{"id":375249,"date":"2025-01-03T13:51:01","date_gmt":"2025-01-03T18:51:01","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/blog\/ich-q9-%e6%94%b9%e8%a8%821%e7%89%88%ef%bc%9a%e8%a3%bd%e8%96%ac%e7%94%a3%e6%a5%ad%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%93%81%e8%b3%aa%e3%83%aa%e3%82%b9%e3%82%af%e7%ae%a1%e7%90%86%e3%82%92%e5%bc%b7\/"},"modified":"2025-01-03T13:51:01","modified_gmt":"2025-01-03T18:51:01","slug":"ich-q9-%e6%94%b9%e8%a8%821%e7%89%88%ef%bc%9a%e8%a3%bd%e8%96%ac%e7%94%a3%e6%a5%ad%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%93%81%e8%b3%aa%e3%83%aa%e3%82%b9%e3%82%af%e7%ae%a1%e7%90%86%e3%82%92%e5%bc%b7","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/ich-q9-%e6%94%b9%e8%a8%821%e7%89%88%ef%bc%9a%e8%a3%bd%e8%96%ac%e7%94%a3%e6%a5%ad%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%93%81%e8%b3%aa%e3%83%aa%e3%82%b9%e3%82%af%e7%ae%a1%e7%90%86%e3%82%92%e5%bc%b7\/","title":{"rendered":"ICH Q9 \u6539\u8a021\u7248\uff1a\u88fd\u85ac\u7523\u696d\u306b\u304a\u3051\u308b\u54c1\u8cea\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u306e\u66f4\u65b0\u3068\u3001\u5f37\u56fa\u306a\u6c5a\u67d3\u7ba1\u7406\u6226\u7565\u3078\u306e\u9053\u7b4b"},"content":{"rendered":"\n

2005\u5e74\u306b\u767a\u884c\u3055\u308c\u305fICH Q9\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u9069\u7528\u3067\u304d\u308bQRM\u306e\u539f\u5247\u3068\u30c4\u30fc\u30eb\u306e\u4f8b\u3092\u793a\u3057\u305f\u3002\u3053\u308c\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306b\u7d71\u5408\u3057\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u306b\u5bfe\u3059\u308b\u7a4d\u6975\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5968\u52b1\u3057\u3001\u7d99\u7d9a\u7684\u6539\u5584\u306e\u6587\u5316\u3092\u91b8\u6210\u3059\u308b\u305f\u3081\u306e\u753b\u671f\u7684\u306a\u4e00\u6b69\u3067\u3042\u3063\u305f\u3002ICH\u304c\u7b56\u5b9a\u3057\u305f\u69d8\u3005\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4e2d\u3067\u3082\u3001Q9\u306f\u4ee5\u4e0b\u3092\u898f\u5b9a\u3059\u308b\u6975\u3081\u3066\u91cd\u8981\u306a\u3082\u306e\u3067\u3042\u308b\u3002 <\/span>\u305d\u306e<\/span> \u533b\u85ac\u54c1\u30bb\u30af\u30bf\u30fc\u306b\u304a\u3051\u308b\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08QRM\uff09\u306e\u67a0\u7d44\u307f\u3067\u3042\u308b\u3002\u6700\u8fd1\u306eICH Q9\u306e\u6539\u8a021\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u304c\u5927\u304d\u304f\u9032\u6b69\u3057\u305f\u3002 <\/span>\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u3002<\/span> <\/span><\/p>\n

\u6539\u8a02\u306e\u7406\u7531<\/strong><\/span><\/p>\n

\u6280\u8853\u306e\u9032\u6b69\u3001\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306e\u5909\u5316\u3001\u60a3\u8005\u4e2d\u5fc3\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306e\u91cd\u8996\u306e\u9ad8\u307e\u308a\u306a\u3069\u3001\u533b\u85ac\u54c1\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u306f2005\u5e74\u4ee5\u964d\u5927\u304d\u304f\u5909\u5316\u3057\u3066\u3044\u308b\u3002ICH Q9\u306e\u6539\u8a021\u7248\u3067\u306f\u3001\u5f53\u521d\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6539\u826f\u3057\u3001\u3088\u308a\u660e\u78ba\u306b\u3057\u3001\u6700\u65b0\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u3067\u3001\u3053\u308c\u3089\u306e\u9032\u5c55\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u308b\u3002\u6539\u8a02\u306e\u76ee\u7684\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\u3002 <\/span>\u53d6\u308a\u9664\u304f <\/span>\u66d6\u6627\u3055<\/span>,<\/span> \u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u5f37\u5316\u3057\u3001\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u6539\u5584\u3057\u3001\u7d99\u7d9a\u7684\u6539\u5584\u3092\u4fc3\u9032\u3057\u3001\u898f\u5236\u9075\u5b88\u3092\u652f\u63f4\u3059\u308b\u3002 <\/span> <\/span><\/p>\n

