{"id":10372,"date":"2026-06-30T10:33:30","date_gmt":"2026-06-30T02:33:30","guid":{"rendered":"https:\/\/regask.com\/?p=10372"},"modified":"2026-06-30T10:33:30","modified_gmt":"2026-06-30T02:33:30","slug":"gmp%e6%96%bd%e8%a1%8c%e3%81%af2026%e5%b9%b46%e6%9c%88","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/gmp-enforcement-june-2026\/","title":{"rendered":"GMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u306e\u57f7\u884c\u304c\u5f37\u5316\uff1aFDA\u306e\u8b66\u544a\u66f8\u3001\u8f38\u5165\u898f\u5236\u2026"},"content":{"rendered":"<p id=\"ember1956\" class=\"ember-view reader-text-block__paragraph\"><span class=\"TextRun SCXW61959956 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW61959956 BCX0\"><strong>2026\u5e74\u534a\u3070\u306b\u306fGMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u306e\u57f7\u884c\u304c\u8457\u3057\u304f\u5f37\u5316\u3055\u308c\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u5206\u91ce\u306e\u4e3b\u8981\u30c8\u30ec\u30f3\u30c9\u306e\u4e2d\u3067\u3001\u88fd\u9020\u691c\u67fb\u304c\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u898f\u5236\u8b66\u544a\u306e\u4e2d\u3067\u6700\u3082\u5927\u304d\u306a\u5272\u5408\u3092\u5360\u3081\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u3002.<\/strong> \u305d\u306e\u539f\u52d5\u529b\u306f\u3001\u7c73\u56fdFDA\u306e\u6d3b\u52d5\u306e\u660e\u3089\u304b\u306a\u6025\u5897\u3060\u3063\u305f\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">(<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">CGMP\u8b66\u544a\u66f8\u306e\u9023\u7d9a\u767a\u884c\u3068\u8f38\u5165\u5dee\u3057\u6b62\u3081\u63aa\u7f6e\u306e\u62e1\u5927<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">)<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u65e5\u672c\u3068\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u3067\u306e\u691c\u67fb\u6d3b\u52d5\u3068\u4e26\u884c\u3057\u3066\u3002\u88fd\u9020\u304a\u3088\u3073\u54c1\u8cea\u30c1\u30fc\u30e0\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u306f\u6700\u3082\u76f4\u63a5\u7684\u306a\u696d\u52d9\u4e0a\u306e\u5f71\u97ff\u3092\u3082\u305f\u3089\u3059\u50be\u5411\u3067\u3059\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u3057\u306a\u3044<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u751f\u6210\u3059\u308b\u3060\u3051\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u66f8\u985e\u4f5c\u6210;<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u6b62\u307e\u308b\u00a0<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u88fd\u54c1<\/span><span class=\"NormalTextRun SCXW61959956 BCX0\">\u00a0\u914d\u9001\u3002.<\/span><\/span><span class=\"EOP Selected SCXW61959956 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n\t<div id=\"gap-865156380\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-865156380 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h3><strong><span class=\"TextRun MacChromeBold SCXW170068198 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW170068198 BCX0\">FDA\u306fCGMP\u306b\u95a2\u3059\u308b\u8b66\u544a\u66f8\u3068\u8f38\u5165\u8b66\u544a\u3092\u5f37\u5316\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-1040980137\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1040980137 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW80589066 