Validación del proceso de manufactura de Latanoprost 0,005% Solución Oftálmica estéril de un laboratorio farmacéutico nacional 2021
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente trabajo tuvo como objetivo validar el proceso de manufactura el producto Latanoprost 0,005% solución oftálmica estéril de un laboratorio farmacéutico nacional, el cual tiene como objetivo validar el proceso de manufactura, durante los meses de diciembre del año 2021 y enero del año 2022, tanto en condiciones normales como, en condiciones desfavorables que puedan presentarse durante la fabricación, garantizando proporcionar productos de alto grado de calidad. Se recolectaron muestras en cada etapa del proceso (fabricación, envasado y acondicionado) de tres lotes, que fueron utilizadas en los estudios y/o pruebas como: identificación y contenido de Latanoprost, pH, peso específico, aspecto y controles microbiológicos. Las valoraciones de Latanoprost se encontraron dentro de los criterios de aceptación 0.0450 mg/mL - 0,0550 mg/mL (90.0% - 110%), el peso específico se encontró dentro de los criterios de aceptación de 6,0 – 8,0. En el proceso de acondicionado se realizaron las pruebas de identificación y aspecto encontrándose dentro de los criterios de aceptación. Se concluye que el método de manufactura validado es confiable, consistente y puede emplearse en los análisis previstos.
ABSTRACT The objective of this work was to validate the manufacturing process of the product Latanoprost 0.005% sterile ophthalmic solution of a national pharmaceutical laboratory, which aims to validate the manufacturing process, during the months of December and January 2021-2022, both under normal conditions and under normal conditions that may occur during manufacturing, ensuring the provision of high quality products. Samples were collected at each stage of the process (manufacturing, packaging and conditioning) from three batches, which were used in studies and/or tests such as: identification and content of Latanoprost, pH, specific weight, appearance and microbiological controls. Latanoprost titrations were found within the acceptance criteria 0.0450 mg/mL - 0.0550 mg/mL (90.0% - 110%), the specific weight was found within the acceptance criteria of 6.0 - 8.0. In the conditioning process, the identification and appearance tests were carried out and were found to be within the acceptance criteria. It is concluded that the validated manufacturing method is reliable, consistent and can be used in routine analyses.
ABSTRACT The objective of this work was to validate the manufacturing process of the product Latanoprost 0.005% sterile ophthalmic solution of a national pharmaceutical laboratory, which aims to validate the manufacturing process, during the months of December and January 2021-2022, both under normal conditions and under normal conditions that may occur during manufacturing, ensuring the provision of high quality products. Samples were collected at each stage of the process (manufacturing, packaging and conditioning) from three batches, which were used in studies and/or tests such as: identification and content of Latanoprost, pH, specific weight, appearance and microbiological controls. Latanoprost titrations were found within the acceptance criteria 0.0450 mg/mL - 0.0550 mg/mL (90.0% - 110%), the specific weight was found within the acceptance criteria of 6.0 - 8.0. In the conditioning process, the identification and appearance tests were carried out and were found to be within the acceptance criteria. It is concluded that the validated manufacturing method is reliable, consistent and can be used in routine analyses.
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Oftalmología