{"id":19392,"date":"2026-11-11T23:05:55","date_gmt":"2026-11-11T22:05:55","guid":{"rendered":"https:\/\/www.s-vt.net\/dq-%e8%a8%ad%e8%a8%88%e6%99%82%e9%81%a9%e6%a0%bc%e6%80%a7%e8%a9%95%e4%be%a1\/"},"modified":"2026-11-11T23:34:02","modified_gmt":"2026-11-11T22:34:02","slug":"design-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/ja\/design-qualification\/","title":{"rendered":"DQ \u2013 \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1"},"content":{"rendered":"

\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09\u3068\u306f\u3001\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u8a2d\u5099\u306e\u8a08\u753b\u3055\u308c\u305f\u8a2d\u8a08\u304c\u3001\u610f\u56f3\u3057\u305f\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>

<\/i>\u6587\u66f8\u306b\u3088\u308b\u5b9f\u8a3c<\/strong>\u8a2d\u8a08\u3068\u4f7f\u7528\u76ee\u7684\u3092\u8ffd\u8de1\u53ef\u80fd\u306a\u5f62\u3067\u7167\u5408\u3057\u307e\u3059\u3002<\/span><\/div>
<\/i>\u4e8b\u524d\u306e\u30ea\u30b9\u30af\u5206\u6790<\/strong>\u8a2d\u8a08\u304c\u78ba\u5b9a\u3059\u308b\u524d\u306b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002<\/span><\/div>
<\/i>\u8981\u6c42\u4ed5\u69d8\u66f8\u3068\u6a5f\u80fd\u4ed5\u69d8\u66f8<\/strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u6587\u66f8\u3068\u306e\u4f53\u7cfb\u7684\u306a\u7167\u5408\u3002<\/span><\/div><\/div>

\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u5b9a\u7fa9<\/h2>
<\/i>

Aide-M\u00e9moire GMP<\/h3>

\u300c\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u8a2d\u5099\u306e\u8a08\u753b\u3055\u308c\u305f\u8a2d\u8a08\u304c\u3001\u610f\u56f3\u3057\u305f\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3002\u300d\uff08\u533b\u85ac\u54c1\u306e\u88fd\u9020\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306b\u304a\u3051\u308b\u9069\u683c\u6027\u8a55\u4fa1\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u67fb\u5bdf\uff09<\/p><\/div>

<\/i>

EU-GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 Annex 15<\/h3>

\u300c\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u53ca\u3073\u88c5\u7f6e\u306b\u3064\u3044\u3066\u63d0\u6848\u3055\u308c\u305f\u8a2d\u8a08\u304c\u3001\u610f\u56f3\u3057\u305f\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3002\u300d<\/p><\/div><\/div>

DQ\u524d\u306e\u30ea\u30b9\u30af\u5206\u6790<\/h2>

\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u524d\u306b\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5305\u62ec\u7684\u306a\u30ea\u30b9\u30af\u5206\u6790\u3092\u884c\u3046\u306e\u304c\u4e00\u822c\u7684\u3067\u3059\u3002\u8a2d\u8a08\u524d\u306b\u30ea\u30b9\u30af\u3092\u6d17\u3044\u51fa\u3059\u3053\u3068\u3067\u3001\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u30ea\u30b9\u30af\u3092\u91cd\u307f\u4ed8\u3051\u3057\u3066\u8003\u616e\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u9ad8\u3044\u30d7\u30ed\u30bb\u30b9\u5b89\u5168\u6027\u304c\u5f97\u3089\u308c\u3001\u8003\u3048\u3089\u308c\u308b\u30a8\u30e9\u30fc\u8981\u56e0\u3092\u4e8b\u524d\u306b\u307b\u307c\u6392\u9664\u3067\u304d\u307e\u3059\u3002<\/p>

