{"id":12289,"date":"2026-04-20T01:12:00","date_gmt":"2026-04-20T01:12:00","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=12289"},"modified":"2026-03-09T02:25:21","modified_gmt":"2026-03-09T02:25:21","slug":"everything-about-pharmaceutical-quality-management-systems","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/everything-about-pharmaceutical-quality-management-systems\/","title":{"rendered":"\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u3059\u3079\u3066"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"12289\" class=\"elementor elementor-12289\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u533b\u85ac\u54c1\u306b\u304a\u3044\u3066\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306f\u5fc5\u9808\u306e\u8981\u7d20\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u306b\u306f\u3001\u53b3\u683c\u306a\u898f\u5236\u3078\u306e\u6e96\u62e0\u3092\u652f\u63f4\u3057\u306a\u304c\u3089\u3001\u88fd\u54c1\u306e\u6700\u9ad8\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u9769\u65b0\u7684\u306a\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u8981\u3067\u3059\u3002\u305d\u3053\u3067\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u51fa\u756a\u3067\u3059\uff01<img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-12297 aligncenter\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems.jpg\" alt=\"\u533b\u85ac\u54c1\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\" width=\"1000\" height=\"1000\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-300x300.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-150x150.jpg 150w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-768x768.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-12x12.jpg 12w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-600x600.jpg 600w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/Pharmaceutical-Quality-Management-Systems-100x100.jpg 100w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/p><p>QMS\u306f\u3001\u533b\u85ac\u54c1\u304c\u4e00\u8cab\u3057\u3066\u88fd\u9020\u3055\u308c\u3001\u9ad8\u3044\u7d14\u5ea6\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u3057\u304b\u3057\u3001QMS\u3068\u306f\u4e00\u4f53\u4f55\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u88fd\u85ac\u30d3\u30b8\u30cd\u30b9\u306e\u305f\u3081\u306bQMS\u3092\u78ba\u7acb\u3059\u308b\u306b\u306f\u3069\u3046\u3059\u308c\u3070\u3088\u3044\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u305d\u306e\u7b54\u3048\u3092\u898b\u3064\u3051\u307e\u3057\u3087\u3046\uff01<\/p><h2><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3068\u306f\uff1f<\/strong><\/h2><p>\u4e00\u822c\u7684\u306b\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u4e0d\u53ef\u6b20\u306a\u5b9a\u7fa9\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3068\u65b9\u91dd\u3067\u69cb\u6210\u3055\u308c\u308b\u3002\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u6700\u5927\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u8a2d\u8a08\u304b\u3089\u958b\u767a\u3001\u8a66\u9a13\u306b\u81f3\u308b\u307e\u3067\u3001\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u30ab\u30d0\u30fc\u3057\u307e\u3059\u3002.<\/p><p>\u76e3\u67fb\u3001\u5909\u66f4\u7ba1\u7406\u3001\u30d7\u30ed\u30bb\u30b9\u7ba1\u7406\u3001\u9069\u5207\u306a\u6587\u66f8\u5316\u306f\u3059\u3079\u3066QMS\u306e\u4e00\u90e8\u3067\u3059\u3002\u30ea\u30b9\u30af\u3078\u306e\u5bfe\u5fdc\u3001\u88fd\u54c1\u54c1\u8cea\u306e\u9038\u8131\u306e\u53ef\u80fd\u6027\u306e\u8ffd\u8de1\u3001\u305d\u3057\u3066\u5f37\u56fa\u306a\u898f\u5236\u9075\u5b88\u306e\u305f\u3081\u306b\u3001\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u983c\u308a\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002QMS\u306e\u8a73\u7d30\u3092\u7406\u89e3\u3059\u308b\u524d\u306b\u3001\u3053\u3053\u3067\u306f\u88fd\u85ac\u306b\u304a\u3051\u308b\u54c1\u8cea\u3068\u306f\u4f55\u304b\u3092\u6982\u89b3\u3057\u307e\u3059\uff1a<\/p><ul><li>\u85ac\u306e\u6709\u52b9\u6027\u306b\u4e0d\u53ef\u6b20\u306a\u533b\u85ac\u54c1\u6709\u52b9\u6210\u5206\u306e\u5b58\u5728\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3002.<\/li><li>\u4e0d\u7d14\u7269\u304a\u3088\u3073ICH Q1\u3001Q2\u3001Q3\u8981\u7d20\u304c\u5b58\u5728\u3057\u306a\u3044\u304b\u3001\u307e\u305f\u306f\u8a31\u5bb9\u3067\u304d\u308b\u5b89\u5168\u306a\u9650\u754c\u5024\u5185\u306b\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/li><li>\u5de5\u7a0b\u7ba1\u7406\u3092\u9069\u7528\u3057\u3001\u30a2\u30c3\u30bb\u30a4\u306e\u7cbe\u5ea6\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3001\u85ac\u5264\u304c\u6b63\u78ba\u306b\u671b\u307e\u3057\u3044\u6cbb\u7642\u52b9\u679c\u3092\u3082\u305f\u3089\u3059\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u3002.