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\/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u30002\u4e07\u5186\/\u540d<br \/>\n2\uff09\u300c\u5165\u9580\u7de8\u300d\uff0b\u300c\u57fa\u790e\u7de8\u300d\uff1aQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u30008\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u300012\u4e07\u5186\/\u540d<br \/>\n3\uff09\u300c\u5165\u9580\u7de8\u300d\uff0b\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u539f\u85ac\u7de8\u300d\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\u3000\u3000\u3000\u300013.5\u4e07\u5186\/\u540d<br \/>\n2. \u4e2d\u7d1a\u8005\u30af\u30e9\u30b9<br \/>\n1\uff09\u300c\u57fa\u790e\u7de8\u300d\uff1aQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u30008\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\u3000\u3000\u3000 12\u4e07\u5186\/\u540d<br \/>\n2\uff09\u300c\u57fa\u790e\u7de8\u300d\uff0b\u300c\u539f\u85ac\u7de8\u300d\uff1aQA\u30bb\u30f3\u30bf\u30fc\u6cd5\u4eba\u4f1a\u54e1\u8077\u54e1\u53ca\u3073\u500b\u4eba\u4f1a\u54e1\u3000\u3000\u30009\u4e07\u5186\/\u540d<br \/>\nQA\u30bb\u30f3\u30bf\u30fc\u975e\u4f1a\u54e1\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000 \u300013.5\u4e07\u5186\/\u540d<br \/>\n3\uff0e\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 \u30001.5\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<br \/>\n\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u3042\u308b\u3044\u306f\u4e2d\u7d1a\u30af\u30e9\u30b9\u306e\u300c\u5165\u9580\u7de8\u300d\u3001\u300c\u57fa\u790e\u7de8\u300d\u3001\u304a\u3088\u3073\uff62\u539f\u85ac\u7de8\uff63\u306e\u4e00\u90e8\u79d1\u76ee\u53d7\u8b1b\u306e\u5834\u5408\uff1a<br \/>\n3\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\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\u300cGMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u6982\u8981\uff08\u6539\u8a027\u7248\uff09\u300d\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><strong>\u8b1b\u5ea7\u306e\u6982\u8981<\/strong><br \/>\n1.\u300c\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u300d\uff1a<br \/>\n1)\u300c\u5165\u9580\u7de8\u300d\u306e\u307f\u306e\u53d7\u8b1b\u3082\u53ef\u80fd\u3067\u3059\u3002\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u8005\u306f\u300c\u5165\u9580\u7de8\u300d\u53d7\u8b1b\u3092\u5fc5\u9808\u3068\u3057\u307e\u3059\u3002\u300c\u539f\u85ac\u7de8\u300d\u53d7\u8b1b\u8005\u306f\u300c\u5165\u9580\u7de8\u300d\u3068\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u3092\u5fc5\u9808\u3068\u3057\u307e\u3059\u3002<br \/>\n2) \u8a8d\u5b9a\u8a66\u9a13\uff1a\u300c\u5165\u9580\u7de8\u300d\u306e\u307f\u306e\u53d7\u8b1b\u8005\u306b\u306f\u8a8d\u5b9a\u8a66\u9a13\u3092\u884c\u3044\u307e\u305b\u3093\u3002\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u8005\u306b\u306f\u300c\u5165\u9580\u7de8\u300d\u30fb\u300c\u57fa\u790e\u7de8\u300d\u3092\u3001\u300c\u539f\u85ac\u7de8\u300d\u53d7\u8b1b\u8005\u306b\u306f\u300c\u5165\u9580\u7de8\u300d\u30fb\u300c\u57fa\u790e\u7de8\u300d\u30fb\u300c\u539f\u85ac\u7de8\u300d\u3092\u5bfe\u8c61\u3068\u3059\u308b\u8a8d\u5b9a\u8a66\u9a13\u3092\u884c\u3044\u307e\u3059\u3002\u5408\u683c\u8005\u306b\u305d\u308c\u305e\u308c\u300c\u8a8d\u5b9a\u8a3c\u300d\u3092\u6388\u4e0e\u3057\u307e\u3059\u3002<br \/>\n2. \u300c\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u300d\uff1a<br \/>\n1)\u300c\u539f\u85ac\u7de8\u300d\u53d7\u8b1b\u8005\u306f\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u3092\u5fc5\u9808\u3068\u3057\u307e\u3059\u3002<br \/>\n2) \u8a8d\u5b9a\u8a66\u9a13\uff1a\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u8005\u306b\u306f\u300c\u57fa\u790e\u7de8\u300d\u3092\u3001\u300c\u539f\u85ac\u7de8\u300d\u53d7\u8b1b\u8005\u306b\u306f\u300c\u57fa\u790e\u7de8\u300d\u30fb\u300c\u539f\u85ac\u7de8\u300d\u3092\u5bfe\u8c61\u3068\u3059\u308b\u8a8d\u5b9a\u8a66\u9a13\u3092\u884c\u3044\u307e\u3059\u3002\u5408\u683c\u8005\u306b\u305d\u308c\u305e\u308c\u300c\u8a8d\u5b9a\u8a3c\u300d\u3092\u6388\u4e0e\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u7b2c6\u671f\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u6982\u8981\uff082017\u5e7412\u670822\u65e5\uff5e2018\u5e742\u670823\u65e5\uff09<br \/>\n<\/strong>\n<table id=\"tablepress-110\" class=\"tablepress tablepress-id-110 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=\"3\" class=\"column-1\">1<\/td><td rowspan=\"3\" class=\"column-2\">12\u670822\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u5165\u9580\u7de8\u3011<\/td><td