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\/>\n\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u3067\u306f\u3001\u8b1b\u7fa9\u7528\u306e\u539f\u7a3f\u30924\u5206\u518a\uff08\u5165\u9580\u7de8\u3001\u57fa\u790e\u7de8\u3001\u7121\u83cc\u7de8\u3001\u539f\u85ac\u7de8\uff09\u3068\u3057\u3066\u914d\u5e03\u3057\u3001\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u3067\u306f\u30013\u5206\u518a\uff08\u57fa\u790e\u7de8\u3001\u7121\u83cc\u7de8\u3001\u539f\u85ac\u7de8\uff09\u3068\u3057\u3066\u914d\u5e03\u3057\u307e\u3059\u3002<br \/>\n6. \u5b9a\u3000\u54e1\uff1a<br \/>\n\u521d\u7d1a\u8005\u30fb\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u3044\u305a\u308c\u308230\u540d\u3002<br \/>\n\uff08\u5148\u7740\u53d7\u4ed8\u9806\u3001\u7533\u3057\u8fbc\u307f\u7de0\u5207\u308a\u65e5\uff1a\u521d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a2018\u5e7410\u670826\u65e5\uff08\u91d1\uff09\u3001\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a2018\u5e7412\u670825\u65e5\uff08\u706b\uff09\uff09<br \/>\n7. \u4f1a\u3000\u5834\uff1a<br \/>\n\u5927\u962a\u7523\u696d\u5275\u9020\u9928\u306e\u7814\u4fee\u5ba4\uff08\u96fb\u8a71\uff1a06-6264-9800\uff09<br \/>\n\uff08\u5927\u962a\u5730\u4e0b\u9244\u4e2d\u592e\u7dda\uff65\u583a\u7b4b\u7dda\uff62\u583a\u7b4b\u672c\u753a\u99c5\uff63\u4e0b\u8eca\u3001\u2460\u30fb \u246b\u756a\u51fa\u53e3\u3088\u308a\u5f92\u6b69\u7d045\u5206\u3002<br \/>\n\u7814\u4fee\u5ba4\u306e\u5ba4\u756a\u53f7\u7b49\u306f\u5225\u9014\u53d7\u8b1b\u8005\u3078\u9023\u7d61\u3002)<br \/>\n8. \u8a8d\u5b9a\u8a66\u9a13\u53d7\u9a13\u8cc7\u683c\uff1a<br \/>\n\u8a8d\u5b9a\u8a66\u9a13\u5bfe\u8c61\u306e\u8b1b\u5ea7\u306e\u8b1b\u7fa9\u6642\u9593\u306e60%\u4ee5\u4e0a\u53d7\u8b1b\u8005\u3002<br \/>\n\uff1c\u53d7\u8b1b\u8cbb\u7528\u7b49\uff1e\uff08\u4ee5\u4e0b\u3001\u300cNPO-QA\u30bb\u30f3\u30bf\u30fc\u300d\u3092\u300cQA\u30bb\u30f3\u30bf\u30fc\u300d\u3068\u3059\u308b\u3002\uff09<br \/>\n1. \u300c\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u300d\u8b1b\u5ea7:<br \/>\n1)\u300c\u5165\u9580\u7de8\u300d(1\u65e5)\uff1a QA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u30001.5\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u3000\u3000\u30002\u4e07\u5186\/\u540d<br \/>\n2)\u300c\u5165\u9580\u7de8\u300d\uff0b\u300c\u57fa\u790e\u7de8\u300d(6\u65e5)\uff1a<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000 8\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 12\u4e07\u5186\/\u540d<br \/>\n3)\u300c\u5165\u9580\u7de8\u300d\uff0b\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u7121\u83cc\u7de8\u300d\u3042\u308b\u3044\u306f\u300c\u539f\u85ac\u7de8\u300d(7\u65e5)\uff1a<br \/>\nQA\u30bb\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000 9\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000 \u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 13.5\u4e07\u5186\/\u540d<br \/>\n4)\u300c\u5165\u9580\u7de8\u300d\uff0b\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u7121\u83cc\u7de8\u300d\u304a\u3088\u3073\u300c\u539f\u85ac\u7de8\u300d(8\u65e5)\uff1a<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u300010\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u300015\u4e07\u5186\/\u540d<br \/>\n2. \u300c\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u300d\u8b1b\u5ea7\uff1a<br \/>\n1)\u300c\u57fa\u790e\u7de8\u300d(6\u65e5)\uff1a\u3000QA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000 8\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 12\u4e07\u5186\/\u540d<br \/>\n2)\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u7121\u83cc\u7de8\u300d\u3042\u308b\u3044\u306f\u300c\u539f\u85ac\u7de8\u300d(7\u65e5)\uff1a<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u30009\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000 \u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u300013.5\u4e07\u5186\/\u540d<br \/>\n3)\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u7121\u83cc\u7de8\u300d\u304a\u3088\u3073\u300c\u539f\u85ac\u7de8\u300d(8\u65e5)\uff1a<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000 \u3000\u300010\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000 \u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u3000\u3000\u300015\u4e07\u5186\/\u540d<\/p>\n<p>3.