<\/li><li>\u3059\u3079\u3066\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u9069\u5207\u306b\u6587\u66f8\u5316\u3057\u300121 CFR 210\/211\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u5fc5\u8981\u306a\u533b\u85ac\u54c1\u898f\u5236\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3002.<\/li><li>\u88fd\u54c1\u306e\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3057\u3001\u9867\u5ba2\u306e\u671f\u5f85\u306b\u5fdc\u3048\u3001\u305d\u308c\u3092\u8d85\u3048\u308b\u305f\u3081\u306b\u3001\u6b20\u9665\u304c\u767a\u751f\u3059\u308b\u524d\u306b\u691c\u51fa\u3057\u3001\u9632\u6b62\u3059\u308b\u3053\u3068\u3002.<\/li><\/ul><h2><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u30c8\u30c3\u30d7\u898f\u5236<\/strong><\/h2><p>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u3054\u7406\u89e3\u3044\u305f\u3060\u3051\u305f\u3068\u3053\u308d\u3067\u3001\u6b21\u306f\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u3081\u3050\u308b\u898f\u5236\u306b\u3064\u3044\u3066\u304a\u8a71\u3057\u3057\u307e\u3057\u3087\u3046\uff1a<\/p><h3><strong>ISO 9001:2015<\/strong><\/h3><p>ISO 9001:2015\u306f\u3001QMS\u306e\u4e3b\u8981\u306a\u8981\u4ef6\u3092\u5b9a\u7fa9\u3057\u3001\u88fd\u85ac\u4f01\u696d\u306e\u52b9\u7387\u5316\u3092\u652f\u63f4\u3059\u308bISO 9000\u30d5\u30a1\u30df\u30ea\u30fc\u306e\u4e00\u822c\u7684\u306a\u898f\u683c\u3067\u3059\u3002\u4ee5\u4e0b\u306e\u5206\u91ce\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\uff1a<\/p><ul><li><strong>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u601d\u8003\u3002.<\/strong><\/li><li><strong>QMS\u3002.<\/strong><\/li><li><strong>\u5909\u5316\u3059\u308b\u3002.<\/strong><\/li><li><strong>\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7.<\/strong><\/li><li><strong>\u30d7\u30ed\u30bb\u30b9\u30fb\u30a2\u30d7\u30ed\u30fc\u30c1\u3002.<\/strong><\/li><\/ul><p>\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\u306b\u3088\u308b\u3053\u306e\u898f\u683c\u306f\u3001cGMP\u304a\u3088\u3073ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u6574\u5408\u3057\u3001\u30c7\u30fc\u30bf\u4e3b\u5c0e\u306e\u610f\u601d\u6c7a\u5b9a\u3068\u7d99\u7d9a\u7684\u6539\u5584\u3092\u91cd\u8996\u3057\u3066\u3044\u308b\u3002\u4ee5\u4e0b\u306f\u3001ISO 9001:2015\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u4e3b\u8981\u306aQMS\u69cb\u6210\u8981\u7d20\u3067\u3042\u308b\uff1a<\/p><ul><li>\u660e\u78ba\u306a\u76ee\u6a19\u3092\u8a2d\u5b9a\u3057\u3001\u305d\u308c\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5185\u7684\u30fb\u5916\u7684\u8981\u56e0\u3092\u7406\u89e3\u3059\u308b\u3002.<\/li><li>\u4e3b\u8981\u306a\u5f79\u5272\u3068\u8cac\u4efb\u3092\u660e\u78ba\u306b\u3057\u3001\u30c8\u30c3\u30d7\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u5dfb\u304d\u8fbc\u3080\u3002.<\/li><li>\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u305d\u308c\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306e\u63aa\u7f6e\u3092\u76f4\u3061\u306b\u8b1b\u3058\u308b\u3002\u307e\u305f\u3001\u76ee\u6a19\u9054\u6210\u306b\u5f79\u7acb\u3064\u6709\u76ca\u306a\u6a5f\u4f1a\u3092\u898b\u3064\u3051\u308b\u3002.<\/li><li>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u78ba\u4fdd\u3057\u3001\u9069\u5207\u306a\u6587\u66f8\u5316\u3092\u7dad\u6301\u3059\u308b\u3002.<\/li><li>\u533b\u85ac\u54c1QMS\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u614e\u91cd\u306b\u8a55\u4fa1\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u66f4\u65b0\u3059\u308b\u3002.<\/li><\/ul><h3><strong>FDA 21 CFR \u30d1\u30fc\u30c8210<\/strong><\/h3><p>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306b\u95a2\u3059\u308b\u3082\u3046\u4e00\u3064\u306e\u91cd\u8981\u306a\u898f\u683c\u306f\u300121 CFR Part 210\u3067\u3042\u308b\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/how-are-medicine-tablets-made\/\"><u>\u533b\u85ac\u54c1\u9320\u5264\u88fd\u9020\u306e\u67a0\u7d44\u307f<\/u><\/a>. .\u3053\u306e\u6cd5\u5f8b\u306f\u3001\u533b\u85ac\u54c1\u3001\u30d2\u30c8\u7528\u306e\u751f\u7269\u5b66\u7684\u88fd\u5264\u3001\u304a\u3088\u3073\u3001\u533b\u7642\u7528\u533b\u85ac\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u3002<em>\u00a0<\/em><strong><em>\u201c\u300c\u533b\u85ac\u54c1\u3067\u3042\u308b\u30d2\u30c8\u7d30\u80de\u3001\u7d44\u7e54\u3001\u7d30\u80de\u30fb\u7d44\u7e54\u7531\u6765\u88fd\u54c1\uff08HCT\/P\uff09\u300d\u3002.