{"id":432,"date":"2024-01-24T14:06:14","date_gmt":"2024-01-24T13:06:14","guid":{"rendered":"https:\/\/www.asinfarma.com\/seminario-expertos\/?p=432"},"modified":"2025-12-30T10:20:38","modified_gmt":"2025-12-30T09:20:38","slug":"primeros-meses-de-transicion-del-anexo-1-eu-gmp-2023-2024","status":"publish","type":"post","link":"https:\/\/www.asinfarma.com\/seminario-expertos\/2024\/primeros-meses-de-transicion-del-anexo-1-eu-gmp-2023-2024\/","title":{"rendered":"Primeros meses de transici\u00f3n del Anexo 1 EU GMP (2023 &#8211; 2024)"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong>Ponente<\/strong>: <em><em><em><em>Xavier Casterat, NOVARTIS FARMAC\u00c9UTICA<\/em><\/em><\/em><\/em> SA<\/p>\n\n\n\n<p>El 25 de agosto de 2022 entr\u00f3 en vigor la versi\u00f3n definitiva del Anexo 1 exceptuando la disposici\u00f3n 8.123 sobre frecuencia de esterilizaci\u00f3n de los liofilizadores, que entra en vigor en agosto de 2024. En general una norma que da el marco de aplicaci\u00f3n de los principios del <em>Quality Risk Management<\/em> a la fabricaci\u00f3n de productos est\u00e9riles, hasta ahora un campo muy prescriptivo, pero que tambi\u00e9n representa un vuelco en el dise\u00f1o de las instalaciones de fabricaci\u00f3n de este tipo de productos.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Retos principales en la aplicaci\u00f3n del Nuevo Anexo 1<\/li>\n\n\n\n<li>Etapas para el estado de cumplimiento<\/li>\n\n\n\n<li>Experiencias sobre el estado actual<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div id=\"XavierCasterat\" class=\"wp-block-group round has-global-color-13-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\"><div class=\"wp-block-image is-style-rounded\">\n<figure class=\"aligncenter size-thumbnail is-resized\"><img decoding=\"async\" src=\"https:\/\/www.asinfarma.com\/seminario-expertos\/wp-content\/uploads\/sites\/2\/2024\/01\/Xavier-Casterat-150x150.jpg\" alt=\"Xavier Casterat\" class=\"wp-image-286\" style=\"width:200px\"\/><\/figure><\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-center\"><strong>Xavier Casterat<\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\" style=\"font-size:15px\"><strong>Global Auditor GMP<\/strong><br>Novartis Farmac\u00e9utica SA <\/p>\n\n\n<div style=\"font-size:15px\"><div class=\"su-expand su-expand-collapsed su-expand-link-style-underlined\" data-height=\"1\"><div class=\"su-expand-content su-u-trim\" style=\"color:#333333;max-height:1px;overflow:hidden\">\n\n\n\n<p style=\"font-size:15px\">Farmac\u00e9utico de background, ha trabajado durante m\u00e1s de 20 a\u00f1os en la administraci\u00f3n sanitaria realizando inspecciones GMP. Desde hace tres a\u00f1os realiza auditorias GMP en Europa y Oriente Medio.<\/p>\n\n\n<\/div><div class=\"su-expand-link su-expand-link-more\" style=\"text-align:center\"><a href=\"javascript:;\" style=\"color:#176585;border-color:#176585\"><i class=\"sui sui-plus\" style=\"\" aria-label=\"\"><\/i><span style=\"border-color:#176585\">Ver m\u00e1s<\/span><\/a><\/div><div class=\"su-expand-link su-expand-link-less\" style=\"text-align:center\"><a href=\"javascript:;\" style=\"color:#176585;border-color:#176585\"><i class=\"sui sui-minus\" style=\"\" aria-label=\"\"><\/i><span style=\"border-color:#176585\">Ver menos<\/span><\/a><\/div><\/div><\/div>\n\n\n\n<p> <\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/www.asinfarma.com\/seminario-expertos\/wp-content\/uploads\/sites\/2\/2024\/01\/logo-seminario-expertos.svg\" alt=\"Seminario expertos en procesos as\u00e9pticos\" class=\"wp-image-164\"\/><\/figure>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Ponente: Xavier Casterat, NOVARTIS FARMAC\u00c9UTICA SA El 25 de agosto de 2022 entr\u00f3 en vigor la versi\u00f3n definitiva del Anexo 1 exceptuando la disposici\u00f3n 8.123 sobre frecuencia de esterilizaci\u00f3n de los liofilizadores, que entra en vigor en agosto de 2024. En general una norma que da el marco de aplicaci\u00f3n de los principios del Quality &#8230; <a title=\"Primeros meses de transici\u00f3n del Anexo 1 EU GMP (2023 &#8211; 2024)\" class=\"read-more\" href=\"https:\/\/www.asinfarma.com\/seminario-expertos\/2024\/primeros-meses-de-transicion-del-anexo-1-eu-gmp-2023-2024\/\" aria-label=\"Leer m\u00e1s sobre Primeros meses de transici\u00f3n del Anexo 1 EU GMP (2023 &#8211; 2024)\">Leer m\u00e1s<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[9],"class_list":["post-432","post","type-post","status-publish","format-standard","hentry","category-sin-categoria","tag-9","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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