Establishing from scratch a Quality Management System that constantly monitors all the phases of the drug preparation process, ensuring that these are carried out according to the specified quality requirements, is an extremely complex multidisciplinary activity.
On the basis of its extensive international experience, the BeForPharma team is able to respond to its clients’ expectations of appropriateness, sustainability and effectiveness, guaranteeing the highest safety conditions for patients.
A healthcare facility’s internal operators may not yet have sufficient technical competence to guarantee an adequate level of quality. Nevertheless, total compliance with the regulations and procedures is the crucial starting point for a constant and progressive improvement in the radiopharmaceutical production processes and the quality of diagnosis and treatment.
Implementing the Quality Management System includes drafting the complete set of procedures governing the activities of the radiopharmaceutical laboratory, developing the validation and qualification programs, training personnel, drafting the master documents such as SMF (Site Master File), VMP (Validation Master Plan), and so on.