<\/em><\/strong>\u00a0\u9023\u90a6\u898f\u5247\u96c6\uff08CFR\uff09\u306b\u8a18\u8f09\u3055\u308c\u3066\u304a\u308a\u30013\u3064\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u304c\u3042\u308b\uff1a<\/p><ul><li><strong>210 (1):<\/strong> \u73fe\u5728\u306eGMP\uff08\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff09\u306e\u72b6\u6cc1\u306b\u3064\u3044\u3066\u8ad6\u3058\u308b\u3002.<\/li><li><strong>210 (2):<\/strong> \u73fe\u884c\u306eGMP\u306e\u9069\u7528\u6027\u3002.<\/li><li><strong>210 (3):<\/strong> \u7b2c210\u90e8\u3001\u7b2c211\u90e8\u3001\u7b2c225\u90e8\u3001\u7b2c226\u90e8\u306b\u9069\u7528\u3055\u308c\u308b\u4e3b\u8981\u306a\u7528\u8a9e\u3068\u5b9a\u7fa9\u3092\u7db2\u7f85\u3002.<\/li><\/ul><p>\u3053\u306e\u30d1\u30fc\u30c8\u306f\u3001\u5f8c\u306e\u30d1\u30fc\u30c8\u306b\u6bd4\u3079\u308b\u3068\u91cd\u8981\u6027\u3084\u8a73\u7d30\u6027\u304c\u4f4e\u3044\u3088\u3046\u306b\u601d\u308f\u308c\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001FDA\u306e\u3044\u304f\u3064\u304b\u306e\u898f\u5236\u306e\u57fa\u790e\u3068\u306a\u308b\u3082\u306e\u3067\u3059\u3002\u88fd\u54c1\u3092\u8ca9\u58f2\u3057\u3088\u3046\u3068\u3059\u308b\u7c73\u56fd\u306e\u3059\u3079\u3066\u306e\u88fd\u85ac\u4f1a\u793e\u306f\u3001FDA\u306e21 CFR Part 210\u3092\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>\u4e07\u304c\u4e00\u3001\u3053\u308c\u3092\u6020\u3063\u305f\u5834\u5408\u3001\u898f\u5236\u9055\u53cd\u3068\u307f\u306a\u3055\u308c\u3001\u8b66\u544a\u72b6\u3084\u7f70\u91d1\u3001\u88fd\u54c1\u56de\u53ce\u3001\u6df1\u523b\u306a\u5834\u5408\u306f\u65bd\u8a2d\u306e\u5b8c\u5168\u9589\u9396\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p><h3><strong>ICH Q8 (R2)<\/strong><\/h3><p>ICH Q8(R2)\u306f\u3001\u88fd\u54c1\u8a2d\u8a08\u3068\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3092\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u7d71\u5408\u3059\u308b\u65b9\u6cd5\u3092\u6982\u8aac\u3057\u305f\u8a73\u7d30\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3042\u308b\u3002\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3057\u3001\u5065\u5168\u306a\u79d1\u5b66\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u9069\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u304c\u533b\u85ac\u54c1\u306b\u54c1\u8cea\u3092\u7d44\u307f\u8fbc\u3080\u3053\u3068\u3092\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002ICH Q8(R2)\u306e\u4e3b\u8981\u6982\u5ff5\u306b\u3064\u3044\u3066\u3001\u3055\u3089\u306b\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\uff1a<\/p><ul><li><strong>\u54c1\u8cea\u30bf\u30fc\u30b2\u30c3\u30c8\u88fd\u54c1\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb<\/strong>:\u533b\u85ac\u54c1\u3068\u305d\u306e\u6027\u80fd\u306b\u671b\u307e\u308c\u308b\u4e3b\u306a\u7279\u6027\u3092\u5b9a\u7fa9\u3059\u308b\u3002\u4f8b\u3048\u3070\u3001\u85ac\u5264\u306e\u6295\u4e0e\u91cf\u3084\u6295\u4e0e\u7d4c\u8def\u306a\u3069\u3092\u6982\u8aac\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/li><li><strong>\u91cd\u8981\u54c1\u8cea\u5c5e\u6027<\/strong>:\u88fd\u54c1\u5168\u4f53\u306e\u54c1\u8cea\u306b\u5927\u304d\u304f\u5f71\u97ff\u3057\u3001\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u539f\u6750\u6599\u3068\u5de5\u7a0b\u306e\u4e3b\u8981\u306a\u5c5e\u6027\u3002.<\/li><li><strong>\u30c7\u30b6\u30a4\u30f3\u30fb\u30b9\u30da\u30fc\u30b9<\/strong>:\u88fd\u54c1\u306b\u671b\u307e\u3057\u3044\u54c1\u8cea\u306e\u51fa\u529b\u3092\u4e0e\u3048\u308b\u6761\u4ef6\u3068\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u7bc4\u56f2\u3002.<\/li><li><strong>\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u6226\u7565<\/strong>:\u671f\u5f85\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u88fd\u54c1\u54c1\u8cea\u7279\u6027\u3092\u5f97\u308b\u305f\u3081\u306e\u88fd\u9020\u5de5\u7a0b\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u8a73\u7d30\u306a\u8a08\u753b\u3002.<\/li><li><strong>\u30ea\u30b9\u30af\u8a55\u4fa1<\/strong>:\u533b\u85ac\u54c1\u306e\u958b\u767a\u304a\u3088\u3073\u54c1\u8cea\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u4e3b\u8981\u306a\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u305d\u308c\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u3092\u7b56\u5b9a\u3059\u308b\u3002.