{"id":374844,"date":"2024-12-23T13:28:26","date_gmt":"2024-12-23T18:28:26","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/blog\/fda%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e6%88%90%e7%86%9f%e5%ba%a6%e3%83%97%e3%83%ad%e3%82%b0%e3%83%a9%e3%83%a0\/"},"modified":"2024-12-23T13:28:26","modified_gmt":"2024-12-23T18:28:26","slug":"fda%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e6%88%90%e7%86%9f%e5%ba%a6%e3%83%97%e3%83%ad%e3%82%b0%e3%83%a9%e3%83%a0","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/fda%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e6%88%90%e7%86%9f%e5%ba%a6%e3%83%97%e3%83%ad%e3%82%b0%e3%83%a9%e3%83%a0\/","title":{"rendered":"FDA\u54c1\u8cea\u7ba1\u7406\u6210\u719f\u5ea6\u30d7\u30ed\u30b0\u30e9\u30e0"},"content":{"rendered":"\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u4e0d\u8db3\u306f\u3001\u88fd\u85ac\u696d\u754c\u3001\u898f\u5236\u5f53\u5c40\u3001\u533b\u7642\u5236\u5ea6\u3001\u305d\u3057\u3066\u6700\u7d42\u7684\u306b\u306f\u60a3\u8005\u306b\u591a\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u91cd\u5927\u306a\u554f\u984c\u3067\u3042\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u533b\u85ac\u54c1\u4e0d\u8db3\u306f\u3001\u88fd\u9020\u3084\u54c1\u8cea\u306e\u554f\u984c\u3092\u542b\u3080\u69d8\u3005\u306a\u8981\u56e0\u306b\u3088\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u3053\u306e\u305f\u3081FDA\u306f\u3001\u533b\u85ac\u54c1\u4e0d\u8db3\u3092\u7de9\u548c\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u306e\u4e00\u3064\u3068\u3057\u3066\u3001\u54c1\u8cea\u7ba1\u7406\u6210\u719f\u5ea6\uff08QMM\uff09\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u7740\u624b\u3057\u305f\u3002FDA\u306e\u54c1\u8cea\u7ba1\u7406\u6210\u719f\u5ea6\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u6210\u719f\u3057\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u88fd\u9020\u696d\u8005\u3092\u8a8d\u3081\u3001\u305d\u308c\u306b\u5831\u3044\u308b\u67a0\u7d44\u307f\u3092\u78ba\u7acb\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u5f37\u56fa\u306a\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u88fd\u9020\u30df\u30b9\u306e\u9632\u6b62\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u6700\u9069\u5316\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u5fb9\u5e95\u3001\u7d99\u7d9a\u7684\u306a\u6539\u5584\u6587\u5316\u306e\u91b8\u6210\u3092\u652f\u63f4\u3057\u3001\u3053\u308c\u3089\u3059\u3079\u3066\u304c\u4e00\u4f53\u3068\u306a\u3063\u3066\u3001\u4e00\u8cab\u3057\u305f\u4e2d\u65ad\u306e\u306a\u3044\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u7dad\u6301\u3092\u76ee\u6307\u3057\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u5b89\u5168\u3067\u6709\u52b9\u306a\u533b\u85ac\u54c1\u304c\u7d99\u7d9a\u7684\u306b\u4f9b\u7d66\u3055\u308c\u3001\u60a3\u8005\u306e\u5065\u5eb7\u304c\u5b88\u3089\u308c\u3001\u3088\u308a\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u8ca2\u732e\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002QMM\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u533b\u85ac\u54c1\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u54c1\u8cea\u76ee\u6a19\u306e\u9054\u6210\u3001\u88fd\u9020\u73fe\u5834\u306e\u54c1\u8cea\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u4fe1\u983c\u6027\u306e\u5411\u4e0a\u306b\u3064\u3044\u3066\u3001\u3042\u3089\u3086\u308b\u30ec\u30d9\u30eb\u306e\u7ba1\u7406\u8077\u306e\u610f\u8b58\u3092\u9ad8\u3081\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