RESUMEN
Abstract In this study, the manufacturing process of lamivudine (3TC) and zidovudine (AZT) tablets (150+300 mg respectively) was evaluated using statistical process control (SPC) tools. These medicines are manufactured by the Fundação para o Remédio Popular "Chopin Tavares de Lima" (FURP) laboratory, and are distributed free of charge to patients infected with HIV by the Ministry of Health DST/AIDS national program. Data of 529 batches manufactured from 2012 to 2015 were collected. The critical quality attributes of weight variation, uniformity of dosage units, and dissolution were evaluated. Process stability was assessed using control charts, and the capability indices Cp, Cpk, Pp, and Ppk (process capability; process capability adjusted for non-centered distribution; potential or global capability of the process; and potential process capability adjusted for non-centered distribution, respectively) were evaluated. 3TC dissolution data from 2013 revealed a non-centered process and lack of consistency compared to the other years, showing Cpk and Ppk lower than 1.0 and the chance of failure of 2,483 in 1,000,000 tablets. Dissolution data from 2015 showed process improvement, revealed by Cpk and Ppk equal to 2.19 and 1.99, respectively. Overall, the control charts and capability indices showed the variability of the process and special causes. Additionally, it was possible to point out the opportunities for process changes, which are fundamental for understanding and supporting a continuous improvement environment.
Asunto(s)
Comprimidos/análisis , Zidovudina/agonistas , VIH/patogenicidad , Lamivudine/agonistas , Pacientes/clasificación , Gestión de la Calidad Total/organización & administración , Honorarios y Precios/estadística & datos numéricos , Laboratorios/clasificación , Materiales Manufacturados/provisión & distribuciónRESUMEN
Informe presentado en una reunión con los organismos internacionales y embajadas en el Perú. Contiene cuadros estadísticos y gráficos sobre los casos reportados al 20 de febrero de 1991 y lineamientos básicos sobre la canalización de la cooperación externa mediante el MINSA. Finalmente hace un listado presupuestado por rubros, con lo que se necesita para combatir la epidemia