class=\"column-3\">\u533b\u85ac\u54c1\u306e\u4fe1\u983c\u6027\u2015\u884c\u653f\u306b\u643a\u308f\u3063\u305f\u7acb\u5834\u304b\u3089\u2015<\/td><td rowspan=\"3\" class=\"column-4\">\u6210\u7530\u3000\u660c\u7a14<br \/>\n\u6b66\u7530\u3000\u8c4a\u5f66<br \/>\n\u9577\u6c5f\u3000\u6674\u7537<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-3\">\u306a\u305cGQP\/GMP\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u306e\u304b<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-3\">GQP\/GMP\u306e\u6982\u8981\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td rowspan=\"3\" class=\"column-1\">2<\/td><td rowspan=\"3\" class=\"column-2\">\uff11\u670812\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c2\u6761\u3001\u7b2c4\u6761\u304b\u3089\u7b2c6\u6761\u306e\u89e3\u8aac<\/td><td rowspan=\"3\" class=\"column-4\">\u7af9\u5185\u3000\u7965\u96c4<br \/>\n\u539f\u3000\u3000\u4fca\u82f1<br \/>\n\u85e4\u91d1\u3000\u548c\u4e00<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c7\u6761\uff08\u88fd\u54c1\u6a19\u6e96\u66f8\uff09\u306e\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c8\u6761\uff08\u624b\u9806\u66f8\uff09\u306e\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td rowspan=\"3\" class=\"column-1\">3<\/td><td rowspan=\"3\" class=\"column-2\">\uff11\u670819\u65e5\uff08\u91d1\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<\/td><td rowspan=\"3\" class=\"column-4\">\u539f\u3000\u3000\u4fca\u82f1<br \/>\n\u5965\u5ddd\u3000\u9686\u653f<br \/>\n\u4e2d\u5c71\u3000\u662d\u4e00<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c11\u6761\uff08\u54c1\u8cea\u7ba1\u7406\uff09\u306e\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-10\">\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<\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td rowspan=\"3\" class=\"column-1\">4<\/td><td rowspan=\"3\" class=\"column-2\">1\u670826\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c13\u6761\u3000\uff08\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff09\u306e\u89e3\u8aac<\/td><td rowspan=\"3\" class=\"column-4\">\u6e05\u539f\u3000\u5b5d\u96c4<br \/>\n\u8d8a\u8c37\u3000\u6e05\u4e00<br \/>\n\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-12\">\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<\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c19\u6761\uff08\u6559\u80b2\u8a13\u7df4\uff09\u306e\u89e3\u8aac<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-14\">\n\t<td rowspan=\"2\" class=\"column-1\">5<\/td><td rowspan=\"2\" class=\"column-2\">2\u67082\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<br \/>\nGMP\u7701\u4ee4\u3000\u7b2c15\u6761\uff08\u9038\u8131\u7ba1\u7406\uff09<br \/>\nGMP\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<br \/>\nGMP\u7701\u4ee4\u3000\u7b2c17\u6761\uff08\u56de\u53ce\u51e6\u7406\uff09\u306e\u89e3\u8aac<\/td><td rowspan=\"2\" class=\"column-4\">\u521d\u4ee3\u3000\u79c0\u4e00<br \/>\n\u7af9\u5185\u3000\u7965\u96c4<\/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<br \/>\nGMP\u7701\u4ee4\u3000\u7b2c20\u6761\uff08\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u7ba1\u7406\uff09<\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td rowspan=\"3\" class=\"column-1\">6<\/td><td rowspan=\"3\" class=\"column-2\">2\u67089\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u539f\u85ac\u7de8\u3011<br \/>\n<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c21\u6761\uff08\u539f\u85ac\u306e\u54c1\u8cea\u7ba1\u7406\uff09<br \/>\nGMP\u7701\u4ee4\u3000\u7b2c22\u6761\uff08\u539f\u85ac\u306e\u6587\u66f8\u53ca\u3073\u8a18\u9332\u306e\u7ba1\u7406\uff09\u306e\u89e3\u8aac<br \/>\n<\/td><td rowspan=\"3\" class=\"column-4\">\u6dfb\u7530\u3000\u613c\u4ecb<br \/>\n\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td class=\"column-3\">ICH-Q7\u300c\u539f\u85acGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\uff081\uff5e8\uff09\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td class=\"column-3\">ICH-Q7\u300c\u539f\u85acGMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\uff089\uff5e20\uff09\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-1\">7<\/td><td class=\"column-2\">2\u670823\u65e5\uff08\u91d1\uff09<br \/>\n<\/td><td class=\"column-3\">\u300c\u8a8d\u5b9a\u8a66\u9a13\u300d\uff1a\u5165\u9580\u7de8\u30fb\u57fa\u790e\u7de8\uff0810\uff1a00\uff5e11\uff1a30\uff09<br \/>\n\u300c\u8a8d\u5b9a\u8a66\u9a13\u300d\uff1a\u539f\u85ac\u7de8\uff0811\uff1a45\uff5e12\uff1a15\uff09<br \/>\n\u4ea4\u6d41\u4f1a\uff08\u7121\u6599\uff09\uff1a12\uff1a30\uff5e14\uff1a30\uff08\u5168\u53d7\u8b1b\u8005\u3001\u5168\u8b1b\u5e2b\u53c2\u52a0\uff09<\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-110 