u6210\u719f\u5ea6\u30e2\u30c7\u30ea\u30f3\u30b0\u306b\u57fa\u3065\u3044\u3066\u304a\u308a\u3001\u88fd\u85ac\u4f01\u696d\u304c\u60a3\u8005\u306e\u30cb\u30fc\u30ba\u3068\u4f01\u696d\u76ee\u6a19\u3092\u6e80\u305f\u3057\u306a\u304c\u3089\u696d\u52d9\u3092\u6539\u5584\u3059\u308b\u306e\u3092\u652f\u63f4\u3059\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u898f\u5236\u9075\u5b88\u306b\u3068\u3069\u307e\u3089\u305a\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u53ef\u7528\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u5148\u624b\u3092\u6253\u3063\u305f\u5bfe\u7b56\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3092\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n

\u6700\u8fd1\u306e\u66f4\u65b0\u3067\u3001FDA\u306fCDER\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u6210\u719f\u5ea6\uff08QMM\uff09\u30d7\u30ed\u30b0\u30e9\u30e0\u3092<\/em>\u516c\u8868\u3057\u305f\uff1aPractice Areas and Prototype Assessment Protocol Development\u3092\u767a\u8868\u3057\u305f\u3002<\/em>CDER\u306e\u54c1\u8cea\u7ba1\u7406 (fda.gov)<\/em><\/a>. <\/em>\u3053\u306e\u6587\u66f8\u3067\u306f\u3001\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u304a\u3051\u308b\u30d0\u30a4\u30a2\u30b9\u3084\u500b\u4eba\u306e\u4e3b\u89b3\u6027\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u3001\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u62c5\u5f53\u8005\u306e\u30c1\u30fc\u30e0\u304c\u7d44\u7e54\u306e\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u304a\u3044\u3066\u3069\u306e\u3088\u3046\u306b\u6a19\u6e96\u5316\u3055\u308c\u305f\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u30fb\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f7f\u7528\u3059\u308b\u304b\u3092\u6982\u8aac\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u30015\u3064\u306e\u91cd\u8981\u306a\u5b9f\u8df5\u9818\u57df\u3092\u30ab\u30d0\u30fc\u3059\u308b\uff1a <\/p>\n\n\n\n

    \n
  1. \u7d4c\u55b6\u9663\u306b\u3088\u308b\u54c1\u8cea\u3078\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\uff1a<\/strong>\u7d4c\u55b6\u9663\u304c\u6b63\u3057\u3044\u6a21\u7bc4\u3092\u793a\u3057\u3001\u54c1\u8cea\u76ee\u6a19\u3092\u3088\u308a\u5e83\u7bc4\u306a\u7d44\u7e54\u76ee\u6a19\u3068\u6574\u5408\u3055\u305b\u3001\u5fc5\u8981\u306a\u8cc7\u6e90\u3092\u63d0\u4f9b\u3057\u3001\u900f\u660e\u6027\u306e\u3042\u308b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30c1\u30e3\u30cd\u30eb\u3092\u80b2\u6210\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u7d44\u7e54\u5168\u4f53\u306b\u54c1\u8cea\u6587\u5316\u3092\u91b8\u6210\u3059\u308b\u3002<\/li>\n\n\n\n
  2. \u4e8b\u696d\u7d99\u7d9a\uff1a <\/strong>\u4e8b\u696d\u7d99\u7d9a\u306e\u5b9f\u8df5\u306f\u3001\u5b89\u5b9a\u3057\u305f\u533b\u85ac\u54c1\u4f9b\u7d66\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u696d\u52d9\u306e\u56de\u5fa9\u529b\u3092\u78ba\u4fdd\u3057\u3001\u6df7\u4e71\u304b\u3089\u4fdd\u8b77\u3057\u3001\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3078\u306e\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002<\/li>\n\n\n\n
  3. \u9ad8\u5ea6\u306a\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff08PQS\uff09\uff1a<\/strong>\u9ad8\u5ea6\u306a\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u57fa\u672c\u7684\u306a\u54c1\u8cea\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8d85\u3048\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u3001\u300cQuality by Design\uff08QbD\uff09\u300d\u3084\u30ea\u30b9\u30af\u7ba1\u7406\u30a2\u30d7\u30ed\u30fc\u30c1\u306a\u3069\u306e\u54c1\u8cea\u539f\u5247\u3092\u7d44\u307f\u8fbc\u3093\u3060\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u9ad8\u5ea6\u306aPQS\u306f\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u7d99\u7d9a\u7684\u306a\u9069\u5408\u6027\u3001\u80fd\u529b\u3001\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u3002 <\/li>\n\n\n\n