ICH Q9 \u6539\u8a02\u7b2c 1 \u7248\u306e\u4e3b\u306a\u5909\u66f4\u70b9\uff1a<\/strong><\/span> <\/span><\/p>\n

    \n
  1. \u660e\u77ad\u3055\u3068\u69cb\u9020\u306e\u5f37\u5316\uff1a<\/strong>\n
      \n
    1. \u4eca\u56de\u306e\u6539\u8a02\u3067\u306f\u3001\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3001\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u30ec\u30d3\u30e5\u30fc\u306e\u305f\u3081\u306e\u660e\u78ba\u306a\u30b9\u30c6\u30c3\u30d7\u3068\u8003\u616e\u4e8b\u9805\u304c\u6982\u8aac\u3055\u308c\u3001QRM\u306b\u5bfe\u3059\u308b\u3088\u308a\u69cb\u9020\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u304c\u63d0\u4f9b\u3055\u308c\u3066\u3044\u308b\u3002<\/li>\n
    2. \u3053\u306e\u6539\u8a02\u7248\u3067\u306f\u3001\u91cd\u8981\u306a\u6982\u5ff5\u306b\u3064\u3044\u3066\u8a73\u7d30\u306a\u89e3\u8aac\u3092\u52a0\u3048\u3001\u7d44\u7e54\u304cQRM\u306e\u539f\u5247\u3092\u7406\u89e3\u3057\u3001\u5b9f\u65bd\u3057\u3084\u3059\u304f\u306a\u3063\u3066\u3044\u308b\u3002\u4eca\u56de\u306e\u6539\u8a02\u3067\u306f\u3001\u4e0d\u78ba\u5b9f\u6027\u3001\u91cd\u8981\u6027\u3001\u8907\u96d1\u6027\u3092\u76db\u308a\u8fbc\u3080\u3053\u3068\u3067\u3001QRM\u306e\u5f62\u5f0f\u3092\u6574\u3048\u305f\u3002 <\/li>\n<\/ol>\n<\/li>\n
    3. \u65b0\u3057\u3044\u30c4\u30fc\u30eb\u3068\u30c6\u30af\u30cb\u30c3\u30af\u306e\u7d71\u5408\uff1a<\/strong>\n
        \n
      1. \u6539\u8a021\u7248\u3067\u306f\u3001\u3053\u306e\u5206\u91ce\u306b\u304a\u3051\u308b\u6700\u65b0\u306e\u9032\u6b69\u3092\u53cd\u6620\u3057\u3001\u65b0\u3057\u3044\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30c4\u30fc\u30eb\u3084\u65b9\u6cd5\u8ad6\u304c\u76db\u308a\u8fbc\u307e\u308c\u3066\u3044\u308b\u3002\u4f8b\u3048\u3070\u3001\u30d7\u30ed\u30bb\u30b9\u30de\u30c3\u30d4\u30f3\u30b0\u3084\u539f\u56e0\u30fb\u5f71\u97ff\u30c0\u30a4\u30a2\u30b0\u30e9\u30e0\u306e\u3088\u3046\u306a\u5358\u7d14\u306a\u6280\u6cd5\u304b\u3089\u3001\u6545\u969c\u30e2\u30fc\u30c9\u3001\u5f71\u97ff\u3001\u81f4\u547d\u5ea6\u89e3\u6790\u306e\u3088\u3046\u306a\u3088\u308a\u5f71\u97ff\u529b\u306e\u3042\u308b\u8a55\u4fa1\u6280\u6cd5\u307e\u3067\u542b\u307e\u308c\u3066\u3044\u308b\u3002 <\/li>\n
      2. \u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3068\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u6539\u5584\u3059\u308b\u305f\u3081\u306b\u3001\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u3001\u4e88\u6e2c\u5206\u6790\u3001\u30c7\u30fc\u30bf\u5206\u6790\u306e\u5229\u7528\u3092\u5968\u52b1\u3057\u3066\u3044\u308b\u3002\u4f8b\u3048\u3070\u3001\u7d2f\u7a4d\u548c\u3084\u52a0\u91cd\u79fb\u52d5\u5e73\u5747\u306a\u3069\u306e\u69d8\u3005\u306a\u7ba1\u7406\u56f3\u304c\u3042\u308b\u3002 <\/li>\n<\/ol>\n<\/li>\n
      3. \u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b\uff1a<\/strong>\n
          \n
        1. \u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u306f\u3001\u52b9\u679c\u7684\u306a\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u3001\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u9593\u3067\u306e\u30ea\u30b9\u30af\u60c5\u5831\u306e\u6b63\u78ba\u304b\u3064\u52b9\u7387\u7684\u306a\u5171\u6709\u304c\u3088\u308a\u91cd\u8996\u3055\u308c\u3066\u3044\u308b\u3002QRM\u306e\u539f\u5247\u3092\u901a\u3058\u3066\u5f97\u3089\u308c\u305f\u77e5\u8b58\u3084\u7d4c\u9a13\u306f\u3001\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u610f\u601d\u6c7a\u5b9a\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u30b9\u30c6\u30c3\u30d7\u3068\u3057\u3066\u5171\u6709\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002 <\/span>. <\/span> <\/span><\/li>\n
