The reference scenario
The production processes of the pharmaceutical sector provide rigid protocols and demand compliance with extremely high standards in order that products that guarantee quality, safety and efficacy are made available to health professionals.
In the field of nuclear medicine the medicines used are called radiopharmaceuticals. These include one or more radionuclides (radioactive isotopes), incorporated for medical purposes, and can be used alone or linked to tissue-specific carriers; they can be designed for diagnostic or therapeutic purposes.
For diagnosis, we use radionuclides capable of emitting “γ” radiation which, although not interacting with the human body, is detected by special instruments that give a representative image of the spatio-temporal distribution of the radio-labeled substance inside the organism.
Equipment used: single photon emission computed tomography (SPECT) and positron emission tomography (PET).
Applications: mainly the study of tumors, but also in cardiology and neurology, in particular for the study of Parkinson’s and Alzheimer’s.
For therapy purposes, we use radionuclides that emit “β” or “α” radiation (mass particles) that interact strongly with the organism, inducing a lethal effect on the diseased (tumor) cells at which they are directed.
Applications: mainly in the field of oncology and for thyroid dysfunction.
Because of their short life cycle, radiopharmaceuticals are often released even before all quality control tests have been completed, and therefore the production process is monitored continuously. The quality of the finished product, in these cases, is guaranteed by the robustness of the production process, understood as meaning strict observance of all rules and guidelines during each stage of production.
Pharmaceutical companies that produce radiopharmaceuticals and distribute them to hospitals must meticulously adhere to the Good Manufacturing Standards, (also known as Good Manufacturing Practices or GMP).
It should however be emphasized that the production of radiopharmaceuticals is not exclusively the domain of private companies: many hospital departments of nuclear medicine are equipped with a radiopharmacy laboratory, in which it is possible to prepare a radiopharmaceutical. In this case, given that the production is already managed in a highly controlled environment, such as the hospital, the rules it must meet are somewhat less stringent rules such as the NBP-MN (Norms for Good Preparation of Radiopharmaceuticals for Nuclear Medicine). These, published as an annex to the XII edition of the Official Pharmacopoeia of the Italian Republic, are in any case similar to the GMP and contain a series of specific indications for the production of hospital radiopharmaceuticals.
As most radiopharmaceuticals are administered to patients intravenously, they need to be sterile; this is made possible by meticulously following the indications provided by Annex 1 of the GMP which concerns the production of sterile medicines, and by classifying the premises for production as clean rooms, in accordance with ISO 14644 and ISO 14698 on air contamination and environments.
The indications mentioned above are valid both for radiopharmaceuticals produced by pharmaceutical companies, and those produced in laboratories set up on site in nuclear medicine hospitals.
Finally, in the case of radiopharmaceuticals, due to their radioactive nature, compliance with the rules relating to radiation protection – aimed at minimizing the risks of using unsealed radioactive sources – becomes indispensable.