from cache --><\/p>\n<p><strong>\u7b2c4\u671f\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u6982\u8981\uff082018\u5e743\u67082\u65e5\uff5e4\u670820\u65e5\uff09<br \/>\n<\/strong>\n<table id=\"tablepress-111\" class=\"tablepress tablepress-id-111 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=\"4\" class=\"column-1\">1<\/td><td rowspan=\"4\" class=\"column-2\">3\u67082\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">\u627f\u8a8d\u7533\u8acb\u306b\u3064\u3044\u3066\u2015\u5f8c\u767a\u533b\u85ac\u54c1\u306e\u7533\u8acb\u3092\u4e2d\u5fc3\u3068\u3057\u3066\u2015<\/td><td rowspan=\"4\" class=\"column-4\">\u5965\u5ddd\u3000\u9686\u653f<br \/>\n\u9df9\u898b\u3000\u6587\u9686<br \/>\n\u9ad8\u5e73\u3000\u6b63\u884c<br \/>\n\u4eba\u898b\u3000\u82f1\u660e<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-3\">\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u7b49\u3068\u56fd\u5185\u7ba1\u7406\u4eba\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-3\">GMP\u76e3\u67fb\u3068\u539f\u6599\u4f9b\u7d66\u8005\u7ba1\u7406\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-3\">GDP\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td rowspan=\"4\" class=\"column-1\">2<\/td><td rowspan=\"4\" class=\"column-2\">3\u67089\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c8\u6761\uff08\u624b\u9806\u66f8\uff09\u306e\u4e8b\u4f8b\u89e3\u8aac<\/td><td rowspan=\"4\" class=\"column-4\">\u539f\u3000\u3000\u4fca\u82f1<br \/>\n\u8d8a\u8c37\u3000\u6e05\u4e00<br \/>\n\u521d\u4ee3\u3000\u79c0\u4e00<br \/>\n<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c10\u6761\uff08\u88fd\u9020\u7ba1\u7406\uff09\u306e\u4e8b\u4f8b\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c9\u6761\uff08\u69cb\u9020\u8a2d\u5099\uff09\u3068\u85ac\u5c40\u7b49\u8a2d\u5099\u898f\u5247\u306e\u4e8b\u4f8b\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-3\">GMP\u7701\u4ee4\u3000\u7b2c14\u6761\uff08\u5909\u66f4\u7ba1\u7406\uff09\u3068\u7b2c15\u6761\uff08\u9038\u8131\u7ba1\u7406\uff09\u306e\u4e8b\u4f8b\u89e3\u8aac<\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td rowspan=\"3\" class=\"column-1\">3<\/td><td rowspan=\"3\" class=\"column-2\">3\u670816\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u57fa\u790e\u7de8\u3011<\/td><td class=\"column-3\">ICH-Q9\u300c\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u300d\u306b\u3064\u3044\u3066<\/td><td rowspan=\"3\" class=\"column-4\">\u6728\u7d0d\u3000\u5eb7\u96c4<br \/>\n\u8c37\u91ce\u3000\u5fe0\u55e3<\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td class=\"column-3\">ICH-Q10\u300c\u88fd\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u300d\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-12\">\n\t<td class=\"column-3\">ICH-Q8\u300c\u88fd\u5264\u958b\u767a\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td rowspan=\"4\" class=\"column-1\">4<\/td><td rowspan=\"4\" class=\"column-2\">3\u670823\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<\/td><td rowspan=\"4\" class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<br \/>\n\u7af9\u4fe3\u3000\u660c\u5229<br \/>\n\u5965\u5ddd\u3000\u9686\u653f<br \/>\n\u6589\u85e4\u3000\u3000\u6cc9<\/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<\/td>\n<\/tr>\n<tr class=\"row-15\">\n\t<td class=\"column-3\">\u5206\u6790\u6cd5\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td class=\"column-3\">\u6280\u8853\u79fb\u8ee2\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td rowspan=\"4\" class=\"column-1\">5<\/td><td rowspan=\"4\" class=\"column-2\">3\u670830\u65e5\uff08\u91d1\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<\/td><td rowspan=\"4\" class=\"column-4\">\u7af9\u5185\u3000\u7965\u96c4<br \/>\n\u7684\u5834\u3000\u6587\u5e73<br \/>\n\u6e05\u539f\u3000\u5b5d\u96c4<br \/>\n\u4f0a\u85e4\u3000\u771f\u57fa\u592b<\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td class=\"column-3\">\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-3\">\u9069\u5408\u6027\u8abf\u67fb\u3068\u6307\u6458\u4e8b\u9805\uff08\u67fb\u5bdf\u5b98\u306e\u7acb\u5834\u304b\u3089\uff09\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-20\">\n\t<td class=\"column-3\">GMP\u8abf\u67fb\u3078\u306e\u5bfe\u5fdc<\/td>\n<\/tr>\n<tr class=\"row-21\">\n\t<td rowspan=\"3\" class=\"column-1\">6<\/td><td rowspan=\"3\" class=\"column-2\">4\u67086\u65e5\uff08\u91d1\uff09<br \/>\n\u3010\u539f\u85ac\u7de8\u3011<br \/>\n<\/td><td