The failure mode, effects and criticality analysis (FMECA) method: a useful approach for risk management plan in advanced therapy medicinal products manufacturing

      The cell therapy facility from Etablissement Français du Sang (EFS) is implicated in the development and production of Advanced Therapy Medicinal Product (ATMP). Mesenchymal stromal cells are amplified ex vivo for several clinical applications in regenerative medicine. In compliance with the Good Manufacturing Practice and ICH Q9 guidelines, we evaluated the security and the reliability of this process by a prospective risk analysis such as the failure Mode, Effects and Criticality Analysis (FMECA) method.
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