<\/li><\/ul><h3><strong>ICH Q10<\/strong><\/h3><p>ICH Q10\u306f\u300c\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u300d\u3068\u3057\u3066\u77e5\u3089\u308c\u308b\u898f\u683c\u3067\u3042\u308a\u3001FDA\uff08\u7c73\u56fd\uff09\u3001EMA\uff08EU\uff09\u3001PMDA\uff08\u65e5\u672c\uff09\u3001\u30ab\u30ca\u30c0\u4fdd\u5065\u7701\u306a\u3069\u3001\u3059\u3079\u3066\u306e\u4e3b\u8981\u898f\u5236\u6a5f\u95a2\u3067\u63a1\u7528\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>\u57fa\u672c\u7684\u306a\u958b\u767a\u304b\u3089\u5546\u696d\u751f\u7523\u3001\u3055\u3089\u306b\u306f\u88fd\u9020\u4e2d\u6b62\u307e\u3067\u3001\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u53ca\u3076\u3002.<\/p><p>\u3053\u306e\u898f\u683c\u306f\u3001\u305d\u306e3\u539f\u5247\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001CAPA\u30b7\u30b9\u30c6\u30e0\u3001\u5909\u66f4\u7ba1\u7406\u3001\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u306a\u3069\u306eQMS\u8981\u7d20\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\uff1a<\/p><ul><li><strong>\u88fd\u54c1\u306e\u5b9f\u73fe\u3002.<\/strong><\/li><li><strong>\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u72b6\u614b\u3002.<\/strong><\/li><li><strong>\u7d99\u7d9a\u7684\u306a\u6539\u5584\u3002.<\/strong><\/li><\/ul><p>\u305d\u306e\u771f\u4fa1\u3092\u767a\u63ee\u3057\u3066\u3044\u308b\u306e\u306f\u3001\u533b\u85ac\u54c1\u306e\u6280\u8853\u7684\u8981\u4ef6\u3092\u8abf\u548c\u3055\u305b\u3066\u3044\u308b\u3053\u3068\u3060\u3002\u305d\u306e\u76ee\u7684\u306f\u3001\u4e16\u754c\u4e2d\u3067\u60a3\u8005\u306e\u5b89\u5168\u6027\u3068\u533b\u85ac\u54c1\u306e\u6709\u52b9\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/p><h3><strong>PIC\/S GMP\uff08PE 009-14\uff09 <\/strong><\/h3><p>ICH Q10\u3068\u3088\u304f\u4f3c\u3066\u3044\u308b\u3002 <a href=\"https:\/\/picscheme.org\/en\/news\/revision-of-pic-s-gmp-guide-pe-009-14\" target=\"_blank\" rel=\"noopener\"><u>PIC\/S GMP\uff08PE 009-14\uff09\u3082\u307e\u305f\u3001\u6b21\u306e\u3088\u3046\u306a\u76ee\u6a19\u3092\u63b2\u3052\u3066\u3044\u308b\u3002<\/u><\/a>\u00a0\u9ad8\u54c1\u8cea\u306e\u533b\u85ac\u54c1\u304c\u4e00\u8cab\u3057\u3066\u88fd\u9020\u3055\u308c\u308b\u3088\u3046\u3001\u7570\u306a\u308b\u62e0\u70b9\u9593\u3067GMP\u57fa\u6e96\u3084\u691c\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u6574\u5408\u3055\u305b\u308b\u3002.<\/p><p>\u307e\u305f\u3001\u4e0a\u7d1a\u7ba1\u7406\u8077\u306e\u8cac\u4efb\u3084\u65bd\u8a2d\u30fb\u8a2d\u5099\u306a\u3069\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u4ef6\u3082\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u56fd\u5185\u304a\u3088\u3073\u56fd\u969b\u7684\u306a\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u304c\u6574\u5408\u3059\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u4fe1\u983c\u6027\u304c\u5927\u5e45\u306b\u5411\u4e0a\u3059\u308b\u3002.<\/p><h2><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u6587\u66f8\u5316\u69cb\u9020\u3068\u306f\uff1f <\/strong><\/h2><p>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u4e00\u90e8\u3067\u3042\u308b\u898f\u5236\u3068\u898f\u683c\u3092\u3054\u7406\u89e3\u3044\u305f\u3060\u3044\u305f\u3068\u3053\u308d\u3067\u3001\u305d\u306e\u6587\u66f8\u69cb\u9020\u306e\u6982\u8981\u3092\u3054\u8aac\u660e\u3057\u307e\u3059\uff1a<\/p><h3><strong>\u54c1\u8cea\u65b9\u91dd<\/strong><\/h3><p>\u54c1\u8cea\u65b9\u91dd\u306f\u3001\u4f01\u696d\u306e\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3092\u6982\u8aac\u3059\u308b\u30cf\u30a4\u30ec\u30d9\u30eb\u306a\u6587\u66f8\u3067\u3042\u308b\u3002\u4f1a\u793e\u306e\u65b9\u91dd\u3001\u76ee\u7684\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u6226\u7565\u3092\u7db2\u7f85\u3057\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u306e\u6307\u91dd\u3068\u306a\u308b\u3002.<\/p><h3><strong>\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb <\/strong><\/h3><p>\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb\u306f\u3001\u533b\u85ac\u54c1QMS\u306e\u4e2d\u6838\u3068\u306a\u308b\u30d7\u30ed\u30bb\u30b9\u3001\u69cb\u9020\u3001\u7bc4\u56f2\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u308b\u3002\u3055\u3089\u306b\u3001\u7570\u306a\u308b\u88fd\u85ac\u30d7\u30ed\u30bb\u30b9\u9593\u306e\u76f8\u4e92\u95a2\u4fc2\u3082\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb\u306f\u901a\u5e38\u3001ICH Q10\u3001PIC\/S GMP\u3001EU GMP\u3067\u8a00\u53ca\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><h3><strong>\u624b\u9806\u3068\u696d\u52d9\u4f53\u5236 <\/strong><\/h3><p>\u6b21\u306f\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u624b\u9806\u3068\u4f5c\u696d\u69cb\u6210\u3067\u3059\u3002\u3053\u3053\u3067\u306f\u3001\u85ac\u306e\u8a2d\u8a08\u3084\u958b\u767a\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u624b\u9806\u3092\u3001\u30d3\u30b8\u30e5\u30a2\u30eb\u3084\u8868\u3092\u4f7f\u3063\u3066\u308f\u304b\u308a\u3084\u3059\u304f\u8aac\u660e\u3057\u307e\u3059\u3002\u307e\u305f <a href=\"https:\/\/pharmamachinecn.com\/ja\/sop-in-pharmaceutical-industry\/\"><u>\u5404\u30b9\u30c6\u30c3\u30d7\u306eSOP\u3092\u4f5c\u6210\u3059\u308b<\/u><\/a>\u00a0\u5b89\u5b9a\u3057\u305f\u54c1\u8cea\u306e\u88fd\u54c1\u3078\u306e\u9053\u3092\u958b\u304f\u3002.<\/p><h3><strong>\u30d5\u30a9\u30fc\u30e0\u3068\u8a18\u9332 <\/strong><\/h3><p>\u691c\u67fb\u5ba4\u5831\u544a\u66f8\u3084\u30d0\u30c3\u30c1\u8a18\u9332\u306a\u3069\u306e\u66f8\u5f0f\u3084\u8a18\u9332\u306f\u3001\u5b9f\u65bd\u3055\u308c\u305f\u4f5c\u696d\u306e\u8a3c\u62e0\u3068\u306a\u308b\u3002\u3053\u308c\u306fQMS\u306e\u91cd\u8981\u306a\u4e00\u90e8\u3067\u3042\u308a\u3001\u5404\u624b\u9806\u304c\u524d\u8ff0\u306e\u898f\u5236\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002.<\/p><h2><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u30d7\u30ed\u30bb\u30b9\u306e\u4e3b\u8981\u8981\u7d20 <\/strong><\/h2><p>\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u6587\u66f8\u7ba1\u7406\u3001\u5909\u66f4\u7ba1\u7406\u3001\u6559\u80b2\u7ba1\u7406\u3001\u76e3\u67fb\u7ba1\u7406\u306a\u3069\u306e\u8907\u6570\u306e\u8981\u7d20\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3057\u3088\u3046\uff1a<\/p><ul><li><strong>\u6587\u66f8\u7ba1\u7406<\/strong>:\u6587\u66f8\u306e\u4f5c\u6210\u3001\u627f\u8a8d\u3001\u914d\u5e03\u3001\u6539\u8a02\u3001\u5b9f\u65bd\u306b\u95a2\u308f\u308b\u3002\u3064\u307e\u308a\u3001\u6587\u66f8\u304c\u4f5c\u6210\u3055\u308c\u3001\u627f\u8a8d\u3055\u308c\u3001\u4e00\u610f\u306e\u8b58\u5225\u5b50\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3001\u95a2\u9023\u3059\u308b\u62c5\u5f53\u8005\u3068\u5171\u6709\u3055\u308c\u308b\u3002\u5927\u304d\u306a\u5909\u66f4\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u54c1\u8cea\u554f\u984c\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304c\u884c\u308f\u308c\u308b\u3002.<\/li><li><strong>\u30c1\u30a7\u30f3\u30b8\u30fb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong>:\u5909\u66f4\u7ba1\u7406\u3068\u306f\u3001QMS\u306e\u30d7\u30ed\u30bb\u30b9\u3084\u6587\u66f8\u306b\u52a0\u3048\u3089\u308c\u305f\u5909\u66f4\u3092\u51e6\u7406\u3059\u308b\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u5404\u5909\u66f4\u306f\u3001\u3088\u308a\u660e\u78ba\u306b\u3059\u308b\u305f\u3081\u306b\u3001\u8a73\u7d30\u306a\u6b63\u5f53\u6027\u3068\u5f71\u97ff\u3092\u53d7\u3051\u308b\u30b7\u30b9\u30c6\u30e0\u3092\u4f34\u3046\u3002\u305d\u306e\u76ee\u7684\u306f\u3001\u5909\u66f4\u304c\u5b9f\u884c\u53ef\u80fd\u3067\u3042\u308a\u3001\u88fd\u54c1\u304c\u6700\u7d42\u60a3\u8005\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308a\u7d9a\u3051\u3001\u5927\u304d\u306a\u30ea\u30b9\u30af\u3092\u4f34\u308f\u306a\u3044\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/li><li><strong>\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30fb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong>:\u3053\u306e\u6587\u66f8\u306b\u306f\u3001\u305d\u306e\u540d\u306e\u901a\u308a\u3001\u5f93\u696d\u54e1\u3092\u6700\u65b0\u306e\u72b6\u614b\u306b\u4fdd\u3061\u3001\u8cc7\u683c\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u7814\u4fee\u8a08\u753b\u3001\u7d42\u4e86\u3057\u305f\u7814\u4fee\u306e\u8a18\u9332\u3001\u8a55\u4fa1\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002.<\/li><li><strong>\u30ea\u30b9\u30af\u7ba1\u7406<\/strong>:\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u8a55\u4fa1\u3057\u3001\u8efd\u6e1b\u3059\u308b\u305f\u3081\u306e\u4e00\u9023\u306e\u624b\u9806\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306f\u9069\u5207\u306b\u6587\u66f8\u5316\u3055\u308c\u3001\u9069\u5207\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u3002.<\/li><li><strong>\u76e3\u67fb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong>:\u76e3\u67fb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3082\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u4e00\u8981\u7d20\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u3001\u5916\u90e8\u76e3\u67fb\u304a\u3088\u3073\u5185\u90e8\u76e3\u67fb\u306e\u8a08\u753b\u3001\u5b9f\u65bd\u3001\u6587\u66f8\u5316\u3001\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3092\u4e2d\u5fc3\u306b\u5c55\u958b\u3055\u308c\u308b\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u898b\u76f4\u3057\u3001\u5c06\u6765\u306e\u6539\u5584\u306e\u4f59\u5730\u3092\u898b\u3064\u3051\u308b\u305f\u3081\u306b\u6d3b\u7528\u3067\u304d\u307e\u3059\u3002.