{"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":"ia-gmp-decodage-des-nouvelles-images-annexe-22-equipes-reglementaires","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/","title":{"rendered":"L&#039;IA dans les BPF : d\u00e9codage de la nouvelle annexe 22 du PIC\/S pour la r\u00e9glementation\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">Sur\u00a0<\/span><b><span data-contrast=\"auto\">7 juillet 2025<\/span><\/b><span data-contrast=\"auto\">, le\u00a0<\/span><a href=\"https:\/\/picscheme.org\/en\/picscheme\"><b><span data-contrast=\"none\">Programme de coop\u00e9ration en mati\u00e8re d&#039;inspection pharmaceutique (PIC\/S)<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0publi\u00e9\u00a0<\/span><b><span data-contrast=\"auto\">Annexe 22<\/span><\/b><span data-contrast=\"auto\">\u00a0au guide des BPF PIC\/S. Cette nouvelle annexe d\u00e9taille les attentes r\u00e9glementaires relatives \u00e0 l&#039;utilisation des\u00a0<\/span><b><span data-contrast=\"auto\">Intelligence artificielle (IA) et apprentissage automatique (ML)<\/span><\/b><span data-contrast=\"auto\">\u00a0dans\u00a0<\/span><b><span data-contrast=\"auto\">Environnements r\u00e9glement\u00e9s par les BPF<\/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 mise \u00e0 jour comble les lacunes dans\u00a0<\/span><b><span data-contrast=\"auto\">Annexe 11<\/span><\/b><span data-contrast=\"auto\">, qui ne couvre pas enti\u00e8rement l&#039;\u00e9volution des technologies d&#039;IA\/ML. L&#039;objectif est de garantir\u00a0<\/span><b><span data-contrast=\"auto\">int\u00e9gration de l&#039;IA s\u00fbre, fiable et transparente<\/span><\/b><span data-contrast=\"auto\">\u00a0dans les op\u00e9rations pharmaceutiques, en particulier dans les domaines affectant directement\u00a0<\/span><b><span data-contrast=\"auto\">s\u00e9curit\u00e9 des patients, qualit\u00e9 des produits et int\u00e9grit\u00e9 des donn\u00e9es<\/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-656397062\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-656397062 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1054482245\">\n\n\t<div id=\"col-910802592\" 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\">Principales dispositions de l&#039;annexe 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-779307659\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-779307659 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">L&#039;annexe 22 est une\u00a0<\/span><b><span data-contrast=\"auto\">nouvel ajout<\/span><\/b><span data-contrast=\"auto\">\u00a0plut\u00f4t qu\u2019une r\u00e9vision, con\u00e7ue pour compl\u00e9ter l\u2019annexe 11 avec des exigences sp\u00e9cifiques \u00e0 l\u2019IA.<\/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\">L\u2019annexe limite strictement le champ d\u2019utilisation de l\u2019IA dans les BPF :\u00a0<\/span><b><span data-contrast=\"auto\">uniquement des mod\u00e8les d&#039;IA\/ML statiques avec des sorties d\u00e9terministes<\/span><\/b><span data-contrast=\"auto\">\u00a0peuvent \u00eatre d\u00e9ploy\u00e9s dans des applications critiques. Les syst\u00e8mes utilisant\u00a0<\/span><b><span data-contrast=\"auto\">mod\u00e8les dynamiques, r\u00e9sultats probabilistes ou apprentissage adaptatif<\/span><\/b><span data-contrast=\"auto\">\u00a0sont\u00a0<\/span><b><span data-contrast=\"auto\">interdit dans les contextes critiques des BPF<\/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 g\u00e9n\u00e9rative et grands mod\u00e8les de langage (LLM)<\/span><\/b><span data-contrast=\"auto\">\u00a0ne sont pas autoris\u00e9s dans les op\u00e9rations critiques. Dans les contextes non critiques, leur utilisation n&#039;est acceptable qu&#039;avec\u00a0<\/span><b><span data-contrast=\"auto\">Surveillance humaine dans la boucle (HITL)<\/span><\/b><span data-contrast=\"auto\">\u00a0par du personnel qualifi\u00e9.