        2. \u30ea\u30b9\u30af\u95a2\u9023\u306e\u6c7a\u5b9a\u3084\u884c\u52d5\u3092\u4f1d\u3048\u308b\u969b\u306e\u900f\u660e\u6027\u3068\u660e\u78ba\u6027\u306e\u91cd\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002<\/span><\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n
        3. \u7d99\u7d9a\u7684\u6539\u5584\u3092\u91cd\u8996\uff1a<\/strong>\n
            \n
          1. \u4eca\u56de\u306e\u6539\u5b9a\u306f\u3001\u4ee5\u4e0b\u306e\u5fc5\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002 <\/span>\u7d99\u7d9a\u7684\u306a<\/span> \u7d99\u7d9a\u7684\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u30ea\u30b9\u30af\u306e\u518d\u8a55\u4fa1\u306e\u5fc5\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002 <\/span>\u7d99\u7d9a\u7684\u306a<\/span> \u3092\u63a8\u9032\u3059\u308b\u3002<\/span> <\/span><\/li>\n
          2. \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u3068\u66f4\u65b0\u306e\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u69cb\u7bc9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002 <\/span>\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/span>\u3053\u308c\u3089\u306b\u306f<\/span>\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3084\u30ca\u30ec\u30c3\u30b8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8 <\/span>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306e\u30ca\u30ec\u30c3\u30b8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/span>. <\/span> <\/span>
            <\/span><\/li>\n<\/ol>\n<\/li>\n
          3. \u4ed6\u306e ICH \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u306e\u6574\u5408\u6027\uff1a<\/strong>\n
              \n
            1. \u6539\u8a021\u3067\u306f\u3001Q9\u3092Q10\uff08\u533b\u85ac\u54c1\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff09\u3084Q12\uff08\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u306a\u3069\u306e\u4ed6\u306e\u95a2\u9023\u3059\u308bICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u6574\u5408\u3055\u305b\u3001\u3088\u308a\u307e\u3068\u307e\u308a\u306e\u3042\u308b\u898f\u5236\u306e\u67a0\u7d44\u307f\u3092\u69cb\u7bc9\u3057\u3066\u3044\u308b\u3002<\/span> <\/span><\/li>\n
            2. \u3053\u306e\u8abf\u6574\u306b\u3088\u308a\u3001QRM\u306e\u539f\u5247\u304c\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u69d8\u3005\u306a\u5074\u9762\u306b\u4e00\u8cab\u3057\u3066\u9069\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u3002 <\/span>\u3053\u308c\u306b\u306f\u3001QMS\u306b\u304a\u3051\u308b\u8a08\u753b\u7684\u306a\uff08\u88fd\u54c1\u30ec\u30d3\u30e5\u30fc\u3001\u691c\u67fb\u3001\u76e3\u67fb\u3001\u307e\u305f\u306f\u5909\u66f4\u7ba1\u7406\uff09\u53ca\u3073\u8a08\u753b\u5916\u306e\uff08\u30eb\u30fc\u30c8\u30b1\u30fc\u30b9\u307e\u305f\u306f\u30ea\u30b3\u30fc\u30eb\uff09\u30d7\u30ed\u30bb\u30b9\u306e\u5909\u66f4\u304c\u542b\u307e\u308c\u308b\u3002 <\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

