{"id":6256,"date":"2016-06-28T10:36:37","date_gmt":"2016-06-28T01:36:37","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=fszblog&p=6256"},"modified":"2025-11-12T20:24:01","modified_gmt":"2025-11-12T11:24:01","slug":"pharmaceutical04","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=pharmaceutical04","title":{"rendered":"FDA Quality Metrics\u96fb\u5b50\u30c7\u30fc\u30bf\u5831\u544a\u624b\u9806\u767a\u8868"},"content":{"rendered":"

FDA\u304c Quality Metrics \u306e\u96fb\u5b50\u30c7\u30fc\u30bf\u3067\u306e\u5831\u544a\u306e\u624b\u9806\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002<\/p>\n

QUALITY METRICS TECHNICAL CONFORMANCE GUIDE
\nDraft Guidance for Industry Request for Quality Metrics, published July 28, 2015
\nRevision History June 2016 1.0 Initial version
\n\uff1c\u539f\u6587\u306f\u3053\u3061\u3089<\/a>\uff1e<\/p>\n

\u3053\u308c\u304b\u3089\u3001\u30a2\u30e1\u30ea\u30ab\u306b\u306a\u3069\u306b\u8f38\u51fa\u3057\u3066\u3044\u308b\u88fd\u85ac\u4f1a\u793e\u306e\u7686\u69d8\u306f\u672c\u683c\u7684\u306bFDA\u306b\u5bfe\u3057\u3066\u3001Quality Metrics\u306e\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u30fb\u5831\u544a\u3092\u691c\u8a0e\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002
\n\u3082\u3046\u3054\u6e96\u5099\u306f\u6574\u3063\u3066\u3044\u307e\u3059\u3067\u3057\u3087\u3046\u304b\u3002<\/p>\n

\u25a0Quality Metrics\u3068\u306f
\nFDA\u306fUS\u56fd\u5185\u3067\u8ca9\u58f2\u3057\u3066\u3044\u308b\u533b\u85ac\u54c1\u304a\u3088\u3073\u305d\u306eAPI\u306e\u88fd\u9020\u4f1a\u793e\u306b\u3001Quality Metrics\u306e\u60c5\u5831\u63d0\u51fa\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u3002
\n\uff082016\u5e74\u3088\u308aData\u53ce\u96c6\u30012017\u5e74\u3088\u308a\u5831\u544a\u958b\u59cb\u3092\u4e88\u5b9a\uff09
\n\u88fd\u54c1\u6bce\u3001\u30e9\u30a4\u30f3\u3054\u3068\u306bMetrics\u63d0\u51fa\u3092\u5e0c\u671b<\/p>\n

\u6b21\u306e\uff12\u70b9\u306e\u7684\u3068\u3057\u3066\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002
\n\uff11\uff0eFDA\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
\n\uff12\uff0e\u533b\u85ac\u54c1\u306e\u6b20\u54c1\u306e\u4e88\u6e2c\u306e\u8cc7\u6599<\/p>\n

\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u3044\u3051\u306a\u3044\u9805\u76ee\u306f\u3001\u4ee5\u4e0b\u3092\u542b\u3080\u6700\u4f4e\uff11\uff10\u9805\u76ee\u3002
\n\uff11\uff0e\u751f\u7523\u8a08\u753b\u3055\u308c\u305f\u30ed\u30c3\u30c8\u6570
\n\uff12\uff0e\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
\n\uff13\uff0e\u751f\u7523\u8a08\u753b\u4e2d\u300130\u65e5\u4ee5\u4e0a\u51fa\u8377\u5224\u5b9a\u304c\u4fdd\u7559\u306e\u30ed\u30c3\u30c8\u6570
\n\uff14\uff0e\u4fdd\u5b58\u5b89\u5b9a\u6027\u8a66\u9a13\u3092\u542b\u3081\u3066\u3001\u898f\u683c\u5916\uff08OOS\uff09
\n\uff15\uff0e\uff0e\uff0e\uff0e\uff0e<\/p>\n

\u5c11\u3057\u9a5a\u3044\u305f\u306e\u306f\u3001\u3053\u306e\u5831\u544a\u3092\u96fb\u5b50\u7684\u306b\u5b9f\u65bd\u53ef\u80fd\u306a\u3093\u3067\u3059\u304c\u3001\u305d\u306e\u5831\u544a\u5f62\u5f0f\u304cXML\u3067\u3068\u8a00\u3046\u3082\u306e\u3002
\n\u307b\u30fc\u3002\u3002\u3002\u3002\u306a\u304b\u306a\u304b\u9032\u3093\u3067\u308b\u306a\u3068\u601d\u3044\u307e\u3059\u3002CSV\u306a\u3069\u3067\u3042\u308c\u3070\u3001\u3059\u3067\u306e\u8d85\u4e00\u822c\u7684\u3067\u3059\u304c\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u4e16\u754c\u4ee5\u5916\u3067XML\u306b\u306f\u3042\u307e\u308a\u304a\u76ee\u306b\u304b\u304b\u3089\u306a\u3044\u3093\u3067\u306f\u306a\u3044\u304b\u306a\u3068\u601d\u3044\u307e\u3059\u3002<\/p>\n

\u305d\u3053\u3067\u5f0a\u793e\u3067\u306f\u3001\u7c21\u5358\u306bFDA\u5831\u544a\u7528XML\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3059\u308bEXCEL\u3092\u4f5c\u6210\u3044\u305f\u3057\u307e\u3057\u305f\u3002
\n\u305d\u306e\u300c\u7c21\u5358FDA\u5831\u544a\u7528XML\u30d5\u30a1\u30a4\u30eb\u51fa\u529bEXCEL<\/a>\u300d\u3000\u3092\u7121\u511f\u3067\u3054\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/strong>
\n\uff08\u30c8\u30ec\u30f3\u30c9\u30de\u30a4\u30af\u30ed\u306e\u30a6\u30a4\u30eb\u30b9\u30d0\u30b9\u30bf\u30fc\u3001EXCEL\u30de\u30af\u30ed\u30c1\u30a7\u30c3\u30af\u6e08\u3001\u30d1\u30bf\u30fc\u30f3\u30d5\u30a1\u30a4\u30eb\uff1a12.635.00\uff09<\/p>\n

\"qualitymetrics2\"<\/p>\n

\u25a0XML\u3068\u306f
\nExtensible Markup Language\uff08\u30a8\u30af\u30b9\u30c6\u30f3\u30b7\u30d6\u30eb \u30de\u30fc\u30af\u30a2\u30c3\u30d7 \u30e9\u30f3\u30b2\u30fc\u30b8\uff09
\n\u8a73\u7d30\u306f\u30a6\u30a3\u30ad\u30da\u30c7\u30a3\u30a2<\/a>\u3067\u3002<\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-6256","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\/6256","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=6256"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=6256"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}