\u3000\u8a8d\u5b9a\u8a3c\u53d6\u5f97\u8005\uff08\u6ce8\uff11\uff09\u306e\u53d7\u8b1b\u6599<br \/>\n\u300c\u5165\u9580\u7de8\u300d\uff1a\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u3000 1.5\u4e07\u5186\/\u540d<br \/>\n\u300c\u8a8d\u5b9a\u8a3c\u53d6\u5f97\u8005\u300d\u304c\u30015\u5e74\u6bce\u306e\u300c\u8a8d\u5b9a\u8a3c\u300d\u66f4\u65b0\u6761\u4ef6\u78ba\u4fdd\u306e\u305f\u3081\u3001\u521d\u7d1a\u8005<br \/>\n\u30af\u30e9\u30b9\u3042\u308b\u3044\u306f\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u300c\u5165\u9580\u7de8\u300d\u3001\u300c\u57fa\u790e\u7de8\u300d\u3001\u300c\u7121\u83cc\u7de8\u300d\u304a\u3088\u3073<br \/>\n\u300c\u539f\u85ac\u7de8\uff63\u306e\u4e00\u90e8\u8b1b\u5ea7\u79d1\u76ee\u53d7\u8b1b\u306e\u5834\u5408\uff1a\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 4\u5343\u5186\/\u6642\u9593\/\u540d<br \/>\n\u6ce8\uff11\uff1aQA\u30bb\u30f3\u30bf\u30fc\u304c\u3053\u308c\u307e\u3067\u306b\u958b\u8b1b\u3057\u305f\u300cGMP\u62c5\u5f53\u8005\u7814\u4fee\uff65\u8a8d\u5b9a\u8b1b\u5ea7\uff08\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u304a\u3088\u3073\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\uff09\u300d\u306e\u300c\u8a8d\u5b9a\u8a3c\u300d\u53d6\u5f97\u8005\u3002<br \/>\n4. \u53d7\u8b1b\u6599\u306f2\uff5e3\u5206\u5272\u53ef\uff08\u5225\u7d19\u306e\u53c2\u52a0\u7533\u8fbc\u7528\u7d19\u5099\u8003\u6b04\u306b\u305d\u306e\u65e8\u8a18\u5165\u4e0b\u3055\u3044\u3002\uff09<br \/>\n5. \u305d\u306e\u4ed6\uff1a\u8a8d\u5b9a\u8a66\u9a13\u3001\u8a8d\u5b9a\u8a3c\u7b49\u306e\u8a73\u7d30\u306f\u3001\u5225\u7d19\u300c\u300cGMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u6982\u8981\uff08\u6539\u8a028\u7248\uff09\u300d\u3092\u53c2\u7167\u4e0b\u3055\u3044\u3002<\/p>\n<p><strong>\u7b2c7\u671f\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u6982\u8981\uff082018\u5e7411\u67089\u65e5\uff5e2019\u5e741\u670811\u65e5\uff09<br \/>\n<\/strong>\n<table id=\"tablepress-119\" class=\"tablepress tablepress-id-119 tbody-has-connected-cells\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">\u56de<\/th><th class=\"column-2\">\u65e5\u3000\u6642<\/th><th class=\"column-3\">\u8b1b\u5ea7\u5185\u5bb9<\/th><th class=\"column-4\">\u8b1b\u5e2b\uff1dNPO-QA\u4f1a\u54e1<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr class=\"row-2\">\n\t<td rowspan=\"2\" class=\"column-1\">1<\/td><td rowspan=\"2\" class=\"column-2\">11\u67089\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u5165\u9580\u7de8\u3011<\/td><td class=\"column-3\">1. \u958b\u8b1b\u306b\u5f53\u305f\u3063\u3066<br \/>\n2. \u306a\u305cGQP\/GMP\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u306e\u304b\uff08\u8a082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6b66\u7530\u3000\u8c4a\u5f66<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-3\">GQP\/GMP\u306e\u6982\u8981\u89e3\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df2\u898b\u3000\u88d5<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td rowspan=\"3\" class=\"column-1\">2<\/td><td rowspan=\"3\" class=\"column-2\">11\u670816\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c\uff12\u6761\u3001\u7b2c\uff14\u6761\u304b\u3089\u7b2c\uff16\u6761\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7af9\u5185\u3000\u7965\u96c4<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c\uff17\u6761\uff08\u88fd\u54c1\u6a19\u6e96\u66f8\uff09\u306e\u89e3\u8aac\uff082.5\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7530\u4e2d\u3000\u4e00\u99ac<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c\uff18\u6761\uff08\u624b\u9806\u66f8\uff09\u306e\u89e3\u8aac\uff081.5\u6642\u9593\uff09<\/td><td