{"id":1760,"date":"2017-12-11T15:03:53","date_gmt":"2017-12-11T06:03:53","guid":{"rendered":"https:\/\/npo-qa.jp\/wordpress\/?p=1760"},"modified":"2019-09-02T13:50:35","modified_gmt":"2019-09-02T04:50:35","slug":"%e5%89%b5%e7%ab%8b14%e5%91%a8%e5%b9%b4%e3%82%bb%e3%83%9f%e3%83%8a%e3%83%bc%e3%81%ae%e3%81%94%e6%a1%88%e5%86%85","status":"publish","type":"post","link":"https:\/\/npo-qa.jp\/wordpress\/2017\/12\/11\/%e5%89%b5%e7%ab%8b14%e5%91%a8%e5%b9%b4%e3%82%bb%e3%83%9f%e3%83%8a%e3%83%bc%e3%81%ae%e3%81%94%e6%a1%88%e5%86%85\/","title":{"rendered":"\u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u306e\u3054\u6848\u5185"},"content":{"rendered":"<p>  \u8b39\u5553<br \/>\n\u3000\u5e73\u7d20\u306f\u683c\u5225\u306e\u304a\u5f15\u304d\u7acb\u3066\u3092\u3044\u305f\u3060\u304d\u3001\u539a\u304f\u5fa1\u793c\u7533\u3057\u4e0a\u3052\u307e\u3059\u3002<br \/>\n\u3000NPO-QA\u30bb\u30f3\u30bf\u30fc\u306f\u7686\u69d8\u306e\u3054\u652f\u63f4\u306b\u3088\u308a\u3001\u5275\u7acb14\u5468\u5e74\u3092\u8fce\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002<br \/>\n\u3000\u4f8b\u5e74\u901a\u308aNPO-QA\u30bb\u30f3\u30bf\u30fc\u3067\u306f\u300c\u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u300d\u3092\u4e0b\u8a18\u8981\u9818\u3067\u958b\u50ac\u3044\u305f\u3057\u307e\u3059\u3002<br \/>\n\u3000\u662f\u975e\u3054\u53c2\u52a0\u9802\u304d\u307e\u3059\u3088\u3046\u3054\u6848\u5185\u7533\u3057\u4e0a\u3052\u307e\u3059\u3002<\/p>\n<p><strong>\u3054\u6848\u5185<\/strong><\/p>\n<hr>\n<p>\u65e5\u3000\u7a0b \uff1a \u5927\u962a\u4f1a\u5834\u30002018\u5e742\u670816\u65e5\uff08\u91d1\uff09\u3000\u3000\u6771\u4eac\u4f1a\u5834\u30002018\u5e743\u67087\u65e5\uff08\u6c34\uff09<br \/>\n\u6642\u3000\u9593 \uff1a 10\uff1a20\uff5e16\uff1a20\u3000\uff08\u53d7\u4ed8\u958b\u59cb\uff1a9\uff1a50\uff5e\uff09<br \/>\n\u4f1a\u3000\u5834 \uff1a \uff08\u5927\u962a\uff09\u5927\u962a\u7523\u696d\u5275\u9020\u9928\u30004\u968e\u3000\u30a4\u30d9\u30f3\u30c8\u30db\u30fc\u30eb\u3000<br \/>\n\u3000\u3000\u3000 \u3000 \uff08\u6771\u4eac\uff09\u54c1\u5ddd\u533a\u7acb\u7dcf\u5408\u533a\u6c11\u4f1a\u9928\uff08\u304d\u3085\u308a\u3042\u3093\uff09\u5c0f\u30db\u30fc\u30eb<br \/>\n\u53c2\u52a0\u6599 \uff1a NPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\u3000\uff08\u500b\u4eba\u4f1a\u54e1\u53ca\u3073\u6cd5\u4eba\u4f1a\u54e1\u4f1a\u793e\u8077\u54e1\uff09\u30005,000\u5186<br \/>\n\u3000 \u3000 \u3000    NPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\u4ee5\u5916\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u30008,000\u5186\u3000<br \/>\n\u3000\u3000\u3000\u3000\u3000\u3010\u53c2\u52a0\u6599\u306f\u5f53\u65e5\u4f1a\u5834\u306e\u53d7\u4ed8\u306b\u3066\u304a\u652f\u6255\u9858\u3044\u307e\u3059\u3011<br \/>\n\u5b9a\u3000\u54e1 \uff1a 300\u540d\u3000<\/p>\n<p><strong>\u4e3b\u3000\u50ac<\/strong><\/p>\n<hr>\n<p>\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\u3000<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>\u8b1b\u6f14\u30d7\u30ed\u30b0\u30e9\u30e0<\/strong><\/p>\n<hr>\n\n<table id=\"tablepress-114\" class=\"tablepress tablepress-id-114 tbody-has-connected-cells\">\n<thead>\n<tr class=\"row-1\">\n\t<th colspan=\"2\" class=\"column-1\">\u8b1b\u6f14\u30d7\u30ed\u30b0\u30e9\u30e0<\/th><th colspan=\"2\" class=\"column-3\">\u8b1b\u3000\u5e2b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">10\uff1a20\uff5e10\uff1a30<\/td><td class=\"column-2\">\u958b\u4f1a\u6328\u62f6<\/td><td class=\"column-3\"><\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">10\uff1a30\uff5e11\uff1a30<\/td><td