<\/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 mise en \u0153uvre doit \u00eatre\u00a0<\/span><b><span data-contrast=\"auto\">multidisciplinaire<\/span><\/b><span data-contrast=\"auto\">, impliquant\u00a0<\/span><b><span data-contrast=\"auto\">assurance qualit\u00e9 (AQ), scientifiques des donn\u00e9es, \u00e9quipes informatiques, PME et consultants<\/span><\/b><span data-contrast=\"auto\">. Chaque \u00e9tape du cycle de vie de l&#039;IA, de\u00a0<\/span><b><span data-contrast=\"auto\">s\u00e9lection et formation d&#039;algorithmes jusqu&#039;\u00e0 la validation, les tests et le d\u00e9ploiement<\/span><\/b><span data-contrast=\"auto\">\u2014doit \u00eatre\u00a0<\/span><b><span data-contrast=\"auto\">inform\u00e9 sur les risques, tra\u00e7able et document\u00e9<\/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\">L\u2019intention r\u00e9glementaire est claire : pr\u00e9venir les comportements impr\u00e9visibles de l\u2019IA, renforcer l\u2019explicabilit\u00e9 et l\u2019auditabilit\u00e9, pr\u00e9server\u00a0<\/span><b><span data-contrast=\"auto\">int\u00e9grit\u00e9 des donn\u00e9es<\/span><\/b><span data-contrast=\"auto\">, et assurer\u00a0<\/span><b><span data-contrast=\"auto\">responsabilit\u00e9 humaine<\/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-590815748\" 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\">Pourquoi c&#039;est important<\/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-1111446490\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1111446490 {\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\">L&#039;annexe 22 accro\u00eet consid\u00e9rablement les exigences de conformit\u00e9 pour les fabricants pharmaceutiques qui envisagent l&#039;IA. Les entreprises qui utilisent\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">mod\u00e8les d&#039;IA dynamiques ou adaptatifs<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0peut-\u00eatre besoin de\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">repenser la conception et la strat\u00e9gie du syst\u00e8me<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">. Exigences pour\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">explicabilit\u00e9, ind\u00e9pendance des donn\u00e9es de test et tra\u00e7abilit\u00e9<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0pourrait \u00e9galement augmenter\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">exigences de pr\u00e9paration \u00e0 l&#039;audit<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0et\u00a0<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">n\u00e9cessiter<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0une collaboration interfonctionnelle plus \u00e9troite.<\/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-22324304\" 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\">Pertinence<\/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-1491171576\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1491171576 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Cette mise \u00e0 jour est essentielle pour\u00a0:<\/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\">\u00c9quipes R\u00e9glementaires et Qualit\u00e9<\/span><\/b><span data-contrast=\"auto\">\u00a0assurer le respect des attentes 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\">Scientifiques des donn\u00e9es et sp\u00e9cialistes en informatique<\/span><\/b><span data-contrast=\"auto\">\u00a0gestion du d\u00e9veloppement et de l&#039;int\u00e9gration des syst\u00e8mes d&#039;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\">fabricants de produits pharmaceutiques<\/span><\/b><span data-contrast=\"auto\">\u00a0planification ou exploitation de processus pilot\u00e9s par l&#039;IA dans des environnements r\u00e9glement\u00e9s par les BPF<\/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-1291817327\" 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\">Prochaines \u00e9tapes pour l&#039;industrie<\/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-1112013560\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1112013560 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les organisations devraient commencer\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9valuations des lacunes internes<\/span><\/b><span data-contrast=\"auto\">\u00a0comparer les syst\u00e8mes d&#039;IA\/ML actuels avec les exigences de l&#039;Annexe 22. Une attention particuli\u00e8re devrait \u00eatre port\u00e9e sur\u00a0<\/span><b><span data-contrast=\"auto\">validation du mod\u00e8le, rigueur des tests et transparence des donn\u00e9es<\/span><\/b><span data-contrast=\"auto\">Bien que l\u2019annexe 22 soit nouvelle, un alignement pr\u00e9coce peut att\u00e9nuer les perturbations de conformit\u00e9 une fois que la mise en \u0153uvre devient obligatoire.