class=\"column-4\">\u4f50\u85e4\u3000\u8015\u6cbb<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td rowspan=\"3\" class=\"column-1\">3<\/td><td rowspan=\"3\" class=\"column-2\">11\u670822\u65e5\uff08\u6728\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c10\u6761\uff08\u88fd\u9020\u7ba1\u7406\uff09\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u5165\u8c37\u3000\u5eb7\u4e00<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c11\u6761\uff08\u54c1\u8cea\u7ba1\u7406\uff09\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u5965\u5ddd\u3000\u9686\u653f<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c12\u6761\uff08\u88fd\u9020\u6240\u304b\u3089\u306e\u51fa\u8377\u306e\u7ba1\u7406\uff09\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u4e2d\u5c71\u3000\u662d\u4e00<\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td rowspan=\"3\" class=\"column-1\">4<\/td><td rowspan=\"3\" class=\"column-2\">11\u670830\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c13\u6761\uff08\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6e05\u539f\u3000\u5b5d\u96c4<\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c9\u6761\uff08\u69cb\u9020\u8a2d\u5099\uff09\u3001\u85ac\u5c40\u7b49\u69cb\u9020\u8a2d\u5099\u898f\u5247\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u8d8a\u8c37\u3000\u6e05\u4e00<\/td>\n<\/tr>\n<tr class=\"row-12\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c19\u6761\uff08\u6559\u80b2\u8a13\u7df4\uff09\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u4eba\u898b\u3000\u82f1\u660e<\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td rowspan=\"3\" class=\"column-1\">5<\/td><td rowspan=\"3\" class=\"column-2\">12\u67087\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c14\u6761\uff08\u5909\u66f4\u7ba1\u7406\uff09\u3001\u7b2c15\u6761\uff08\u9038\u8131\u7ba1\u7406\uff09\u306e\u89e3\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u521d\u4ee3\u3000\u79c0\u4e00<\/td>\n<\/tr>\n<tr class=\"row-14\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c16\u6761\uff08\u54c1\u8cea\u7b49\u306b\u95a2\u3059\u308b\u60c5\u5831\u53ca\u3073\u54c1\u8cea\u4e0d\u826f\u7b49\u306e\u51e6\u7406\uff09\u7b2c17\u6761\uff08\u56de\u53ce\u51e6\u7406\uff09\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7530\u4e2d\u3000\u4e00\u99ac<\/td>\n<\/tr>\n<tr class=\"row-15\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c18\u6761\uff08\u81ea\u5df1\u70b9\u691c\uff09\u3001\u7b2c20\u6761\uff08\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u7ba1\u7406\uff09\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7af9\u5185\u3000\u7965\u96c4<\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td rowspan=\"2\" class=\"column-1\">6<\/td><td rowspan=\"2\" class=\"column-2\">12\u670814\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u7121\u83cc\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c24\u6761\uff08\u7121\u83cc\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406\uff09\u3001\u7b2c25\u6761\uff08\u7121\u83cc\u533b\u85ac\u54c1\u306e\u6559\u80b2\u8a13\u7df4\uff09\u53ca\u3073\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b49\u306e\u89e3\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df2\u898b\u3000\u88d5<\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c23\u6761\uff08\u7121\u83cc\u533b\u85ac\u54c1\u306e\u88fd\u9020\u6240\u306e\u69cb\u9020\u8a2d\u5099\uff09\u3001\u85ac\u5c40\u7b49\u69cb\u9020\u8a2d\u5099\u898f\u5247\u306e\u7b2c7\u6761\uff08\u7121\u83cc\u533b\u85ac\u54c1\u306e\u69cb\u9020\u8a2d\u5099\uff09\u53ca\u3073\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b49\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6dfb\u7530\u3000\u614e\u4ecb<\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td rowspan=\"2\" class=\"column-1\">7<\/td><td