              \u88fd\u85ac\u696d\u754c\u3078\u306e\u5f71\u97ff<\/strong><\/span> <\/span><\/p>\n

              ICH Q9 R1\u306e\u6539\u8a02\u306f\u91cd\u8981\u3067\u3042\u308b\u3002 <\/span>\u91cd\u8981<\/span>\u54c1\u8cea\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u3088\u308a\u5f37\u56fa\u306a\u67a0\u7d44\u307f\u3092\u63d0\u4f9b\u3059\u308b\u3002\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u4ee5\u4e0b\u306e\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308b\u3002 <\/span>\u3088\u308a\u69cb\u9020\u5316\u3055\u308c\u305f<\/span>\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u3088\u308a\u69cb\u9020\u7684\u3067\u4f53\u7cfb\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5c0e\u5165\u3059\u308b\u3002 <\/span>\u30ea\u30b9\u30af\u7ba1\u7406<\/span>r<\/span>\u30e9\u30a4\u30f3<\/span>s<\/span>\u30d7\u30ed\u30bb\u30b9\u3092\u6539\u5584\u3057<\/span>s<\/span>\u6700\u9069\u5316<\/span>s<\/span> \u30ea\u30bd\u30fc\u30b9\u3092\u6d3b\u7528\u3057\u3001\u696d\u52d9\u52b9\u7387\u3092\u9ad8\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u3055\u3089\u306b\u3001\u3053\u308c\u3089\u306e\u6539\u8a02\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u898f\u5236\u9075\u5b88\u3092\u652f\u63f4\u30fb\u5f37\u5316\u3057\u3001\u975e\u9075\u5b88\u306e\u30b3\u30b9\u30c8\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u5b89\u5168\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u900f\u660e\u3067\u52b9\u679c\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u4fe1\u983c\u3092\u80b2\u307f\u3001\u898f\u5236\u5f53\u5c40\u3084\u533b\u7642\u5c02\u9580\u5bb6\u3001\u305d\u3057\u3066\u60a3\u8005\u304b\u3089\u306e\u4f1a\u793e\u306e\u8a55\u5224\u3092\u9ad8\u3081\u308b\u3002 <\/span> <\/span><\/p>\n

              \u5805\u7262\u306aCCS\u3078\u306e\u9053 <\/strong><\/span><\/p>\n

              \u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306f\u533b\u85ac\u54c1\u88fd\u9020\u306e\u91cd\u8981\u306a\u5074\u9762\u3067\u3059\u3002<\/span>\u306e\u91cd\u8981\u306a\u5074\u9762\u3067\u3042\u308b\u3002<\/span>\u88fd\u54c1 <\/span>\u88fd\u54c1 <\/span> \u306f\u5b89\u5168\u3067\u3001\u7d14\u7c8b\u3067\u3001\u52b9\u679c\u7684\u3067\u3042\u308b\u3002\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08QRM\uff09\u306b\u95a2\u3059\u308bICH Q9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u5f37\u56fa\u306a\u67a0\u7d44\u307f\u3092\u78ba\u7acb\u3059\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3002\u6700\u8fd1\u306e\u6539\u8a021\u306b\u3088\u308a\u3001ICH Q9\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3057\u3066\u3001\u6c5a\u67d3\u306b\u95a2\u9023\u3059\u308b\u3082\u306e\u3092\u542b\u3080\u30ea\u30b9\u30af\u7ba1\u7406\u306b\u3064\u3044\u3066\u3001\u3088\u308a\u660e\u78ba\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002 <\/span> <\/span><\/p>\n

              \u6c5a\u67d3\u7ba1\u7406\u306b\u304a\u3051\u308bICH Q9R1\u306e\u5f79\u5272 <\/strong><\/span><\/p>\n

