Resumen

ALONSO-RODRIGUEZ, Heidy L; CUELLAR-DE LA CRUZ, Mirta E.  y  CALVO-ALONSO, Amalia M.. Validation System for the manufacturing process of the Active Pharmaceutical Ingredient Furvina. Ing. Ind. [online]. 2021, vol.42, n.1, pp. 29-49.  Epub 04-Mayo-2021. ISSN 1815-5936.

In this work, a Validation System was designed for the manufacturing process of the Active Pharmaceutical Ingredient, Furvina, obtained from chemical synthesis in the production plant of the Center for Chemical Bioactives. To achieve this objective and have a prior knowledge of that manufacturing process, the flowcharts of the production and quality control processes were prepared. A diagnosis was made on the status of the validation studies. A system planning was carried out through the 5W and H analysis and a procedure was prepared to identify the objects to be validated in the Furvina manufacturing. The main results were the validation system for the Furvina manufacturing process and a methodology to carry out the validation studies, based on the Deming cycle (plan-do-verify-act).

Palabras clave : System; Validation; Active Pharmaceutical Ingredient.

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