<\/li><\/ul><h2><strong>\u54c1\u8cea\u7ba1\u7406\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u306e\u30e1\u30ea\u30c3\u30c8 <\/strong><\/h2><p>\u54c1\u8cea\u7ba1\u7406\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u4e16\u754c\u5e02\u5834\u898f\u6a21\u306f\u6b21\u306e\u3088\u3046\u306b\u63a8\u5b9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u3054\u5b58\u77e5\u3067\u3059\u304b\uff1f <a href=\"https:\/\/www.google.com\/url?sa=t&amp;source=web&amp;rct=j&amp;opi=89978449&amp;url=https:\/\/www.grandviewresearch.com\/industry-analysis\/quality-management-software-market&amp;ved=2ahUKEwjGsqGvzreQAxXb9wIHHWvgMggQFnoECBsQAQ&amp;usg=AOvVaw2PQ-PFSlw2_dAX5nqVDLMh\" target=\"_blank\" rel=\"noopener\"><u>2024\u5e74\u306b\u306f111\u51044000\u4e07\u7c73\u30c9\u30eb\u306b\u9054\u3057\u3001206\u51046000\u4e07\u7c73\u30c9\u30eb\u306b\u9054\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u308b\u3002<\/u><\/a>\u00a0\u5104\u30c9\u30eb\u306b\u9054\u3059\u308b\u3068\u4e88\u60f3\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u306e\u5927\u304d\u306a\u6210\u9577\u306f\u3001\u533b\u85ac\u54c1\u3092\u542b\u3080\u591a\u304f\u306e\u7523\u696d\u304cQMS\u3092\u63a1\u7528\u3057\u3001\u6b21\u306e\u3088\u3046\u306a\u30e1\u30ea\u30c3\u30c8\u3092\u4eab\u53d7\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3042\u308b\uff1a<\/p><h3><strong>\u88fd\u54c1\u306e\u4e00\u8cab\u6027 <\/strong><\/h3><p>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3059\u308b\u3068\u3001\u3059\u3079\u3066\u306e\u30d7\u30ed\u30bb\u30b9\u304c\u6a19\u6e96\u5316\u3055\u308c\u307e\u3059\u3002\u30c1\u30fc\u30e0\u3084\u30b7\u30d5\u30c8\u304c\u5909\u308f\u3063\u3066\u3082\u3001\u4e00\u8cab\u3057\u305f\u88fd\u54c1\u54c1\u8cea\u306e\u5411\u4e0a\u306b\u3064\u306a\u304c\u308b\u3070\u3089\u3064\u304d\u304c\u306a\u304f\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30df\u30b9\u304c\u5927\u5e45\u306b\u6e1b\u5c11\u3057\u3001\u88fd\u54c1\u3084\u30b5\u30fc\u30d3\u30b9\u306b\u5bfe\u3059\u308b\u9867\u5ba2\u6e80\u8db3\u5ea6\u3068\u4fe1\u983c\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002.<\/p><h3><strong>\u7af6\u4e89\u529b\u306e\u5411\u4e0a<\/strong><\/h3><p>\u533b\u85ac\u54c1QMS\u306f\u307e\u305f\u3001\u4f01\u696d\u306e\u8a55\u5224\u3068\u5e02\u5834\u30b7\u30a7\u30a2\u3092\u9ad8\u3081\u307e\u3059\u3002\u52b9\u679c\u7684\u306a\u9038\u8131\u9632\u6b62\u3068\u5909\u66f4\u7ba1\u7406\u6226\u7565\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u591a\u304f\u306e\u9867\u5ba2\u304c\u8cb4\u793e\u306e\u30d3\u30b8\u30cd\u30b9\u306b\u3064\u306a\u304c\u308a\u3001\u65b0\u305f\u306a\u5e02\u5834\u306b\u53c2\u5165\u3057\u3084\u3059\u304f\u306a\u308a\u307e\u3059\u3002.<\/p><h3><strong>\u3088\u308a\u826f\u3044\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 <\/strong><\/h3><p>\u88fd\u85ac\u4f1a\u793e\u3068\u3057\u3066\u3001\u56fd\u969b\u7684\u30fb\u56fd\u5185\u7684\u306a\u898f\u5236\u3084\u57fa\u6e96\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u306f\u5fc5\u9808\u3067\u3059\u3002QMS\u306f\u3001\u5185\u90e8\u76e3\u67fb\u3084\u5916\u90e8\u76e3\u67fb\u306e\u8a18\u9332\u3092\u8ffd\u8de1\u53ef\u80fd\u306a\u5f62\u3067\u4fdd\u5b58\u3059\u308b\u305f\u3081\u3001\u3053\u306e\u70b9\u3067\u5f79\u7acb\u3061\u307e\u3059\u3002\u67fb\u5bdf\u306e\u969b\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u30c7\u30fc\u30bf\u3092\u62bd\u51fa\u3057\u3001FDA\u3001EMA\u3001ICH\u898f\u683c\u3078\u306e\u6e96\u62e0\u3092\u63fa\u308b\u304e\u306a\u3044\u81ea\u4fe1\u3068\u660e\u78ba\u3055\u3067\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p><h3><strong>\u696d\u52d9\u52b9\u7387\u306e\u5411\u4e0a <\/strong><\/h3><p>QMS\u306b\u306f\u69cb\u9020\u5316\u3055\u308c\u305f\u6587\u66f8\u304c\u3042\u308a\u3001\u624b\u4f5c\u696d\u306b\u3088\u308b\u8ffd\u8de1\u3001\u30a8\u30e9\u30fc\u3001\u624b\u623b\u308a\u306e\u5fc5\u8981\u6027\u3092\u4f4e\u6e1b\u3057\u3066\u3044\u308b\u3002\u3059\u3079\u3066\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306f\u6a19\u6e96\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u30b9\u30e0\u30fc\u30ba\u306a\u904b\u7528\u304c\u53ef\u80fd\u3067\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u751f\u7523\u30b3\u30b9\u30c8\u306e\u524a\u6e1b\u3001\u52b9\u7387\u6027\u306e\u5411\u4e0a\u3001\u53ce\u76ca\u6027\u306e\u6539\u5584\u304c\u5b9f\u73fe\u3057\u307e\u3059\u3002.