              ICH Q9R1\u306f\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u542b\u3080\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3001\u8a55\u4fa1\u3001\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3059\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u7a4d\u6975\u7684\u306a\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u4fc3\u9032\u3057\u3001\u65e5\u5e38\u306e\u30d7\u30ed\u30bb\u30b9\u3084\u610f\u601d\u6c7a\u5b9a\u306b\u7d71\u5408\u3059\u308b\u3002\u3053\u3053\u3067\u306f\u3001ICH Q9\u304c\u52b9\u679c\u7684\u306a\u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3078\u306e\u9053\u7b4b\u3068\u3057\u3066\u3069\u306e\u3088\u3046\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u7d39\u4ecb\u3059\u308b\uff1a <\/span> <\/span><\/p>\n

                \n
              1. \u4f53\u7cfb\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\uff1a <\/strong>\n
                  \n
                1. ICH Q9\u3067\u306f\u3001\u6f5c\u5728\u7684\u306a\u6c5a\u67d3\u6e90\u3092\u7279\u5b9a\u3057\u3001\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u5968\u52b1\u3057\u3066\u3044\u308b\u3002<\/span> <\/span><\/li>\n
                2. \u5305\u62ec\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u306f\u3001\u5371\u5bb3\u5206\u6790\u91cd\u8981\u7ba1\u7406\u70b9\uff08HACCP\uff09\u3001\u6545\u969c\u30e2\u30fc\u30c9\u5f71\u97ff\u89e3\u6790\uff08FMEA\uff09\u3001\u30d5\u30a9\u30fc\u30eb\u30c8\u30c4\u30ea\u30fc\u89e3\u6790\uff08FTA\uff09\u306a\u3069\u306e\u30c4\u30fc\u30eb\u304c\u63a8\u5968\u3055\u308c\u308b\u3002<\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n
                3. \u7a4d\u6975\u7684\u306a\u30ea\u30b9\u30af\u7ba1\u7406\uff1a<\/strong>\n
                    \n
                  1. \u540c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u6d88\u6975\u7684\u306a\u5bfe\u5fdc\u3067\u306f\u306a\u304f\u3001\u4e88\u9632\u7684\u306a\u5bfe\u7b56\u306e\u5b9f\u65bd\u3092\u4fc3\u3057\u3066\u3044\u308b\u3002<\/span><\/span> <\/span><\/span><\/li>\n
                  2. \u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u65e9\u671f\u306b\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u85ac\u4f1a\u793e\u306f\u3053\u308c\u3089\u306e\u30ea\u30b9\u30af\u3092\u52b9\u679c\u7684\u306b\u8efd\u6e1b\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3084\u30b7\u30b9\u30c6\u30e0\u3092\u8a2d\u8a08\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span><\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n
                  3. \u7d99\u7d9a\u7684\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u30ec\u30d3\u30e5\u30fc\uff1a<\/span><\/span><\/strong>\n
                      \n
                    1. ICH Q9\u306f\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u306e\u7d99\u7d9a\u7684\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u91cd\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002<\/span> <\/span><\/li>\n
                    2. \u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u3068\u518d\u8a55\u4fa1\u306b\u3088\u308a\u3001\u7d71\u5236\u304c\u6709\u52b9\u3067\u3042\u308a\u7d9a\u3051\u3001\u65b0\u3057\u3044\u60c5\u5831\u3084\u30d7\u30ed\u30bb\u30b9\u306e\u5909\u66f4\u306b\u5bfe\u5fdc\u3057\u3066\u66f4\u65b0\u3055\u308c\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u3002<\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n
                    3. \u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u5f37\u5316\uff1a<\/span><\/span><\/strong>\n
                        \n
                      1. \u52b9\u679c\u7684\u306a\u30ea\u30b9\u30af\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u6c5a\u67d3\u9632\u6b62\u306b\u3068\u3063\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002<\/span> <\/span><\/li>\n
                      2. \u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u3059\u3079\u3066\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u9593\u3067\u900f\u660e\u3067\u660e\u78ba\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u3068\u308a\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3068\u7ba1\u7406\u7b56\u3092\u5168\u54e1\u304c\u8a8d\u8b58\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u5fc5\u8981\u6027\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002<\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n
                      3. \u898f\u5236\u306e\u671f\u5f85\u3068\u306e\u6574\u5408\u6027\uff1a<\/span><\/span> <\/span><\/strong>\n
                          \n
                        1. ICH Q9\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u6c5a\u67d3\u7ba1\u7406\u306b\u95a2\u3059\u308b\u898f\u5236\u8981\u4ef6\u306b\u6cbf\u3046\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span> <\/span><\/li>\n
                        2. \u8abf\u548c\u3055\u308c\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u63d0\u4f9b\u3059\u308b\u3002 <\/span>\u4e16\u754c\u306e\u898f\u5236\u5f53\u5c40\u306b<\/span>\u4e16\u754c\u4e2d\u306e\u898f\u5236\u5f53\u5c40\u306b\u8a8d\u3081\u3089\u308c\u3001\u53d7\u3051\u5165\u308c\u3089\u308c\u3066\u3044\u308b\u3002<\/span> <\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

