Matriz de riesgos de impurezas de nitrosaminas en Naproxeno 500 mg tableta recubierta en un laboratorio peruano
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Date
2022
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Universidad Nacional de Trujillo
Abstract
Este informe se realizó con el objetivo de analizar el riesgo de nitrosaminas como impurezas en Naproxeno 500 mg tableta recubierta en el ingrediente farmacéutico activo (IFA) y en el material de envase primario de un laboratorio peruano. El método utilizado fue el análisis modal de fallos y efectos (AMFE), que consistió en la determinación y reducción del factor de prioridad del riesgo (FPR) a factor de prioridad de riesgo residual (FPR2), para lo cual, se estableció 2 fuentes de contaminación de nitrosaminas como impurezas según USP: IFA y material de envase primario. Se procedió a evaluar la severidad, ocurrencia y detectabilidad de las fallas en mención, con la finalidad de reducir el FPR2 mediante acciones de mitigación. Los resultados obtenidos en las 2 fuentes de contaminación de nitrosaminas fueron: Solicitar a los proveedores de insumos la evaluación de riesgos de nitrosaminas en los insumos suministrados (FPR2=5), desarrollo de una metodología analítica para cuantificar las nitrosaminas en los insumos en los que el fabricante declare presencia de nitrosaminas (FPR=5) y para el IFA fue identificar la presencia de grupos funcionales vulnerables que puedan estar involucrados en la formación de nitrosaminas (FPR=5). Por lo cual, se concluye que en el caso de Naproxeno 500 mg tableta recubierta, el análisis de riesgo permitió determinar las fallas potenciales y mitigar los riesgos de medianamente significativo a no significativo, mediante la elaboración de la matriz de riesgos de nitrosaminas como impurezas.
ABSTRACT This report was carried out with the objective of analyzing the risk of nitrosamines as impurities in Naproxen 500 mg coated tablet in the active pharmaceutical ingredient (API) and in the primary packaging material of a Peruvian laboratory. The method used was the failure mode and effects analysis (FMEA), which consisted in the determination and reduction of the risk priority factor (FPR) to the residual risk priority factor (FPR2), for which 2 sources were required. of contamination of nitrosamines as impurities according to USP: IFA and primary packaging material. We proceeded to evaluate the severity, occurrences and detectability of the failures in question, in order to reduce the FPR2 through mitigation actions. The results obtained in the 2 sources of nitrosamine contamination were: Request input suppliers to assess the risks of nitrosamines in the inputs supplied (FPR2=5), development of an analytical methodology to quantify nitrosamines in the inputs in which the manufacturer declares the presence of nitrosamines (FPR=5) and for the IFA it was to identify the presence of vulnerable functional groups that may be involved in the formation of nitrosamines (FPR=5). Therefore, it is concluded that in the case of Naproxen 500 mg coated tablet, the risk analysis allowed to determine the potential failures and reduce the risks from moderately significant to non-significant, through the elaboration of the risk matrix of nitrosamines as impurities
ABSTRACT This report was carried out with the objective of analyzing the risk of nitrosamines as impurities in Naproxen 500 mg coated tablet in the active pharmaceutical ingredient (API) and in the primary packaging material of a Peruvian laboratory. The method used was the failure mode and effects analysis (FMEA), which consisted in the determination and reduction of the risk priority factor (FPR) to the residual risk priority factor (FPR2), for which 2 sources were required. of contamination of nitrosamines as impurities according to USP: IFA and primary packaging material. We proceeded to evaluate the severity, occurrences and detectability of the failures in question, in order to reduce the FPR2 through mitigation actions. The results obtained in the 2 sources of nitrosamine contamination were: Request input suppliers to assess the risks of nitrosamines in the inputs supplied (FPR2=5), development of an analytical methodology to quantify nitrosamines in the inputs in which the manufacturer declares the presence of nitrosamines (FPR=5) and for the IFA it was to identify the presence of vulnerable functional groups that may be involved in the formation of nitrosamines (FPR=5). Therefore, it is concluded that in the case of Naproxen 500 mg coated tablet, the risk analysis allowed to determine the potential failures and reduce the risks from moderately significant to non-significant, through the elaboration of the risk matrix of nitrosamines as impurities
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Keywords
Nitrosaminas, Naproxeno, IFA, USP.