\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>
  1. 1<\/span>DQ\u8a08\u753b<\/strong>DQ\u8a08\u753b\u66f8\u306e\u4f5c\u6210\u3002<\/span><\/li>
  2. 2<\/span>\u624b\u9806<\/strong>\u9032\u3081\u65b9\u306e\u8a18\u8ff0\u3002<\/span><\/li>
  3. 3<\/span>\u4f5c\u696d\u624b\u9806\u66f8<\/strong>\u4f5c\u696d\u624b\u9806\u306e\u7b56\u5b9a\u3002<\/span><\/li>
  4. 4<\/span>\u8981\u6c42\u4ed5\u69d8\u66f8<\/strong>\u4f5c\u6210\uff1a \u8981\u6c42\u4ed5\u69d8\u66f8<\/a> \u307e\u305f\u306f\u5165\u672d\u66f8\u985e\u3002<\/span><\/li>
  5. 5<\/span>\u30ea\u30b9\u30af\u5206\u6790<\/strong>\u30ea\u30b9\u30af\u5206\u6790\u7d50\u679c\u306e\u53cd\u6620\u3002<\/span><\/li>
  6. 6<\/span>\u627f\u8a8d<\/strong>\u767a\u6ce8\u8005\u304b\u3089\u306e\u627f\u8a8d\u53d6\u5f97\u3002<\/span><\/li>
  7. 7<\/span>\u6a5f\u80fd\u4ed5\u69d8\u66f8\u306e\u78ba\u8a8d<\/strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u6a5f\u80fd\u4ed5\u69d8\u66f8\u3068\u627f\u8a8d\u6e08\u307f\u8981\u6c42\u4ed5\u69d8\u66f8\u3068\u306e\u7167\u5408\u3002<\/span><\/li>
  8. 8<\/span>\u8a2d\u8a08\u56f3\u66f8\u306e\u78ba\u8a8d<\/strong>\u63d0\u51fa\u3055\u308c\u305f\u8a2d\u8a08\u56f3\u66f8\u306e\u7167\u5408\u3002<\/span><\/li>
  9. 9<\/span>\u6a5f\u80fd\u306e\u78ba\u8a8d<\/strong>\u6a5f\u80fd\u8a18\u8ff0\u66f8\uff08 \u5236\u5fa1\u30b7\u30b9\u30c6\u30e0<\/a> \u3092\u542b\u3080\uff09\u3068\u8981\u6c42\u4ed5\u69d8\u66f8\u3068\u306e\u7167\u5408\u3002<\/span><\/li>
  10. 10<\/span>\u6587\u66f8\u5316<\/strong>\u5b9f\u65bd\u5185\u5bb9\u306e\u6587\u66f8\u5316\u3068\u627f\u8a8d\u3002<\/span><\/li><\/ol>

    \u9069\u683c\u6027\u8a55\u4fa1\u306e\u6d41\u308c<\/h2>
    1. 1<\/span>RA \u2013 \u30ea\u30b9\u30af\u5206\u6790<\/strong>\u8a2d\u8a08\u304c\u78ba\u5b9a\u3059\u308b\u524d\u306b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u30fb\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/span><\/li>
    2. 2<\/span>DQ \u2013 \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08\u3053\u306e\u30da\u30fc\u30b8\uff09<\/strong>\u8a2d\u8a08\u304c\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u5b9f\u8a3c\u3002<\/span><\/li>
    3. 3<\/span>IQ \u2013 \u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong>\u767a\u6ce8\u66f8\u985e\u306b\u5bfe\u3059\u308b\u636e\u4ed8\u72b6\u614b\u306e\u78ba\u8a8d\u3002<\/span><\/li>
    4. 4<\/span>OQ \u2013 \u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong>\u4e88\u5b9a\u3055\u308c\u305f\u6a5f\u80fd\u306e\u78ba\u8a8d\u3002<\/span><\/li>
    5. 5<\/span>PQ \u2013 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1<\/a><\/strong>\u904b\u8ee2\u6642\u306b\u6c42\u3081\u3089\u308c\u308b\u6027\u80fd\u306e\u5b9f\u8a3c\u3002<\/span><\/li><\/ol>
      IQ \u2013 \u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\u3078\u9032\u3080 <\/i><\/a><\/div>

      \u5f0a\u793e SEEFRIED Verfahrenstechnik GmbH<\/strong> \u306f\u3001\u304a\u5ba2\u69d8\u3068\u5171\u540c\u3067\u3001\u8981\u6c42\u4ed5\u69d8\u66f8\u3068\u5165\u672d\u66f8\u985e\u3092\u542b\u3080\u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306e\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/p>

