{"id":3060,"date":"2023-08-31T14:09:21","date_gmt":"2023-08-31T05:09:21","guid":{"rendered":"https:\/\/npo-qa.jp\/wordpress\/?p=3060"},"modified":"2024-07-16T14:38:43","modified_gmt":"2024-07-16T05:38:43","slug":"2023%e5%b9%b4%e5%ba%a6%e3%80%80%e9%a6%99%e8%8f%8a%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\/2023\/08\/31\/2023%e5%b9%b4%e5%ba%a6%e3%80%80%e9%a6%99%e8%8f%8a%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":"2023\u5e74\u5ea6\u3000\u9999\u83ca\u30bb\u30df\u30ca\u30fc\u306e\u3054\u6848\u5185"},"content":{"rendered":"<p>\u300c2023\u5e74\u5ea6\u9999\u83ca\u30bb\u30df\u30ca\u30fc\u300d\u3092\u4e0b\u8a18\u306e\u901a\u308a\u3001\u958b\u50ac\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u3054\u6848\u5185<\/strong><\/p>\n<hr \/>\n<p>\u65e5\u3000\u3000\u6642 \uff1a\u3000\uff12\uff10\uff12\uff13\u5e74\uff11\uff10\u6708\uff12\uff10\u65e5\uff08\u91d1\uff09\u3000\uff19\uff1a\uff15\uff10\uff5e\uff11\uff16\uff1a\uff13\uff15<br \/>\n\u958b\u50ac\u65b9\u5f0f \uff1a\u3000\u4f1a\u3000\u5834\u30fb\uff37\uff25\uff22\u4f75\u7528<br \/>\n\u4f1a\u3000\u3000\u5834 \uff1a\u3000\u5927\u962a\u7523\u696d\u5275\u9020\u9928\u3000\uff16\u968e\u3000\uff25\u4f1a\u8b70\u5ba4\uff08\u5b9a\u54e172\u540d\uff09<br \/>\n\u7533\u8fbc\u7de0\u5207 \uff1a\u3000\uff11\uff10\u6708\uff11\uff13\u65e5\uff08\u91d1\uff09<br \/>\n\u53c2 \u52a0\u00a0 \u6599 \uff1a<br \/>\nNPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\uff08\u6cd5\u4eba\u30fb\u8a8d\u5b9a\u8b1b\u5ea7\u8cc7\u683c\u8005\uff09\u00a0 \u00a0\u30006,000\u5186<br \/>\nNPO-QA\u30bb\u30f3\u30bf\u30fc\u4f1a\u54e1\u4ee5\u5916\u3000 \u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u3000\u300010,000\u5186<\/p>\n<p>\u8b1b\u6f14\u8cc7\u6599 \uff1a\u3000WEB\u53d7\u8b1b\u306e\u65b9\u306b\u306f10\u670816\u65e5\uff08\u6708\uff09\u307e\u3067\u306b\u300c\u8cc7\u6599\u96c6(PDF\u7248)\u300d\u306e\u30ea\u30f3\u30af\u3068ZOOM\u60c5\u5831\u3092\u9001\u4fe1\u3044\u305f\u3057\u307e\u3059\u3002<br \/>\n\u4f1a\u5834\u53d7\u8b1b\u306e\u65b9\u306b\u306f\u5f53\u65e5\u306b\u8b1b\u6f14\u8cc7\u6599\u3092\u304a\u6e21\u3057\u3057\u307e\u3059\u3002<\/p>\n<p>\u304a\u7533\u3057\u8fbc\u307f\uff1a\u4e0b\u8a18\u306e\u300c\u304a\u7533\u8fbc\u30d5\u30a9\u30fc\u30e0\u300d\u304b\u3089\u304a\u7533\u3057\u8fbc\u307f\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><a href=\"https:\/\/forms.gle\/N92pjeQaKMKRcvky7\"> \u3010\u304a\u7533\u8fbc\u30d5\u30a9\u30fc\u30e0\u3011<\/a><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3076 alignnone\" src=\"https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a-212x300.png\" alt=\"\" width=\"777\" height=\"1099\" srcset=\"https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a-212x300.png 212w, https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a-724x1024.png 724w, https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a-768x1086.png 768w, https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a-1086x1536.png 1086w, https:\/\/npo-qa.jp\/wordpress\/wp-content\/uploads\/2023\/08\/a4bef8d0543f81eea6ee5a87564f519a.png 1414w\" sizes=\"auto, (max-width: 777px) 100vw, 777px\" \/><\/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<br \/>\n\u65b0\u7dd1\u30bb\u30df\u30ca\u30fc\u904b\u55b6\u8cac\u4efb\u8005\uff1a\u9ad8\u5e73\u3000\u6b63\u884c<br \/>\n\u4e8b\u52d9\u5c40\u62c5\u5f53\uff1a\u4e2d\u4e95\u30fb\u591a\u6839\u4e95\u30fb\u5800\u5ddd\u30fb\u6df1\u898b<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<hr \/>\n<p>&nbsp;<\/p>\n<p><strong>\u8b1b\u6f14\u8981\u65e8<\/strong><\/p>\n<hr \/>\n<p><strong>\u3010\u958b\u4f1a\u6328\u62f6\u3068\u8b1b\u6f141<\/strong><strong>\u3011\u300e\u54c1\u8cea\u78ba\u4fdd\u306e\u91cd\u8981\u6027\u3068NPO-QA\u30bb\u30f3\u30bf\u30fc\u306e\u5f79\u5272\u300f<br \/>\n<\/strong>\u3000\u3000\u3000\u8b1b\u5e2b\uff1aNPO-QA\u30bb\u30f3\u30bf\u30fc\u4ee3\u8868\u7406\u4e8b\u30fb\u6771\u4eac\u7406\u79d1\u5927\u5b66\u85ac\u5b66\u90e8\u85ac\u5b66\u79d1\u6559\u6388\u3000\u6afb\u4e95\u3000\u4fe1\u8c6a<\/p>\n<p>\uff1c\u8b1b\u5e2b\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\uff1e<br \/>\n\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb \u90e8\u9577 \u5be9\u8b70\u5f79 \u57f7\u884c\u5f79\u54e1\u3092\u6b74\u4efb\u3002<br \/>\n\u73fe\u5728\u3001\u6771\u4eac\u7406\u79d1\u5927\u5b66 \u6559\u6388\u3001\u533b\u85ac\u54c1\u6dfb\u52a0\u5264 GMP \u81ea\u4e3b\u57fa\u6e96\u9069\u5408\u5be9\u67fb\u4f1a\u59d4\u54e1\u9577\u3001\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642<br \/>\n\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u8abf\u67fb\u5c02\u9580\u59d4\u54e1\u7b49\u3002NPO-QA \u30bb\u30f3\u30bf\u30fc\u4ee3\u8868\u7406\u4e8b\u3002<\/p>\n<p><strong>\u3010\u8b1b\u6f14\uff12\u3011 \u300e\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u76e3\u67fb\u306e\u305f\u3081\u306e\u6307\u91dd\uff08JIS19011\uff09\u53c2\u8003\u306b\u3057\u305f GMP \u76e3\u67fb\u306e\u8003\u3048\u65b9\u300f<br \/>\n<\/strong>\u3000\u3000\u3000\u8b1b\u5e2b\uff1aNPO-QA\u30bb\u30f3\u30bf\u30fc\u9867\u554f\u3000\u4e0a\u4e45\u6728\u7530 \u52d9<br \/>\n\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u4e0a\u3067\u9069\u5207\u306a\u88fd\u9020\u7ba1\u7406\u3001\u54c1\u8cea\u7ba1\u7406\u3092\u5b9a\u671f\u7684\u306b\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092 GMP \u76e3\u67fb\u3067\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u3002JIS19011 \u306f QMS \u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u8003\u3048\u65b9\u3001\u624b\u6cd5\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002<br \/>\n\u52b9\u679c\u7684\u306a GMP \u76e3\u67fb\u306e\u8003\u3048\u65b9\u304a\u3088\u3073\u76e3\u67fb\u54e1\u306e\u529b\u91cf\u8a55\u4fa1\u306a\u3069\u3092 JIS19011 \u306e\u9805\u76ee\u3092\u53c2\u8003\u306b\u76e3\u67fb\u4e8b\u4f8b\u3092\u542b\u3081\u3066\u7d39\u4ecb\u3059\u308b\u3002<\/p>\n<p>\uff1c\u8b1b\u5e2b\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\uff1e<br \/>\n\u7c73\u56fd\u7cfb\u5316\u5b66\u4f1a\u793e\u306e\u88fd\u85ac\u6280\u8853\u672c\u90e8 Validation Lab \u6240\u9577\u306b\u5f93\u4e8b\u5f8c\u3001\u4ed6\u306e\u7c73\u56fd\u7cfb\u5316\u5b66\u4f1a\u793e\u306e\u4fe1\u983c\u6027\u4fdd\u8a3c\u672c\u90e8\u9577\u3001\u65e5\u672c\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3092\u6b74\u4efb\u3002<br \/>\n\u73fe\u5728\u3001\u65e5\u672c PDA \u88fd\u85ac\u5b66\u4f1a \u9867\u554f\u3001\u516c\u76ca\u8ca1\u56e3\u6cd5\u4eba\u65e5\u672c\u5065\u5eb7\u30fb\u6804\u990a\u98df\u54c1\u5354\u4f1a GMP \u8abf\u67fb\u54e1\u3001QMS \u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3001NPO-QA \u30bb\u30f3\u30bf\u30fc\u9867\u554f\u3002<\/p>\n<p><strong>\u3010\u8b1b\u6f14\uff13\u3011\u300e\u518d\u8003\uff1a\u9038\u8131\u7ba1\u7406\u3068 CAPA \u904b\u7528\u306e\u8ab2\u984c\u300f<br \/>\n<\/strong>\u3000\u3000\u3000\u8b1b\u5e2b\uff1aNPO-QA \u30bb\u30f3\u30bf\u30fc\u9867\u554f \u3000\u5c0f\u5c71 \u9756\u4eba<br \/>\n\u9038\u8131\u7ba1\u7406\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u78ba\u4fdd\u3001\u88fd\u9020\u53ca\u3073\u8a66\u9a13\u691c\u67fb\u30d7\u30ed\u30bb\u30b9\u306e\u7d99\u7d9a\u7684\u6539\u5584\u3001\u3055\u3089\u306b\u306f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\u3068\u7dad\u6301\u306b GMP \u3068 GQP \u306e\u4e21\u9762\u304b\u3089\u5fc5\u9808\u306e\u8981\u4ef6\u3067\u3042\u308b\u3002<br \/>\n\u672c\u8b1b\u3067\u306f\u6628\u4eca\u306e\u88fd\u85ac\u4f01\u696d\u306e GMP \u9055\u53cd\u4e8b\u4f8b\u3092\u8e0f\u307e\u3048\u3001\u9038\u8131\u7ba1\u7406\u3068\u306f\u4f55\u304b\uff1f\u3068\u3044\u3046\u53e4\u304f\u3066\u65b0\u3057\u3044\u8ab2\u984c\u306b\u5bfe\u3057\u3066\u3001\u9038\u8131\u3092\u6b63\u3057\u304f\u8a8d\u8b58\u3057\u3001\u9069\u5207\u306b CAPA \u3092\u904b\u7528\u3059\u308b\u305f\u3081\u306e\u8981\u70b9\u3092\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u3084 GMP \u6559\u80b2\u3082\u8003\u616e\u3057\u306a\u304c\u3089\u8ad6\u3058\u308b\u3002\u3055\u3089\u306b\u3001\u88fd\u9020\u6240\u306e\u65e5\u5e38\u7684\u306a\u30af\u30aa\u30ea\u30c6\u30a3\u30ab\u30eb\u30c1\u30e3\u30fc\u306e\u91b8\u6210\u306b\u3082\u5bc6\u63a5\u306b\u95a2\u4fc2\u3059\u308b\u30a4\u30f3\u30b7\u30c7\u30f3\u30c4\uff08\u9038\u8131\u3068\u306a\u3089\u306a\u3044\u8efd\u5fae\u306a\u4e0d\u5177\u5408\uff09\u306e\u8003\u3048\u65b9\u3068\u53d6\u6271\u3044\u306b\u3064\u3044\u3066\u3082\u8003\u5bdf\u3059\u308b\u3002<\/p>\n<p>\uff1c\u8b1b\u5e2b\u30d7\u30ed\u30d5\u30a3\u30fc\u30eb\uff1e<br \/>\n\u65e5\u7c73\u306e\u5927\u624b\u88fd\u85ac\u4f1a\u793e\u306e\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u7b49\u306b\u52e4\u52d9\u3002\u3053\u306e\u9593\u3001\u539a\u52b4\u7701\u539a\u751f\u52b4\u50cd\u79d1\u5b66\u7814\u7a76\u306e GMP \u6307\u91dd\u3092\u5ea7\u9577\u3068\u3057\u3066\u53d6\u308a\u307e\u3068\u3081\u305f\u4ed6\u3001GDP \u56fd\u969b\u6574\u5408\u5316\u7814\u7a76\u73ed\u7b49\u306b\u53c2\u753b\u3002<br \/>\n\u73fe\u5728\u3001\u65e5\u672c PDA \u88fd\u85ac\u5b66\u4f1a\u4ee3\u8b70\u54e1\u3001\u5c0f\u5c71\u30d5\u30a1\u30fc\u30de\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u4ee3\u8868\u3001NPO-QA \u30bb\u30f3\u30bf\u30fc\u9867\u554f\u3002<\/p>\n<p><strong>\u3010\u8b1b\u6f14\uff14\u3011\u300e\u6cd5\u4ee4\u9075\u5b88\uff08\u8cac\u4efb\u5f79\u54e1\u306e\u8cac\u52d9\uff09\u3000\uff5e \u77e5\u3089\u306a\u304b\u3063\u305f\uff0f\u3088\u304d\u306b\u8a08\u3089\u3048 \u3000\u3067\u306f\u8a31\u3055\u308c\u306a\u3044\u6642\u4ee3 \uff5e\u300f<br \/>\n<\/strong>\u3000\u3000\u3000\u8b1b\u5e2b\uff1aNPO-QA \u30bb\u30f3\u30bf\u30fc\u7406\u4e8b\u3000\u83f1\u8c37 \u535a\u6b21<br \/>\n\u6cd5\u4ee4\u9075\u5b88\u306b\u3064\u3044\u3066\u3001\u85ac\u6a5f\u6cd5\u53ca\u3073\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308a\u79c1\u898b\u3082\u76db\u308a\u8fbc\u307f\u89e3\u8aac\u3057\u305f\u3044\u3002<br 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