  4. \u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30a8\u30af\u30bb\u30ec\u30f3\u30b9<\/strong>\u52b9\u679c\u7684\u306a\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30a8\u30af\u30bb\u30ec\u30f3\u30b9\u306b\u306f\u3001\u60c5\u5831\u3068\u30c7\u30fc\u30bf\u306e\u7ba1\u7406\u304c\u542b\u307e\u308c\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u696d\u52d9\u306b\u304a\u3051\u308b\u60c5\u5831\u306e\u30cb\u30fc\u30ba\u3001\u80fd\u529b\u3001\u304a\u3088\u3073\u9650\u754c\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u308b\u3002\u30c7\u30fc\u30bf\u4e3b\u5c0e\u306e\u610f\u601d\u6c7a\u5b9a\u3068\u3001\u3059\u3079\u3066\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u5f37\u8abf\u3059\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u696d\u52d9\u304c\u76ee\u7684\u306b\u9069\u5408\u3057\u3001\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30ca\u30eb\u30fb\u30a8\u30af\u30bb\u30ec\u30f3\u30b9\u306b\u8ca2\u732e\u3059\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u3002 <\/li>\n\n\n\n
  5. \u5f93\u696d\u54e1\u306e\u30a8\u30f3\u30b2\u30fc\u30b8\u30e1\u30f3\u30c8\uff1a<\/strong>\u5f93\u696d\u54e1\u306f\u3001\u7d44\u7e54\u5185\u306e\u30ec\u30d9\u30eb\u306b\u95a2\u4fc2\u306a\u304f\u3001\u5404\u81ea\u306e\u8cac\u4efb\u306b\u4e3b\u4f53\u7684\u306b\u53d6\u308a\u7d44\u307f\u307e\u3059\u3002\u5f93\u696d\u54e1\u306b\u306f\u3001\u554f\u984c\u3092\u7279\u5b9a\u3057\u3001\u61f8\u5ff5\u3092\u4f1d\u3048\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u554f\u984c\u3092\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u3057\u3001\u30d7\u30ed\u30bb\u30b9\u3001\u624b\u9806\u3001\u6163\u884c\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u306b\u3064\u306a\u304c\u308b\u5909\u66f4\u3092\u958b\u59cb\u3059\u308b\u6a29\u9650\u304c\u4e0e\u3048\u3089\u308c\u3066\u3044\u308b\u3002 <\/li>\n<\/ol>\n\n\n\n

    \u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u30c1\u30fc\u30e0\u306f\u3001\u7d44\u7e54\u5185\u306e\u696d\u52d9\u6163\u884c\u3068\u54c1\u8cea\u6587\u5316\u3092\u8a55\u4fa1\u3057\u3001\u5404\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d42\u4e86\u6642\u306b\u3001\u53c2\u52a0\u8005\u306f\u3001\u7d44\u7e54\u304c\u7d99\u7d9a\u7684\u6539\u5584\u3092\u691c\u8a0e\u3057\u305f\u65b9\u304c\u3088\u3044\u3068\u601d\u308f\u308c\u308b\u5206\u91ce\u3092\u5f37\u8abf\u3057\u305f\u5831\u544a\u66f8\u3092\u53d7\u3051\u53d6\u308b\u3002\u5831\u544a\u66f8\u306b\u306f\u3001QMM \u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u53c2\u52a0\u3057\u3066\u3044\u308b\u7d44\u7e54\u306e\u8eab\u5143\u3092\u958b\u793a\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u30d9\u30f3\u30c1\u30de\u30fc\u30ad\u30f3\u30b0\u30c7\u30fc\u30bf\u3092\u542b\u3081\u308b\u3053\u3068\u3082\u3067\u304d\u308b\u3002\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u306b\u306f\u3001\u53c2\u52a0\u7d44\u7e54\u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3068\u6210\u719f\u5ea6\u3092\u88fd\u85ac\u696d\u754c\u306e\u985e\u4f3c\u7d44\u7e54\u3068\u6bd4\u8f03\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u3001\u4e8b\u696d\u6240\u306e\u898f\u6a21\u3001\u88fd\u54c1\u30bf\u30a4\u30d7\u3001\u8a55\u4fa1\u5e74\u306a\u3069\u306e\u7279\u5b9a\u306e\u57fa\u6e96\u306b\u57fa\u3065\u304d\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u4fe1\u983c\u6027\u306b\u95a2\u3057\u3066\u4e8b\u696d\u6240\u304c\u4ed6\u306e\u4e8b\u696d\u6240\u3068\u6bd4\u8f03\u3057\u3066\u3069\u3046\u306a\u306e\u304b\u3068\u3044\u3046\u8cb4\u91cd\u306a\u6d1e\u5bdf\u304c\u5f97\u3089\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002 <\/p>\n\n\n\n

