Elaboración de dossier para inscripción en el registro sanitario de un producto farmacéutico de categoría I
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Date
2022
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre profesionales fue realizado en el área de Asuntos Regulatorios de un laboratorio farmacéutico ubicado en la ciudad de Lima, teniendo como objetivo elaborar un dossier para Inscripción en el registro sanitario de un producto farmacéutico de categoría I, el cual es presentado ante nuestra entidad regulatoria que es la Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), mediante la Ventanilla Única de Comercio Exterior (VUCE), que es una página virtual, en la cual el usuario puede realizar todo tipo de trámites (inscripciones, reinscripciones, cambios mayos) y pagos. Durante el proceso de recopilación de documentación técnica para la inscripción del producto sanitario se realiza la gestión de apoyo de las diferentes áreas del laboratorio farmacéutico, en el cual se consideran requisitos como: Especificación Técnica y Metodología Analítica del Producto Terminado, Ingrediente Farmacéutico Activo (IFA), y Excipientes, Especificaciones Técnicas del Material de Envase y Empaque, Estudios de Estabilidades, rotulados, validación, certificado de BPM, entre otros para obtener el registro sanitario. Es por ello que el presente informe nos brinda el enfoque de desarrollo de investigación y análisis dentro del proceso de inscripción dando a conocer la finalidad de tramitar un registro sanitario, el cual dio un óptimo resultado obteniéndose la resolución directoral para una libre fabricación, importación, comercialización y control de cambios, sin afectar la calidad, seguridad y eficacia del medicamento.
ABSTRACT This pre-professional internship report was carried out in the Regulatory Affairs area of a pharmaceutical laboratory located in the city of Lima, with the objective of preparing a dossier for registration in the sanitary registry of a category I pharmaceutical product, which is submitted to our regulatory entity, the General Directorate of Medicines, Supplies and Drugs (DIGEMID), through the Foreign Trade Single Window (VUCE), which is a virtual page, where the user can carry out all types of procedures (registrations, re-registrations, changes) and payments. During the process of compiling technical documentation for the registration of the sanitary product, the support management of the different areas of the pharmaceutical laboratory is carried out, in which requirements are considered such as: Technical Specification and Analytical Methodology of the Finished Product, Active Pharmaceutical Ingredient (API), and Excipients, Technical Specifications of the Container and Packaging Material, Stabilities Studies, labeling, validation, BPM certificate, among others to obtain the sanitary registration. That is why this report provides us with the research and analysis development approach within the registration process, showing the purpose of obtaining a sanitary registration, which gave an optimal result obtaining the directorial resolution for a free manufacture, import, commercialization and control of changes, without affecting the quality, safety and efficacy of the medicine.
ABSTRACT This pre-professional internship report was carried out in the Regulatory Affairs area of a pharmaceutical laboratory located in the city of Lima, with the objective of preparing a dossier for registration in the sanitary registry of a category I pharmaceutical product, which is submitted to our regulatory entity, the General Directorate of Medicines, Supplies and Drugs (DIGEMID), through the Foreign Trade Single Window (VUCE), which is a virtual page, where the user can carry out all types of procedures (registrations, re-registrations, changes) and payments. During the process of compiling technical documentation for the registration of the sanitary product, the support management of the different areas of the pharmaceutical laboratory is carried out, in which requirements are considered such as: Technical Specification and Analytical Methodology of the Finished Product, Active Pharmaceutical Ingredient (API), and Excipients, Technical Specifications of the Container and Packaging Material, Stabilities Studies, labeling, validation, BPM certificate, among others to obtain the sanitary registration. That is why this report provides us with the research and analysis development approach within the registration process, showing the purpose of obtaining a sanitary registration, which gave an optimal result obtaining the directorial resolution for a free manufacture, import, commercialization and control of changes, without affecting the quality, safety and efficacy of the medicine.
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Keywords
Inscripción, Registro sanitario, Dossier, Especificaciones técnicas