{"id":19388,"date":"2026-11-11T23:05:51","date_gmt":"2026-11-11T22:05:51","guid":{"rendered":"https:\/\/www.s-vt.net\/oq-%e9%81%8b%e8%bb%a2%e6%99%82%e9%81%a9%e6%a0%bc%e6%80%a7%e8%a9%95%e4%be%a1\/"},"modified":"2026-11-11T23:33:57","modified_gmt":"2026-11-11T22:33:57","slug":"operational-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/ja\/operational-qualification\/","title":{"rendered":"OQ \u2013 \u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1"},"content":{"rendered":"<div style='' class=''><section class='page-content' style=''  ><section class='container'><div style='' class=''><div class='row' style=''><div style='' class=''><div class='col-md-12 ' style=''><div style='' class=''><div class='cma-wysiwyg-editor'><p class=\"svt-lead2\">\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u3068\u306f\u3001\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u8a2d\u5099\u304c\u3001\u636e\u3048\u4ed8\u3051\u3089\u308c\u305f\u72b6\u614b\u307e\u305f\u306f\u5909\u66f4\u3055\u308c\u305f\u72b6\u614b\u3067\u3001\u4e88\u5b9a\u3055\u308c\u305f\u904b\u8ee2\u7bc4\u56f2\u5168\u4f53\u306b\u308f\u305f\u308a\u898f\u5b9a\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><strong>\u6a5f\u80fd\u306e\u78ba\u8a8d<\/strong><span>\u8981\u6c42\u4ed5\u69d8\u66f8\u3067\u6c42\u3081\u3089\u308c\u308b\u6a5f\u80fd\u3068\u306e\u9069\u5408\u3002<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>\u6821\u6b63<\/strong><span>\u8a08\u6e2c\u70b9\u3092\u6821\u6b63\u3057\u3001\u6821\u6b63\u9593\u9694\u3092\u5b9a\u3081\u307e\u3059\u3002<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>\u8a18\u9332\u3068\u5831\u544a\u66f8<\/strong><span>\u8a66\u9a13\u8a18\u9332\u3001\u30ed\u30b0\u30d6\u30c3\u30af\u3001OQ\u5831\u544a\u66f8\u3002<\/span><\/div><\/div><h2>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u5b9a\u7fa9<\/h2><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Aide-M\u00e9moire GMP<\/h3><p>\u300c\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u8a2d\u5099\u304c\u3001\u636e\u3048\u4ed8\u3051\u3089\u308c\u305f\u72b6\u614b\u53c8\u306f\u5909\u66f4\u3055\u308c\u305f\u72b6\u614b\u3067\u3001\u4e88\u5b9a\u3055\u308c\u305f\u904b\u8ee2\u7bc4\u56f2\u5168\u4f53\u306b\u308f\u305f\u308a\u898f\u5b9a\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3002\u300d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>EU-GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 Annex 15<\/h3><p>\u300c\u636e\u3048\u4ed8\u3051\u3089\u308c\u305f\u53c8\u306f\u5909\u66f4\u3055\u308c\u305f\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u88c5\u7f6e\u304c\u3001\u4e88\u5b9a\u3057\u305f\u904b\u8ee2\u7bc4\u56f2\u306b\u304a\u3044\u3066\u671f\u5f85\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3002\u300d<\/p><\/div><\/div><h2>OQ\u306e\u5185\u5bb9<\/h2><p class=\"svt-knote\"><strong>\u524d\u63d0\u6761\u4ef6\uff1a<\/strong> \u307e\u305a <a href=\"https:\/\/www.s-vt.net\/ja\/installation-qualification\/\">IQ<\/a> \u304c\u6b63\u5e38\u306b\u5b8c\u4e86\u3057\u3066\u3044\u308b\u3053\u3068\u3002\u305d\u306e\u3046\u3048\u3067OQ\u3067\u306f\u3001\u6280\u8853\u30b7\u30b9\u30c6\u30e0\u306e\u6a5f\u80fd\u304c <a href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#lastenheft\">\u8981\u6c42\u4ed5\u69d8\u66f8<\/a> \u3067\u6c42\u3081\u3089\u308c\u308b\u6a5f\u80fd\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p><div class=\"svt-kgrid svt-kgrid-3\"><div class=\"svt-kcard\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><h3>\u8a08\u753b\u3068\u6587\u66f8\u5316<\/h3><ul