{"id":8662,"date":"2025-09-11T11:55:50","date_gmt":"2025-09-11T03:55:50","guid":{"rendered":"https:\/\/regask.com\/?p=8662"},"modified":"2025-10-15T14:47:31","modified_gmt":"2025-10-15T06:47:31","slug":"decodificacion-de-ia-gmp-nuevas-imagenes-anexo-22-equipos-reguladores","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/","title":{"rendered":"IA en BPM: Descifrando el nuevo Anexo 22 del PIC\/S para la Regulaci\u00f3n\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">En\u00a0<\/span><b><span data-contrast=\"auto\">7 de julio de 2025<\/span><\/b><span data-contrast=\"auto\">, el\u00a0<\/span><a href=\"https:\/\/picscheme.org\/en\/picscheme\"><b><span data-contrast=\"none\">Esquema de Cooperaci\u00f3n para la Inspecci\u00f3n Farmac\u00e9utica (PIC\/S)<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0publicado\u00a0<\/span><b><span data-contrast=\"auto\">Anexo 22<\/span><\/b><span data-contrast=\"auto\">\u00a0a la Gu\u00eda de BPM de PIC\/S. Este nuevo anexo proporciona expectativas regulatorias detalladas para el uso de\u00a0<\/span><b><span data-contrast=\"auto\">Inteligencia artificial (IA) y aprendizaje autom\u00e1tico (ML)<\/span><\/b><span data-contrast=\"auto\">\u00a0en\u00a0<\/span><b><span data-contrast=\"auto\">Entornos regulados por GMP<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La actualizaci\u00f3n aborda las lagunas en\u00a0<\/span><b><span data-contrast=\"auto\">Anexo 11<\/span><\/b><span data-contrast=\"auto\">, que no cubre completamente las tecnolog\u00edas de IA\/ML en evoluci\u00f3n. El objetivo es garantizar\u00a0<\/span><b><span data-contrast=\"auto\">Integraci\u00f3n de IA segura, confiable y transparente<\/span><\/b><span data-contrast=\"auto\">\u00a0en operaciones farmac\u00e9uticas, particularmente en \u00e1reas que afectan directamente\u00a0<\/span><b><span data-contrast=\"auto\">seguridad del paciente, calidad del producto e integridad de los datos<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-15864517\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-15864517 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1582561704\">\n\n\t<div id=\"col-1319135450\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW123257412 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW123257412 BCX0\" data-ccp-parastyle=\"heading 2\">Disposiciones clave del Anexo 22<\/span><\/span><span class=\"EOP SCXW123257412 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-468740313\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-468740313 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">El Anexo 22 es un\u00a0<\/span><b><span data-contrast=\"auto\">nueva incorporaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0en lugar de una revisi\u00f3n, dise\u00f1ada para complementar el Anexo 11 con requisitos espec\u00edficos de la IA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">El anexo limita estrictamente el alcance del uso de IA en BPM:\u00a0<\/span><b><span data-contrast=\"auto\">Solo modelos est\u00e1ticos de IA\/ML con resultados deterministas<\/span><\/b><span data-contrast=\"auto\">\u00a0Puede implementarse en aplicaciones cr\u00edticas. Sistemas que utilizan\u00a0<\/span><b><span data-contrast=\"auto\">modelos din\u00e1micos, resultados probabil\u00edsticos o aprendizaje adaptativo<\/span><\/b><span data-contrast=\"auto\">\u00a0son\u00a0<\/span><b><span data-contrast=\"auto\">Prohibido en contextos cr\u00edticos de BPM<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">IA generativa y modelos de lenguaje extenso (LLM)<\/span><\/b><span data-contrast=\"auto\">\u00a0No se permiten en operaciones cr\u00edticas. En contextos no cr\u00edticos, su uso solo es aceptable con\u00a0<\/span><b><span data-contrast=\"auto\">Supervisi\u00f3n humana en el circuito (HITL)<\/span><\/b><span data-contrast=\"auto\">\u00a0por personal cualificado.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La implementaci\u00f3n debe ser\u00a0<\/span><b><span data-contrast=\"auto\">multidisciplinario<\/span><\/b><span data-contrast=\"auto\">, involucrando\u00a0<\/span><b><span data-contrast=\"auto\">Garant\u00eda de calidad (QA), cient\u00edficos de datos, equipos de TI, PYMES y consultores<\/span><\/b><span data-contrast=\"auto\">Cada etapa del ciclo de vida de la IA, desde\u00a0<\/span><b><span data-contrast=\"auto\">Selecci\u00f3n y entrenamiento de algoritmos hasta validaci\u00f3n, prueba e implementaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u2014debe ser\u00a0<\/span><b><span data-contrast=\"auto\">informados por el riesgo, rastreables y documentados<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">La intenci\u00f3n regulatoria es clara: prevenir el comportamiento impredecible de la IA, reforzar la explicabilidad y la auditabilidad, preservar\u00a0<\/span><b><span data-contrast=\"auto\">integridad de los datos<\/span><\/b><span data-contrast=\"auto\">, y garantizar\u00a0<\/span><b><span