    QMM\u306f\u7523\u696d\u754c\u306b\u3068\u3063\u3066\u3069\u306e\u3088\u3046\u306a\u5b58\u5728\u304b\uff1f<\/strong><\/h2>\n\n\n\n

    \u7fa9\u52d9\u3067\u306f\u306a\u3044\u304c\u3001\u3053\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u306b\u3068\u3063\u3066\u6709\u76ca\u3067\u3042\u308b\u3002QMM\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306e\u4e00\u3064\u306e\u6226\u7565\u7684\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001QMM\u306f\u65e2\u5b58\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u65b0\u305f\u306a\u8ca0\u62c5\u3084\u8981\u4ef6\u3068\u3059\u3079\u304d\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3042\u308b\u3002\u307b\u3068\u3093\u3069\u306e\u7d44\u7e54\u3067\u306f\u3001\u3059\u3067\u306bQMM\u306b\u6cbf\u3063\u305f\u30d7\u30ed\u30bb\u30b9\u3084\u6163\u884c\u304c\u3042\u308a\u3001\u3088\u308a\u9ad8\u3044\u30ec\u30d9\u30eb\u306eQMM\u3092\u9054\u6210\u3059\u308b\u3053\u3068\u306f\u3001\u7a4d\u6975\u7684\u306a\u7d99\u7d9a\u7684\u6539\u5584\u52aa\u529b\u306e\u7d50\u679c\u3068\u3057\u3066\u81ea\u7136\u306b\u3082\u305f\u3089\u3055\u308c\u308b\u3002\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u8981\u70b9\u3092\u6574\u7406\u3057\u3066\u307f\u3088\u3046\uff1a <\/p>\n\n\n\n

      \n
    1. \u65e2\u5b58\u306e\u5b9f\u52d9\u3068\u306e\u6574\u5408\uff1a<\/strong>\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u306f\u3001PQS \u306e\u5b9f\u65bd\u3084 ICH Q10 \u306e\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306e\u6982\u5ff5\u306e\u53d6\u308a\u5165\u308c\u3092\u901a\u3058\u3066\u3001 \u3044\u304f\u3064\u304b\u306e\u7d44\u7e54\u304c\u65e2\u306b\u3042\u308b\u7a0b\u5ea6 QMM \u306e\u539f\u5247\u306b\u6cbf\u3063\u305f\u30d7\u30ed\u30bb\u30b9\u3084\u6163\u884c\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u8a8d\u3081\u3066\u3044\u308b\u3002QMM \u306f\u3001\u3053\u308c\u3089\u306e\u57fa\u76e4\u306e\u4e0a\u306b\u69cb\u7bc9\u3057\u3001\u7a4d\u6975\u7684\u304b\u3064\u7d99\u7d9a\u7684\u306a\u6539\u5584\u52aa\u529b\u3092\u901a\u3058\u3066\u3001\u3053\u308c\u3089\u306e\u57fa\u76e4 \u3092\u6539\u5584\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3059\u3082\u306e\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u3001\u54c1\u8cea\u65b9\u91dd\u3068\u76ee\u6a19\u3092\u3088\u308a\u5e83\u7bc4\u306a\u4e8b\u696d\u76ee\u6a19\u3068\u6574\u5408\u3055\u305b\u3001\u5f37\u56fa\u306a\u662f\u6b63\u30fb\u4e88\u9632\u51e6\u7f6e\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u78ba\u5b9f\u306b\u5b58\u5728\u3055\u305b\u3001\u7a4d\u6975\u7684\u306a\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u7d99\u7d9a\u7684\u6539\u5584\u3001\u88fd\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308b\u9ad8\u54c1\u8cea\u306a\u533b\u85ac\u54c1\u751f\u7523\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u4f53\u7cfb\u7684\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u5531\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u9054\u6210\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002 <\/li>\n\n\n\n
