Validación del proceso de manufactura de Nifuroxazida 220 mg / 5mL Suspensión Oral de un laboratorio farmacéutico de Lima
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Date
2022
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Universidad Nacional de Trujillo
Abstract
La validación del proceso de manufactura de Nifuroxazida 220 mg / 5mL Suspensión Oral se realizó en las instalaciones de un laboratorio farmacéutico limeño, haciendo uso de tres lotes consecutivos fabricados en el mes de noviembre del año 2021, de manera que se pueda garantizar que el proceso proporcione productos de calidad que saldrán al mercado una vez aprobada la validación de acuerdo a los dispuesto por la normativa interna del laboratorio farmacéutico. Se realizó un plan de muestreo previo al desarrollo de la validación, en el cual se determinaron las condiciones de muestreo del producto para cada etapa del proceso de manufactura. Además, se determinaron los parámetros críticos del proceso y atributos críticos de calidad que tienen impacto relevante en la calidad del producto y se establecieron criterios de aceptación para evaluar los resultados obtenidos. Las etapas del proceso de Fabricación, Envasado y Acondicionado del producto de los lotes en validación se encontraron totalmente bajo control y proporcionan en forma consistente y repetitiva las especificaciones establecidas para el producto en el Protocolo de Validación del laboratoriofarmacéutico. Por lo tanto, se concluyó que el proceso de manufactura es confiable, reproducible, consistente y puede llevarse a cabo en los análisis previstos.
ABSTRACT The validation of the manufacturing process of Nifuroxazide 220 mg / 5mL Oral Suspension was carried out in the facilities of a Lima pharmaceutical laboratory, using three consecutive batches manufactured in the month of November 2021, so that it can be guaranteed that the process quality proportion products that will go on the market once the validation has been approved in accordance with the provisions of the internal regulations of the pharmaceutical laboratory. A test plan was carried out prior to the development of the validation, in which the test conditions of the product were determined for each stage of the manufacturing process. In addition, the critical parameters of the process and the critical quality attributes that have a relevant impact on the quality of the product were determined and the acceptance criteria were subsequently determined to evaluate the results obtained. The stages of the process of Manufacturing, Packaging and Conditioning of the product of the batches under validation were fully under control and consistently and repetitively ensured the specifications established for the product in the Pharmaceutical Laboratory Validation Protocol. Therefore, it was concluded that the manufacturing process is reliable, reproducible, consistent and can be carried out in the planned analyses.
ABSTRACT The validation of the manufacturing process of Nifuroxazide 220 mg / 5mL Oral Suspension was carried out in the facilities of a Lima pharmaceutical laboratory, using three consecutive batches manufactured in the month of November 2021, so that it can be guaranteed that the process quality proportion products that will go on the market once the validation has been approved in accordance with the provisions of the internal regulations of the pharmaceutical laboratory. A test plan was carried out prior to the development of the validation, in which the test conditions of the product were determined for each stage of the manufacturing process. In addition, the critical parameters of the process and the critical quality attributes that have a relevant impact on the quality of the product were determined and the acceptance criteria were subsequently determined to evaluate the results obtained. The stages of the process of Manufacturing, Packaging and Conditioning of the product of the batches under validation were fully under control and consistently and repetitively ensured the specifications established for the product in the Pharmaceutical Laboratory Validation Protocol. Therefore, it was concluded that the manufacturing process is reliable, reproducible, consistent and can be carried out in the planned analyses.
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Keywords
Validación, Proceso de manufactura, Nifuroxazida, Suspensión oral.