DEMOSTRACIÓN DE LA CONSISTENCIA DEL PROCESO DE FABRICACIÓN DE OLEOZON® ORAL MEDIANTE LA REVISIÓN DE LA CALIDAD DEL PRODUCTO

Abstract

Oleozón® Oral, ozonated sunflower oil, is a medicine developed and produced by the National Center for Scientific Research of Cuba. This product, in emulsion form, is widely used with magnificent results in the treatment, among others, of giardiasis and periodontitis. It is well known that Drug Regulatory Bodies require from pharmaceutical manufacturers evidence that these products are produced in a consistent manner, complying with predefined quality specifications. The Product Quality Review (PQR) is part of the evidence they expect to see. The objective of this work was to demonstrate the consistency of the Oleozon® Oral manufacturing process through process controls, a requirement evaluated in the PCR. Statistical methods such as Shewhart charts and mean comparisons were used to analyze the results after one year of work, in accordance with the established quality specifications, and compared with results from previous years. It was concluded that the process of obtaining ozonated sunflower oil in 2020 was under statistical control and that the means of the quality specifications for this year are statistically equal to those of 2019, which demonstrates the consistency of the process of obtaining Oleozon® Oral.