Analysis and risk assessment method fmea/fmeca for the biowaiver procedure

For today there is rich experience of risk management methods application and its principles. Last years risk management is considered to be the most needed in any business-environment. Aim. To study the use of FMEA/FMECA method for the final stages of overall risk assessment for quality of biowaiver procedure based on biopharmaceutical classification system – BCS (hereinafter – biowaiver procedure) and establishment of risk levels for determination of strategy for their processing and control. Results. According to FMEA/FMECA methodology were developed original 5-point and 10-point scales for S, O and D scores that were applied for 14 significant risk factors inherent in biowaiver procedure. Based on analysis of potential causes of risk factors, existing measures for their prevention and detection, S, O and D values were determined for each risk factor and RPN values were calculated. In terms of RPN values exceeding limit values, 5 most critical risk factors were identified, developed a control strategy and proposed preventive measures, that would be taken into account when applying biowaiver to confirm equivalence of generic and reference drugs, and would prevent manifestations of causes of nonconformities. Conclusions. As a result of performed complex of works, an adapted application of FMEA/FMECA method for analysis and risk assessment of biowaiver procedure has become possible. As result of quantitative risk assessment were calculated values of RPN, which, in comparison with limit and critical RPN values, revealed risk factors, causes of which could have the greatest effect on quality of biowaiver procedure. Knowledge of nature of their undesirable manifestation made it possible to reasonably approach the adoption of correct decisions for determination of risk control strategy for biowaiver procedure, and also to ensure its quality with set of preventive actions.