    2. \u8cea\u306e\u6587\u5316\uff1a<\/strong>\u54c1\u8cea\u6587\u5316\u300d\u306e\u5968\u52b1\u3068\u306f\u3001\u54c1\u8cea\u3078\u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u304c\u7d44\u7e54\u5168\u4f53\u306b\u6d78\u900f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3002\u54c1\u8cea\u3068\u306f\u3001\u5358\u306a\u308b\u90e8\u9580\u7684\u306a\u95a2\u5fc3\u4e8b\u3067\u306f\u306a\u304f\u3001\u5168\u5f93\u696d\u54e1\u304c\u53d7\u3051\u5165\u308c\u308b\u30d3\u30b8\u30cd\u30b9\u6587\u5316\u306e\u57fa\u672c\u7684\u306a\u5074\u9762\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u3001\u7d4c\u55b6\u9663\u304c\u3001\u5f93\u696d\u54e1\u304c\u81ea\u5206\u306e\u30a2\u30a4\u30c7\u30a2\u3084\u6539\u5584\u63d0\u6848\u3092\u6c17\u8efd\u306b\u5171\u6709\u3067\u304d\u308b\u74b0\u5883\u3092\u91b8\u6210\u3057\u3001\u7d99\u7d9a\u7684\u306a\u6539\u5584\u6d3b\u52d5\u3084\u60a3\u8005\u5b89\u5168\u3078\u306e\u53d6\u308a\u7d44\u307f\u306b\u5f93\u696d\u54e1\u3092\u53c2\u52a0\u3055\u305b\u308b\u3053\u3068\u3067\u3001\u5f93\u696d\u54e1\u304c\u81ea\u5206\u306e\u5f79\u5272\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u3084\u60a3\u8005\u306e\u5b89\u5168\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u9054\u6210\u3067\u304d\u308b\u3002 <\/li>\n\n\n\n
    3. \u54c1\u8cea\u6307\u6a19\u30d7\u30ed\u30b0\u30e9\u30e0\uff1a<\/strong>\u54c1\u8cea\u6e2c\u5b9a\u57fa\u6e96\u306e\u4f7f\u7528\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u30c7\u30fc\u30bf\u4e3b\u5c0e\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3059\u308b\u3002\u30e1\u30c8\u30ea\u30af\u30b9\u306f\u3001\u7d44\u7e54\u304c\u6539\u5584\u306e\u305f\u3081\u306e\u9818\u57df\u3092\u7279\u5b9a\u3057\u3001\u9032\u6357\u3092\u8ffd\u8de1\u3057\u3001\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u610f\u601d\u6c7a\u5b9a\u3092\u884c\u3046\u306e\u306b\u5f79\u7acb\u3064\u3002\u30d7\u30ed\u30bb\u30b9\u30fb\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u6307\u6a19\uff08CpK\/PpK\uff09\u3001Right First Time Rate\u3001CAPA Effectiveness\u306e\u3088\u3046\u306a\u5148\u884c\u6307\u6a19\u3068\u3001\u9045\u884c\u6307\u6a19\u3092\u4f7f\u3044\u5206\u3051\u308b\u3053\u3068\u3067\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3084\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u6f5c\u5728\u7684\u306a\u554f\u984c\u3092\u4e88\u6e2c\u3067\u304d\u308b\u65e9\u671f\u30b7\u30b0\u30ca\u30eb\u3084\u50be\u5411\u304c\u5f97\u3089\u308c\u308b\u3002 <\/li>\n\n\n\n
    4. \u9577\u671f\u7684\u306a\u30b3\u30b9\u30c8\u524a\u6e1b\uff1a<\/strong>\u6210\u719f\u3057\u305f\u5f37\u56fa\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306b\u6295\u8cc7\u3057\u3001\u3088\u308a\u9ad8\u3044\u30ec\u30d9\u30eb\u306e QMM \u3092\u9054\u6210\u3059\u308b\u3053\u3068\u306f\u3001\u9577\u671f\u7684\u306a\u30b3\u30b9\u30c8\u524a\u6e1b\u306b\u3064\u306a\u304c\u308b\u3002\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u304a\u3051\u308b\u54c1\u8cea\u554f\u984c\u3084\u6df7\u4e71\u3092\u672a\u7136\u306b\u9632\u3050\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u3084\u662f\u6b63\u3001\u6700\u9069\u3067\u306a\u3044\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u9023\u3059\u308b\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002 <\/li>\n\n\n\n