                          ICH Q9 R1\u306b\u304a\u3051\u308b\u6c5a\u67d3\u7ba1\u7406\u306e\u4e3b\u8981\u8981\u7d20 <\/span><\/strong><\/p>\n

                          \u88fd\u9020\u74b0\u5883\u306b\u306f\u8907\u6570\u306e\u6f5c\u5728\u7684\u6c5a\u67d3\u6e90\u304c\u3042\u308b\u3002 <\/span>\u3053\u308c\u3089 <\/span>\u6c5a\u67d3\u6e90\u306b\u306f\u539f\u6750\u6599\u3001\u8a2d\u5099\u3001\u4eba\u54e1\u306a\u3069\u304c\u3042\u308a\u3001\u305d\u308c\u305e\u308c\u306b\u56fa\u6709\u306e\u30ea\u30b9\u30af\u304c\u3042\u308b\u3002\u3059\u3079\u3066\u306e\u6c5a\u67d3\u30ea\u30b9\u30af\u304c\u540c\u3058\u3068\u306f\u9650\u3089\u306a\u3044\u3002\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3082\u306e\u3082\u3042\u308b\u3002 <\/span>\u4ed6\u4eba\u3088\u308a<\/span>\u3067\u3042\u308b\u3002<\/span>ICH Q9\u306e\u30ea\u30d3\u30b8\u30e7\u30f31\u3078\u306e\u66f4\u65b0\u306f\u3001\u30ea\u30b9\u30af\u306e\u91cd\u5927\u6027\u3001\u53ef\u80fd\u6027\u3001\u691c\u51fa\u53ef\u80fd\u6027\u306b\u57fa\u3065\u304f\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u306b\u5f79\u7acb\u3064\u3002<\/span> <\/span><\/p>\n

                          \u30ea\u30b9\u30af\u304c\u7279\u5b9a\u3055\u308c\u3001\u512a\u5148\u9806\u4f4d\u304c\u4ed8\u3051\u3089\u308c\u305f\u3089\u3001\u9069\u5207\u306a\u7ba1\u7406\u63aa\u7f6e\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <\/span>\u7ba1\u7406\u7b56\u306b\u306f\u3001\u5358\u7d14\u306a\u624b\u9806\u306e\u5909\u66f4\u304b\u3089\u3001\u9ad8\u5ea6\u306a\u308d\u904e\u30b7\u30b9\u30c6\u30e0\u3084\u81ea\u52d5\u5316\u306a\u3069\u306e\u3088\u308a\u8907\u96d1\u306a\u6280\u8853\u7684\u89e3\u6c7a\u7b56\u307e\u3067\u3001\u4eba\u70ba\u7684\u306a\u63a5\u89e6\u3092\u6e1b\u3089\u3059\u3082\u306e\u304c\u3042\u308b\u3002 <\/span>\u5b9f\u65bd\u3055\u308c\u305f\u7ba1\u7406\u7b56\u306f\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u4e0a\u3067\u9069\u5207\u304b\u3064\u52b9\u679c\u7684\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u691c\u8a3c\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 <\/span>\u3053\u308c\u306b\u306f\u3001\u5b9a\u671f\u7684\u306a\u8a66\u9a13\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u691c\u67fb\u3001\u691c\u67fb\u7d50\u679c<\/span>,<\/span>\u304a\u3088\u3073\u7ba1\u7406\u63aa\u7f6e\u306e\u8ffd\u52a0\u691c\u8a3c\u3092\u542b\u3080\u3002 <\/span> <\/span><\/p>\n

