Revisión Periódica del producto: Dorzolamida Clorhidrato 2% solución oftálmica en un laboratorio farmacéutico nacional 2021
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente trabajo tiene como objetivo verificar la consistencia del proceso de producción del producto Dorzolamida Clorhidrato 2% Solución Oftálmica, según la normativa nacional e internacional, para lo cual se empleó los lineamientos contenidos en la empresa y la normativa vigente (DIGEMID y ANVISA), donde se contempla ciertos requisitos mínimos que debe contener el informe de Revisión Periódica del Producto: La descripción del producto, resumen de la revisión usada para indicar cuántos lotes fabricados, aprobados y/o rechazados en el periodo evaluado, y que tengan la conformidad para su posterior liberación, la formula maestra vigente del producto, materias primas (principio activo y excipientes), incluidos los materiales de envase y empaque, además los fabricantes y proveedores se encuentran calificados. Los equipos en estado validado empleados en las diferentes etapas del proceso de manufactura, las especificaciones técnicas y técnicas analíticas vigentes de los insumos. Resultados del análisis fisicoquímico del producto en proceso y producto terminado cumple con las especificaciones técnicas vigentes. Se da el cumplimiento de los parámetros y atributos evaluados en cada etapa del proceso de manufactura (fabricación, envasado y acondicionado), donde cumplen con los criterios de aceptación. por lo cual se concluye la ejecución de la revisión periódica del producto Dorzolamida Clorhidrato 2% Solución Oftálmica en un laboratorio farmacéutico nacional según la normativa vigente nacional e internacional según los criterios descritos en el informe para su realización.
ABSTRACT The present work aims to verify the consistency of the production process of the product Dorzolamide Hydrochloride 2% ophthalmic solution according to national and international regulations, for which the guidelines contained in the company and the current regulations (DIGEMID and ANVISA) were used, where certain minimum requirements that the report of the Periodic Product Review must contain are contemplated. The product description, summary of the revision used to indicate how many batches manufactured, approved and rejected in the period and that have the conformity of approved for subsequent release, the current master formulation of the product, raw materials (active ingredient and excipients), including packaging materials, in addition manufacturers and suppliers are qualified. The equipment in validated state used in the different stages of the manufacturing process, the technical specifications and technical analytical in force of the inputs. Results of the physicochemical analysis of the product in process and finished product complies with the current technical specifications. Compliance with the parameters and attributes evaluated at each stage of the manufacturing process (manufacturing, packaging and conditioning) is given, where they meet the acceptance criteria. Therefore, the execution of the periodic review of the product Dorzolamide Hydrochloride 2% Ophthalmic Solution in a national pharmaceutical laboratory according to current national and international regulations according to the criteria described in the report for its realization is concluded.
ABSTRACT The present work aims to verify the consistency of the production process of the product Dorzolamide Hydrochloride 2% ophthalmic solution according to national and international regulations, for which the guidelines contained in the company and the current regulations (DIGEMID and ANVISA) were used, where certain minimum requirements that the report of the Periodic Product Review must contain are contemplated. The product description, summary of the revision used to indicate how many batches manufactured, approved and rejected in the period and that have the conformity of approved for subsequent release, the current master formulation of the product, raw materials (active ingredient and excipients), including packaging materials, in addition manufacturers and suppliers are qualified. The equipment in validated state used in the different stages of the manufacturing process, the technical specifications and technical analytical in force of the inputs. Results of the physicochemical analysis of the product in process and finished product complies with the current technical specifications. Compliance with the parameters and attributes evaluated at each stage of the manufacturing process (manufacturing, packaging and conditioning) is given, where they meet the acceptance criteria. Therefore, the execution of the periodic review of the product Dorzolamide Hydrochloride 2% Ophthalmic Solution in a national pharmaceutical laboratory according to current national and international regulations according to the criteria described in the report for its realization is concluded.
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Keywords
Dorzolamida clorhidrato. Calidad. Proceso