data-contrast=\"auto\">responsabilidad humana<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1936580666\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW72001948 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW72001948 BCX0\" data-ccp-parastyle=\"heading 2\">Por qu\u00e9 es importante<\/span><\/span><span class=\"EOP SCXW72001948 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-270705266\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-270705266 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">El Anexo 22 aumenta significativamente las expectativas de cumplimiento para los fabricantes farmac\u00e9uticos que consideran la IA. Las empresas que utilizan\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">modelos de IA din\u00e1micos o adaptativos<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0Puede que sea necesario\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">repensar el dise\u00f1o y la estrategia del sistema<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">. Requisitos para\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">explicabilidad, independencia de los datos de prueba y trazabilidad<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0Tambi\u00e9n podr\u00eda aumentar\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">exigencias de preparaci\u00f3n para auditor\u00edas<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0y\u00a0<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">necesitar<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0una colaboraci\u00f3n interfuncional m\u00e1s estrecha.<\/span><\/span><span class=\"EOP SCXW218463272 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1976718277\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW217261047 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW217261047 BCX0\" data-ccp-parastyle=\"heading 2\">Pertinencia<\/span><\/span><span class=\"EOP SCXW217261047 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-110645645\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-110645645 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Esta actualizaci\u00f3n es fundamental para:<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<ul>\n<li><b><span data-contrast=\"auto\">Equipos de Regulaci\u00f3n y Calidad<\/span><\/b><span data-contrast=\"auto\">\u00a0garantizar el cumplimiento de las expectativas de GMP<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"auto\">Cient\u00edficos de datos y especialistas en TI<\/span><\/b><span data-contrast=\"auto\">\u00a0gesti\u00f3n del desarrollo y la integraci\u00f3n de sistemas de IA<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"auto\">fabricantes farmac\u00e9uticos<\/span><\/b><span data-contrast=\"auto\">\u00a0planificar u operar procesos impulsados por IA dentro de entornos regulados por GMP<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1975351603\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3><span class=\"TextRun MacChromeBold SCXW116595951 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116595951 BCX0\" data-ccp-parastyle=\"heading 2\">Pr\u00f3ximos pasos para la industria<\/span><\/span><span class=\"EOP SCXW116595951 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:299,&quot;335559739&quot;:299}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-1504845166\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1504845166 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deber\u00edan comenzar\u00a0<\/span><b><span data-contrast=\"auto\">evaluaciones de brechas internas<\/span><\/b><span data-contrast=\"auto\">\u00a0Comparar los sistemas actuales de IA\/ML con los requisitos del Anexo 22. Se debe prestar especial atenci\u00f3n a\u00a0<\/span><b><span data-contrast=\"auto\">Validaci\u00f3n de modelos, rigor de las pruebas y transparencia de los datos<\/span><\/b><span data-contrast=\"auto\">Si bien el Anexo 22 es nuevo, una alineaci\u00f3n temprana puede mitigar las interrupciones en el cumplimiento una vez que su implementaci\u00f3n se vuelva obligatoria.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Se alienta a las partes interesadas a revisar el anexo detenidamente y a prepararse para aportar comentarios en cualquier reuni\u00f3n futura.\u00a0<\/span><b><span data-contrast=\"auto\">per\u00edodos de consulta<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Al pasar de la preparaci\u00f3n a la adaptaci\u00f3n proactiva, las empresas pueden beneficiarse de un apoyo estructurado.\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">En este caso,\u00a0<\/span><\/b><a href=\"https:\/\/regask.com\/es\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0es una soluci\u00f3n impulsada por IA para la inteligencia regulatoria y la orquestaci\u00f3n del flujo de trabajo\u00a0<\/span><\/b><span data-contrast=\"none\">Ayudando a las empresas de ciencias biol\u00f3gicas y bienes de consumo envasados a mantenerse al d\u00eda con las cambiantes regulaciones y pautas globales.