{"id":8506,"date":"2025-07-23T13:48:39","date_gmt":"2025-07-23T05:48:39","guid":{"rendered":"https:\/\/regask.com\/?p=8506"},"modified":"2025-07-23T13:50:16","modified_gmt":"2025-07-23T05:50:16","slug":"eu-gmp%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b32025-ai%e3%82%b3%e3%83%b3%e3%83%94%e3%83%a5%e3%83%bc%e3%82%bf%e5%8c%96%e3%82%b7%e3%82%b9%e3%83%86%e3%83%a0%e6%96%87%e6%9b%b8%e3%81%ae","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","title":{"rendered":"\u6b27\u5dde\u59d4\u54e1\u4f1a\u3001\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306b\u95a2\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u3092\u958b\u59cb"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2025\u5e747\u67087\u65e5<\/strong>\u3001 <a href=\"https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-and-food-safety_en\"><strong>\u6b27\u5dde\u59d4\u54e1\u4f1a\u4fdd\u5065\u98df\u54c1\u5b89\u5168\u7dcf\u5c40<\/strong><\/a> \u30aa\u30fc\u30d7\u30f3\u3057\u305f <strong>\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3<\/strong> \u63d0\u6848\u3055\u308c\u305f\u6539\u6b63\u306b\u3064\u3044\u3066 <strong>EudraLex \u7b2c4\u5dfb \u2013 \u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/strong>\u66f4\u65b0\u306f\u4ee5\u4e0b\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u7b2c4\u7ae0: \u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/strong><\/li>\n<li><strong>\u4ed8\u933211\uff1a\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0<\/strong><\/li>\n<li><strong>\u4ed8\u933222\uff1a\u4eba\u5de5\u77e5\u80fd<\/strong> <em>\uff08\u65b0\u767b\u5834\uff09<\/em><\/li>\n<\/ul>\n<p>\u3053\u308c\u3089\u306e\u63d0\u6848\u3055\u308c\u305f\u5909\u66f4\u306e\u76ee\u7684\u306f\u3001 <strong>GMP\u5b9f\u8df5\u3092\u8fd1\u4ee3\u5316\u3059\u308b<\/strong> \u5f37\u5316\u3059\u308b\u3053\u3068\u306b\u3088\u308a <strong>\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027<\/strong>\u3001\u7d71\u5408 <strong>AI\u30ac\u30d0\u30ca\u30f3\u30b9<\/strong>\u3001\u304a\u3088\u3073\u76e3\u7763\u306e\u6539\u5584 <strong>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0<\/strong> \u305d\u3057\u3066 <strong>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/strong> \u3067 <strong>\u533b\u85ac\u54c1\u88fd\u9020<\/strong>.<\/p>\n<p><strong>\u4e3b\u306a\u30cf\u30a4\u30e9\u30a4\u30c8:<\/strong><\/p>\n<ul>\n<li>\u306e <strong>\u7b2c4\u7ae0\u3092\u66f4\u65b0<\/strong> \u5f37\u8abf\u3059\u308b <strong>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u6587\u66f8\u5316\u306e\u5b9f\u8df5<\/strong>\u3001\u5f37\u5316\u3055\u308c\u305f\u7ba1\u7406\u3068\u3068\u3082\u306b <strong>\u96fb\u5b50\u8a18\u9332<\/strong> \u305d\u3057\u3066 <strong>\u7f72\u540d<\/strong>\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089 <strong>\u8aad\u307f\u3084\u3059\u3055\u3068\u5b8c\u5168\u6027<\/strong> \u3042\u3089\u3086\u308b\u5f62\u5f0f\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3002<\/li>\n<li>\u306e <strong>\u6539\u8a02\u3055\u308c\u305f\u4ed8\u5c5e\u66f811<\/strong> \u306e\u9069\u7528\u3092\u5f37\u5316\u3059\u308b <strong>\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\uff08QRM\uff09<\/strong> \u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u3066 <strong>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0<\/strong>\u3088\u308a\u5f37\u529b\u306a\u898f\u5236\u3092\u5c0e\u5165\u3057\u3001 <strong>\u76e3\u67fb\u8a66\u9a13<\/strong>, <strong>\u30b7\u30b9\u30c6\u30e0\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u76e3\u8996<\/strong>.<\/li>\n<li>\u306e <strong>\u65b0\u305f\u306b\u5c0e\u5165\u3055\u308c\u305f\u9644\u5c5e\u66f822<\/strong> \u4f7f\u7528\u306b\u95a2\u3059\u308b\u660e\u78ba\u306a\u898f\u5236\u67a0\u7d44\u307f\u3092\u78ba\u7acb\u3059\u308b <strong>GMP\u74b0\u5883\u306b\u304a\u3051\u308b\u4eba\u5de5\u77e5\u80fd<\/strong>\u3001\u95a2\u9023\u3059\u308b\u8981\u4ef6\u306b\u5bfe\u51e6\u3059\u308b <strong>\u30e2\u30c7\u30eb\u691c\u8a3c<\/strong>, <strong>\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30c7\u30fc\u30bf\u306e\u54c1\u8cea<\/strong>, <strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u30e1\u30c8\u30ea\u30c3\u30af<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u7d99\u7d9a\u7684\u306a\u4eba\u9593\u306b\u3088\u308b\u76e3\u8996<\/strong>.