<\/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\">Les parties prenantes sont encourag\u00e9es \u00e0 examiner attentivement l\u2019annexe et \u00e0 se pr\u00e9parer \u00e0 apporter leur contribution lors de toute r\u00e9union future.\u00a0<\/span><b><span data-contrast=\"auto\">p\u00e9riodes de consultation<\/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\">En passant de la pr\u00e9paration \u00e0 l\u2019adaptation proactive, les entreprises peuvent b\u00e9n\u00e9ficier d\u2019un accompagnement structur\u00e9.\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Dans ce cas,\u00a0<\/span><\/b><a href=\"https:\/\/regask.com\/fr\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0est une solution bas\u00e9e sur l&#039;IA pour l&#039;intelligence r\u00e9glementaire et l&#039;orchestration des flux de travail\u00a0<\/span><\/b><span data-contrast=\"none\">aider les entreprises du secteur des sciences de la vie et des biens de consommation emball\u00e9s \u00e0 suivre l\u2019\u00e9volution des r\u00e9glementations et des directives mondiales.\u00a0<\/span><b><span data-contrast=\"none\">Il combine une documentation intelligente, des flux de travail automatis\u00e9s et des experts int\u00e9gr\u00e9s<\/span><\/b><span data-contrast=\"none\"> pour permettre une adaptation plus rapide, ce qui r\u00e9duit en fin de compte le risque op\u00e9rationnel.<\/span><\/p>\n<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>R\u00e9server une d\u00e9mo<\/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-1354351592\" 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\">D\u00e9finitions et acronymes :<\/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-744706299\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-744706299 {\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\">: Intelligence artificielle \/ Apprentissage automatique : syst\u00e8mes qui apprennent des mod\u00e8les \u00e0 partir de donn\u00e9es plut\u00f4t que de suivre une programmation fixe.<\/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\">Mod\u00e8le statique<\/span><\/b><span data-contrast=\"none\">:Un mod\u00e8le d&#039;IA qui ne change pas une fois form\u00e9 ; requis dans les applications GMP critiques.<\/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\">Mod\u00e8le dynamique<\/span><\/b><span data-contrast=\"none\">:Syst\u00e8mes d&#039;IA \u00e0 apprentissage continu\/adaptatifs\u00a0; non autoris\u00e9s dans le cadre d&#039;une utilisation critique des BPF.<\/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\">Sortie d\u00e9terministe<\/span><\/b><span data-contrast=\"none\">: R\u00e9sultats pr\u00e9visibles et r\u00e9p\u00e9tables pour une entr\u00e9e donn\u00e9e.<\/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\">Sortie probabiliste<\/span><\/b><span data-contrast=\"none\">: R\u00e9sultats variables m\u00eame avec une entr\u00e9e identique\u00a0; interdit dans les cas d&#039;utilisation critiques.<\/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 g\u00e9n\u00e9rative \/ LLM<\/span><\/b><span data-contrast=\"none\">: Mod\u00e8les g\u00e9n\u00e9rateurs de contenu (par exemple, cr\u00e9ateurs de texte ou d&#039;images) qui fonctionnent de mani\u00e8re probabiliste.<\/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\">:M\u00e9canisme de surveillance n\u00e9cessitant un examen ou une validation humaine des d\u00e9cisions d\u2019IA dans les utilisations non critiques.<\/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\">Explicabilit\u00e9<\/span><\/b><span data-contrast=\"none\">:Capacit\u00e9 \u00e0 comprendre et \u00e0 interpr\u00e9ter les d\u00e9cisions et la logique de l&#039;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\">Ind\u00e9pendance des donn\u00e9es de test<\/span><\/b><span data-contrast=\"none\">:Utilisation d&#039;ensembles de donn\u00e9es distincts des donn\u00e9es de formation pour valider objectivement les performances de l&#039;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-406552460\">\n\n\t<div id=\"col-354413568\" 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>FAQ<\/h3>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-354413568 > .col-inner {\n  margin: 0px 0px -10px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1422755125\" 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-2089980797\" 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\">Qu&#039;est-ce que l&#039;annexe 22 du guide PIC\/S GMP ?