{"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":"ai-gmp%e3%83%87%e3%82%b3%e3%83%bc%e3%83%89%e3%80%81%e6%96%b0%e3%81%97%e3%81%84%e5%86%99%e7%9c%9f%e3%80%81%e9%99%84%e5%b1%9e%e6%9b%b822%e8%a6%8f%e5%88%b6%e3%83%81%e3%83%bc%e3%83%a0","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/ai-gmp-decoding-new-pics-annex-22-regulatory-teams\/","title":{"rendered":"GMP \u306b\u304a\u3051\u308b AI: \u898f\u5236\u5f53\u5c40\u5411\u3051\u306e\u65b0\u3057\u3044 PIC\/S \u9644\u5c5e\u6587\u66f8 22 \u3092\u89e3\u8aad\u3059\u308b"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u306e\u4e0a\u00a0<\/span><b><span data-contrast=\"auto\">2025\u5e747\u67087\u65e5<\/span><\/b><span data-contrast=\"auto\">\u3001\u00a0<\/span><a href=\"https:\/\/picscheme.org\/en\/picscheme\"><b><span data-contrast=\"none\">\u533b\u85ac\u54c1\u691c\u67fb\u5354\u529b\u5236\u5ea6\uff08PIC\/S\uff09<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0\u51fa\u7248\u3055\u308c\u305f\u00a0<\/span><b><span data-contrast=\"auto\">\u5225\u7d1922<\/span><\/b><span data-contrast=\"auto\">\u00a0PIC\/S GMP\u30ac\u30a4\u30c9\u306e\u6539\u8a02\u7248\u3067\u3059\u3002\u3053\u306e\u65b0\u3057\u3044\u4ed8\u5c5e\u66f8\u3067\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u4eba\u5de5\u77e5\u80fd\uff08AI\uff09\u3068\u6a5f\u68b0\u5b66\u7fd2\uff08ML\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u3067\u00a0<\/span><b><span data-contrast=\"auto\">GMP\u898f\u5236\u74b0\u5883<\/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\">\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u5225\u7d1911<\/span><\/b><span data-contrast=\"auto\">\u9032\u5316\u3059\u308bAI\/ML\u6280\u8853\u3092\u5b8c\u5168\u306b\u7db2\u7f85\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u76ee\u6a19\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u5b89\u5168\u3067\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u900f\u660e\u6027\u306e\u9ad8\u3044AI\u7d71\u5408<\/span><\/b><span data-contrast=\"auto\">\u00a0\u88fd\u85ac\u4e8b\u696d\u3001\u7279\u306b\u76f4\u63a5\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5206\u91ce\u306b\u304a\u3044\u3066\u00a0<\/span><b><span data-contrast=\"auto\">\u60a3\u8005\u306e\u5b89\u5168\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027<\/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-728488612\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-728488612 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1326003894\">\n\n\t<div id=\"col-360174569\" 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\">\u9644\u5c5e\u66f822\u306e\u4e3b\u8981\u898f\u5b9a<\/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-372739866\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-372739866 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u9644\u5c5e\u66f822\u306f\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u898f\u8ffd\u52a0<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6539\u8a02\u3067\u306f\u306a\u304f\u3001AI \u56fa\u6709\u306e\u8981\u4ef6\u3092\u4ed8\u9332 11 \u306b\u88dc\u8db3\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/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\">\u4ed8\u5c5e\u66f8\u3067\u306f\u3001GMP \u306b\u304a\u3051\u308b AI \u306e\u4f7f\u7528\u7bc4\u56f2\u3092\u53b3\u3057\u304f\u5236\u9650\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u6c7a\u5b9a\u8ad6\u7684\u306a\u51fa\u529b\u3092\u6301\u3064\u9759\u7684 AI\/ML \u30e2\u30c7\u30eb\u306e\u307f<\/span><\/b><span data-contrast=\"auto\">\u00a0\u91cd\u8981\u306a\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u5c0e\u5165\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u52d5\u7684\u30e2\u30c7\u30eb\u3001\u78ba\u7387\u7684\u51fa\u529b\u3001\u307e\u305f\u306f\u9069\u5fdc\u5b66\u7fd2<\/span><\/b><span data-contrast=\"auto\">\u00a0\u306f\u00a0<\/span><b><span