class=\"svt-klist\"><li>OQ\u5b9f\u65bd\u8a08\u753b<\/li><li>\u500b\u3005\u306e\u6a5f\u80fd\u8a66\u9a13\u306e\u8a66\u9a13\u8a18\u9332<\/li><li>\u30ed\u30b0\u30d6\u30c3\u30af\u306e\u4f5c\u6210<\/li><li>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6280\u8853\u6587\u66f8\u306e\u78ba\u8a8d<\/li><li>\u5b8c\u5168\u6027\u306e\u78ba\u8a8d<\/li><li>OQ\u5b9f\u65bd\u5831\u544a\u66f8<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><h3>\u6a5f\u80fd\u8a66\u9a13<\/h3><ul class=\"svt-klist\"><li>\u500b\u3005\u306e\u6a5f\u80fd\u306e\u78ba\u8a8d<\/li><li>\u54c1\u8cea\u306b\u5f71\u97ff\u3059\u308b\u6a5f\u80fd\u306e\u7279\u5b9a\u3068\u78ba\u8a8d<\/li><li>\u6027\u80fd\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u78ba\u8a8d<\/li><li>\u74b0\u5883\u6761\u4ef6\u306e\u78ba\u8a8d<\/li><li>\u96fb\u78c1\u4e21\u7acb\u6027\uff08EMC\uff09\u306e\u78ba\u8a8d<\/li><li>\u30ea\u30b9\u30af\u5206\u6790\u306e\u898b\u76f4\u3057<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-wrench\" aria-hidden=\"true\"><\/i><h3>\u6821\u6b63\u3068\u904b\u8ee2<\/h3><ul class=\"svt-klist\"><li>\u8a08\u6e2c\u70b9\u306e\u6821\u6b63\u3068\u6821\u6b63\u9593\u9694\u306e\u8a2d\u5b9a<\/li><li>\u53d6\u6271\u8aac\u660e\u66f8\u3092\u88dc\u5b8c\u3059\u308b\u4f5c\u696d\u624b\u9806\u66f8<\/li><li>\u6821\u6b63\u30fb\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u7528\u4f5c\u696d\u624b\u9806\u66f8\u306e\u6539\u8a02<\/li><\/ul><\/div><\/div><h2>\u9069\u683c\u6027\u8a55\u4fa1\u306e\u6d41\u308c<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 \u30ea\u30b9\u30af\u5206\u6790<\/strong><span class=\"svt-step-tx\">\u8a2d\u8a08\u304c\u78ba\u5b9a\u3059\u308b\u524d\u306b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u30fb\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ja\/design-qualification\/\">DQ \u2013 \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong><span class=\"svt-step-tx\">\u8a2d\u8a08\u304c\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u5b9f\u8a3c\u3002<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ja\/installation-qualification\/\">IQ \u2013 \u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong><span class=\"svt-step-tx\">\u767a\u6ce8\u66f8\u985e\u306b\u5bfe\u3059\u308b\u636e\u4ed8\u72b6\u614b\u306e\u78ba\u8a8d\u3002<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong>OQ \u2013 \u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08\u3053\u306e\u30da\u30fc\u30b8\uff09<\/strong><span class=\"svt-step-tx\">\u4e88\u5b9a\u3055\u308c\u305f\u6a5f\u80fd\u306e\u78ba\u8a8d\u3002<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ja\/process-qualification\/\">PQ \u2013 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong><span class=\"svt-step-tx\">\u904b\u8ee2\u6642\u306b\u6c42\u3081\u3089\u308c\u308b\u6027\u80fd\u306e\u5b9f\u8a3c\u3002<\/span><\/li><\/ol><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-ghost\" style=\"flex:0 0 auto\" href=\"https:\/\/www.s-vt.net\/ja\/process-qualification\/\">PQ \u2013 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\u3078\u9032\u3080 <i class=\"fa fa-arrow-right\" aria-hidden=\"true\"><\/i><\/a><\/div><p>\u307e\u305a <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> \u306f\u3001\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u6587\u66f8\u4f5c\u6210\u3068\u78ba\u8a8d\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p><h2>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u3054\u8cea\u554f<\/h2><h3>\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3><p>OQ\u3068\u306f\u3001\u636e\u3048\u4ed8\u3051\u3089\u308c\u305f\u72b6\u614b\u306e\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u8a2d\u5099\u304c\u3001\u4e88\u5b9a\u3055\u308c\u305f\u904b\u8ee2\u7bc4\u56f2\u5168\u4f53\u306b\u308f\u305f\u308a\u671f\u5f85\u3069\u304a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3067\u3059\uff08EU-GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 