info:eu-repo/semantics/bachelorThesis
Validación concurrente del proceso de manufactura de clotrimazol 1g% – gentamicina sulfato 0,1g% – dexametasona acetato 0,04g% (p/p) crema tópica”
Fecha
2011Autor
Tapia Ramírez, Willian Enrique
Institución
Resumen
Within the pharmaceutical industry, validating the concept of framing an advanced concept that seeks to achieve total quality control. While not increase quality, we guarantee the reliability and consistency of it. This work was carried out concurrent validation of the manufacturing process 1g% Clotrimazole - 0.1 g% gentamicin sulfate - dexamethasone acetate 0.04 g% (w / w) topical cream, obtaining documented evidence that the manufacturing process is able to perform consistently and repeatedly established specifications throughout the process.Tests were conducted to determine validation batches for three consecutive standards compliance specifications cited in the process, being assessed at each stage of manufacture, packaging and conditioning. In the analysis of data were used as different statistical mean or average, standard deviation, capability index (Cp) and control charts. The results obtained during the production stage for the description parameters (organoleptic), pH, viscosity and uniform distribution of active ingredient were conforming to the three lots. As for the evaluation during the packaging stage, the results for parameters description (organoleptic), minimum fill, pH, viscosity, water resistance, microbial limit and content of the active substance complies with the specifications already agreed. For the evaluation of other specifications in the stage of conditioning took into account the criteria of presence of the product, packaging printing and complete data, obtaining results within specification evaluated, therefore, was obtained as a conclusion that the process of Clotrimazole manufacturing 1g% - 0.1 g% gentamicin sulfate - dexamethasone acetate 0.04 g% (w / w) topical cream complies with the concurrent validation conducted in this study. The validation report of three consecutive batches of the product standard study was performed demonstrating the consistency and repeatability of results in three batches manufactured