Implementación y ejecución de un procedimiento operativo estándar para la revisión periódica de un producto estéril en un laboratorio farmacéutico nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El desarrollo del presente trabajo de prácticas pre profesionales fue implementar y ejecutar un procedimiento operativo estándar para la revisión periódica de un producto estéril en un laboratorio farmacéutico nacional, para lo cual se empleó la metodología descriptiva y observacional. En la presente investigación se evidenció que los aspectos de identificación son inherentes y confiables del producto, que los lotes evaluados tienen la conformidad de aprobados para su posterior liberación, la formulación está vigente del principio activo, excipientes, material de envase y empaque, además los proveedores se encuentran conformes en la calificación. El mantenimiento del estado validado, especificaciones técnicas y técnica análitica se encuentran vigentes. Los resultados del análisis fisicoquímico del producto cumplen con las especificaciones técnicas. Se cumplen los criterios de aceptación de los parámetros y atributos en todas las etapas de manufactura por lo cual se concluye con la implementación y elaboración de un procedimiento operativo estándar para la revisión periódica de productos según normativa local e internacional, se ejecutó la revisión periódica del producto Cortiflex 50 mg/5mL suspensión inyectable manufacturado en un laboratorio farmacéutico nacional según los criterios descritos en el procedimiento y la estructura del informe. Finalmente se identificaron mejoras en el proceso retirando el análisis de dosaje el cual se encuentra debidamente controlado y actualizando los rangos de aceptación de parámetros críticos en la guía de fabricación
ABSTRACT The development of this work of pre-professional practices was to implement and execute a standard operating procedure for the periodic review of a sterile product in a national pharmaceutical laboratory, for which the descriptive and observational methodology was used. In the present investigation it was evidenced that the identification aspects are inherent and reliable of the product, that the batches evaluated had the conformity of approved and for their subsequent release, the formulation is valid for the active ingredient, excipients, container and packaging material, In addition, the suppliers are satisfied in the qualification. The maintenance of the validated state, technical specifications and analytical technique are in force. The results of the physicochemical analysis of the product comply with the technical specifications. Acceptance criteria for parameters and attributes are met at all stages of manufacturing. It concludes with the implementation of a Standard Operating Procedure for the periodic review of products according to local and international regulations. Likewise, the periodic review of the product Cortiflex 50 mg/5 mL injectable suspension manufactured in a national pharmaceutical laboratory was carried out according to the criteria described in the procedure and structure of the report. Finally, improvements were identified in the process by withdrawing dosage analysis, which is properly controlled, and updating the acceptance ranges of critical parameters in the manufacturing guide.
ABSTRACT The development of this work of pre-professional practices was to implement and execute a standard operating procedure for the periodic review of a sterile product in a national pharmaceutical laboratory, for which the descriptive and observational methodology was used. In the present investigation it was evidenced that the identification aspects are inherent and reliable of the product, that the batches evaluated had the conformity of approved and for their subsequent release, the formulation is valid for the active ingredient, excipients, container and packaging material, In addition, the suppliers are satisfied in the qualification. The maintenance of the validated state, technical specifications and analytical technique are in force. The results of the physicochemical analysis of the product comply with the technical specifications. Acceptance criteria for parameters and attributes are met at all stages of manufacturing. It concludes with the implementation of a Standard Operating Procedure for the periodic review of products according to local and international regulations. Likewise, the periodic review of the product Cortiflex 50 mg/5 mL injectable suspension manufactured in a national pharmaceutical laboratory was carried out according to the criteria described in the procedure and structure of the report. Finally, improvements were identified in the process by withdrawing dosage analysis, which is properly controlled, and updating the acceptance ranges of critical parameters in the manufacturing guide.
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Laboratorio
Producto estéril