Propuesta de un procedimiento operativo estándar (POE) del almacenamiento de materias primas para un laboratorio farmacéutico nacional en Lima, 2022
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El siguiente informe de Prácticas Pre Profesionales, tiene la finalidad de proponer un procedimiento operativo estándar (POE) adecuado para la etapa de Almacenamiento de Materias Primas, así como también proporcionar las indicaciones que corresponden a esta; así mismo, completar la documentación de las Buenas Prácticas de Almacenamiento (BPA) en un laboratorio farmacéutico nacional, se dispone del POE para que la materia prima no sufra daños y/o alteraciones durante su almacenamiento, con la finalidad de asegurar que los insumos estén correctamente conservados para que de esta forma disminuye al máximo aquellos factores que pueden influenciar sobre la calidad de las materias primas y sobre la preservación de estas. Todo ello bajo el cumplimiento del Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos y afines y sus modificatorias – D.S. N° 021 – 2018 – SA. Para la actualizada elaboración de esta propuesta de procedimiento operativo estándar (POE), el documento brindará un fundamento normado en base a la revisión y análisis bibliográfico; que será dirigido hacia los trabajadores del laboratorio garantizando que los procedimientos se realicen a diario y de forma efectiva, para de esta manera los insumos mantengan condiciones de alta calidad llegando con esto a producir productos farmacéuticos o afines seguros y eficaces. En el transcurso de seguir la normativa, el procedimiento propuesto para el Almacenamiento de Materias Primas es parte del cumplimiento en las Buenas Prácticas de Almacenamiento otorgado bajo inspecciones realizadas por la Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), certificando la función del establecimiento dedicado al Almacenamiento y Producción de productos farmacéuticos y afines deben asegurar que las operaciones de Almacenamiento deben estandarizarse, vigilarse y evaluarse periódicamente por medio de auto-inspecciones.
ABSTRACT The following Pre-Professional Practices report has the purpose of proposing a standard operating procedure (SOP) suitable for the Storage of Raw Materials stage, as well as providing the indications that correspond to it; likewise, complete the documentation of the Good Storage Practices (BPA) in a national pharmaceutical laboratory, the POE is available so that the raw material does not suffer damage and/or alterations during its storage, in order to ensure that the supplies are correctly preserved so that in this way the factors that can influence the quality of the raw materials and their preservation are minimized. All this under compliance with the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products and related and its amendments - D.S. No. 021 – 2018 – SA. For the updated preparation of this proposal for a standard operating procedure (SOP), the document will provide a normative foundation based on the review and bibliographic analysis; which will be directed towards the laboratory workers, guaranteeing that the procedures are carried out daily and effectively, so that the supplies maintain high quality conditions, thereby leading to the production of safe and effective pharmaceutical or related products. In the course of following the regulations, the proposed procedure for the Storage of Raw Materials is part of the compliance with the Good Storage Practices granted under inspections carried out by the General Directorate of Medicines, Supplies and Drugs (DIGEMID), certifying the function of the establishment dedicated to the Storage and Production of pharmaceutical and related products must ensure that Storage operations must be standardized, monitored and periodically evaluated through self-inspections.
ABSTRACT The following Pre-Professional Practices report has the purpose of proposing a standard operating procedure (SOP) suitable for the Storage of Raw Materials stage, as well as providing the indications that correspond to it; likewise, complete the documentation of the Good Storage Practices (BPA) in a national pharmaceutical laboratory, the POE is available so that the raw material does not suffer damage and/or alterations during its storage, in order to ensure that the supplies are correctly preserved so that in this way the factors that can influence the quality of the raw materials and their preservation are minimized. All this under compliance with the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products and related and its amendments - D.S. No. 021 – 2018 – SA. For the updated preparation of this proposal for a standard operating procedure (SOP), the document will provide a normative foundation based on the review and bibliographic analysis; which will be directed towards the laboratory workers, guaranteeing that the procedures are carried out daily and effectively, so that the supplies maintain high quality conditions, thereby leading to the production of safe and effective pharmaceutical or related products. In the course of following the regulations, the proposed procedure for the Storage of Raw Materials is part of the compliance with the Good Storage Practices granted under inspections carried out by the General Directorate of Medicines, Supplies and Drugs (DIGEMID), certifying the function of the establishment dedicated to the Storage and Production of pharmaceutical and related products must ensure that Storage operations must be standardized, monitored and periodically evaluated through self-inspections.
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Keywords
Documentación, Procedimiento Operativo Estandarizado (POE), Buenas Prácticas de Almacenamiento (BPA).