of medicinal products in pharmacies, PE 010 - 1 (Draft 2), Geneva ,
Switzerland .
11. Standards for good professional practice ( 2000 ), Pharm. J . 265 ( 7109 ), 233 .
12. Kowalsky , R. J. , and Falen , S. W. ( 2004 ), Radiopharmaceuticals in Nuclear Pharmacy and
Nuclear Medicine , American Pharmacists Association , Forrester Center, WV .
FURTHER READINGS
FURTHER READINGS 95
European Commision . ( 2006 ), EU Guide to Good Manufacturing Practice , Annex 3; draft
proposal, Brussels, Belgium, Apr. 12.