<\/li>\n<\/ul>\n<h4><strong>\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u671f\u9650: 2025\u5e7410\u67087\u65e5<\/strong><\/h4>\n\t<div id=\"gap-588074701\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-588074701 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u306a\u305c\u91cd\u8981\u306a\u306e\u304b:<\/strong><br \/>\u3053\u308c\u3089\u306e\u6539\u8a02\u306b\u3088\u308a\u3001\u6b21\u306e\u3088\u3046\u306a\u52b9\u679c\u304c\u671f\u5f85\u3055\u308c\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5f37\u5316\u3059\u308b <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong><\/li>\n<li>\u5408\u308f\u305b\u308b <strong>\u65b0\u8208\u30c7\u30b8\u30bf\u30eb\u6280\u8853<\/strong><\/li>\n<li>\u63a8\u9032\u3059\u308b <strong>\u904b\u7528\u52b9\u7387<\/strong><\/li>\n<li>\u5c0e\u5165 <strong>\u65b0\u305f\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8ca0\u62c5\u306f\u6700\u5c0f\u9650<\/strong><\/li>\n<\/ul>\n<p><strong>\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u610f\u898b\u306f\u3001\u5b9f\u7528\u7684\u3067\u6280\u8853\u306e\u9032\u6b69\u306b\u6cbf\u3063\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7b56\u5b9a\u3059\u308b\u4e0a\u3067\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002<\/strong> \u3053\u308c\u3089\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001\u7279\u306b\u4ee5\u4e0b\u306e\u5206\u91ce\u306e\u5c02\u9580\u5bb6\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002 <strong>\u54c1\u8cea\u3001\u898f\u5236\u696d\u52d9\u3001IT\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001GMP\u306b\u304a\u3051\u308bAI\u5c0e\u5165<\/strong>\u898f\u5236\u3055\u308c\u305f\u74b0\u5883\u3002<\/p>\n<p><strong>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/strong><br \/>\u95a2\u4fc2\u8005\u306f\u3001\u7b2c4\u7ae0\u3001\u4ed8\u933211\u3001\u4ed8\u933222\u306e\u6539\u8a02\u6848\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u5185\u90e8\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u90e8\u9580\u6a2a\u65ad\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u8abf\u6574\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b3\u30e1\u30f3\u30c8\u306f\u3001 <a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u30dd\u30fc\u30bf\u30eb <strong>2025\u5e7410\u67087\u65e5<\/strong>.<\/a><\/p>\n<p><strong>RegASK\u304c\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3064\u304b<\/strong><br \/>RegASK \u306f\u3001GMP \u3084 AI \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306a\u3069\u306e\u898f\u5236\u306e\u66f4\u65b0\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3057\u3001\u30e9\u30a4\u30d5 \u30b5\u30a4\u30a8\u30f3\u30b9 \u30c1\u30fc\u30e0\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3057\u3001\u6e96\u5099\u3092\u6574\u3048\u3089\u308c\u308b\u3088\u3046\u306b\u3059\u308b AI \u99c6\u52d5\u578b\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002<br \/><a href=\"https:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b<\/strong><\/a><strong> \u307e\u305f\u306f <\/strong><a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\"><strong>\u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/strong><\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:1em;margin-bottom:1em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-1216832010\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1216832010 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>\u3088\u304f\u3042\u308b\u8cea\u554f<\/strong><\/h4>\n\t<div id=\"gap-1314846787\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1314846787 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><strong> \u66f4\u65b0\u3055\u308c\u305f EU GMP \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4ed8\u9332 22 \u3068\u306f\u4f55\u3067\u3059\u304b?