data-contrast=\"auto\">\u91cd\u8981\u306aGMP\u306e\u72b6\u6cc1\u3067\u306f\u7981\u6b62\u3055\u308c\u3066\u3044\u308b<\/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\">\u751f\u6210AI\u3068\u5927\u898f\u6a21\u8a00\u8a9e\u30e2\u30c7\u30eb\uff08LLM\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u91cd\u8981\u306a\u696d\u52d9\u3067\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002\u91cd\u8981\u3067\u306a\u3044\u72b6\u6cc1\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u5834\u5408\u306b\u306e\u307f\u4f7f\u7528\u304c\u8a31\u53ef\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u30d2\u30e5\u30fc\u30de\u30f3\u30fb\u30a4\u30f3\u30fb\u30b6\u30fb\u30eb\u30fc\u30d7\uff08HITL\uff09\u306b\u3088\u308b\u76e3\u8996<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6709\u8cc7\u683c\u8005\u306b\u3088\u308b\u3002<\/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\">\u5b9f\u88c5\u306f\u00a0<\/span><b><span data-contrast=\"auto\">\u5b66\u969b\u7684\u306a<\/span><\/b><span data-contrast=\"auto\">\u3001\u95a2\u4fc2\u3059\u308b\u00a0<\/span><b><span data-contrast=\"auto\">\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u3001\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30b9\u30c8\u3001IT\u30c1\u30fc\u30e0\u3001\u4e2d\u5c0f\u4f01\u696d\u3001\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/span><\/b><span data-contrast=\"auto\">AI\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u3042\u3089\u3086\u308b\u6bb5\u968e\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u9078\u629e\u3068\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304b\u3089\u691c\u8a3c\u3001\u30c6\u30b9\u30c8\u3001\u5c55\u958b\u307e\u3067<\/span><\/b><span data-contrast=\"auto\">-\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u00a0<\/span><b><span data-contrast=\"auto\">\u30ea\u30b9\u30af\u60c5\u5831\u306b\u57fa\u3065\u304d\u3001\u8ffd\u8de1\u53ef\u80fd\u3067\u3001\u6587\u66f8\u5316\u3055\u308c\u305f<\/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\">\u898f\u5236\u306e\u610f\u56f3\u306f\u660e\u78ba\u3067\u3059\u3002\u4e88\u6e2c\u4e0d\u53ef\u80fd\u306aAI\u306e\u884c\u52d5\u3092\u9632\u304e\u3001\u8aac\u660e\u53ef\u80fd\u6027\u3068\u76e3\u67fb\u53ef\u80fd\u6027\u3092\u5f37\u5316\u3057\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027<\/span><\/b><span data-contrast=\"auto\">\u3001\u305d\u3057\u3066\u78ba\u5b9f\u306b\u00a0<\/span><b><span data-contrast=\"auto\">\u4eba\u9593\u306e\u8aac\u660e\u8cac\u4efb<\/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-590318135\" 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\">\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/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-1463506924\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1463506924 {\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\">\u9644\u5c5e\u6587\u66f822\u306f\u3001AI\u3092\u691c\u8a0e\u3057\u3066\u3044\u308b\u88fd\u85ac\u4f1a\u793e\u306b\u5bfe\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u671f\u5f85\u3092\u5927\u5e45\u306b\u5f15\u304d\u4e0a\u3052\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u52d5\u7684\u307e\u305f\u306f\u9069\u5fdc\u578bAI\u30e2\u30c7\u30eb<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0\u5fc5\u8981\u306b\u306a\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u30b7\u30b9\u30c6\u30e0\u8a2d\u8a08\u3068\u6226\u7565\u3092\u518d\u8003\u3059\u308b<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">. \u8981\u4ef6\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u8aac\u660e\u53ef\u80fd\u6027\u3001\u30c6\u30b9\u30c8\u30c7\u30fc\u30bf\u306e\u72ec\u7acb\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0\u5897\u52a0\u3059\u308b\u53ef\u80fd\u6027\u3082\u3042\u308b\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u76e3\u67fb\u6e96\u5099\u306e\u8981\u6c42<\/span><\/span><span class=\"TextRun SCXW218463272 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0\u305d\u3057\u3066\u00a0<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">\u5fc5\u8981\u3068\u306a\u308b<\/span><span class=\"NormalTextRun SCXW218463272 BCX0\">\u00a0\u90e8\u9580\u9593\u306e\u9023\u643a\u5f37\u5316\u3002<\/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-668162509\" 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\">\u95a2\u9023\u6027<\/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-117730643\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-117730643 