\u00a0<\/span><b><span data-contrast=\"none\">Combina documentaci\u00f3n inteligente, flujos de trabajo automatizados y expertos integrados<\/span><\/b><span data-contrast=\"none\"> para permitir una adaptaci\u00f3n m\u00e1s r\u00e1pida, lo que en \u00faltima instancia reduce el riesgo operativo.<\/span><\/p>\n<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>Reservar una demostraci\u00f3n<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1575296833\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3><span class=\"TextRun MacChromeBold SCXW156847865 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW156847865 BCX0\">Definiciones y acr\u00f3nimos:<\/span><\/span><span class=\"EOP SCXW156847865 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/h3>\n\t<div id=\"gap-1235471239\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1235471239 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><b><span data-contrast=\"none\">IA\/ML<\/span><\/b><span data-contrast=\"none\">:Inteligencia artificial\/Aprendizaje autom\u00e1tico: sistemas que aprenden patrones a partir de datos en lugar de seguir una programaci\u00f3n fija.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Modelo est\u00e1tico<\/span><\/b><span data-contrast=\"none\">:Un modelo de IA que no cambia una vez entrenado; necesario en aplicaciones GMP cr\u00edticas.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Modelo din\u00e1mico<\/span><\/b><span data-contrast=\"none\">:Sistemas de IA de aprendizaje continuo\/adaptativo; no permitidos en usos cr\u00edticos de GMP.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Salida determinista<\/span><\/b><span data-contrast=\"none\">:Resultados predecibles y repetibles para una entrada determinada.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Salida probabil\u00edstica<\/span><\/b><span data-contrast=\"none\">:Resultados variables incluso con entradas id\u00e9nticas; no permitido en casos de uso cr\u00edticos.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">IA generativa \/ LLM<\/span><\/b><span data-contrast=\"none\">:Modelos generadores de contenido (por ejemplo, creadores de texto o im\u00e1genes) que operan de forma probabil\u00edstica.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">HITL (Human-In-The-Loop)<\/span><\/b><span data-contrast=\"none\">:Mecanismo de supervisi\u00f3n que requiere la revisi\u00f3n o validaci\u00f3n humana de las decisiones de la IA en usos no cr\u00edticos.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Explicabilidad<\/span><\/b><span data-contrast=\"none\">:Capacidad para comprender e interpretar las decisiones y la l\u00f3gica de la IA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<li><b><span data-contrast=\"none\">Independencia de los datos de prueba<\/span><\/b><span data-contrast=\"none\">:Uso de conjuntos de datos separados de los datos de entrenamiento para validar objetivamente el rendimiento de la IA.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335557856&quot;:16777215,&quot;335559738&quot;:210,&quot;335559739&quot;:210,&quot;335572071&quot;:4,&quot;335572072&quot;:4,&quot;335572073&quot;:0,&quot;335572075&quot;:4,&quot;335572076&quot;:4,&quot;335572077&quot;:0,&quot;335572079&quot;:4,&quot;335572080&quot;:4,&quot;335572081&quot;:0,&quot;335572083&quot;:4,&quot;335572084&quot;:4,&quot;335572085&quot;:0,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;}\">\u00a0<\/span><\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1978829671\">\n\n\t<div id=\"col-1438322624\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1438322624 > .col-inner {\n  margin: 0px 0px -10px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1655382972\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-3303584113\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW43675964 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW43675964 BCX0\">\u00bfQu\u00e9 es el Anexo 22 de la Gu\u00eda GMP del PIC\/S?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-3303584113 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW65768994 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW65768994 BCX0\">El Anexo 22 es una nueva gu\u00eda emitida por PIC\/S que establece expectativas regulatorias para el uso de IA y ML en la fabricaci\u00f3n farmac\u00e9utica regulada por GMP.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1655382972 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1460814051\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-1189305266\" class=\"text\">\n\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW93685708 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW93685708 BCX0\">\u00bfSe permiten modelos de IA din\u00e1mica o IA generativa en aplicaciones GMP?