ABSTRACT
When manufacturing radiopharmaceuticals there is always a need to think outside the box. The use of potent compounds for drug manufacturing does not lend itself easily to certain industry standards for manufacturing sterile products such as open vial filling and large clean room environments. When using radioactive isotopes in the manufacturing process, the issues of shielding, contamination, and airborne volatility must be taken into account. This does not mean that current Good Manufacturing Practices (cGMPs) are not carried out or followed when dealing with the manufacture of a radiopharmaceutical, but the industry must always try to be innovative and cutting edge in order to meet cGMPs considering the specialized needs of radiopharmaceutical manufacturing.