<\/span><\/span><\/h4>\n\t\t\n<style>\n#text-2089980797 {\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\">L&#039;annexe 22 est une nouvelle directive publi\u00e9e par le PIC\/S qui d\u00e9finit les attentes r\u00e9glementaires pour l&#039;utilisation de l&#039;IA et du ML dans la fabrication pharmaceutique r\u00e9glement\u00e9e par les BPF.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1422755125 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-804342627\" 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-2464601325\" 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\">Les mod\u00e8les d\u2019IA dynamique ou g\u00e9n\u00e9ratifs sont-ils autoris\u00e9s dans les applications GMP\u00a0?<\/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-2464601325 {\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\">Les mod\u00e8les d&#039;IA dynamiques, adaptatifs ou probabilistes sont interdits dans les applications GMP critiques. L&#039;IA g\u00e9n\u00e9rative et les LLM ne peuvent \u00eatre utilis\u00e9s que dans les applications non critiques, avec une supervision humaine.<\/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-804342627 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-128864205\" 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-1507494344\" 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\">Pourquoi l\u2019annexe 22 se concentre-t-elle sur les mod\u00e8les d\u2019IA statiques et d\u00e9terministes ?<\/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-1507494344 {\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\">Les mod\u00e8les statiques et d\u00e9terministes fournissent des r\u00e9sultats pr\u00e9visibles et reproductibles, r\u00e9duisant ainsi les risques pour la s\u00e9curit\u00e9 des patients, la qualit\u00e9 des produits et l\u2019int\u00e9grit\u00e9 des donn\u00e9es.<\/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-128864205 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-523576098\" 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-4026290741\" 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\">Comment peut-on\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW110541706 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">\u00a0aider les entreprises\u00a0<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">se conformer \u00e0<\/span><span class=\"NormalTextRun SCXW110541706 BCX0\">\u00a0Annexe 22 ?<\/span><\/span><\/span><\/h4>\n\t\t\n<style>\n#text-4026290741 {\n  line-height: 2.1;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a class=\"Hyperlink SCXW12507906 BCX0\" href=\"https:\/\/regask.com\/fr\/\" 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\">\u00a0fournit des renseignements r\u00e9glementaires bas\u00e9s sur l&#039;IA et une orchestration des flux de travail pour\u00a0<\/span><span class=\"NormalTextRun SCXW12507906 BCX0\">moniteur<\/span><span class=\"NormalTextRun SCXW12507906 BCX0\">\u00a0Analysez les nouvelles exigences, comme l&#039;Annexe 22, comparez-les aux processus existants de l&#039;entreprise et identifiez les \u00e9carts de conformit\u00e9. Notre plateforme prend en charge une documentation structur\u00e9e, des processus de validation et des analyses d&#039;experts, aidant ainsi les \u00e9quipes \u00e0 s&#039;adapter plus rapidement et \u00e0 r\u00e9duire les risques r\u00e9glementaires.<\/span><\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-523576098 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On\u00a0July 7, 2025, the\u00a0Pharmaceutical Inspection Co-operation Scheme (PIC\/S)\u00a0published\u00a0Annex 22\u00a0to the PIC\/S GMP Guide. This new annex provides detailed regulatory expectations for the use of\u00a0Artificial Intelligence (AI) and Machine Learning (ML)\u00a0in\u00a0GMP-regulated environments.\u00a0 The update addresses gaps in\u00a0Annex 11, which does not fully cover evolving AI\/ML technologies. The goal is to ensure\u00a0safe, reliable, and transparent AI integration\u00a0in&#8230;<\/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 v28.0 (Yoast SEO v28.0) - 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 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