Browsing by Author "Rodriguez Escobar, Sebastian"
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Item Validación de proceso de manufactura de una forma farmacéutica sólida en una planta farmacéutica(Universidad Santiago de Cali, 2023) Rodriguez Escobar, Sebastian; Lindo Sanclemente, Juliana Alejandra; Ciro Monsalve, Yhors AlexanderThis project consists of carrying out a concurrent validation of the manufacturing process of (calcium carbonate + vitamin D), produced by Fabrifarma S.A in the city of Cali. This validation is carried out in order to comply with the requirements set out in Resolution 1160 of 2016 of the Ministry of health and social protection, to make a diagnosis in the manufacturing process, in which a documentary review of the master formula, manufacturing instructions, analytical techniques and specifications of the finished product will be made. With this, the parameters to be improved will be detected and relevant corrective actions will be established, to start with the validation process based on the criteria established by Good Manufacturing Practices (GMP) and the validation master plan.