Validación del proceso de producción de ciprofloxacina 500mg tabletas en Laboratorios Coaspharma

The present work contains a proposal for the validation of the production process of Ciprofloxacin 500mg tablets in COASPHARMA laboratories in the city of Bogotá, complying with the requirements and guidelines of the FDA (Food and Drug Administration) and the WHO (World Health Organization). To start the validation process it is necessary to carry out a preliminary evaluation which consists of compiling historical documents that evidence a retrospective validation of the drug, giving way to the realization of the first concurrent validation starting with a validation protocol, in which the stages of the process, parameters and everything necessary for the analysis of the production process are delimited, later by means of experimental tests and with the help of statistical tools the standardization and qualification of the production process was carried out. Finally, the validation of the process was documented demonstrating that the process is capable of meeting the specifications and requirements necessary for the manufacture of the product following the guidelines given by the control and quality bodies for this industry.

• Fecha de publicación: 2020
• Institución: Universidad de América
• Repositorio: Lumieres
• Idioma: spa
• OAI Identifier: oai:repository.uamerica.edu.co:20.500.11839/8127
• Acceso en línea: https://hdl.handle.net/20.500.11839/8127
• Palabra clave: Atributos de calidad; Control estadístico del proceso; Validación del proceso de fabricación; Quality attributes; Statistical control of the process; Validation of the manufacturing process; Tesis y disertaciones académicas
• License: Atribución – No comercial