class=\"column-2\">\u3010\u7814\u947d\u8b1b\u6f14\u3011\uff1a\u300cPIC\/S\u3092\u8e0f\u307e\u3048\u305f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u969b\u300d<\/td><td class=\"column-3\"> NPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1<\/td><td class=\"column-4\">\u9ad8\u5e73\u3000\u6b63\u884c<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">11\uff1a30\uff5e12\uff1a30<\/td><td class=\"column-2\">\u3010\u7814\u947d\u8b1b\u6f14\u3011\uff1a\u300c\u6d17\u6d44\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u300d<\/td><td class=\"column-3\"> NPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1<\/td><td class=\"column-4\">\u4eba\u898b\u3000\u82f1\u660e<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">12\uff1a30\uff5e13\uff1a30<\/td><td colspan=\"3\" class=\"column-2\"> \uff5e\u3000\u663c\u3000\u98df\u3000\uff5e<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">13\uff1a30\uff5e14\uff1a30<\/td><td class=\"column-2\">\u3010\u4e00\u822c\u8b1b\u6f14\u3011\uff1a\u300c\u5305\u88c5\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u300d<\/td><td class=\"column-3\">\u682a\u5f0f\u4f1a\u793e \u30a4\u30fc\u30ba\u3000\u4ee3\u8868\u53d6\u7de0\u5f79<\/td><td class=\"column-4\">\u5e73\u6fa4\u3000\u5bdb<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">14\uff1a30\uff5e14\uff1a45<\/td><td colspan=\"3\" class=\"column-2\">\uff5e\u3000\u4f11\u3000\u61a9\u3000\uff5e<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">14\uff1a45\uff5e16\uff1a15<\/td><td class=\"column-2\">\u3010\u7279\u5225\u8b1b\u6f14\u3011\uff1a\u300cGMP\u9069\u5408\u6027\u8abf\u67fb\u306b\u95a2\u3059\u308b\u6700\u8fd1\u306e\u6307\u5c0e\u72b6\u6cc1\u3068PMDA\u306e\u6d3b\u52d5\u306b\u3064\u3044\u3066\u300d<\/td><td class=\"column-3\">\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u3000\u5be9\u8b70\u5f79\uff08\u54c1\u8cea\u7ba1\u7406\u62c5\u5f53\uff09<\/td><td class=\"column-4\">\u6afb\u4e95\u3000\u4fe1\u8c6a<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td rowspan=\"2\" class=\"column-1\">16\uff1a15\uff5e16\uff1a20<\/td><td rowspan=\"2\" class=\"column-2\">\u9589\u4f1a\u6328\u62f6 <\/td><td class=\"column-3\"> \uff08\u5927\u962a\u4f1a\u5834\uff09<\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td class=\"column-3\">\uff08\u6771\u4eac\u4f1a\u5834\uff09<\/td><td class=\"column-4\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-114 from cache -->\n<hr>\n<p><strong>\u3010\u304a\u9858\u3044\u3011<\/strong><br \/>\n\u53c2\u52a0\u7533\u8fbc\u66f8\u3092\u30e1\u30fc\u30eb\u306b\u6dfb\u4ed8\u3057\u3066\u304a\u9001\u308a\u3044\u305f\u3060\u304f\u3068\u304d\u306f\u3001<br \/>\n\u4ef6\u540d\u6b04\u306b\u300c\u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u53c2\u52a0\u7533\u3057\u8fbc\u307f\uff08\u5927\u962a\u4f1a\u5834\uff09\u300d<br \/>\n\u3000\u3000\u3000\u3000\u300c\u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u53c2\u52a0\u7533\u3057\u8fbc\u307f\uff08\u6771\u4eac\u4f1a\u5834\uff09\u300d<br \/>\n\u306e\u3069\u3061\u3089\u304b\u306e\u3054\u8a18\u5165\u3092\u304a\u9858\u3044\u81f4\u3057\u307e\u3059\u3002<\/p>\n<hr>\n<p><strong>\u53c2\u52a0\u7533\u3057\u8fbc\u307f\u66f8<\/strong><br \/>\n<a href=\"https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2017\/12\/d561419b8bafc8631a107c671d3631e5-2.xlsx\">\u3010\u5927\u962a\u4f1a\u5834\u7528\u3011NPO-QA\u30bb\u30f3\u30bf\u30fc \u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u7533\u8fbc\u66f8(HP\u6dfb\u4ed8\uff09<\/a><br \/>\n<a href=\"https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2017\/12\/8afac3a0181cd48b41ccb47d956e65d5.xlsx\">\u3010\u6771\u4eac\u4f1a\u5834\u7528\u3011NPO-QA\u30bb\u30f3\u30bf\u30fc \u5275\u7acb14\u5468\u5e74\u30bb\u30df\u30ca\u30fc\u7533\u8fbc\u66f8(HP\u6dfb\u4ed8\uff09<\/a>\u3000<\/p>\n<hr>\n<p><strong>\u3010\u8b1b \u6f14 \u8981 \u65e8\u3011<\/strong><br \/>\n\u3010\u7814\u947d\u8b1b\u6f14\u3011\u3000\u300cPIC\/S\u3092\u8e0f\u307e\u3048\u305f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u969b\u300d\u3000\u3000\uff2e\uff30\uff2f\uff0d\uff31\uff21\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\u3000\u9ad8\u5e73 \u6b63\u884c<br \/>\n\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u306f\u5916\u89b3\u3067\u306f\u78ba\u8a8d\u3067\u304d\u306a\u3044\u3053\u3068\u304b\u3089\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u3088\u308a\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u65e5\u672c\u3067\u306f1996\u5e74\u306b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u304c\uff27\uff2d\uff30\u9069\u5408\u306e\u8a31\u53ef\u8981\u4ef6\u3068\u306a\u308a\u3001\u66f4\u306b2013\u5e748\u6708\u306b\u306f\uff30\uff29\uff23\uff0f\uff33 \uff27\uff2d\uff30\u3068\u306e\u6574\u5408\u53ca\u3073\u54c1\u8cea\u4fdd\u8a3c\u306e\u5145\u5b9f\u306e\u89b3\u70b9\u304b\u3089\uff27\uff2d\uff30\u7701\u4ee4\u306e\u65bd\u884c\u901a\u77e5\u304c\u6539\u6b63\u3055\u308c\u3001\u65e5\u672c\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u5316\u304c\u56f3\u3089\u308c\u305f\u3002<br \/>\n\u3053\u306e\u57fa\u6e96\u3067\u306f\u3001\u5f93\u6765\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u76ee\u7684\u306f\u5909\u308f\u3089\u306a\u3044\u304c\u3001\uff29\uff23\uff28\uff31\uff18, Q\uff19, Q10\u3001\u88fd\u54c1\u54c1\u8cea\u306e\u7167\u67fb\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30de\u30b9\u30bf\u30fc\u30d7\u30e9\u30f3\u3001\u6280\u8853\u79fb\u8ee2\u3001Continuous\/Continued Process Verification\u306a\u3069\u3068\u3044\u3063\u305f\u65b0\u305f\u6982\u5ff5\u304c\u53d6\u308a\u5165\u308c\u3089\u308c\u305f\u3002<br \/>\n\u672c\u8b1b\u6f14\u3067\u306f\u3001\u65b0\u305f\u306a\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u306e\u30dd\u30a4\u30f3\u30c8\u3001\u53ca\u3073\uff30\uff29\uff23\uff0f\uff33 \uff27\uff2d\uff30\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5b9f\u969b\u306b\u3064\u3044\u3066\u89e3\u8aac\u3059\u308b\u3002\u3000\u3000<br \/>\n\u3000\u3000\u3000<br \/>\n\u3010\u7814\u947d\u8b1b\u6f14\u3011 \u300c\u6d17\u6d44\u5de5\u7a0b\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u300d\u3000\u3000\uff2e\uff30\uff2f\uff0d\uff31\uff21\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\u3000\u4eba\u898b \u82f1\u660e\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000<br \/>\n\u6539\u6b63\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u3067\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u3092\u660e\u78ba\u306b\u610f\u8b58\u3057\u305f\u4e0a\u3067\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u306b\u5fdc\u3058\u3066\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5bfe\u8c61\u3001\u691c\u8a0e\u5bfe\u8c61\u9805\u76ee\u53ca\u3073\u691c\u8a0e\u7bc4\u56f2\u7b49\u3092\u9078\u629e\u3057\u305f\u79d1\u5b66\u7684\u306a\u6839\u62e0\u53ca\u3073\u5224\u65ad\u7b49\u306b\u57fa\u3065\u304f\u5bfe\u5fdc\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u308b\u3002<br 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