Adverse Events and Corrective and Preventive Actions

Everything that is not compliant with SOP, guidelines, national and international standards, and legal requirements could affect the quality and safety of the cellular products and all processes. To guarantee the safety of cellular products, to protect recipients, donors, and personnel, it is necessary to have in place a robust system for reporting, investigating, and resolving all occurrences: errors, accidents, adverse events, biological product deviations, and complaints.