Validación concurrente del proceso de fabricación de Clonixinato de lisina 125 mg + Pargeverina clorhidrato 10 mg tabletas recubiertas de un laboratorio farmacéutico nacional
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Date
2021
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tiene como finalidad determinar si el proceso de fabricación de Clonixinato de lisina 125 mg + Pargeverina clorhidrato 10 mg tabletas recubiertas de un laboratorio farmacéutico nacional cumple con los parámetros de validación concurrente establecidos según protocolo de validación y las Buenas Prácticas de Manufactura. Para ello se validaron tres lotes consecutivos, donde se aplicó los ensayos y controles en la etapa de mezcla (aspecto, densidad aparente, densidad por asentamiento, porcentaje de humedad) y etapa de compresión (aspecto, peso, peso promedio, dureza, friabilidad, desintegración, disolución, Cp y Cpk de pesos y durezas). Los tres lotes cumplieron con todos los controles y ensayos realizados, resultando dentro de las especificaciones establecidas en el protocolo de validación del laboratorio farmacéutico. Por lo tanto, se concluye que el proceso de fabricación de dicha especialidad es conforme para su empleo en la producción y cumple las condiciones para asegurar un proceso reproducible y consistente, cumpliendo los criterios de validación establecidos.
ABSTRACT The purpose of this pre-professional practice report is to determine if the manufacturing process of Clonixinate of lysine 125 mg + Pargeverine hydrochloride 10 mg coated tablets from a national pharmaceutical laboratory complies with the concurrent validation parameters established according to the validation protocol and the Good Manufacturing Practices. For this, three consecutive batches were validated, where the tests and controls were applied in the mixing stage (appearance, apparent density, settlement density, percentage of moisture) and compression stage (appearance, weight, average weight, hardness, friability, disintegration, dissolution, Cp and Cpk of weights and hardnesses). The three batches complied with all controls and tests performed, resulting within the specifications established in the validation protocol of the pharmaceutical laboratory. Therefore, it is declared that the manufacturing process of said specialty is compliant for its use in production and meets the conditions to ensure a reproducible and consistent process, meeting the established validation criteria.
ABSTRACT The purpose of this pre-professional practice report is to determine if the manufacturing process of Clonixinate of lysine 125 mg + Pargeverine hydrochloride 10 mg coated tablets from a national pharmaceutical laboratory complies with the concurrent validation parameters established according to the validation protocol and the Good Manufacturing Practices. For this, three consecutive batches were validated, where the tests and controls were applied in the mixing stage (appearance, apparent density, settlement density, percentage of moisture) and compression stage (appearance, weight, average weight, hardness, friability, disintegration, dissolution, Cp and Cpk of weights and hardnesses). The three batches complied with all controls and tests performed, resulting within the specifications established in the validation protocol of the pharmaceutical laboratory. Therefore, it is declared that the manufacturing process of said specialty is compliant for its use in production and meets the conditions to ensure a reproducible and consistent process, meeting the established validation criteria.
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Keywords
Validación. Proceso. Fabricación. Clonixinato de lisina. Pargeverina. clorhidrato