Annex 15\uff09\u3002<\/p><h3>OQ\u306e\u524d\u63d0\u6761\u4ef6\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3><p>\u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u304c\u6b63\u5e38\u306b\u5b8c\u4e86\u3057\u3066\u3044\u308b\u3053\u3068\u3067\u3059\u3002<\/p><h3>OQ\u3067\u306f\u4f55\u3092\u78ba\u8a8d\u3057\u307e\u3059\u304b\uff1f<\/h3><p>\u8a2d\u5099\u306e\u6a5f\u80fd\u304c\u8981\u6c42\u4ed5\u69d8\u66f8\u3067\u6c42\u3081\u3089\u308c\u308b\u6a5f\u80fd\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u500b\u3005\u306e\u6a5f\u80fd\u3001\u54c1\u8cea\u306b\u5f71\u97ff\u3059\u308b\u6a5f\u80fd\u3001\u6027\u80fd\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u74b0\u5883\u6761\u4ef6\u3001\u8a08\u6e2c\u70b9\u306e\u6821\u6b63\u3001\u96fb\u78c1\u4e21\u7acb\u6027\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p><h3>OQ\u3067\u306f\u3069\u306e\u3088\u3046\u306a\u6587\u66f8\u304c\u4f5c\u6210\u3055\u308c\u307e\u3059\u304b\uff1f<\/h3><p>OQ\u8a08\u753b\u66f8\u3001\u8a66\u9a13\u8a18\u9332\u3001\u6821\u6b63\u9593\u9694\u3001\u904b\u8ee2\u30fb\u6821\u6b63\u30fb\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u7528\u306e\u4f5c\u696d\u624b\u9806\u66f8\u3001\u30ed\u30b0\u30d6\u30c3\u30af\u3001\u6700\u7d42\u7684\u306aOQ\u5831\u544a\u66f8\u3067\u3059\u3002<\/p><h2 class=\"svt-pcta-h\">\u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002\u304a\u96fb\u8a71\uff1a <a href=\"tel:+494203789492\">+49 4203 789492<\/a> \u3001\u307e\u305f\u306f\u30e1\u30fc\u30eb\uff1a <a href=\"mailto:&#105;n&#102;&#111;&#64;&#115;&#45;&#118;t.n&#101;t\">&#105;&#110;fo&#64;&#115;&#45;vt.n&#101;t<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/ja\/contact\/?produkt=Verfahrenstechnische%20Beratung\">\u304a\u554f\u3044\u5408\u308f\u305b\u3092\u9001\u4fe1<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#planung\">\u30b5\u30fc\u30d3\u30b9\u4e00\u89a7<\/a><\/div><\/div><h2>\u305d\u306e\u4ed6\u306e\u30b5\u30fc\u30d3\u30b9<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#planung\"><span>\u8a08\u753b<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#basic-engineering\"><span>\u30d9\u30fc\u30b7\u30c3\u30af\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#konstruktion\"><span>\u8a2d\u8a08\u652f\u63f4<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#beschaffung\"><span>\u8abf\u9054\u652f\u63f4<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#lastenheft\"><span>\u30d7\u30ed\u30bb\u30b9\u30d7\u30e9\u30f3\u30c8\u306e\u8981\u6c42\u4ed5\u69d8\u66f8<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#terminplanung\"><span>\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u8a08\u753b\u30fb\u7ba1\u7406<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/plant-engineering-project-execution\/#bauueberwachung\"><span>\u65bd\u5de5\u76e3\u7406<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/design-qualification\/\"><span>DQ \u2013 \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/installation-qualification\/\"><span>IQ \u2013 \u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/process-qualification\/\"><span>PQ \u2013 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ja\/process-optimisation\/\"><span>\u30d7\u30ed\u30bb\u30b9\u6700\u9069\u5316<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Service\",\"name\":\"OQ \u2013 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