BCX0\">FDA\u306f\u3001\u91cd\u5927\u306aCGMP\u9055\u53cd\u3092\u6307\u6458\u3059\u308b\u8b66\u544a\u66f8\u3092\u76f8\u6b21\u3044\u3067\u767a\u884c\u3057\u305f\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">(<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u7121\u83cc\u88fd\u9020\u3001\u539f\u85ac\uff08API\uff09\u88fd\u9020\u3001\u304a\u3088\u3073\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u65bd\u8a2d\u5168\u4f53\u306b\u308f\u305f\u3063\u3066<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">)\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u3055\u3089\u306b\u3001\u56fd\u5883\u3067\u306eGMP\u975e\u6e96\u62e0\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u8eab\u4f53\u691c\u67fb\u306a\u3057\u306e\u62d8\u7559\u62e1\u5927\u3082\u5b9f\u65bd\u3055\u308c\u305f\u3002\u3053\u306e\u7d44\u307f\u5408\u308f\u305b\u304c\u6df1\u523b\u306a\u554f\u984c\u3068\u306a\u3063\u3066\u3044\u308b\u3002\u8b66\u544a\u66f8\u306f\u65bd\u8a2d\u306e\u8a55\u5224\u3092\u640d\u306a\u3046\u4e00\u65b9\u3001\u8f38\u5165\u62d8\u7559\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9055\u53cd\u306e\u767a\u898b\u3092\u5373\u5ea7\u306b\u9055\u53cd\u3078\u3068\u5909\u3048\u3066\u3057\u307e\u3046\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u4f9b\u7d66<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u00a0\u4e2d\u65ad\u3002\u7121\u83cc\u6027\u4fdd\u8a3c\u3001\u30c7\u30fc\u30bf\u6574\u5408\u6027\u3001\u304a\u3088\u3073API\u5236\u5fa1\u306f\u3001\u624b\u7d19\u5168\u4f53\u3092\u901a\u3057\u3066\u7e70\u308a\u8fd4\u3057\u8a00\u53ca\u3055\u308c\u305f\u3002<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">,\u00a0<\/span><span class=\"NormalTextRun SCXW80589066 BCX0\">\u307e\u3055\u306b\u3001\u662f\u6b63\u63aa\u7f6e\u304c\u6700\u3082\u9045\u308c\u308b\u7b87\u6240\u3060\u3002\u8f38\u5165\u8b66\u544a\u3092\u53d7\u3051\u305f\u30b5\u30a4\u30c8\u306f\u3001\u6839\u672c\u7684\u306a\u554f\u984c\u304c\u89e3\u6c7a\u3055\u308c\u308b\u305a\u3063\u3068\u524d\u306b\u3001\u7c73\u56fd\u5e02\u5834\u304b\u3089\u7de0\u3081\u51fa\u3055\u308c\u3066\u3057\u307e\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW76108789 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW76108789 BCX0\">\u65e5\u672c\u306e\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u304cGMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u67fb\u5bdf\u7d50\u679c\u3092\u516c\u8868\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-2021484967\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2021484967 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW28283816 BCX0\">\u65e5\u672c\u306e\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u306f\u3001\u539f\u85ac\u7ba1\u7406\u306b\u7126\u70b9\u3092\u5f53\u3066\u305fGMP\u67fb\u5bdf\u4e8b\u4f8b\u5831\u544a\u66f8\u3092\u516c\u8868\u3057\u305f\u3002\u4e8b\u4f8b\u5831\u544a\u66f8\u306f\u3001\u4e00\u822c\u7684\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u306f\u7570\u306a\u308a\u3001\u9759\u304b\u306b\u8cb4\u91cd\u306a\u4fa1\u5024\u3092\u6301\u3064\u3002\u67fb\u5bdf\u5b98\u306e\u5b9f\u969b\u306e\u671f\u5f85\u3068\u3001\u6307\u6458\u3055\u308c\u305f\u5177\u4f53\u7684\u306a\u4e0d\u5099\u306e\u30e2\u30fc\u30c9\u304c\u793a\u3055\u308c\u3066\u304a\u308a\u3001\u62bd\u8c61\u7684\u306a\u539f\u5247\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u5b9f\u8df5\u7684\u3067\u3042\u308b\u3002\u54c1\u8cea\u7ba1\u7406\u30c1\u30fc\u30e0\u306f\u3001\u67fb\u5bdf\u5b98\u304c\u91cd\u8996\u3059\u308b\u5177\u4f53\u7684\u306a\u7ba1\u7406\u30dd\u30a4\u30f3\u30c8\u3092\u3001\u3053\u306e\u3088\u3046\u306a\u5831\u544a\u66f8\u304b\u3089\u62bd\u51fa\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u00a0<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">(<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3001\u6587\u66f8\u5316\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u8cc7\u683c\u8a8d\u5b9a<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">)<\/span><span class=\"NormalTextRun SCXW28283816 BCX0\">\u00a0\u305d\u3057\u3066\u3001\u691c\u67fb\u5b98\u304c\u8abf\u67fb\u3092\u884c\u3046\u524d\u306b\u3001\u81ea\u793e\u306eAPI\u76e3\u8996\u4f53\u5236\u3092\u8abf\u67fb\u7d50\u679c\u3068\u7167\u3089\u3057\u5408\u308f\u305b\u3066\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u8a55\u4fa1\u3059\u308b\u3002.