<\/p><h2><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u8ab2\u984c <\/strong><\/h2><p>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3044\u304f\u3064\u304b\u306e\u5229\u70b9\u304c\u3042\u308b\u4e00\u65b9\u3067\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u6ce8\u610f\u3059\u3079\u304d\u8ab2\u984c\u3082\u3042\u308b\uff1a<\/p><ul><li>\u56fd\u969b\u898f\u683c\u3082\u56fd\u5185\u898f\u683c\u3082\u3001\u6642\u4ee3\u3084\u30cb\u30fc\u30ba\u306e\u5909\u5316\u306b\u5408\u308f\u305b\u3066\u6539\u8a02\u30fb\u66f4\u65b0\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u5909\u5316\u306b\u5bfe\u5fdc\u3057\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u7d71\u5408\u3059\u308b\u3053\u3068\u306f\u9762\u5012\u306a\u3053\u3068\u3067\u3059\u3002.<\/li><li>\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u554f\u984c\u304b\u3089\u3001\u8907\u6570\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3084\u6d41\u901a\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u983c\u3089\u3056\u308b\u3092\u5f97\u306a\u3044\u3053\u3068\u3082\u591a\u3044\u3002\u3057\u304b\u3057\u3001\u5f7c\u3089\u304c\u6c7a\u3081\u3089\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u30af\u30ed\u30b9\u30c1\u30a7\u30c3\u30af\u3059\u308b\u3053\u3068\u306f\u975e\u5e38\u306b\u96e3\u3057\u304f\u3001\u6700\u7d42\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u640d\u306a\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/li><li>\u88fd\u85ac\u3092\u542b\u3080\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u3067\u306f\u300124\u6642\u9593\u306b50\u5104\u30da\u30fc\u30b8\u5206\u306e\u30c6\u30ad\u30b9\u30c8\u304c\u4f5c\u6210\u3055\u308c\u308b\u3002\u3053\u308c\u306f\u6bce\u65e5\u6570\u5341\u30c6\u30e9\u30d0\u30a4\u30c8\u306e\u30c7\u30fc\u30bf\u306b\u76f8\u5f53\u3057\u3001\u81a8\u5927\u306a\u91cf\u3067\u3042\u308b\u3002\u3053\u308c\u3060\u3051\u306e\u30c7\u30fc\u30bf\u3092\u4fdd\u5b58\u3057\u3001\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u3092\u7d20\u65e9\u304f\u5f15\u304d\u51fa\u3059\u3053\u3068\u306f\u3001\u4f9d\u7136\u3068\u3057\u3066\u5927\u304d\u306a\u61f8\u6848\u4e8b\u9805\u3067\u3042\u308b\u3002.<\/li><li>\u5f93\u696d\u54e1\u306b\u5341\u5206\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u63d0\u4f9b\u3057\u3001\u65b0\u3057\u3044\u5909\u5316\u3084\u30d7\u30ed\u30bb\u30b9\u306b\u9069\u5fdc\u3059\u308b\u3053\u3068\u3092\u5b66\u3070\u305b\u308b\u3053\u3068\u306f\u3001\u5fc5\u305a\u3057\u3082\u30b9\u30e0\u30fc\u30ba\u3067\u306f\u306a\u304f\u3001\u30d5\u30e9\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u306a\u304c\u308b\u3002.<\/li><\/ul><p>\u3057\u305f\u304c\u3063\u3066\u3001\u533b\u85ac\u54c1QMS\u3092\u5c0e\u5165\u3059\u308b\u969b\u306b\u306f\u3001\u3053\u308c\u3089\u306e\u8ab2\u984c\u3092\u7ba1\u7406\u3057\u3001\u9867\u5ba2\u306b\u6700\u9ad8\u54c1\u8cea\u306e\u533b\u85ac\u54c1\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u30b3\u30c4\u3092\u8eab\u306b\u3064\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><h2><strong>\u3088\u304f\u3042\u308b\u8cea\u554f <\/strong><\/h2><h3><strong>\u88fd\u85ac\u696d\u754c\u3067\u54c1\u8cea\u7ba1\u7406\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u306b\u306f\uff1f <\/strong><\/h3><p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u306f\u3001QMS\u3092\u5c0e\u5165\u3057\u3001\u54c1\u8cea\u7ba1\u7406\u5c5e\u6027\u3092\u5b9a\u7fa9\u3057\u3001GMP\u3084\u305d\u306e\u4ed6\u306e\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><h3><strong>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406\u3068\u306f\uff1f <\/strong><\/h3><p>\u533b\u85ac\u54c1QMS\u306b\u304a\u3051\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3068\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a55\u4fa1\u3001\u9078\u5b9a\u3001\u76e3\u8996\u3057\u3001\u539f\u6750\u6599\u3084\u8a2d\u5099\u306b\u95a2\u3059\u308b\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u6307\u3059\u3002.<\/p><h3><strong>\u533b\u85ac\u54c1QMS\u3068\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fcQMS\u306f\u3069\u3046\u9055\u3046\u306e\u3067\u3059\u304b\uff1f <\/strong><\/h3><p>\u533b\u85ac\u54c1QMS\u306f\u533b\u85ac\u54c1\u958b\u767a\u3068\u6700\u7d42\u5264\u5f62\u306b\u91cd\u70b9\u3092\u7f6e\u304f\u306e\u306b\u5bfe\u3057\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fcQMS\u306f\u7d30\u80de\u30d9\u30fc\u30b9\u306e\u6cbb\u7642\u85ac\u306a\u3069\u751f\u7269\u5b66\u7684\u306b\u99c6\u52d5\u3059\u308b\u88fd\u54c1\u306b\u9069\u3057\u3066\u3044\u308b\u3002.