CHAPTER 7. QUALITY ASSURANCE AND QUALITY CONTROL
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soon after preparation. In addition, records of receipt and disposal of
radioactive materials must be kept in accordance with national legislation.
There should be a regular process of review of the documentation to
ensure that it is still appropriate and also that all the necessary records are
being maintained. Review of retrospective quality control testing records is
critical to ensure that the methods and materials used are consistently
producing products of the required standard.
7.3. CONTROL OF STARTING MATERIALS
One of the major aspects of quality is the source and purity of the non-
radioactive starting materials. These include: components of kits for
technetium radiopharmaceuticals, target materials for use in nuclear reactors
or cyclotrons, adsorbents used in columns inside radionuclide generators, and
eluents and diluents used in the preparation of the final product. Since these
marerials are non-radioactive, it is possible to carry out extensive testing of
their quality in the same way as for normal pharmaceutical products. Some of
the techniques and equipment required will not be readily available in a
hospital radiopharmacy or nuclear medicine department (e.g. mass
spectroscopy and nuclear magnetic resonance spectroscopy). It is therefore
prudent to purchase materials from radiopharmaceutical manufacturers where
possible, since they will have performed quality control procedures on the
materials they are supplying. In an increasing number of countries, there is now
a mechanism that controls the release of pharmaceutical products, including
radiopharmaceuticals and radiopharmaceutical kits, to the market. Such
controls will include checking the systems that manufacturers use to ensure the
quality of their products. Although this increases the cost to the user at least
part of this extra cost is offset by improved quality.
Where the whole manufacturing process is performed in-house, a greater
degree of responsibility for quality has to be assumed by the producer, and
comprehensive testing of the raw materials is necessary. This is particularly true
where the synthesis of non-radioactive components takes place prior to their
incorporation into radiopharmaceuticals or radiopharmaceutical kits. Testing
may require the use of analytical techniques such as infrared and ultraviolet
spectroscopy, mass spectroscopy and nuclear magnetic resonance, and the
department should ensure that it has access to such facilities. Details of the
synthesis and analysis of certain kits are provided in IAEA-TECDOCs 649 and
805 (included in the bibliography to this chapter). Information on the specifi
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cations that radiopharmaceuticals should meet is also available in national and
international pharmacopoeias.