      \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u3054\u8cea\u554f<\/h2>

      \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>

      DQ\u3068\u306f\u3001\u65bd\u8a2d\u3001\u30b7\u30b9\u30c6\u30e0\u3001\u8a2d\u5099\u306e\u8a08\u753b\u3055\u308c\u305f\u8a2d\u8a08\u304c\u3001\u610f\u56f3\u3057\u305f\u4f7f\u7528\u76ee\u7684\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u5b9f\u8a3c\u3059\u308b\u3053\u3068\u3067\u3059\uff08EU-GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 Annex 15\uff09\u3002<\/p>

      DQ\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u30b9\u30c6\u30c3\u30d7\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/h3>

      DQ\u8a08\u753b\u66f8\u3001\u9032\u3081\u65b9\u306e\u8a18\u8ff0\u3001\u8981\u6c42\u4ed5\u69d8\u66f8\u307e\u305f\u306f\u5165\u672d\u66f8\u985e\u3001\u30ea\u30b9\u30af\u5206\u6790\u306e\u53cd\u6620\u3001\u6a5f\u80fd\u4ed5\u69d8\u66f8\u30fb\u8a2d\u8a08\u56f3\u66f8\u30fb\u6a5f\u80fd\u8a18\u8ff0\u66f8\u3068\u8981\u6c42\u4ed5\u69d8\u66f8\u3068\u306e\u7167\u5408\u3001\u305d\u3057\u3066\u6587\u66f8\u5316\u3068\u627f\u8a8d\u306a\u3069\u3067\u3059\u3002<\/p>

      \u306a\u305c\u30ea\u30b9\u30af\u5206\u6790\u3092DQ\u306e\u524d\u306b\u884c\u3046\u306e\u3067\u3059\u304b\uff1f<\/h3>

      \u8a2d\u8a08\u524d\u306b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u8a2d\u8a08\u306b\u53cd\u6620\u3055\u305b\u308b\u305f\u3081\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u30d7\u30ed\u30bb\u30b9\u5b89\u5168\u6027\u304c\u9ad8\u307e\u308a\u3001\u30a8\u30e9\u30fc\u8981\u56e0\u3092\u4e8b\u524d\u306b\u307b\u307c\u6392\u9664\u3067\u304d\u307e\u3059\u3002<\/p>

      DQ\u306e\u6b21\u306f\u4f55\u3092\u884c\u3044\u307e\u3059\u304b\uff1f<\/h3>

      DQ\u306b\u7d9a\u3044\u3066\u3001\u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u3001\u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u3001\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09\u3092\u884c\u3044\u307e\u3059\u3002<\/p>

      \u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044<\/h2>
      \u8a2d\u8a08\u6642\u9069\u683c\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u304a\u6c17\u8efd\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002\u304a\u96fb\u8a71\uff1a +49 4203 789492<\/a> \u3001\u307e\u305f\u306f\u30e1\u30fc\u30eb\uff1a info@s-vt.net<\/a>.<\/div>
      \u304a\u554f\u3044\u5408\u308f\u305b\u3092\u9001\u4fe1<\/a>\u30b5\u30fc\u30d3\u30b9\u4e00\u89a7<\/a><\/div><\/div>

      \u305d\u306e\u4ed6\u306e\u30b5\u30fc\u30d3\u30b9<\/h2>
      \u8a08\u753b<\/span><\/i><\/a>\u30d9\u30fc\u30b7\u30c3\u30af\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0<\/span><\/i><\/a>\u8a2d\u8a08\u652f\u63f4<\/span><\/i><\/a>\u8abf\u9054\u652f\u63f4<\/span><\/i><\/a>\u30d7\u30ed\u30bb\u30b9\u30d7\u30e9\u30f3\u30c8\u306e\u8981\u6c42\u4ed5\u69d8\u66f8<\/span><\/i><\/a>\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u8a08\u753b\u30fb\u7ba1\u7406<\/span><\/i><\/a>\u65bd\u5de5\u76e3\u7406<\/span><\/i><\/a>IQ \u2013 \u8a2d\u5099\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/span><\/i><\/a>OQ \u2013 \u904b\u8ee2\u6642\u9069\u683c\u6027\u8a55\u4fa1<\/span><\/i><\/a>PQ \u2013 \u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1<\/span><\/i><\/a>\u30d7\u30ed\u30bb\u30b9\u6700\u9069\u5316<\/span><\/i><\/a><\/div>