Qualification and Validation Activities
Production process, environments and analytical methods: BeForPharma issues validation declarations according to law for hospital facilities
Validation of the production process Before starting the production of a radiopharmaceutical, it is necessary to verify its repeatability, safety and sensitivity: in short, the entire production process must be validated. Given the intrinsic characteristics of radiopharmaceuticals, and in particular their short half-life cycle, BeForPharma implements a step-by-step validation process. Well-timed upstream controls avoid any unnecessary waste of time and allow the almost immediate release of the drug, in total safety.
Validation of the environments Sterile conditions are a prerequisite of the environments in which radiopharmaceuticals are produced: the handling of raw materials and the final product, which will be administered intravenously, must take place in properly sanitized cleanrooms. Before any production begins, BeForPharma examines the environments to ensure that they comply with the dictates of Good Manufacturing Practice (GMP) and with the ISO standards on particle contamination and microbiological contamination. This validation process bestows the environment with a specific “degree” of cleanliness – ranked with a letter – calculated on the basis of numerous parameters such as the number of changes of air performed, the precautions taken by the medical staff and the presence of a sterilization chamber.