{"id":11586,"date":"2019-06-22T14:41:39","date_gmt":"2019-06-22T05:41:39","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=knowledge&p=11586"},"modified":"2025-04-04T10:52:25","modified_gmt":"2025-04-04T01:52:25","slug":"11586","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=11586","title":{"rendered":"Quality Metrics\u3068\u306f"},"content":{"rendered":"\n

Quality Metrics\uff08\u30af\u30aa\u30ea\u30c6\u30a3\u30e1\u30a4\u30c8\u30ea\u30c3\u30af\u30b9\uff09\u306fFDA\u306fUS\u56fd\u5185\u3067\u8ca9\u58f2\u3057\u3066\u3044\u308b\u533b\u85ac\u54c1\u304a\u3088\u3073\u000b\u305d\u306eAPI\u306e\u88fd\u9020\u4f1a\u793e\u306bQuality Metrics\u306e\u000b\u60c5\u5831\u63d0\u51fa\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\uff082016\u5e74\u3088\u308aData\u53ce\u96c6\u30012017\u5e74\u3088\u308a\u5831\u544a\u958b\u59cb\u3092\u4e88\u5b9a\uff09\u88fd\u54c1\u6bce\u3001\u30e9\u30a4\u30f3\u3054\u3068\u306bMetrics\u63d0\u51fa\u3092\u5e0c\u671b\u3055\u308c\u3066\u304a\u308a\u3001\u6b21\u306e\uff12\u70b9\u306e\u7684\u3068\u3057\u3066\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n

\u30fbFDA\u306e\u67fb\u5bdf\u8a08\u753b\u3092\u7acb\u6848\u6642\u306b\u3001\u67fb\u5bdf\u5bfe\u8c61\u306e\u512a\u5148\u5ea6\u30fb\u67fb\u5bdf\u9593\u9694\u30fb\u983b\u5ea6\u3092\u6c7a\u5b9a\u3059\u308b\u70ba\u306e\u57fa\u790e\u8cc7\u6599
\u30fb\u533b\u85ac\u54c1\u306e\u6b20\u54c1\u306e\u4e88\u6e2c\u306e\u8cc7\u6599<\/p>\n\n\n\n