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u3053\u306e\u66f4\u65b0\u306f\u4ee5\u4e0b\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059:<\/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\">\u898f\u5236\u304a\u3088\u3073\u54c1\u8cea\u30c1\u30fc\u30e0<\/span><\/b><span data-contrast=\"auto\">\u00a0GMP\u306e\u671f\u5f85\u3078\u306e\u6e96\u62e0\u306e\u78ba\u4fdd<\/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\">\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30b9\u30c8\u3068IT\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8<\/span><\/b><span data-contrast=\"auto\">\u00a0AI\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a\u3068\u7d71\u5408\u306e\u7ba1\u7406<\/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\">\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc<\/span><\/b><span data-contrast=\"auto\">\u00a0GMP\u898f\u5236\u74b0\u5883\u5185\u3067\u306eAI\u4e3b\u5c0e\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u8a08\u753b\u307e\u305f\u306f\u904b\u7528<\/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-1982945521\" 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\">\u696d\u754c\u306e\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/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-60411759\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-60411759 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u7d44\u7e54\u306f\u307e\u305a\u00a0<\/span><b><span data-contrast=\"auto\">\u5185\u90e8\u30ae\u30e3\u30c3\u30d7\u8a55\u4fa1<\/span><\/b><span data-contrast=\"auto\">\u00a0\u73fe\u5728\u306eAI\/ML\u30b7\u30b9\u30c6\u30e0\u3092\u9644\u5c5e\u6587\u66f822\u306e\u8981\u4ef6\u3068\u6bd4\u8f03\u3059\u308b\u3002\u7279\u306b\u4ee5\u4e0b\u306e\u70b9\u306b\u91cd\u70b9\u3092\u7f6e\u304f\u3079\u304d\u3067\u3042\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u30e2\u30c7\u30eb\u306e\u691c\u8a3c\u3001\u30c6\u30b9\u30c8\u306e\u53b3\u5bc6\u3055\u3001\u30c7\u30fc\u30bf\u306e\u900f\u660e\u6027<\/span><\/b><span data-contrast=\"auto\">\u9644\u5c5e\u66f822\u306f\u65b0\u3057\u3044\u3082\u306e\u3067\u3059\u304c\u3001\u65e9\u671f\u306e\u8abf\u6574\u306b\u3088\u308a\u3001\u5c0e\u5165\u304c\u7fa9\u52d9\u5316\u3055\u308c\u305f\u969b\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6df7\u4e71\u3092\u8efd\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/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\">\u95a2\u4fc2\u8005\u306f\u3001\u3053\u306e\u4ed8\u9332\u3092\u3088\u304f\u8aad\u3093\u3067\u3001\u4eca\u5f8c\u306e\u5354\u8b70\u306e\u969b\u306b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u63d0\u4f9b\u3059\u308b\u6e96\u5099\u3092\u3057\u3066\u304a\u304f\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u76f8\u8ac7\u671f\u9593<\/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\">\u6e96\u5099\u304b\u3089\u7a4d\u6975\u7684\u306a\u9069\u5fdc\u3078\u306e\u79fb\u884c\u306b\u304a\u3044\u3066\u3001\u4f01\u696d\u306f\u69cb\u9020\u5316\u3055\u308c\u305f\u30b5\u30dd\u30fc\u30c8\u306e\u6069\u6075\u3092\u53d7\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">\u3053\u306e\u5834\u5408\u3001\u00a0<\/span><\/b><a href=\"https:\/\/regask.com\/ja\/\"><b><span data-contrast=\"none\">RegASK<\/span><\/b><\/a><b><span data-contrast=\"none\">\u00a0\u898f\u5236\u60c5\u5831\u3068\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306eAI\u99c6\u52d5\u578b\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u00a0<\/span><\/b><span data-contrast=\"none\">\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u4f01\u696d\u3084\u6d88\u8cbb\u8ca1\u4f01\u696d\u304c\u3001\u5909\u5316\u3059\u308b\u4e16\u754c\u7684\u306a\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"none\">\u30b9\u30de\u30fc\u30c8\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3001\u81ea\u52d5\u5316\u3055\u308c\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u7d71\u5408\u3055\u308c\u305f\u5c02\u9580\u5bb6\u3092\u7d44\u307f\u5408\u308f\u305b\u305f<\/span><\/b><span