Validación del proceso de manufactura de ALKOYODO solución (Povidona yodada 10 %) en el Laboratorio ALKOFARMA E.I.R.L

• Autor: Arroyo Arroyo, Francies Jhompier
• Formato: tesis de grado
• Fecha de Publicación: 2017
• Institución: Universidad Nacional de Trujillo
• Repositorio: UNITRU-Tesis
• Lenguaje: español
• OAI Identifier: oai:dspace.unitru.edu.pe:20.500.14414/8002
• Enlace del recurso: https://hdl.handle.net/20.500.14414/8002
• Nivel de acceso: acceso abierto
• Materia: Exactitud, Linealidad, Precisión, Validación

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 protocol approved by the area of quality control of the company, taking into account the acceptance criteria as indicated in the USP 39; The process capacity for each test was also calculated for each stage (manufacturing and packaging), obtaining as results that in the stage of manufacture lot F1040116 shows a better profile in terms of the technical criteria of validation, with respect to the pH test, by Another part of lot F1040076 did so in the titration test, with respect to the stage of packaging lot F1040116 is the one that shows better profile as regards the technical criteria of validation with respect to the volume test, and lot F1040116, in the test of PH, and lot F1040076, in the titration test, finally the Cp for the tests in the manufacturing and packaging process was greater than 1.33, and with respect to the microbiological profile the three batches analyzed have total compliance. Concluding that the validation of the manufacturing process is linear, accurate, and accurate, and being Cp> 1, the manufacturing process was potentially able to meet specifications, so the validated process is reliable and can still be used In successive fabrications.