{"id":4545,"date":"2024-08-27T15:29:53","date_gmt":"2024-08-27T20:29:53","guid":{"rendered":"https:\/\/scrconsultings.com\/?p=4545"},"modified":"2026-01-27T11:52:56","modified_gmt":"2026-01-27T16:52:56","slug":"how-to-prepare-for-pharmacovigilance-certification-audits-in-peru-digemid","status":"publish","type":"post","link":"https:\/\/scrconsultings.com\/es\/how-to-prepare-for-pharmacovigilance-certification-audits-in-peru-digemid\/","title":{"rendered":"Recomendaciones m\u00e1s importantes para obtener la certificaci\u00f3n de Buenas Pr\u00e1cticas de Farmacovigilancia en Per\u00fa"},"content":{"rendered":"<p class=\"translation-block\">Las actividades de auditor\u00eda de farmacovigilancia deben verificar, bas\u00e1ndose en la revisi\u00f3n de evidencia objetiva, que el sistema de farmacovigilancia es adecuado, efectivo y cumple con los criterios establecidos en las regulaciones nacionales. Para una auditor\u00eda exitosa, se recomienda:\n<br>\n- Contar con un correo electr\u00f3nico y un n\u00famero de tel\u00e9fono dedicados al departamento de farmacovigilancia del establecimiento.<br>\n- Informar a DIGEMID sobre el Oficial de Farmacovigilancia (FV) y el establecimiento farmac\u00e9utico a trav\u00e9s del sistema de e-Reporting.<br>\n- Mantener actualizados los Procedimientos Operativos Est\u00e1ndar (POEs) y los documentos de farmacovigilancia.<br>\n- Establecer un programa de autoinspecci\u00f3n\/auditor\u00eda general en Farmacovigilancia (FV) o cuando se detecte una deficiencia o necesidad de acci\u00f3n correctiva.<br>\n- Hacer seguimiento a las acciones preventivas o correctivas resultantes de una no conformidad.<br>\n- Cumplir con los programas anuales seg\u00fan el cronograma establecido (capacitaci\u00f3n, b\u00fasquedas de literatura, Informes de Seguridad Peri\u00f3dicos (PSRs), etc.).<br>\n- Seguir las directrices de la Gu\u00eda de Inspecci\u00f3n de Buenas Pr\u00e1cticas de Farmacovigilancia descritas en R.M. N\u00b01053-2020\/MINSA.<\/p>","protected":false},"excerpt":{"rendered":"<p>&#8211; Pharmacovigilance audit activities should verify, based on the examination of objective evidence, that the pharmacovigilance system is adequate, effective, and complies with the criteria established in national regulations. For a successful audit, it is recommended to: &#8211; Have an email and phone number dedicated to the pharmacovigilance department of the establishment. &#8211; Inform DIGEMID [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":4609,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46,86],"tags":[],"class_list":["post-4545","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-good-pharmacovigilance-practices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How to Prepare for Pharmacovigilance Certification Audits in Peru (DIGEMID)<\/title>\n<meta name=\"description\" content=\"Practical recommendations to obtain Good Pharmacovigilance Practices certification in Peru: audit preparation, dedicated PV contact channels, e-reporting to DIGEMID, 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