Elaboración del procedimiento operativo estándar para el manejo de reactivos en el área de control fisicoquímico de un laboratorio farmacéutico
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Date
2022
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Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe tiene como objetivo elaborar un procedimiento estándar operativo para el manejo de reactivos en el área de control fisicoquímico de un laboratorio farmacéutico, teniendo en cuenta el manual de las buenas prácticas de manufactura (BPM) y el manual de las buenas prácticas de laboratorio (BPL) ya que ambas son un conjunto de normas que establecen procedimiento y requisitos que garantizan que los datos generados por los laboratorios sean confiables para su correcta comercialización. El procedimiento operativo estándar (POE) es un documento que brindan información actualizada a los trabajadores de laboratorio para garantiza que el procedimiento a realizar se haga de manera diaria con un flujo ya establecido. En el caso del POE del manejo de reactivos se está detallado la recepción del reactivo documentos a revisar, el almacenamiento de los mismos según su hoja de seguridad que es entregada directamente por el proveedor, también se detalla su eliminación y el control físico que los reactivos. Este tipo de actualizaciones de procedimientos en las distintas áreas basándose en los manuales de las buenas prácticas de manufactura y las buenas prácticas de laboratorio permite que el laboratorio pueda comercializar un producto de calidad.
ABSTRACT This report aims to develop a standard operating procedure for the handling of reagents in the physicochemical control area of a pharmaceutical laboratory, taking into account the manual of good manufacturing practices (GMP) and the manual of good laboratory practices (GLP) since both are a set of standards that establish procedure and requirements that guarantee that the data generated by the laboratories are reliable for its correct commercialization. The Standard Operating Procedure (SOP) is a document that provides up-to-date information to laboratory workers to ensure that the procedure to be performed is done on a daily basis with an already established flow. In the case of the SOP of the handling of reagents, the receipt of the reagent documents to be reviewed is detailed, the storage of the same according to its safety sheet that is delivered directly by the supplier, its elimination and the physical control that the reagents are also detailed. This type of procedural updates in the different areas based on the manuals of good manufacturing practices and good laboratory practices allows the laboratory to market a quality product.
ABSTRACT This report aims to develop a standard operating procedure for the handling of reagents in the physicochemical control area of a pharmaceutical laboratory, taking into account the manual of good manufacturing practices (GMP) and the manual of good laboratory practices (GLP) since both are a set of standards that establish procedure and requirements that guarantee that the data generated by the laboratories are reliable for its correct commercialization. The Standard Operating Procedure (SOP) is a document that provides up-to-date information to laboratory workers to ensure that the procedure to be performed is done on a daily basis with an already established flow. In the case of the SOP of the handling of reagents, the receipt of the reagent documents to be reviewed is detailed, the storage of the same according to its safety sheet that is delivered directly by the supplier, its elimination and the physical control that the reagents are also detailed. This type of procedural updates in the different areas based on the manuals of good manufacturing practices and good laboratory practices allows the laboratory to market a quality product.
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Keywords
Reactivos, Control de calidad