rowspan=\"2\" class=\"column-2\">12\u670821\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u539f\u85ac\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c21\u6761\uff08\u539f\u85ac\u306e\u54c1\u8cea\u7ba1\u7406\uff09\u3001<br \/>\n\u7b2c22\u6761\uff08\u539f\u85ac\u306e\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u7ba1\u7406\uff09\u306e\u89e3\u8aac<br \/>\n<br \/>\nICH-Q7\uff08\u539f\u85acGMP\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\uff081\u304b\u30898\uff09\u306e\u89e3\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6dfb\u7530\u3000\u614e\u4ecb<\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-3\">ICH-Q7\uff08\u539f\u85acGMP\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\uff089\u304b\u308920\uff09\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td rowspan=\"2\" class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-20\">\n\t<td class=\"column-1\">8<\/td><td class=\"column-2\">1\u670811\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u8a8d\u5b9a\u8a66\u9a13\u3011<br \/>\n<\/td><td class=\"column-3\">\uff08\u5165\u9580\u7de8\u30fb\u57fa\u790e\u7de8\uff09\uff1a10\uff1a30\uff5e11\uff1a45<br \/>\n\uff08\u7121\u83cc\u7de8\uff09\uff1a11\uff1a55\uff5e12\uff1a15<br \/>\n\uff08\u539f\u85ac\u7de8\uff09\uff1a12\uff1a25\uff5e12\uff1a45<br \/>\n\u4ea4\u6d41\u4f1a\uff1a13\uff1a00\uff5e14\uff1a30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-119 from cache --><\/p>\n<p><strong>\u7b2c5\u671f\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u6982\u8981\uff082019\u5e741\u670818\u65e5\uff5e3\u670815\u65e5\uff09<br \/>\n<\/strong>\n<table id=\"tablepress-121\" class=\"tablepress tablepress-id-121 tbody-has-connected-cells\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">\u56de<\/th><th class=\"column-2\">\u65e5\u3000\u6642<\/th><th class=\"column-3\">\u8b1b\u5ea7\u5185\u5bb9<\/th><th class=\"column-4\">\u8b1b\u5e2b\uff1dNPO-QA\u4f1a\u54e1<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr class=\"row-2\">\n\t<td rowspan=\"5\" class=\"column-1\">1<\/td><td rowspan=\"5\" class=\"column-2\">1\u670818\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">\u958b\u8b1b\u306b\u5f53\u305f\u3063\u3066<br \/>\n<\/td><td class=\"column-4\">\u6b66\u7530\u3000\u8c4a\u5f66<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-3\">\u533b\u85ac\u54c1\u3092\u53d6\u308a\u5dfb\u304f\u6700\u8fd1\u306e\u72b6\u6cc1\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6210\u7530\u3000\u660c\u7a14<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u6539\u6b63\u306e\u8981\u70b9\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df2\u898b\u3000\u88d5<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-3\">\u627f\u8a8d\u7533\u8acb\u306e\u6982\u8981\u3068\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u7b49\u3068\u306e\u95a2\u4fc2\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df9\u898b\u3000\u6587\u9686<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-3\">GMP\u76e3\u67fb\u3068\u539f\u6599\u4f9b\u7d66\u8005\u7ba1\u7406\u306b\u3064\u3044\u3066\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df2\u898b\u3000\u88d5<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td rowspan=\"2\" class=\"column-1\">2<\/td><td rowspan=\"2\" class=\"column-2\">1\u670825\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">ICH-Q9\uff08\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u53ca\u3073ICH-Q10\uff08\u88fd\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u6982\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6728\u7d0d\u3000\u5eb7\u535a<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-3\">ICH-Q8\uff08\u88fd\u5264\u958b\u767a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306e\u6982\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u8c37\u91ce\u3000\u5fe0\u55e3<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td rowspan=\"3\" class=\"column-1\">3<\/td><td