  1. FDA Quality Metrics\u5831\u544a\u5bfe\u8c61
    \u533b\u85ac\u54c1(\u6700\u7d42\u88fd\u54c1\u3001API)\u3068OTC\u533b\u85ac\u54c1\u3002\u3053\u308c\u3089\u306e\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u4fc2\u308b\u3001\u59d4\u8a17\u88fd\u9020\u5148\u3001\u8a66\u9a13\u6a5f\u95a2\u3092\u542b\u3080
    \u6ce8\uff09\u6b21\u306e\u533b\u85ac\u54c1\u985e\u306f\u73fe\u72b6\u5bfe\u8c61\u5916\uff1a\u533b\u7642\u30ac\u30b9\u3001\u653e\u5c04\u6027\u691c\u67fb\u85ac\u3001\u8f38\u8840\u95a2\u9023\u3001\u907a\u4f1d\u5b50\u5de5\u5b66\u30fbcell\u57f9\u990a\u7b49\u3002\u000b\u3000\u3000\u5305\u88c5\u8cc7\u6750\u3001\u6dfb\u52a0\u5264<\/li>
  2. \u5831\u544a\u3057\u306a\u3051\u308c\u3070\u3044\u3051\u306a\u3044\u9805\u76ee\u306f\u3001\u4ee5\u4e0b\u3092\u542b\u3080\u6700\u4f4e10\u9805\u76ee\u3002
    \u2460\u3000\u751f\u7523\u8a08\u753b\u3055\u308c\u305f\u30ed\u30c3\u30c8\u6570
    \u2461\u3000\u88fd\u9020\u4e2d\u30fb\u88fd\u9020\u5f8c(\u54c1\u8cea\u691c\u67fb)\u306b\u898f\u683c\u4e0d\u9069\u5408\u306b\u306a\u3063\u305f\u30ed\u30c3\u30c8\u6570
    \u2462\u3000\u751f\u7523\u8a08\u753b\u4e2d\u300130\u65e5\u4ee5\u4e0a\u51fa\u8377\u5224\u5b9a\u304c\u4fdd\u7559\u306e\u30ed\u30c3\u30c8\u6570
    \u2463\u3000\u4fdd\u5b58\u5b89\u5b9a\u6027\u8a66\u9a13\u3092\u542b\u3081\u3066\u3001\u898f\u683c\u5916\uff08OOS\uff09\u8a66\u9a13\u7d50\u679c\u304c\u5224\u660e\u3057\u305f\u6570
    \u2464\u3000\u51fa\u8377\u3055\u308c\u305f\u30ed\u30c3\u30c8\u6570\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u306b\u4f9b\u3055\u308c\u305f\u30ed\u30c3\u30c8\u6570
    \u2465\u3000\u30e9\u30dc\u30a8\u30e9\u30fc\u304c\u5426\u5b9a\u3067\u304d\u306a\u304f\u3001OOS\u3068\u306e\u7d50\u679c\u306b\u306a\u3063\u305f\u51fa\u8377\u30ed\u30c3\u30c8\u6570\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u30ed\u30c3\u30c8\u6570
    \u2466\u3000\u53d7\u9818\u3057\u305f\u82e6\u60c5\u306e\u6570
    \u2467\u3000\u51fa\u8377\u82e5\u3057\u304f\u306f\u6b21\u306e\u5de5\u7a0b\u3078\u306e\u4f7f\u7528\u304c\u8a08\u753b\u3055\u308c\u305f”\u4e2d\u9593\u4f53\u201c\u30ed\u30c3\u30c8\u6570
    \u2468\u3000\u54c1\u8cea\u7167\u67fb\uff08\u5e74\u6b21\uff09\u304c\u3001\u7167\u67fb\u5bfe\u8c61\u671f\u9593\u5f8c\u300030\u65e5\u4ee5\u5185\u306b\u884c\u308f\u308c\u308b\u304b
    \u2469\u3000\u88fd\u54c1\u306e\u5e74\u6b21\u7167\u67fb\u306e\u5b9f\u65bd\u6570<\/li>
  3. FDA Quality Metrics\u8981\u6c42\u9805(\u6bd4\u7387\u3092\u7b97\u51fa\uff09
    \u2460\u3000Lot Acceptance Rate \uff08\u9069\u5408\u7387\uff09
    \u2461\u3000Right First Time Rate \uff08\u975e\u9038\u8131\u767a\u751f\u7387\uff09
    \u2462\u3000Product Quality Complaint Rate \uff08\u88fd\u54c1\u54c1\u8cea\u82e6\u60c5\u7387\uff09
    \u2463\u3000Invalidated Out-of-Specification (OOS) Rate \uff08OOS\u6bd4\u7387\uff09
    \u2464\u3000Annual Product Review (APR) on Time Rate\uff08\u5b9a\u6642\u5e74\u6b21\u7167\u67fb\u5b8c\u6210\u7387\uff09<\/li>
  4. FDA Quality Metrics Option\u5831\u544a\u9805\u76ee
    \u2460\u3000\u7d4c\u55b6\u8005\u306e\u95a2\u4e0e\u000b
    \u2461\u3000CAPA\u52b9\u679c\u6e2c\u5b9a\u000b
    \u2462\u3000\u5de5\u7a0b\u80fd\u529b\u30fb\u6027\u80fd<\/li><\/ol>\n\n\n\n

    FDA Quality Metrics\u306a\u3069\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u30ec\u30dd\u30fc\u30c8\u304c\u7c21\u5358\u306b\u4f5c\u6210\u3067\u304d\u307e\u3059\u3002<\/h4>\n\n\n\n

    FDA Quality Metrics\u306e\u305f\u305f\u304d\u53f0\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u51fa\u6765\u307e\u3059\u3002\u30a4\u30d9\u30f3\u30c8\u304c\u767a\u751f\u3057\u305f\u6642\u306b\u8a18\u9332\u3055\u308c\u305f\u6587\u66f8\u3067\u3059\u306e\u3067\u3001\u3042\u3068\u304b\u3089\u601d\u3044\u51fa\u3057\u305f\u6587\u7ae0\u3068\u306f\u6bd4\u3079\u7269\u306b\u306a\u3089\u306a\u3044\u307b\u3069\u65b0\u9bae\u3067\u3001\u9593\u9055\u3044\u304c\u306a\u304f\u3001\u7d30\u90e8\u307e\u3067\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3042\u308c\u3070\u3001\u884c\u653f\u306b\u5bfe\u3057\u3066\u306e\u5831\u544a\u8cc7\u6599\u3068\u3044\u3046\u610f\u5473\u5408\u3044\u3060\u3051\u3067\u306f\u306a\u304f\u81ea\u793e\u306e\u54c1\u8cea\u4fdd\u8a3c\u696d\u52d9\u3068\u3057\u3066\u3001\u5f79\u7acb\u3064\u30ec\u30dd\u30fc\u30c8\u306b\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n