data-contrast=\"none\"> \u3088\u308a\u8fc5\u901f\u306a\u9069\u5fdc\u3092\u53ef\u80fd\u306b\u3057\u3001\u6700\u7d42\u7684\u306b\u306f\u904b\u7528\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002<\/span><\/p>\n<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\/\" target=\"_blank\" class=\"button secondary\" rel=\"noopener\" style=\"border-radius:99px;\">\n\t\t<span>\u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/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-920385995\" 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\">\u5b9a\u7fa9\u3068\u982d\u5b57\u8a9e:<\/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-998550495\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-998550495 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ul>\n<li><b><span data-contrast=\"none\">AI\/ML<\/span><\/b><span data-contrast=\"none\">: \u4eba\u5de5\u77e5\u80fd \/ \u6a5f\u68b0\u5b66\u7fd2 - \u56fa\u5b9a\u3055\u308c\u305f\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u306b\u5f93\u3046\u306e\u3067\u306f\u306a\u304f\u3001\u30c7\u30fc\u30bf\u304b\u3089\u30d1\u30bf\u30fc\u30f3\u3092\u5b66\u7fd2\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u3002<\/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\">\u9759\u7684\u30e2\u30c7\u30eb<\/span><\/b><span data-contrast=\"none\">: \u4e00\u5ea6\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3059\u308b\u3068\u5909\u5316\u3057\u306a\u3044 AI \u30e2\u30c7\u30eb\u3002\u91cd\u8981\u306a GMP \u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u5fc5\u8981\u3067\u3059\u3002<\/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\">\u52d5\u7684\u30e2\u30c7\u30eb<\/span><\/b><span data-contrast=\"none\">: \u7d99\u7d9a\u5b66\u7fd2\/\u9069\u5fdc\u578b AI \u30b7\u30b9\u30c6\u30e0\u3002\u91cd\u8981\u306a GMP \u4f7f\u7528\u3067\u306f\u8a31\u53ef\u3055\u308c\u307e\u305b\u3093\u3002<\/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\">\u6c7a\u5b9a\u8ad6\u7684\u306a\u51fa\u529b<\/span><\/b><span data-contrast=\"none\">: \u7279\u5b9a\u306e\u5165\u529b\u306b\u5bfe\u3057\u3066\u4e88\u6e2c\u53ef\u80fd\u304b\u3064\u518d\u73fe\u53ef\u80fd\u306a\u7d50\u679c\u3002<\/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\">\u78ba\u7387\u7684\u51fa\u529b<\/span><\/b><span data-contrast=\"none\">: \u540c\u4e00\u306e\u5165\u529b\u3067\u3042\u3063\u3066\u3082\u7d50\u679c\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u91cd\u8981\u306a\u4f7f\u7528\u4f8b\u3067\u306f\u8a31\u53ef\u3055\u308c\u307e\u305b\u3093\u3002<\/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\">\u751f\u6210AI \/ LLM<\/span><\/b><span data-contrast=\"none\">\u78ba\u7387\u7684\u306b\u52d5\u4f5c\u3059\u308b\u30b3\u30f3\u30c6\u30f3\u30c4\u751f\u6210\u30e2\u30c7\u30eb (\u4f8b: \u30c6\u30ad\u30b9\u30c8\u307e\u305f\u306f\u753b\u50cf\u30af\u30ea\u30a8\u30fc\u30bf\u30fc)\u3002<\/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\uff08\u30d2\u30e5\u30fc\u30de\u30f3\u30fb\u30a4\u30f3\u30fb\u30b6\u30fb\u30eb\u30fc\u30d7\uff09<\/span><\/b><span data-contrast=\"none\">: \u91cd\u8981\u3067\u306a\u3044\u7528\u9014\u306b\u304a\u3051\u308b AI \u306e\u6c7a\u5b9a\u306b\u3064\u3044\u3066\u4eba\u9593\u306b\u3088\u308b\u30ec\u30d3\u30e5\u30fc\u307e\u305f\u306f\u691c\u8a3c\u3092\u5fc5\u8981\u3068\u3059\u308b\u76e3\u8996\u30e1\u30ab\u30cb\u30ba\u30e0\u3002<\/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\">\u8aac\u660e\u53ef\u80fd\u6027<\/span><\/b><span data-contrast=\"none\">AI 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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 pharmaceutical operations, particularly in areas directly affecting\u00a0patient safety, product quality, and data integrity.\u00a0<\/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\/ja\/ai-gmp\u30c7\u30b3\u30fc\u30c9\u3001\u65b0\u3057\u3044\u5199\u771f\u3001\u9644\u5c5e\u66f822\u898f\u5236\u30c1\u30fc\u30e0\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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\/ja\/ai-gmp\u30c7\u30b3\u30fc\u30c9\u3001\u65b0\u3057\u3044\u5199\u771f\u3001\u9644\u5c5e\u66f822\u898f\u5236\u30c1\u30fc\u30e0\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" 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