<\/p><h2><strong>\u7d50\u8ad6 <\/strong><\/h2><p>\u9867\u5ba2\u306e\u4fe1\u983c\u3092\u7372\u5f97\u3057\u3001\u7af6\u5408\u4ed6\u793e\u306b\u5dee\u3092\u3064\u3051\u308b\u306b\u306f\u3001\u533b\u85ac\u54c1\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u304a\u5ba2\u69d8\u306e\u88fd\u9020\u30cb\u30fc\u30ba\u306b\u5fdc\u3048\u308b\u4e00\u6d41\u306e\u6a5f\u5668\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5bfe\u5fdc\u6a5f\u5668\u3092\u3069\u3053\u3067\u624b\u306b\u5165\u308c\u3089\u308c\u308b\u304b\u3001\u304a\u60a9\u307f\u3067\u3059\u304b\uff1f\u4e0b\u8a18\u307e\u3067\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/\"><u>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u306e\u533b\u85ac\u54c1\u6a5f\u5668<\/u><\/a>\u00a0\u304a\u5ba2\u69d8\u306e\u65e5\u5e38\u696d\u52d9\u3092\u52b9\u7387\u5316\u3059\u308b\u3001\u9769\u65b0\u7684\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u6570\u3005\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\uff01<\/p><h2><strong>\u53c2\u8003\u6587\u732e:<\/strong><\/h2><p><a href=\"https:\/\/www.scilife.io\/blog\/qms-in-pharma-guide\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005\u306e\u305f\u3081\u306e\u533b\u85ac\u54c1QMS\u5b8c\u5168\u30ac\u30a4\u30c9<\/strong><\/em><\/span><\/a>.<\/p><p><a href=\"https:\/\/www.blog-qhse.com\/en\/quality-management-system-for-the-pharmaceutical-industry\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong> \u88fd\u85ac\u696d\u754c\u5411\u3051\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3002.<\/strong><\/em><\/span><\/a><\/p><p><a href=\"https:\/\/pharmuni.com\/glossary\/qms-pharmaceutical-industry\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bQMS\uff08\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/strong><\/em><\/span><\/a><\/p><p><a href=\"https:\/\/simplerqms.com\/pharmaceutical-quality-management-system\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u533b\u85ac\u54c1\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09<\/strong><\/em><\/span><\/a><\/p><p><a href=\"https:\/\/www.fda.gov\/media\/71553\/download\" target=\"_blank\" rel=\"noopener\"><strong><em><span style=\"text-decoration: underline;\">\u696d\u754c\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9 Q10 \u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/span><\/em><\/strong><\/a>.<\/p><h2><b>\u8457\u4f5c\u6a29\u306b\u3064\u3044\u3066\u00a0<\/b><\/h2><p>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u30fb\u30b0\u30eb\u30fc\u30d7\u306e\u66f8\u9762\u306b\u3088\u308b\u4e8b\u524d\u306e\u660e\u793a\u7684\u306a\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u672c\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u4e0a\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u8907\u88fd\u3001\u5909\u66f4\u3001\u516c\u958b\u3001\u8868\u793a\u3001\u9001\u4fe1\u3001\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u5229\u7528\u3057\u305f\u308a\u3001\u305d\u306e\u3088\u3046\u306a\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u4f7f\u7528\u3057\u3066\u4f55\u3089\u304b\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u69cb\u7bc9\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u4f7f\u7528\u8a31\u53ef\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a <a href=\"mailto:info@pharmamachinecn.com\"><span style=\"text-decoration: underline;\">info@pharmamachinecn.com<\/span><\/a><\/p><h2><b>\u514d\u8cac\u4e8b\u9805:<\/b><\/h2><p>\u672c\u8a18\u4e8b\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u306f\u3001\u4e00\u822c\u7684\u306a\u60c5\u5831\u63d0\u4f9b\u306e\u307f\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u3044\u304b\u306a\u308b\u60c5\u5831\u306b\u3064\u3044\u3066\u3082\u3001\u305d\u306e\u6b63\u78ba\u6027\u3001\u59a5\u5f53\u6027\u3001\u9069\u6642\u6027\u3001\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u307e\u305f\u3001\u672c\u8a18\u4e8b\u306e\u5185\u5bb9\u306e\u8aa4\u8b2c\u307e\u305f\u306f\u8131\u6f0f\u306b\u3064\u3044\u3066\u4e00\u5207\u306e\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u305b\u3093\u3002.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Safety and efficacy are must-have elements in pharmaceuticals. 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