                          \u6587\u66f8\u5316\u306f\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u901a\u3058\u3066\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002 <\/span>\u6c5a\u67d3\u6e90\u306e\u7279\u5b9a\u3001\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u3068\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u3001\u5b9f\u65bd\u3068\u691c\u8a3c\u3092\u901a\u3057\u305f\u7ba1\u7406\u63aa\u7f6e\u306f\u3059\u3079\u3066\u3001\u30ea\u30b9\u30af\u306e\u78ba\u5b9f\u306a\u30ec\u30d3\u30e5\u30fc\u304c\u5b8c\u4e86\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002 <\/span>\u3053\u306e\u6587\u66f8\u5316\u306f\u3001\u5c06\u6765\u3001\u65bd\u8a2d\u5168\u4f53\u306e\u30ea\u30b9\u30af\u3092\u518d\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u5909\u66f4\u304c\u5fc5\u8981\u306b\u306a\u3063\u305f\u3068\u304d\u306b\u3001\u898b\u76f4\u3059\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002 <\/span>\u9069\u5207\u306a\u6587\u66f8\u5316<\/span>s<\/span>\u900f\u660e\u6027\u3068\u898f\u5236\u9075\u5b88\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306b\u53d6\u3089\u308c\u305f\u63aa\u7f6e\u306e\u660e\u78ba\u306a\u8a3c\u8de1\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/span> <\/span><\/p>\n

                          \u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u306e\u305f\u3081\u306eICH Q9 R1\u5b9f\u65bd\u306e\u305f\u3081\u306e\u5b9f\u8df5\u7684\u30b9\u30c6\u30c3\u30d7 <\/strong><\/span><\/p>\n

                          QRM\u3092\u7528\u3044\u305f\u6c5a\u67d3\u9632\u6b62\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5b9f\u65bd\u306b\u306f\u3001\u5b66\u969b\u7684\u306a\u7814\u7a76\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002<\/span>y<\/span> \u30ea\u30b9\u30af\u7ba1\u7406\u3078\u306e\u652f\u63f4\u3068\u732e\u8eab<\/span> \u751f\u7523\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3001\u6280\u8853\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u305d\u306e\u4ed6\u306e\u30b5\u30dd\u30fc\u30c8\u90e8\u9580\u3092\u542b\u3080\u3001\u6a5f\u80fd\u6a2a\u65ad\u7684\u306a\u30ea\u30b9\u30af\u7ba1\u7406\u30c1\u30fc\u30e0\u306e\u8a2d\u7acb\u306f\u3001\u5f37\u529b\u306a\u5c02\u9580\u77e5\u8b58\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/span> \u30d7\u30ed\u30b0\u30e9\u30e0\u5b9f\u65bd\u306e\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u5305\u62ec\u7684\u306a\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u5b9f\u65bd\u3067\u3042\u308b\u3002<\/span> QRM\u30c4\u30fc\u30eb\u3092\u7528\u3044\u3066\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u5404\u6bb5\u968e\u306b\u304a\u3051\u308b\u6f5c\u5728\u7684\u306a\u6c5a\u67d3\u6e90\u306b\u7126\u70b9\u3092\u5f53\u3066\u305f\u5fb9\u5e95\u7684\u306a\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u305d\u306e\u7d50\u679c\u3092\u8868\u3057\u3001\u8a55\u4fa1\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/span> \u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u7d50\u679c\u306b\u57fa\u3065\u304d\u3001\u7279\u5b9a\u3055\u308c\u305f\u7279\u5b9a\u306e\u6c5a\u67d3\u30ea\u30b9\u30af\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306e\u7ba1\u7406\u6226\u7565\u3092\u7b56\u5b9a\u3059\u308b\u3002<\/span> \u3053\u308c\u3089\u306e\u6226\u7565\u3092\u5b9f\u65bd\u3057\u3001\u3059\u3079\u3066\u306e\u8077\u54e1\u304c\u65b0\u3057\u3044\u624b\u9806\u306b\u3064\u3044\u3066\u8a13\u7df4\u3092\u53d7\u3051\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002<\/span> \u52b9\u679c\u30c1\u30a7\u30c3\u30af\u306e\u691c\u8a3c<\/span> \u5b9f\u65bd\u3055\u308c\u305f\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u9069\u5207\u3067\u3042\u308b\u3053\u3068<\/span>.<\/span> \u4ee5\u4e0b\u3092\u901a\u3058\u3001\u7ba1\u7406\u63aa\u7f6e\u306e\u6709\u52b9\u6027\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3059\u308b\u3002<\/span> \u30b3\u30f3<\/span>\u7d99\u7d9a\u7684\u306a\u6539\u5584\u30eb\u30fc\u30d7<\/span> \u5b9a\u671f\u7684\u306a\u691c\u67fb\u3001\u8a66\u9a13\u3001\u76e3\u67fb\u3002 <\/span>\u30ec\u30d3\u30e5\u30fc<\/span> \u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3068\u7ba1\u7406\u6226\u7565\u3092\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u66f4\u65b0\u3059\u308b\u3002 <\/span> <\/span><\/p>\n

