{"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-1206005051\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1206005051 {\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-648406754\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-648406754 {\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-427801881\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-427801881 {\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 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