<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW93685708 BCX0\"><span class=\"SCXW93685708 BCX0\">\u00a0<\/span><br class=\"SCXW93685708 BCX0\" \/><\/span><\/h4>\n\t\t\n<style>\n#text-1189305266 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW9051628 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW9051628 BCX0\">Los modelos de IA din\u00e1micos, adaptativos o probabil\u00edsticos est\u00e1n prohibidos en aplicaciones cr\u00edticas de GMP. La IA generativa y los LLM solo pueden utilizarse en aplicaciones no cr\u00edticas con supervisi\u00f3n humana.<\/span><\/span><span class=\"EOP SCXW9051628 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1460814051 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-845766548\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-2688665185\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW93685708 BCX0\"><span class=\"TextRun MacChromeBold SCXW71618274 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW71618274 BCX0\">\u00bfPor qu\u00e9 el Anexo 22 se centra en modelos de IA est\u00e1ticos y deterministas?<\/span><\/span><span class=\"LineBreakBlob BlobObject DragDrop SCXW71618274 BCX0\"><span class=\"SCXW71618274 BCX0\">\u00a0<\/span><br class=\"SCXW71618274 BCX0\" \/><\/span><\/span><\/h4>\n\t\t\n<style>\n#text-2688665185 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW75775714 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75775714 BCX0\">Los modelos est\u00e1ticos y deterministas proporcionan resultados predecibles y repetibles, lo que reduce los riesgos para la seguridad del paciente, la calidad del producto y la integridad de los datos.<\/span><\/span><span class=\"EOP SCXW75775714 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-845766548 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-438834521\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-701800894\" class=\"text\">\n\t\t\n<h4><span class=\"LineBreakBlob BlobObject DragDrop SCXW93685708 BCX0\"><span class=\"LineBreakBlob BlobObject DragDrop SCXW71618274 BCX0\"><span class=\"NormalTextRun SCXW110541706 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW110541706 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">\u00a0ayudar a las empresas\u00a0<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">Cumplir con<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">\u00a0Anexo 22?<\/span><\/span><\/span><\/h4>\n\t\t\n<style>\n#text-701800894 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a class=\"Hyperlink SCXW12507906 BCX0\" href=\"https:\/\/regask.com\/es\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW12507906 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW12507906 BCX0\" data-ccp-charstyle=\"Hyperlink\">RegASK<\/span><\/span><\/a><span class=\"TextRun SCXW12507906 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW12507906 BCX0\">\u00a0Proporciona inteligencia regulatoria impulsada por IA y orquestaci\u00f3n del flujo de trabajo para\u00a0<\/span><span class=\"NormalTextRun SCXW12507906 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW12507906 BCX0\">\u00a0Nuevos requisitos, como el Anexo 22, los compara con los procesos existentes de la empresa y detecta las deficiencias de cumplimiento. Nuestra plataforma facilita la documentaci\u00f3n estructurada, los flujos de trabajo de validaci\u00f3n y la informaci\u00f3n de expertos, lo que ayuda a los equipos a adaptarse con mayor rapidez y a reducir el riesgo regulatorio.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-438834521 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 7 de julio de 2025, el Esquema de Cooperaci\u00f3n para la Inspecci\u00f3n Farmac\u00e9utica (PIC\/S) public\u00f3 el Anexo 22 de la Gu\u00eda de BPF del PIC\/S. Este nuevo anexo detalla las expectativas regulatorias para el uso de la Inteligencia Artificial (IA) y el Aprendizaje Autom\u00e1tico (AA) en entornos regulados por las BPF. La actualizaci\u00f3n aborda las deficiencias del Anexo 11, que no abarca completamente las tecnolog\u00edas de IA\/AA en evoluci\u00f3n. El objetivo es garantizar una integraci\u00f3n segura, fiable y transparente de la IA en\u2026<\/p>","protected":false},"author":32,"featured_media":8663,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33],"tags":[],"class_list":["post-8662","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Decoding the New PIC\/S Annex 22 for Regulatory Teams | RegASK<\/title>\n<meta name=\"description\" content=\"Find out What the New PIC\/S Annex 22 Means for Compliance Teams regarding compliance with AI and ML standards in pharmaceuticals.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/decodificacion-de-ia-gmp-nuevas-imagenes-anexo-22-equipos-reguladores\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AI in GMP: Decoding the New PIC\/S Annex 22 for Regulatory Teams\" \/>\n<meta property=\"og:description\" content=\"Find out What the New PIC\/S Annex 22 Means for Compliance Teams regarding compliance with AI and ML standards in pharmaceuticals.