1. Calidad de productos farmacéuticos y afines en el Perú pesquisados por digemid, 2002 - 2006
- Author
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Coral Monge, María Margarita, Juárez Eyzaguirre, José, and Bravo Orellana, Gustavo
- Subjects
Reglamento ,Inquiry ,DIGEMID ,Calidad de medicamento ,Vigilancia sanitaria ,Medicine quality ,Regulation ,Sanity alertness ,Pesquisa - Abstract
2843 inquiries were checked, pharmaceuticals and related products, made by the Control and Monitoring Equipment Establishments of DIGEMID from 2002 to 2006. The physicochemical and microbiological analyses were realized by the National Institute of Health and then evaluated by the Control and Monitoring Product. Of the whole of products were found that 65% are satisfied and 35% did not comply. The results of the non-compliant were classified to determine the main observations about quality: Unauthorized labeling 40%, Deficient product 27%, Critical 17%, Specification change 14%, Without sanitary record 1% and Unauthorized presentation form 1 %. In their investigation: 45% were brand name drugs, generic drugs 30%, 10% medical supplies and 9% cosmetics. Were in conformity: brand drugs 69%, generic drugs 64%, medical supplies 60% and cosmetics 68%. Regarding the type of pharmaceutical establishment in accordance presenting their products are: labs 69%, drugstores 62%, importing 67%. By country of origin, the line were 71% home and 59% foreign., Se revisaron 2843 pesquisas de productos farmacéuticos y afines, realizadas por el Equipo de Control y Vigilancia de Establecimientos de la DIGEMID de 2002 a 2006. Los análisis fisicoquímicos y microbiológicos fueron realizados por el Instituto Nacional de Salud y luego evaluados por el Equipo de Control y Vigilancia de Productos. Del total de productos pesquisados, se encontró que el 65% son conformes y 35% no conformes. Los resultados de los no conformes se clasificaron para determinar las principales observaciones a la calidad: Rotulado no Autorizado 40%, Producto Deficiente 27%, Crítico 17%, Cambio de especificación 14%, Sin registro sanitario 1% y Forma de presentación no autorizada 1%. De las pesquisas realizadas: 45% fueron medicamentos de marca, 30% medicamentos genéricos, 10% material médico y 9% cosméticos. Resultaron conformes: Medicamentos de marca 69%, medicamentos genéricos 64%, material médico 60% y cosméticos 68%. Respecto al tipo de Establecimiento Farmacéutico que presentan conformidad en sus productos tenemos: Laboratorios 69%, Droguerías 62% e Importadoras 67%. Según país de procedencia, los conformes fueron 71% nacionales y 59% extranjeros.
- Published
- 2009