Issues for Consideration
When preparing radiopharmaceuticals, consideration should be given to the following general principles:
- For patients - all radiopharmaceuticals must be prepared in accordance with pharmaceutical quality requirements; radiopharmaceuticals for parenteral administration must be protected from any airborne contamination (dust and other particles which may be present in the environment or originate from the operator or accessory materials) as much as possible.
For personnel and environment - during the preparation and handling of radiopharmaceuticals the personnel should be adequately protected against the hazards of external radiation. Both the personnel and environment should be protected against contamination with radioactive or biological materials, although standards of protection vary from country to country.
Quality of the radiopharmaceutical
The radiopharmaceutical should comply with the requirements set out in a monograph of a pharmacopoeia or in an in-house monograph. Such requirements are related to radioactivity, identity, radionuclidic, radiochemical and chemical purity, sterility and apyrogenicity, pH, isotonicity, level of residual solvents. These concepts are described in detail in the Quality Control Module.
To achieve the required quality, Good Radiopharmacy Practice (GRP) is applied. GRP combines principles of traditional pharmaceutical preparation with particular aspects of radiation protection.
GRP is that part of quality assurance that is aimed at ensuring that radiopharmaceuticals are consistently prepared and handled to a quality appropriate to their intended use. It comprises a previously defined preparation process known to lead to a radiopharmaceutical of optimal quality. GRP is of particular importance for radiopharmaceuticals since many of them are released for use before all quality controls are performed due to the short half-life of the radionuclide.
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