The purpose of this validation is to provide documented evidence that a specific radiopharmaceutical production process enables the output of a radiopharmaceutical product that completely meets the specifications and quality attributes predefined and required by the regulations (FDA 1987).
BeForPharma, while being able to guarantee, step by step, every phase of any project, is sometimes called on to analyze and validate only the final phases of the process. It must be said that this activity often highlights errors caused by an inadequate design that, thanks to a series of operational tests, can be identified and corrected.