<\/span><\/p>\n<h3><strong><span class=\"TextRun MacChromeBold SCXW154821105 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW154821105 BCX0\">\u30c9\u30df\u30cb\u30ab\u5171\u548c\u56fd\u306f\u8f38\u5165\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u691c\u67fb\u3092\u62e1\u5927\u3057\u305f\u3002<\/span><\/span><\/strong><\/h3>\n\t<div id=\"gap-677811303\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-677811303 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW41450848 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW41450848 BCX0\">\u30c9\u30df\u30cb\u30ab\u5171\u548c\u56fd\u306eDIGEMAPS\u306f\u3001GMP\u691c\u67fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5916\u56fd\u3067\u88fd\u9020\u30fb\u8f38\u5165\u3055\u308c\u305f\u533b\u85ac\u54c1\u306b\u3082\u62e1\u5927\u3057\u305f\u3002\u5916\u56fd\u306e\u65bd\u8a2d\u3078\u306e\u9069\u7528\u7bc4\u56f2\u62e1\u5927\u306f\u3001\u3088\u308a\u5e83\u7bc4\u306a\u5730\u57df\u7684\u50be\u5411\u306e\u4e00\u90e8\u3067\u3042\u308a\u3001\u898f\u5236\u5f53\u5c40\u306f\u56fd\u5185\u65bd\u8a2d\u3060\u3051\u3067\u306a\u304f\u3001\u88fd\u9020\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u306b\u5bfe\u3059\u308b\u4fdd\u8a3c\u3092\u307e\u3059\u307e\u3059\u6c42\u3081\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u5e02\u5834\u306b\u8f38\u51fa\u3059\u308b\u88fd\u9020\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u5916\u56fd\u65bd\u8a2d\u306eGMP\u30b9\u30c6\u30fc\u30bf\u30b9\u306f\u3001\u00a0<\/span><span class=\"NormalTextRun SCXW41450848 BCX0\">\u6c7a\u5b9a\u3059\u308b<\/span><span class=\"NormalTextRun SCXW41450848 BCX0\"> \u3053\u308c\u307e\u3067\u8f38\u51fa\u56fd\u306e\u76e3\u7763\u306b\u4f9d\u5b58\u3057\u3066\u3044\u305f\u5730\u57df\u3078\u306e\u30a2\u30af\u30bb\u30b9\u304c\u5236\u9650\u3055\u308c\u3001\u4e00\u3064\u306e\u5de5\u5834\u3067\u554f\u984c\u304c\u767a\u751f\u3059\u308c\u3070\u3001\u4e00\u5ea6\u306b\u8907\u6570\u306e\u5e02\u5834\u304c\u9589\u9396\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/span><\/span><span class=\"EOP SCXW41450848 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/p>\n<h3><strong><span class=\"NormalTextRun SCXW224609958 BCX0\">\u4f55\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u3053\u308c\u306f<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u5e73\u5747<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u00a0\u306e\u305f\u3081\u306b\u00a0<\/span><span class=\"NormalTextRun SCXW224609958 BCX0\">\u88fd\u9020\u696d\u8005\uff1f<\/span><\/strong><\/h3>\n\t<div id=\"gap-991977634\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-991977634 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"NormalTextRun SCXW116620405 BCX0\">FDA\u304c\u56fd\u5883\u3092\u8d8a\u3048\u3066\u6d3b\u52d5\u3092\u62e1\u5927\u3057\u3001\u65e5\u672c\u3068\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u306e\u67fb\u5bdf\u6a5f\u95a2\u304c\u6d3b\u52d5\u7bc4\u56f2\u3092\u5e83\u3052\u308b\u306b\u3064\u308c\u3066\u3001GMP\u306e\u57f7\u884c\u306f\u5f37\u5316\u3055\u308c\u3001 <\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">\u30b0\u30ed\u30fc\u30d0\u30eb\u5316\u3059\u308b<\/span><span class=\"NormalTextRun SCXW116620405 BCX0\">. 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