GMP, which stands for Good Manufacturing Practice, plays a crucial role in the development of medication for research purposes, including radioactive medicine and medical isotopes. Adhering to the rigorous GMP regulations outlined in various annexes is essential. For instance, Annex 1 specifies infrastructure requirements, including personnel training and conditions in the production facility. And Annex 3 adds specific regulations for the production, inspection, storage, and distribution of nuclear medicines, with a strong focus on radiation safety, quality assurance, and appropriate equipment and environment. Also other annexes are relevant for radiopharmaceutical drug development under GMP.

GMP originates among other things from the Thalidomide affair, a tragic event in the late 1950s and early 1960s. Thalidomide, a drug initially marketed as a sedative and later as a treatment for morning sickness in pregnant women, led to severe birth defects in thousands of children worldwide. The drug caused limb deformities and other developmental abnormalities in babies whose mothers had taken it during pregnancy. This prompted the need for stricter controls and greater visibility throughout the production process, ensuring the safety of the end product for patients.

GMP aims to maintain strict and continuous control over all production aspects like personnel, equipment, and infrastructure. This means that factors such as air pressure, temperature, and microbiological status are constantly monitored, allowing for rapid adjustments in case of any deviations. Strict requirements also apply to personnel and infrastructure to minimise the risk of errors. The primary goal is to ensure patient safety by meeting predefined criteria for radiopharmaceuticals, or radioactive medicines, including chemical, quality control, and microbiological standards. “You have to be sure that the product you intended to make has indeed been produced. Otherwise, you only harm the patient, which can cause serious damage”, says Hendrikse.

Getting the FIELD-LAB facility up to GMP standards is not an easy task, as there are some conflicts to address when navigating between pharmaceutical law and nuclear energy law, Hendrikse explains. “The nuclear energy law takes precedence over pharmaceutical law at all times. The main disparity lies in environmental requirements: dispensing demands minimal microbiological particles in the production area, necessitating overpressure environments, while nuclear energy law mandates underpressure to contain radioactivity.”

Within the hot cells at FIELD-LAB, where the isotope or medicine is located, a negative pressure is maintained. The pressure outside the hot cell is higher. This is crucial in the unlikely event of a leak, ensuring that any radioactive air remains contained within the hot cell. In pharmaceutical settings, however, the opposite principle applies. Air moves outward due to the pressure difference, pushing impurities away from the product. This prevents the product from coming into contact with contaminants.