    5. \u898f\u5236\u4e0a\u306e\u30e1\u30ea\u30c3\u30c8\uff1a<\/strong>\u7d44\u7e54\u304c\u3001\u3088\u308a\u9ad8\u3044QMM\u683c\u4ed8\u3051\u3092\u901a\u3058\u3066\u3001\u5f37\u56fa\u3067\u6210\u719f\u3057\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u54c1\u8cea\u6163\u884c\u3001\u4e26\u3073\u306b\u54c1\u8cea\u6587\u5316\u3092\u5b9f\u8a3c\u3059\u308b\u5834\u5408\u3001\u691c\u67fb\u983b\u5ea6\u306e\u4f4e\u6e1b\u53ca\u3073\u898f\u5236\u306e\u67d4\u8edf\u6027\u5411\u4e0a\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/li>\n<\/ol>\n\n\n\n

      CAI\u306f\u3001QMM\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5c0e\u5165\u3092\u76ee\u6307\u3059\u7d44\u7e54\u306b\u5bfe\u3057\u3001\u5e45\u5e83\u3044\u5c02\u9580\u77e5\u8b58\u3068\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3053\u306e\u30b5\u30dd\u30fc\u30c8\u306b\u306f\u3001\u5f37\u56fa\u306aPQS\u306e\u958b\u767a\u3068\u5f37\u5316\u3001\u54c1\u8cea\u6e2c\u5b9a\u57fa\u6e96\u306e\u898b\u76f4\u3057\u3068\u6539\u826f\u3001\u54c1\u8cea\u6587\u5316\u306e\u5c0e\u5165\u306b\u5411\u3051\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u6226\u7565\u8a08\u753b\u306e\u63d0\u4f9b\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002 <\/p>\n","protected":false},"excerpt":{"rendered":"

      \u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u4e0d\u8db3\u306f\u3001\u88fd\u85ac\u696d\u754c\u3001\u898f\u5236\u5f53\u5c40\u3001\u533b\u7642\u5236\u5ea6\u3001\u305d\u3057\u3066\u6700\u7d42\u7684\u306b\u306f\u60a3\u8005\u306b\u591a\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u91cd\u5927\u306a\u554f\u984c\u3067\u3042\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u533b\u85ac\u54c1\u4e0d\u8db3\u306f\u3001\u88fd\u9020\u3084\u54c1\u8cea\u306e\u554f\u984c\u3092\u542b\u3080\u69d8\u3005\u306a\u8981\u56e0\u306b\u3088\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u3053\u306e\u305f\u3081FDA\u306f\u3001\u533b\u85ac\u54c1\u4e0d\u8db3 […]<\/p>\n","protected":false},"author":41,"featured_media":374847,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[517,591,592,593],"tags":[290,301,306,428,429,430,431,432,433],"resource-featured-status":[],"resource-type":[],"class_list":["post-374844","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-517","category-591","category-592","category-593","tag-quality-risk-mgt","tag-fda","tag-drug-shortages","tag-quality-management","tag-qmm","tag-business-continuity","tag-employee-engagement","tag-quality-metric-program","tag-regulatory"],"acf":[],"featured_image_src":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/01\/Martina-McDonagh-FDA-Quality-Management-Maturity-Blog-1.jpg","featured_image_src_square":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/01\/Martina-McDonagh-FDA-Quality-Management-Maturity-Blog-1.jpg","author_info":{"display_name":"Christina Stanevich","author_link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/author\/christina-stanevich\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/374844","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/comments?post=374844"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/374844\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media\/374847"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media?parent=374844"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/categories?post=374844"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/tags?post=374844"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-featured-status?post=374844"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-type?post=374844"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}