                          \u5f37\u56fa\u306a\u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30fb\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30fb\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u5b9f\u65bd\u306f\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002 <\/span>\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002<\/span> \u3069\u306e\u3088\u3046\u306a\u7d44\u7e54\u306b\u304a\u3044\u3066\u3082\u3001\u54c1\u8cea\u6587\u5316\u306e\u91b8\u6210\u306b\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002 <\/span>\u52b9\u679c\u7684\u306aQRM\u306f\u3001\u3053\u306e\u54c1\u8cea\u3068\u30ea\u30b9\u30af\u610f\u8b58\u306e\u6587\u5316\u3092\u7d44\u7e54\u5168\u4f53\u306b\u4fc3\u9032\u3059\u308b\u3002 <\/span>\u65bd\u8a2d\u5168\u4f53\u3067\u6c5a\u67d3\u30ea\u30b9\u30af\u306b\u95a2\u3059\u308b\u30aa\u30fc\u30d7\u30f3\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u5968\u52b1\u3057\u3001\u5b9f\u65bd\u3055\u308c\u305f\u7ba1\u7406\u63aa\u7f6e\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u8a13\u7df4\u3059\u308b\u3002 <\/span> <\/span><\/p>\n

                          \u7d50\u8ad6 <\/strong><\/span><\/p>\n

                          ICH Q9\u306e\u6539\u8a021\u7248\u306f\u3001\u88fd\u85ac\u696d\u754c\u304c\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5353\u8d8a\u6027\u3092\u76ee\u6307\u3059\u4e0a\u3067\u91cd\u8981\u306a\u4e00\u6b69\u3092\u8e0f\u307f\u51fa\u3057\u305f\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3002\u66f4\u65b0\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5411\u4e0a\u3055\u305b\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u7d99\u7d9a\u7684\u306a\u6539\u5584\u3068\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u63a8\u9032\u3057\u3001\u6700\u7d42\u7684\u306b\u306f\u3001\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u30b9\u30d4\u30fc\u30c9\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span> m<\/span>\u30de\u30fc\u30b1\u30c3\u30c8<\/span>\u60a3\u8005 <\/span>\u60a3\u8005\u306e<\/span>\u30cb\u30fc\u30ba<\/span>. The revised guidance also provides a robust framework for contamination control in the industry. By adopting the principles and practices outlined in the guideline, companies can proactively manage contamination risks, ensuring the safety, purity, and efficacy of their products. The enhancements from the revision provide a framework, offering clearer guidance and incorporating the latest best practices. Embracing ICH Q9 not only aids in regulatory compliance but also drives continuous improvement and innovation in contamination control, ultimately protecting patient health and safety. As the industry continues to evolve, the principles of QRM will remain a cornerstone of ensuring the safe and effective delivery of pharmaceutical products to patients worldwide. <\/span> <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":40,"featured_media":375250,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[517,518,680],"tags":[283,290,335,359,360,483,484],"resource-featured-status":[],"resource-type":[],"class_list":["post-375249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-517","category-gmp","category-opm--","tag-contamination-control-strategy","tag-quality-risk-mgt","tag-pharmaceuticalindustry-2","tag-ich-q9","tag-qcr","tag-revision","tag-ccs"],"acf":[],"featured_image_src":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/07\/Annex-21-1.jpg","featured_image_src_square":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2024\/07\/Annex-21-1.jpg","author_info":{"display_name":"Linh Nguyen","author_link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/author\/linh-nguyen\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/375249","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\/40"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/comments?post=375249"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/posts\/375249\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media\/375250"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/media?parent=375249"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/categories?post=375249"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/tags?post=375249"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-featured-status?post=375249"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/ja\/wp-json\/wp\/v2\/resource-type?post=375249"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}