class=\"column-3\">ICH-Q11\u300c\u539f\u85ac\u306e\u958b\u767a\u3068\u88fd\u9020\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u306b\u3064\u3044\u3066<\/td><td rowspan=\"4\" class=\"column-4\">\u6e05\u539f\u3000\u5b5d\u96c4<br \/>\n\u6dfb\u7530\u3000\u613c\u4ecb<br \/>\n\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-22\">\n\t<td class=\"column-3\">\u539f\u85ac\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u4e8b\u4f8b\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-23\">\n\t<td class=\"column-3\">ICH-Q3A\u3001Q3C\u3001Q3D\u304a\u3088\u3073M7\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066<\/td>\n<\/tr>\n<tr class=\"row-24\">\n\t<td class=\"column-1\">7<\/td><td class=\"column-2\">4\u670820\u65e5\uff08\u91d1\uff09<br \/>\n<\/td><td class=\"column-3\">\u300c\u8a8d\u5b9a\u8a66\u9a13\u300d\uff1a\u57fa\u790e\u7de8\uff0810\uff1a00\uff5e11\uff1a30\uff09<br \/>\n\u300c\u8a8d\u5b9a\u8a66\u9a13\u300d\uff1a\u539f\u85ac\u7de8\uff0811\uff1a45\uff5e12\uff1a15\uff09<br \/>\n\u4ea4\u6d41\u4f1a\uff08\u7121\u6599\uff09\uff1a\uff0812\uff1a30\uff5e14\uff1a30\uff09\uff08\u5168\u53d7\u8b1b\u8005\u3001\u5168\u8b1b\u5e2b\u53c2\u52a0\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-111 from cache --><br \/>\n\u6ce8\uff1a\u8b1b\u5e2b\u306e\u90fd\u5408\u306b\u3088\u308a\u65e5\u7a0b\u304c\u5909\u66f4\u306b\u306a\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u300cGMP\u62c5\u5f53\u8005\u7814\u4fee\uff65\u8a8d\u5b9a\u8b1b\u5ea7\u300d\u306e\u6982\u8981\u3000\u6539\u8a02\uff17\u7248<br \/>\n<\/strong><\/p>\n<p>\uff11\uff0e\u8da3\u65e8\u30fb\u76ee\u7684<br \/>\n2002\u5e74\u306e\u85ac\u4e8b\u6cd5\u306e\u5168\u9762\u6539\u6b63\u306b\u3088\u308a\u3001GQP\u7701\u4ee4\u7b2c10\u6761\u3067\u306f\u3001\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u306f\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u306eGMP\u5b9f\u65bd\u72b6\u6cc1\u306e\u7ba1\u7406\u76e3\u7763\u3092\u7fa9\u52d9\u3065\u3051\u3089\u308c\u3001GMP\u7701\u4ee4\u7b2c18\u6761\u3067\u306f\u3001\u533b\u85ac\u54c1\u88fd\u9020\u696d\u8005\u306fGMP\u5b9f\u65bd\u72b6\u6cc1\u306e\u81ea\u5df1\u70b9\u691c\u3092\u7fa9\u52d9\u3065\u3051\u3089\u308c\u3066\u3044\u308b\u3002<br \/>\nGMP\u306e\u5b9f\u65bd\u306b\u3064\u3044\u3066\u306f\u3001\u7701\u4ee4\u3067\u793a\u3055\u308c\u305f\u8da3\u65e8\u3092\u9075\u5b88\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304c\u3001\u305d\u306e\u5bfe\u5fdc\u306f\u3001\u300c\u3042\u308b\u3079\u304d\u59ff\u300d\u3092\u76ee\u6307\u3057\u306a\u304c\u3089\u3001\u305d\u308c\u305e\u308c\u306e\u88fd\u9020\u6240\u306e\u72b6\u6cc1\u7b49\u3092\u8e0f\u307e\u3048\u305f\u4e0a\u3067\u5408\u7406\u7684\u304b\u3064\u52b9\u7387\u7684\u306b\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u306f\u3044\u3046\u307e\u3067\u3082\u306a\u3044\u3002<br \/>\n\u3057\u304b\u3057\u306a\u304c\u3089\u3001\u7701\u4ee4\u306e\u8da3\u65e8\u306e\u89e3\u91c8\u306a\u3069\u306b\u95a2\u3059\u308b\u5404\u4f01\u696d\u306eGMP\u62c5\u5f53\u8005\u306e\u77e5\u8b58\u30fb\u7d4c\u9a13\u306a\u3069\u306e\u4e0d\u8db3\u306b\u3088\u308a\u3001\u304b\u306a\u3089\u305a\u3057\u3082\u5408\u7406\u7684\u304b\u3064\u52b9\u7387\u7684\u306a\u5bfe\u5fdc\u304c\u306a\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u304c\u307f\u3089\u308c\u308b\u3088\u3046\u3067\u3042\u308b\u3002<br \/>\n\u3053\u308c\u306f\u3001GMP\u62c5\u5f53\u8005\u3078\u306e\u7d4c\u9a13\u30fb\u77e5\u8b58\u306e\u7d99\u627f\u304c\u5186\u6ed1\u3067\u306a\u304b\u3063\u305f\u308a\u3001\u59d4\u53d7\u8a17\u306e\u6025\u62e1\u5927\u30fb\u65b0\u898f\u53c2\u5165\u306a\u3069\u306e\u6d41\u308c\u306e\u4e2d\u3067\u3001GMP\u62c5\u5f53\u8005\u306e\u6559\u80b2\u8a13\u7df4\u304c\u5fc5\u305a\u3057\u3082\u5145\u5206\u3067\u306a\u304b\u3063\u305f\u308a\u3059\u308b\u5834\u5408\u304c\u3042\u308b\u3053\u3068\u306a\u3069\u304c\u539f\u56e0\u3068\u8003\u3048\u3089\u308c\u308b\u3002<br \/>\n\u3053\u306e\u305f\u3081\u3001GMP\u62c5\u5f53\u8005\u3078\u306eON THE JOB\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30fb\u6559\u80b2\u8a13\u7df4\u306b\u52a0\u3048\u3001GMP\u5bfe\u5fdc\u7d4c\u9a13\u8005\u306b\u3088\u308b\u7d4c\u9a13\u30fb\u77e5\u8b58\u306e\u7d99\u627f\u3001\u7cfb\u7d71\u7684\u30fb\u52b9\u7387\u7684\u306a\u7814\u4fee\u306e\u5834\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u3002<br \/>\nNPO-QA\u30bb\u30f3\u30bf\u30fc\u3067\u306f\u3001\u5f93\u6765\u304b\u3089GMP\u5bfe\u5fdc\u306b\u95a2\u3059\u308b\u5f53\u9762\u306e\u8ab2\u984c\u3092\u4e2d\u5fc3\u3068\u3059\u308b\u5b9f\u8df5\u7684\u306a\u89e3\u8aac\u30fb\u4e8b\u4f8b\u7d39\u4ecb\u306a\u3069\u3092\u884c\u3063\u3066\u304d\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u5b9f\u7e3e\u3092\u57fa\u306b\u3001GMP\u5bfe\u5fdc\u7d4c\u9a13\u8005\u306b\u3088\u308b\u7d4c\u9a13\u30fb\u77e5\u8b58\u306e\u7d99\u627f\u3092\u542b\u3081\u3001\u7cfb\u7d71\u7684\u30fb\u52b9\u7387\u7684\u306b\u7814\u4fee\u3059\u308b\u5834\u3092\u63d0\u4f9b\u3057\u3001\u7814\u4fee\u5f8c\u306e\u8a66\u9a13\u306b\u3088\u308a\u5408\u683c\u8005\u3078\u8a8d\u5b9a\u8a3c\u3092\u767a\u884c\u3059\u308b\u3053\u3068\u3092\u4f01\u753b\u3057\u305f\u3002<br \/>\n\u3053\u306e\u4f01\u753b\u306b\u3088\u308a\u3001GMP\u62c5\u5f53\u8005\u306e\u80fd\u529b\u5411\u4e0a\u3001\u30ec\u30d9\u30eb\u306e\u5747\u4e00\u5316\u3092\u56f3\u308b\u3068\u5171\u306b\u3001\u5ba2\u89b3\u7684\u8a55\u4fa1\u306b\u3088\u308bGMP\u62c5\u5f53\u8005\u306e\u8cc7\u683c\u306e\u78ba\u7acb\u306b\u8ca2\u732e\u3057\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u308b\u3002<br \/>\nGMP\u306f\u9069\u7528\u5bfe\u8c61\u304c\u5e83\u304f\u3001\u95a2\u9023\u6cd5\u898f\u985e\u3082\u591a\u3044\u3053\u3068\u304b\u3089\u3001GMP\u62c5\u5f53\u8005\u306e\u62c5\u5f53\u7bc4\u56f2\u304c\u5e83\u304f\u306a\u308b\u307b\u3069\u3001\u9ad8\u5ea6\u306e\u77e5\u898b\u3084\u8c4a\u5bcc\u306a\u7d4c\u9a13\u304c\u6c42\u3081\u3089\u308c\u308b\u3053\u3068\u306b\u306a\u308b\u3002<br \/>\n\u3053\u306e\u305f\u3081\u3001\u4eca\u56de\u4f01\u753b\u306e\u300cGMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\u300d\uff08\u4ee5\u4e0b\u3001\u300cGMP\u8a8d\u5b9a\u8b1b\u5ea7\u300d\u3068\u3044\u3046\u3002\uff09\u3067\u306f\u3001\u521d\u7d1a\u8005\u3001\u4e2d\u7d1a\u8005\u3001\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\u306b\u5206\u3051\u308b\u3068\u3068\u3082\u306b\u3001GMP\u7701\u4ee4\u306e\u7b2c1\u6761-\u7b2c20\u6761\uff08\u539f\u85ac\u30fb\u88fd\u5264\u30fb\u5305\u88c5\u30fb\u7121\u83cc\u533b\u85ac\u54c1\u7b49\u306b\u5171\u901a\uff09\u3001\u7b2c21\u6761\uff0d22\u6761\uff08\u539f\u85ac\uff09\u3001\u7b2c23\u6761-\u7b2c25\u6761\uff08\u7121\u83cc\u533b\u85ac\u54c1\uff09\u306a\u3069\u306e\u533a\u5206\u3054\u3068\u306e\u8b1b\u5ea7\u3068\u3059\u308b\u3053\u3068\u3068\u3057\u305f\u3002<br \/>\n\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u300cGMP\u7701\u4ee4\u7b49\u306e\u6cd5\u898f\u985e\u306e\u7528\u8a9e\u3001\u5185\u5bb9\u3092\u6b63\u3057\u304f\u7406\u89e3\u30fb\u89e3\u91c8\u3057\u3001GMP\u95a2\u9023\u6587\u66f8\u985e\u3084GMP\u5bfe\u5fdc\u69cb\u9020\u8a2d\u5099\u306a\u3069\u306b\u3064\u3044\u3066\u3001GMP\u898f\u5236\u306b\u9069\uff65\u4e0d\u9069\u306e\u5224\u65ad\u3092\u4e0b\u3057\u5f97\u308b\u80fd\u529b\u306e\u990a\u6210\u3002\u300d\u3068\u3059\u308b\u3002<br \/>\n\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u300cGMP\u95a2\u9023\u6587\u66f8\u985e\u4f5c\u6210\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5b9f\u65bd\u304a\u3088\u3073GMP\u5bfe\u5fdc\u69cb\u9020\u8a2d\u5099\u306e\u69cb\u7bc9\u306b\u969b\u3057\u3001GMP\u5bfe\u5fdc\u306b\u95a2\u3057\u3066\u6307\u5c0e\u3067\u304d\u308b\u80fd\u529b\u306e\u990a\u6210\u3002\u540c\u6642\u306bICH\u3001PIC\/S\u306a\u3069\u56fd\u969b\u7684\u306aGMP\u95a2\u9023\u898f\u5236\u985e\u306e\u77e5\u8b58\u3092\u7fd2\u5f97\u3059\u308b\u3053\u3068\u3002\u300d\u3068\u3059\u308b\u3002<br \/>\n\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u300c\u56fd\u5185\u5916\u306e\u88fd\u85ac\u4f01\u696d\u306eGMP\u9069\u5408\u6027\u78ba\u8a8d\u3068\u6307\u5c0e\u696d\u52d9\u306b\u3064\u3044\u3066\u3001\u8cac\u4efb\u8005\u30af\u30e9\u30b9\u3092\u52d9\u3081\u5f97\u308b\u80fd\u529b\u306e\u990a\u6210\u3002\u300d\u3068\u3059\u308b\u3002<br \/>\n\u306a\u304a\u3001GMP\u8a8d\u5b9a\u8b1b\u5ea7\u306b\u304a\u3051\u308bGMP\u62c5\u5f53\u8005\u3068\u306f\u3001\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u696d\u8005\u3001\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u95a2\u9023\u4f01\u696d\u3001\u3055\u3089\u306b\u306f\u5927\u5b66\u30fb\u7814\u7a76\u6a5f\u95a2\u306b\u304a\u3044\u3066\u3001\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\uff08GMP\u7701\u4ee4\uff09\u3084\u95a2\u9023\u3059\u308b\u7701\u4ee4\u30fb\u898f\u5247\u30fb\u901a\u77e5\u985e\uff08\u3053\u308c\u3089\u3092\u7dcf\u79f0\u3057\u3066\u3001GMP\u6cd5\u898f\u985e\u3068\u3044\u3046\u3002\uff09\u306e\u9069\u7528\u30fb\u904b\u7528\u7b49\u306b\u4fc2\u308f\u308b\u8005\u3001\u307e\u305f\u306f\u9069\u7528\u30fb\u904b\u7528\u306b\u4fc2\u308f\u308b\u8005\u306e\u6559\u80b2\u30fb\u6307\u5c0e\u7b49\u306b\u4fc2\u308f\u308b\u8005\u3092\u3044\u3046\u3002<\/p>\n<p>\uff12\uff0e\u904b\u55b6\u7d44\u7e54<br \/>\n\uff11\uff09GMP\u8a8d\u5b9a\u8b1b\u5ea7\u306f\u3001NPO\u2010QA\u30bb\u30f3\u30bf\u30fc\u306e\u7406\u4e8b\u4f1a\u306b\u6240\u5c5e\u3059\u308b\u300c\u54c1\u8cea\u4fdd\u8a3c\u59d4\u54e1\u4f1a\u300d\u304c\u5f53\u30bb\u30f3\u30bf\u30fc\u306e\u4e8b\u52d9\u5c40\u306e\u652f\u63f4\u306e\u57fa\u3067\u904b\u55b6\u3059\u308b\u3002<br \/>\n\uff12\uff09GMP\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u8b1b\u5e2b\u306f\u3001\u4ee5\u4e0b\u306e\u30a4\u306e\u9805\u306b\u9069\u3059\u308b\u8005\u3067\u3001\u30ed\u3001\u30cf\u306e\u9805\u306b\u5f93\u3046\u3053\u3068\u3002<br \/>\n\u30a4\u3000\u884c\u653f\u304a\u3088\u3073\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u8ca9\u58f2\u696d\u304a\u3088\u3073\u88fd\u9020\u696d\u4f01\u696d\u3001\u3042\u308b\u3044\u306f\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306e\u95a2\u9023\u4f01\u696d\u7b49\u3067\u3001GMP\u62c5\u5f53\u8005\u3068\u3057\u3066\u306e\u8c4a\u5bcc\u306a\u696d\u52d9\u7d4c\u9a13\u304c\u3042\u308a\u3001\u304b\u3064\u300c\u54c1\u8cea\u4fdd\u8a3c\u59d4\u54e1\u4f1a\u300d\u304c\u9069\u5f53\u3068\u8a8d\u3081\u305f\u8005\u3002<br \/>\n\u30ed\u3000\u8b1b\u5e2b\u3092\u52d9\u3081\u308b\u8b1b\u5ea7\u306e\u958b\u8b1b\u524d\u306b\u3001\u8b1b\u5e2b\u76f8\u4e92\u306b\u3088\u308b\u7814\u4fee\u3092\u53d7\u8b1b\u3059\u308b\u3053\u3068\u3002<br \/>\n\u30cf\u3000\u8b1b\u5e2b\u306f\u3001\u62c5\u5f53\u3059\u308b\u8b1b\u5ea7\u306e\u6559\u6750\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3002\u4ed6\u306e\u8b1b\u5e2b\u304c\u4f5c\u6210\u3057\u305f\u6559\u6750\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u308b\u304c\u3001\u3053\u306e\u5834\u5408\u306f\u3001\u4f5c\u6210\u8005\u304b\u3089\u306e\u5341\u5206\u306a\u8aac\u660e\uff65\u5f15\u304d\u7d99\u304e\u3092\u53d7\u3051\u308b\u3053\u3068\u3002<\/p>\n<p>\uff13\uff0eGMP\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u4f53\u7cfb\u3068\u30ab\u30ea\u30ad\u30e5\u30e9\u30e0<br \/>\n\uff11\uff09GMP\u8a8d\u5b9a\u8b1b\u5ea7\u306f\u3001\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u3001\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u3001\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\u3054\u3068\u306b\u958b\u8b1b\u3059\u308b\u3002<br \/>\n\uff12\uff09\u8b1b\u5ea7\u306e\u7a2e\u985e\u3068\u3057\u3066\u306f\u3001\u5f53\u9762\u3001\u300c\u5165\u9580\u7de8\u300d\u3001\u300c\u57fa\u790e\u7de8\u300d\u3001\u300c\u539f\u85ac\u7de8\u300d\u3001\u3068\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u65b0\u898f\u8b1b\u5ea7\u3092\u8a2d\u7acb\u3059\u308b\u3002<br \/>\n\u300c\u5165\u9580\u7de8\u300d\u3068\u306f\u3001\u300c\u57fa\u790e\u7de8\u300d\u306e\u7406\u89e3\u306b\u5fc5\u8981\u306a\u8003\u3048\u65b9\u3084\u57fa\u672c\u7684\u306a\u77e5\u8b58\u3092\u5f97\u308b\u305f\u3081\u306e\u8b1b\u5ea7\u3068\u3059\u308b\u3002<br \/>\n\u300c\u57fa\u790e\u7de8\u300d\u3068\u306f\u3001GMP\u7701\u4ee4\u7b2c1\u6761\u304b\u3089\u7b2c20\u6761\u3084\u95a2\u9023\u3059\u308bGQP\u7701\u4ee4\u3084ICH\u3084PIC\/S\u306eGMP\u306a\u3069\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u95a2\u3059\u308b\u8b1b\u5ea7\u3068\u3059\u308b\u3002<br \/>\n\u300c\u539f\u85ac\u7de8\u300d\u3068\u306f\u3001GMP\u7701\u4ee4\u7b2c21\uff0d22\u6761\u3084PIC\/S-GMP\u306e\u30d1\u30fc\u30c82\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3082\u3042\u308bICHQ7\u300c\u539f\u85acGMP\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u3001\u307e\u305fICHQ11\u300c\u539f\u85ac\u306e\u958b\u767a\u3068\u88fd\u9020\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u306a\u3069\u306b\u95a2\u3059\u308b\u8b1b\u5ea7\u3068\u3059\u308b\u3002<br \/>\n\uff13\uff09\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u3068\u306f\u3001GMP\u7701\u4ee4\u7b49\u306e\u6cd5\u898f\u985e\u306e\u7528\u8a9e\u3001\u5185\u5bb9\u3092\u6b63\u3057\u304f\u7406\u89e3\u30fb\u89e3\u91c8\u3057\u3001GMP\u95a2\u9023\u6587\u66f8\u985e\u3084GMP\u5bfe\u5fdc\u69cb\u9020\u8a2d\u5099\u306a\u3069\u306b\u3064\u3044\u3066\u3001GMP\u898f\u5236\u306b\u9069\uff65\u4e0d\u9069\u306e\u5224\u65ad\u3092\u4e0b\u3057\u5f97\u308b\u80fd\u529b\u306e\u990a\u6210\u3092\u4e3b\u305f\u308b\u76ee\u7684\u3068\u3059\u308b\u30af\u30e9\u30b9\u3092\u3044\u3046\u3002<br \/>\n\uff14\uff09\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u3068\u306f\u3001GMP\u95a2\u9023\u6587\u66f8\u985e\u4f5c\u6210\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5b9f\u65bd\u304a\u3088\u3073GMP\u5bfe\u5fdc\u69cb\u9020\u8a2d\u5099\u306e\u69cb\u7bc9\u306b\u969b\u3057\u3001GMP\u5bfe\u5fdc\u306b\u95a2\u3057\u3066\u6307\u5c0e\u3067\u304d\u308b\u80fd\u529b\u306e\u990a\u6210\u3002\u540c\u6642\u306bICH\u3001PIC\/S\u306a\u3069\u56fd\u969b\u7684\u306aGMP\u95a2\u9023\u898f\u5236\u985e\u306e\u77e5\u8b58\u3092\u7fd2\u5f97\u3059\u308b\u3053\u3068\u3092\u4e3b\u305f\u308b\u76ee\u7684\u3068\u3059\u308b\u30af\u30e9\u30b9\u3092\u3044\u3046\u3002<br \/>\n\uff15\uff09\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\u3068\u306f\u3001\u56fd\u5185\u5916\u306e\u88fd\u85ac\u4f01\u696d\u306eGMP\u9069\u5408\u6027\u78ba\u8a8d\u3068\u6307\u5c0e\u696d\u52d9\u306b\u3064\u3044\u3066\u3001\u8cac\u4efb\u8005\u30af\u30e9\u30b9\u3092\u52d9\u3081\u5f97\u308b\u80fd\u529b\u306e\u990a\u6210\u3092\u4e3b\u305f\u308b\u76ee\u7684\u3068\u3059\u308b\u30af\u30e9\u30b9\u3092\u3044\u3046\u3002<br \/>\n\uff16\uff09\u300c\u5165\u9580\u7de8\u300d\u306e\u307f\u306e\u53d7\u8b1b\u3092\u8a8d\u3081\u308b\u3002\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u8005\u306f\u300c\u5165\u9580\u7de8\u300d\u53d7\u8b1b\u3092\u5fc5\u9808\u3068\u3059\u308b\u3002<br \/>\n\u300c\u539f\u85ac\u7de8\u300d\u53d7\u8b1b\u8005\u306f\u300c\u5165\u9580\u7de8\u300d\u304a\u3088\u3073\u300c\u57fa\u790e\u7de8\u300d\u53d7\u8b1b\u3092\u5fc5\u9808\u3068\u3059\u308b\u3002<br \/>\n\uff17\uff09\u30ab\u30ea\u30ad\u30e5\u30e9\u30e0<br \/>\n\u30a4\u3000\u521d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u53d7\u8b1b\u8005\u306b\u914d\u5e03\u3059\u308b\u300c\u30c6\u30ad\u30b9\u30c8\u300d\u3092\u53c2\u7167\u306e\u3053\u3068\u3002<br \/>\n\u30ed\u3000\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u53d7\u8b1b\u8005\u306b\u914d\u5e03\u3059\u308b\u300c\u30c6\u30ad\u30b9\u30c8\u300d\u3092\u53c2\u7167\u306e\u3053\u3068\u3002<br \/>\n\u30cf\u3000\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u691c\u8a0e\u4e2d\u3002<\/p>\n<p>\uff14\uff0e\u53d7\u8b1b\u8005\u306e\u8cc7\u683c\u8981\u4ef6<br \/>\n\uff11\uff09\u521d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u5236\u9650\u3092\u8a2d\u3051\u306a\u3044\u3002<br \/>\n\uff12\uff09\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u5236\u9650\u3092\u8a2d\u3051\u306a\u3044\u3002<br \/>\n\uff13\uff09\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\uff1a\u691c\u8a0e\u4e2d\u3002<\/p>\n<p>\uff15\uff0e\u8a8d\u5b9a\u8a66\u9a13\u3001\u53d7\u9a13\u8cc7\u683c\u304a\u3088\u3073\u8a8d\u5b9a\u8a3c<br \/>\n\uff11\uff09\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u8a8d\u5b9a\u8a66\u9a13\u306f\u3001\u6240\u5b9a\u306e\u8b1b\u5ea7\u4fee\u4e86\u5f8c\u3001\u53d7\u9a13\u8cc7\u683c\u3092\u6e80\u305f\u3059\u3082\u306e\u3092\u5bfe\u8c61\u306b\u5b9f\u65bd\u3059\u308b\u3002\u8a66\u9a13\u554f\u984c\u5f62\u5f0f\u306f\u8907\u6570\u56de\u7b54\u304b\u3089\u306e\u9078\u629e\u65b9\u5f0f\u3068\u3057\u3001\u8a66\u9a13\u554f\u984c\u306e\u6301\u3061\u5e30\u308a\u306f\u3067\u304d\u306a\u3044\u3002<br \/>\n\uff12\uff09\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u8a8d\u5b9a\u8a66\u9a13\u306f\u3001\u521d\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u5834\u5408\u3068\u540c\u69d8\u3068\u3059\u308b\u3002<br \/>\n\uff13\uff09\u4e0a\u7d1a\u8005\u30af\u30e9\u30b9\u306e\u8a8d\u5b9a\u8a66\u9a13\u306b\u3064\u3044\u3066\u306f\u3001\u691c\u8a0e\u4e2d\u3002<br \/>\n\uff14\uff09\u8a8d\u5b9a\u8a66\u9a13\u306f\u3001\u300c\u5165\u9580\u7de8\u300d\u306e\u307f\u306e\u53d7\u8b1b\u8005\u306b\u306f\u884c\u308f\u306a\u3044\u304c\u3001\u300c\u57fa\u790e\u7de8\u300d\u3001\u300c\u539f\u85ac\u7de8\u300d\u3054\u3068\u306b\u5b9f\u65bd\u3059\u308b\u3002\u8a73\u7d30\u306f\u3001\u5225\u9014\u5b9a\u3081\u308b\u3002<br \/>\n\uff15\uff09\u8a8d\u5b9a\u8a66\u9a13\u306e\u7d50\u679c\u306f\u8a66\u9a13\u5f8c\u539f\u52477\u65e5\u4ee5\u5185\u306b\u53d7\u9a13\u8005\u306b\u90f5\u4fbf\u3067\u9001\u9054\u3059\u308b\u3002<br \/>\n\uff16\uff09\u7b2c1\u56de\u76ee\u306e\u8a8d\u5b9a\u8a66\u9a13\u306e\u4e0d\u5408\u683c\u8005\u306e\u305f\u3081\u3001\u5f53\u8a72\u8a66\u9a13\u5f8c\uff14\u9031\u9593\u7a0b\u5ea6\u4ee5\u5185\u306b\u518d\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3002\u518d\u8a66\u9a13\u65e5\u306b\u3064\u3044\u3066\u306f\u3001\u53d7\u9a13\u8005\u306e\u90fd\u5408\u3092\u8003\u616e\u3059\u308b\u3002<br \/>\n\uff17\uff09\u7b2c1\u56de\u76ee\u306e\u8a8d\u5b9a\u8a66\u9a13\u306e\u4e0d\u5408\u683c\u8005\u306e\u305f\u3081\u306e\u8b1b\u5ea7\u304a\u3088\u3073\u518d\u518d\u8a66\u9a13\u306f\u5b9f\u65bd\u3057\u306a\u3044\u3002\u306a\u304a\u3001\u7b2c1\u56de\u76ee\u306e\u8a8d\u5b9a\u8a66\u9a13\u3092\u3084\u3080\u3092\u5f97\u305a\u53d7\u9a13\u3067\u304d\u306a\u3044\u8005\u3082\u518d\u8a66\u9a13\u3092\u53d7\u9a13\u3067\u304d\u308b\u3002<br \/>\n\uff18\uff09\u53d7\u9a13\u8cc7\u683c\uff1a\u3044\u305a\u308c\u306e\u30af\u30e9\u30b9\u3082\u5f53\u8a72\u8b1b\u5ea7\u6642\u9593\u306e\u51fa\u5e2d\u738760\uff05\u4ee5\u4e0a\u306e\u8005\u3068\u3059\u308b\u3002<br \/>\n\uff19\uff09\u5408\u5426\u5224\u5b9a\u57fa\u6e96\u306f\u3001\u8a8d\u5b9a\u8a66\u9a13\u8a55\u4fa1\u30fb\u5224\u5b9a\u59d4\u54e1\u4f1a\u3067\u5225\u9014\u5b9a\u3081\u308b\u3002<br \/>\n10\uff09\u8a8d\u5b9a\u8a66\u9a13\u306b\u5408\u683c\u3057\u305f\u8005\u306b\u5bfe\u3057\u3001\u8a72\u5f53\u3059\u308b\u30af\u30e9\u30b9\u306e\u300c\u8a8d\u5b9a\u8a3c\u300d\u3092\u4ea4\u4ed8\u3059\u308b\u3002<\/p>\n<p>\uff16\uff0e\u8a8d\u5b9a\u8a3c\u306e\u6709\u52b9\u671f\u9593\u3068\u66f4\u65b0\u6761\u4ef6<br \/>\n\uff11\uff09\u8a8d\u5b9a\u8a3c\u306e\u6709\u52b9\u671f\u9593\u306f\u8a8d\u5b9a\u8a3c\u4ea4\u4ed8\u65e5\u3088\u308a5\u30b1\u5e74\u3068\u3059\u308b\u3002<br \/>\n\uff12\uff09\u8a8d\u5b9a\u8a3c\u306e\u6709\u52b9\u671f\u9593\u306e\u7d42\u4e86\u306b\u4f34\u3046\u66f4\u65b0\u306e\u6761\u4ef6\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3002<br \/>\n\u30a4\u3000\u6709\u52b9\u671f\u95935\u30ab\u5e74\u9593\u5185\u306b\u3001NPO-QA\u30bb\u30f3\u30bf\u30fc\u304c\u958b\u50ac\u3059\u308bGMP\u95a2\u9023\u306e\u8b1b\u7fd2\u4f1a\u3001\u8b1b\u6f14\u4f1a\u53ca\u3073GMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u4e00\u90e8\u30925\u56de\u4ee5\u4e0a\u53d7\u8b1b\u3059\u308b\u3053\u3068\u3002\u3053\u306e5\u56de\u306e\u51853\u56de\u306f\u6709\u52b9\u671f\u9593\u7d42\u4e86\u76f4\u8fd1\u306e3\u30b1\u5e74\u9593\u5185\u306e\u8b1b\u7fd2\u4f1a\u3001\u8b1b\u6f14\u4f1a\u3067\u3042\u308b\u3053\u3068\u3002<br \/>\n\u30ed\u3000\u305d\u306e\u4ed6\u3001\u7279\u5225\u306e\u7406\u7531\u304c\u3042\u308a\u3001\u54c1\u8cea\u4fdd\u8a3c\u59d4\u54e1\u4f1a\u304c\u8a8d\u3081\u305f\u5834\u5408\u3002<br \/>\n\u30cf\u3000\u8a8d\u5b9a\u8a3c\u53d6\u5f97\u8005\u306b\u306f\u3001\u66f4\u65b0\u6642\u671f\u306b\u8fd1\u3065\u3044\u305f\u6642\u70b9\u3067NPO-QA\u30bb\u30f3\u30bf\u30fc\u304b\u3089\u66f4\u65b0\u5e0c\u671b\u306e\u6709\u7121\u7b49\u306b\u3064\u3044\u3066\u9023\u7d61\u3059\u308b\u3002<br \/>\n\u30cb\u3000\u66f4\u65b0\u306f1\u56de\u9650\u308a\u3068\u3059\u308b\u3002<\/p>\n<p>\uff17\uff0e\u8cbb\u7528\u7b49\u306b\u3064\u3044\u3066<br \/>\n\uff11\uff09GMP\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u958b\u8b1b\u306b\u3068\u3082\u306a\u3046\u8af8\u8cbb\u7528\u304a\u3088\u3073\u8a8d\u5b9a\u8a3c\u66f4\u65b0\u306e\u305f\u3081\u306e\u8cbb\u7528\u7b49\u306b\u3064\u3044\u3066\u306f\u3001NPO-QA\u30bb\u30f3\u30bf\u30fc\u4e8b\u52d9\u5c40\u304c\u5225\u9014\u5b9a\u3081\u308b\u3002<br \/>\n\uff12\uff09\u8a8d\u5b9a\u8a3c\u53d6\u5f97\u8005\u306b\u5bfe\u3059\u308bNPO-QA\u30bb\u30f3\u30bf\u30fc\u4e3b\u50ac\u884c\u4e8b\u53c2\u52a0\u512a\u9047\u63aa\u7f6e\u7b49\u306b\u3064\u3044\u3066\u306f\u3001NPO-QA\u30bb\u30f3\u30bf\u30fc\u4e8b\u52d9\u5c40\u304c\u5225\u9014\u5b9a\u3081\u308b\u3002<\/p>\n<p><strong>\u4e3b\u3000\u50ac<br \/>\n<\/strong><br \/>\n\u7279\u5b9a\u975e\u55b6\u5229\u6d3b\u52d5\u6cd5\u4eba<br \/>\n\u533b\u85ac\u54c1\u30fb\u98df\u54c1\u54c1\u8cea\u4fdd\u8a3c\u652f\u63f4\u30bb\u30f3\u30bf\u30fc\uff08\u7565\u79f0\uff1aNPO-QA\u30bb\u30f3\u30bf\u30fc\uff09<br \/>\n\u3012540-0026 \u5927\u962a\u5e02\u4e2d\u592e\u533a\u5185\u672c\u753a1-4-12\u30003\u968e<br \/>\nE-mail\uff1anpo-qa@galaxy.ocn.ne.jp\u3000\/\u3000TEL 06-6910-1455\/FAX 06-6910-1456<\/p>\n<p><strong>\u7533\u3000\u8fbc<br \/>\n<\/strong><br \/>\n\u300e\u7b2c6\u671f GMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\uff08\u5165\u9580\u7de8\u30fb\u57fa\u790e\u7de8\u30fb\u539f\u85ac\u7de8\u3001\u521d\u7d1a\u8005\u30af\u30e9\u30b9\uff09\u3001\u7b2c4\u671fGMP\u62c5\u5f53\u8005\u7814\u4fee\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\uff08\u57fa\u790e\u7de8\u30fb\u539f\u85ac\u7de8\u3001\u4e2d\u7d1a\u8005\u30af\u30e9\u30b9\uff09\u300f\u306e\u7533\u3057\u8fbc\u307f\u306f\u4ee5\u4e0b\u306e\u65b9\u6cd5\u306b\u3066\u7533\u3057\u8fbc\u307f\u304f\u3060\u3055\u3044\u3002<\/p>\n<p>1)\u4ee5\u4e0b\u30ea\u30f3\u30af\u304b\u3089\u53c2\u52a0\u7533\u8fbc\u66f8\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u3066FAX\u304b\u3089\u306e\u7533\u8fbc\u307f<br \/>\n<a href=\"https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2017\/09\/1498a5f2aa97f2942386c9160f71baf4.docx\">\u7b2c6\u671f\u521d\u7d1a\u8005\u304a\u3088\u3073\u7b2c4\u671f\u4e2d\u7d1a\u8005\u8a8d\u5b9a\u8b1b\u5ea7\u306e\u53c2\u52a0\u7533\u3057\u8fbc\u307f\u7528FAX\u7528\u7d19\uff08170909\uff09<\/a><br \/>\n<a 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