    \u307e\u305f\u3001\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u5831\u544a\u66f8\u306a\u3069\u3092\u51fa\u529b\u3059\u308b\u3068\u3001\u5e74\u9593\u306b\u6ca2\u5c71\u4f5c\u6210\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30ec\u30dd\u30fc\u30c8\u306b\u4e00\u8cab\u6027\u3092\u4fdd\u3064\u4e8b\u304c\u3067\u304d\u307e\u3059\u3002\u30ec\u30dd\u30fc\u30c8\u3092\u305d\u308c\u305e\u308c\u3067\u4f5c\u6210\u3059\u308b\u3068\u3001\u305d\u306e\u30ec\u30dd\u30fc\u30c8\u9593\u306e\u6574\u5408\u6027\u3092\u3068\u308b\u306e\u304c\u96e3\u3057\u3044\u3068\u601d\u3044\u307e\u3059\u30021\u3064\u306e\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u51fa\u529b\u3067\u304d\u308c\u3070\u3001\u305d\u306e\u30ec\u30dd\u30fc\u30c8\u9593\u306e\u6574\u5408\u6027\u304c\u4fdd\u305f\u308c\u3066\u3001\u975e\u5e38\u306b\u8cc7\u6599\u4f5c\u6210\u304c\u697d\u306b\u306a\u308a\u307e\u3059\u3002\u5b9f\u7e3e\u306f\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u81ea\u52d5\u3067\u8a18\u8f09\u3059\u308b\u3001\u5bfe\u7b56\u306f\u3058\u3063\u304f\u308a\u4eba\u304c\u8003\u3048\u3066\u8a18\u8f09\u3059\u308b\u3002\u5f97\u610f\u6280\u3092\u5206\u62c5\u3059\u308b\u4e8b\u304c\u5927\u4e8b\u3067\u3059\u3002<\/p>\n\n\n\n

    \u5229\u70b9\u306e\u307e\u3068\u3081<\/strong><\/p>\n\n\n\n

    1. \u5831\u544a\u8cc7\u6599\u4f5c\u6210\u6642\u9593\u304c\u3059\u304f\u306a\u304f\u306a\u308a\u3001\u3088\u308a\u6df1\u3044\u8003\u5bdf\u306b\u6642\u9593\u304c\u4f7f\u3048\u308b<\/li>
    2. \u7d4c\u7def\u3001\u5185\u5bb9\u306e\u9593\u9055\u3048\u304c\u306a\u304f\u306a\u308a\u3001\u7167\u67fb\u306e\u3082\u308c\u304c\u306a\u304f\u306a\u308b<\/li>
    3. \u60c5\u5831\uff08\u30a4\u30d9\u30f3\u30c8\u60c5\u5831\u3001\u5de5\u5834\u306a\u3069\u306e\u30de\u30b9\u30bf\u30fc\u60c5\u5831\uff09\u304c\u4e00\u5143\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3001\u5404\u5831\u544a\u3067\u60c5\u5831\u306e\u6574\u5408\u6027\u304c\u53d6\u308c\u308b<\/li><\/ol>\n\n\n\n

      \u30ec\u30dd\u30fc\u30c8\u51fa\u529b\u307e\u3067\u306e\u7c21\u5358\uff13\u30b9\u30c6\u30c3\u30d7
      <\/strong><\/p>\n\n\n\n

      1. \u54c1\u8cea\u30a4\u30d9\u30f3\u30c8\u7ba1\u7406\u3092\u884c\u3044\u3001\u305d\u306e\u60c5\u5831\u3092\u84c4\u7a4d\u3057\u307e\u3059\u3002<\/li>
      2. \u51fa\u529b\u3057\u305f\u3044\u30ec\u30dd\u30fc\u30c8\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3068\u30ec\u30dd\u30fc\u30c8\u306b\u51fa\u529b\u3057\u305f\u3044\u60c5\u5831\u306e\u5b9a\u7fa9\u3092QA\u30c0\u30f4\u30a3\u30f3\u30c1\u306b\u767b\u9332\u3057\u307e\u3059\u3002
        \u9038\u8131\u3001\u5909\u66f4\u7ba1\u7406\u306a\u3069\u306e\u7a2e\u5225\u3001\u671f\u9593\u3001\u5e74\u9593\u767a\u751f\u4ef6\u6570\uff08\u88fd\u54c1\u5225\u3001\u5de5\u5834\u5225\u3001\u5de5\u7a0b\u5225\u306a\u3069\uff09<\/li>
      3. \u30ec\u30dd\u30fc\u30c8\u3092\u51fa\u529b\u3057\u307e\u3059\u3002<\/li><\/ol>\n\n\n\n

        \u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3057\u3066\u306e\u3054\u8aac\u660e\u306f\u3053\u3061\u3089<\/a>\u3002<\/p>\n\n\n\n

        \u7c21\u5358\u306b\u3001Quality Metrics\u306eFDA\u5831\u544a\u7528XML\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3059\u308b\u30c4\u30fc\u30eb
        \u7c21\u5358FDA\u5831\u544a\u7528XML\u30d5\u30a1\u30a4\u30eb\u51fa\u529bEXCEL\uff08\u7121\u511f\uff09\u306f        \u3053\u3061\u3089<\/a>\u3002<\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-11586","news","type-news","status-publish","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/11586","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11586"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=11586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}