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/decodificacion-de-ia-gmp-nuevas-imagenes-anexo-22-equipos-reguladores\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-11T03:55:50+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-15T06:47:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Hannah Nordin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/\"},\"author\":{\"name\":\"Hannah Nordin\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\"},\"headline\":\"AI in GMP: Decoding the New PIC\\\/S Annex 22 for Regulato&hellip;\",\"datePublished\":\"2025-09-11T03:55:50+00:00\",\"dateModified\":\"2025-10-15T06:47:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/\"},\"wordCount\":867,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ai-gmp-new-pics-annex-22-means-compliance-teams.png\",\"articleSection\":[\"Regulatory News\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/\",\"name\":\"Decoding the New PIC\\\/S Annex 22 for Regulatory Teams | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ai-gmp-new-pics-annex-22-means-compliance-teams.png\",\"datePublished\":\"2025-09-11T03:55:50+00:00\",\"dateModified\":\"2025-10-15T06:47:31+00:00\",\"description\":\"Find out What the New PIC\\\/S Annex 22 Means for Compliance Teams regarding compliance with AI and ML standards in pharmaceuticals.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ai-gmp-new-pics-annex-22-means-compliance-teams.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ai-gmp-new-pics-annex-22-means-compliance-teams.png\",\"width\":800,\"height\":600,\"caption\":\"Ai Gmp New Pics Annex 22 Means Compliance Teams\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@RegASK\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\",\"name\":\"Hannah Nordin\",\"sameAs\":[\"https:\\\/\\\/regask.com\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Descifrando el nuevo Anexo 22 del PIC\/S para equipos reguladores | RegASK","description":"Descubra qu\u00e9 significa el nuevo Anexo 22 del PIC\/S para los equipos de cumplimiento con respecto al cumplimiento de los est\u00e1ndares de IA y ML en productos farmac\u00e9uticos.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/decodificacion-de-ia-gmp-nuevas-imagenes-anexo-22-equipos-reguladores\/","og_locale":"es_ES","og_type":"article","og_title":"AI in GMP: Decoding the New PIC\/S Annex 22 for Regulatory Teams","og_description":"Find out What the New PIC\/S Annex 22 Means for Compliance Teams regarding compliance with AI and ML standards in pharmaceuticals.","og_url":"https:\/\/regask.com\/es\/decodificacion-de-ia-gmp-nuevas-imagenes-anexo-22-equipos-reguladores\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2025-09-11T03:55:50+00:00","article_modified_time":"2025-10-15T06:47:31+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png","type":"image\/png"}],"author":"Hannah Nordin","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Hannah Nordin","Est. reading time":"4 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/#article","isPartOf":{"@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/"},"author":{"name":"Hannah Nordin","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65"},"headline":"AI in GMP: Decoding the New PIC\/S Annex 22 for Regulato&hellip;","datePublished":"2025-09-11T03:55:50+00:00","dateModified":"2025-10-15T06:47:31+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/"},"wordCount":867,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png","articleSection":["Regulatory News"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/","url":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/","name":"Descifrando el nuevo Anexo 22 del PIC\/S para equipos reguladores | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png","datePublished":"2025-09-11T03:55:50+00:00","dateModified":"2025-10-15T06:47:31+00:00","description":"Descubra qu\u00e9 significa el nuevo Anexo 22 del PIC\/S para los equipos de cumplimiento con respecto al cumplimiento de los est\u00e1ndares de IA y ML en productos farmac\u00e9uticos.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/09\/ai-gmp-new-pics-annex-22-means-compliance-teams.png","width":800,"height":600,"caption":"Ai Gmp New Pics Annex 22 Means Compliance Teams"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Habilitando decisiones regulatorias m\u00e1s inteligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/@RegASK"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65","name":"Hannah Nordin","sameAs":["https:\/\/regask.com"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/8662","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=8662"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/8662\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/8663"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=8662"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=8662"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=8662"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}