1
tesis de grado
Publicado 2017
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The pharmaceutical industry to comply with Peruvian legislation, must incorporate the analysis of the validation of production processes within its records. In this sense, the present report develops the validation of the manufacturing process in the laboratory ALKOFARMA E.I.R.L of a pharmaceutical solution, which has as active ingredient 10% iodized Povidone. In the initial part of this work we proceed to compile all the bibliographic information necessary to proceed with the first exploratory analyzes. In the validation process, three consecutive batches were analyzed: F1040076, F1040116 and F1060196 from ALKOYODO Solution in 1000 mL presentation, taking into account technical validation criteria such as linearity, accuracy, precision and robustness in the manufacturing and packaging stages, For the tests of volume, titration, pH and microbiological profile, according to the validation...