rowspan=\"3\" class=\"column-2\">2\u67081\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">\u88fd\u54c1\u54c1\u8cea\u7167\u67fb\u306e\u610f\u5473\u3068\u4e8b\u4f8b\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td class=\"column-3\">\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u88fd\u9020\u306b\u95a2\u3059\u308b\u8ab2\u984c\u3068\u7559\u610f\u70b9\uff081.5\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9234\u6728\u3000\u88d5\u4ecb<\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td class=\"column-3\">GDP\u306b\u3064\u3044\u3066\uff081.5\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-12\">\n\t<td rowspan=\"4\" class=\"column-1\">4<\/td><td rowspan=\"4\" class=\"column-2\">2\u67088\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">\u6d17\u6d44\u3001\u7a7a\u8abf\u3001\u7528\u6c34\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td class=\"column-3\">\u5206\u6790\u6cd5\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u5965\u5ddd\u3000\u9686\u653f<\/td>\n<\/tr>\n<tr class=\"row-14\">\n\t<td class=\"column-3\">\u88fd\u5264\u8a2d\u5099\u306e\u9069\u683c\u6027\u8a55\u4fa1\u306e\u4e8b\u4f8b\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7af9\u4fe3\u3000\u660c\u5229<\/td>\n<\/tr>\n<tr class=\"row-15\">\n\t<td class=\"column-3\">\u6280\u8853\u79fb\u8ee2\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9f4b\u85e4\u3000\u6cc9<\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td rowspan=\"4\" class=\"column-1\">5<\/td><td rowspan=\"4\" class=\"column-2\">2\u670814\u65e5\uff08\u6728\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0\u9069\u6b63\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7af9\u5185\u3000\u7965\u96c4<\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td class=\"column-3\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u7684\u5834\u3000\u6587\u5e73<\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td class=\"column-3\">\u9069\u5408\u6027\u8abf\u67fb\u3068\u6307\u6458\u4e8b\u4f8b\uff08\u5143\u8abf\u67fb\u54e1\u306e\u7acb\u5834\u304b\u3089\uff09\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6e05\u539f\u3000\u5b5d\u96c4<\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-3\">GMP\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc\u306b\u3064\u3044\u3066\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u4f0a\u85e4\u3000\u771f\u57fa\u592b<\/td>\n<\/tr>\n<tr class=\"row-20\">\n\t<td rowspan=\"2\" class=\"column-1\">6<\/td><td rowspan=\"2\" class=\"column-2\">2\u670822\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u7121\u83cc\u7de8\u3011<\/td><td class=\"column-3\">\u300c\u7121\u83cc\u64cd\u4f5c\u6cd5\u306b\u3088\u308b\u7121\u83cc\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u95a2\u3059\u308b\u6307\u91dd\u300d\u306e\u89e3\u8aac\uff083\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6dfb\u7530\u3000\u614e\u4ecb<\/td>\n<\/tr>\n<tr class=\"row-21\">\n\t<td class=\"column-3\">\u300c\u6700\u7d42\u6ec5\u83cc\u6cd5\u306b\u3088\u308b\u7121\u83cc\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u95a2\u3059\u308b\u6307\u91dd\u300d\u306e\u89e3\u8aac\uff082\u6642\u9593\uff09<\/td><td class=\"column-4\">\u9df2\u898b\u3000\u88d5<\/td>\n<\/tr>\n<tr class=\"row-22\">\n\t<td rowspan=\"3\" class=\"column-1\">7<\/td><td rowspan=\"3\" class=\"column-2\">3\u67081\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u539f\u85ac\u7de8\u3011<\/td><td class=\"column-3\">ICH-Q11\uff08\u539f\u85ac\u306e\u958b\u767a\u3068\u88fd\u9020\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306e\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u6e05\u539f\u3000\u5b5d\u96c4<\/td>\n<\/tr>\n<tr class=\"row-23\">\n\t<td class=\"column-3\">\u539f\u85ac\u88fd\u9020\u8a2d\u5099\u306e\u9069\u683c\u6027\u8a55\u4fa1\u306e\u4e8b\u4f8b\u89e3\u8aac\uff081\u6642\u9593\uff09<\/td><td class=\"column-4\">\u4e2d\u5d8b\u3000\u5145\u5e78<\/td>\n<\/tr>\n<tr class=\"row-24\">\n\t<td 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