<\/strong><br \/>\n\u4ed8\u9332 22 \u306f\u3001EudraLex \u7b2c 4 \u5dfb\u3067\u65b0\u305f\u306b\u63d0\u6848\u3055\u308c\u305f\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u3059\u3002\u30e2\u30c7\u30eb\u306e\u691c\u8a3c\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0 \u30c7\u30fc\u30bf\u6a19\u6e96\u3001\u4eba\u9593\u306b\u3088\u308b\u76e3\u8996\u306a\u3069\u3001\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u4eba\u5de5\u77e5\u80fd\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u4ef6\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong> \u9644\u5c5e\u66f8 11 \u306b\u57fa\u3065\u3044\u3066\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u306b\u3069\u306e\u3088\u3046\u306a\u5909\u66f4\u304c\u52a0\u3048\u3089\u308c\u307e\u3059\u304b?<\/strong><br \/>\n\u6539\u8a02\u3055\u308c\u305f\u9644\u5c5e\u6587\u66f811\u3067\u306f\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u306b\u5bfe\u3059\u308b\u3088\u308a\u53b3\u683c\u306a\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u5b9f\u8df5\u304c\u5c0e\u5165\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u76e3\u67fb\u8a66\u9a13\u3001\u96fb\u5b50\u7f72\u540d\u3001\u30b7\u30b9\u30c6\u30e0\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u76e3\u8996\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong> \u6539\u8a02\u3055\u308c\u305f EU GMP \u7b2c 4 \u7ae0\u306e\u6587\u66f8\u5316\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b?<\/strong><br \/>\n\u6539\u8a02\u3055\u308c\u305f\u7b2c4\u7ae0\u3067\u306f\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3001\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u30ac\u30d0\u30ca\u30f3\u30b9\u3001\u305d\u3057\u3066\u3042\u3089\u3086\u308b\u5f62\u5f0f\u306e\u6587\u66f8\u306e\u9069\u5207\u306a\u53d6\u308a\u6271\u3044\u304c\u91cd\u8996\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u96fb\u5b50\u8a18\u9332\u3068\u7f72\u540d\u306e\u7ba1\u7406\u306b\u95a2\u3059\u308b\u8981\u4ef6\u3082\u5f37\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>On July 7, 2025, the European Commission\u2019s Directorate-General for Health and Food Safety opened a public consultation on proposed revisions to EudraLex Volume 4 \u2013 Good Manufacturing Practice (GMP) Guidelines. The updates apply to: Chapter 4: Documentation Annex 11: Computerized Systems Annex 22: Artificial Intelligence (newly introduced) These proposed changes aim to modernize GMP practices by strengthening data integrity, integrating AI governance, and improving oversight of computerized systems and documentation in pharmaceutical manufacturing. Key highlights: The updated Chapter 4 emphasizes risk-based documentation practices, along with enhanced management of electronic records and signatures, while ensuring the legibility and integrity of documentation across all formats. The revised Annex 11 reinforces the application&#8230;<\/p>","protected":false},"author":32,"featured_media":8508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33],"tags":[],"class_list":["post-8506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>European Commission Launches GMP Consultation | RegASK<\/title>\n<meta name=\"description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. Discover key changes in Chapter 4, Annex 11, and the new Annex 22 before the October 7, 2025 deadline.\" \/>\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\/ja\/eu-gmp\u30ac\u30a4\u30c9\u30e9\u30a4\u30f32025-ai\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u6587\u66f8\u306e\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Launches Public Consultation on Updated GMP Guidelines for AI, Computerized Systems, and Documentation\" \/>\n<meta property=\"og:description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. 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