{"id":19422,"date":"2026-11-11T23:07:03","date_gmt":"2026-11-11T22:07:03","guid":{"rendered":"https:\/\/www.s-vt.net\/dq-%e8%ae%be%e8%ae%a1%e7%a1%ae%e8%ae%a4%ef%bc%88design-qualification%ef%bc%89\/"},"modified":"2026-11-11T23:34:49","modified_gmt":"2026-11-11T22:34:49","slug":"design-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/zh\/design-qualification\/","title":{"rendered":"DQ \u2013 \u8bbe\u8ba1\u786e\u8ba4\uff08Design Qualification\uff09"},"content":{"rendered":"

\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\u662f\u4ee5\u4e66\u9762\u5f62\u5f0f\u8bc1\u660e\uff1a\u8bbe\u65bd\u3001\u7cfb\u7edf\u548c\u8bbe\u5907\u7684\u8ba1\u5212\u8bbe\u8ba1\u9002\u7528\u4e8e\u9884\u5b9a\u7528\u9014\u3002<\/p>

<\/i>\u4e66\u9762\u8bc1\u660e<\/strong>\u8bbe\u8ba1\u4e0e\u7528\u9014\u7ecf\u8fc7\u53ef\u8ffd\u6eaf\u7684\u6bd4\u5bf9\u3002<\/span><\/div>
<\/i>\u9884\u5148\u98ce\u9669\u5206\u6790<\/strong>\u5728\u8bbe\u8ba1\u5b9a\u578b\u4e4b\u524d\u8bc6\u522b\u98ce\u9669\u3002<\/span><\/div>
<\/i>\u7528\u6237\u9700\u6c42\u8bf4\u660e\u4e0e\u529f\u80fd\u89c4\u683c\u8bf4\u660e<\/strong>\u4e0e\u4f9b\u5e94\u5546\u6587\u4ef6\u8fdb\u884c\u7cfb\u7edf\u6bd4\u5bf9\u3002<\/span><\/div><\/div>

\u8bbe\u8ba1\u786e\u8ba4\u7684\u5b9a\u4e49<\/h2>
<\/i>

GMP Aide-M\u00e9moire<\/h3>

\u201c\u4ee5\u4e66\u9762\u5f62\u5f0f\u8bc1\u660e\uff1a\u8bbe\u65bd\u3001\u7cfb\u7edf\u548c\u8bbe\u5907\u7684\u8ba1\u5212\u8bbe\u8ba1\u9002\u7528\u4e8e\u9884\u5b9a\u7528\u9014\u3002\u201d\uff08\u836f\u54c1\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\u4e2d\u7684\u786e\u8ba4\u4e0e\u9a8c\u8bc1\u68c0\u67e5\uff09<\/p><\/div>

<\/i>

\u6b27\u76df GMP \u6307\u5357\u9644\u5f55 15<\/h3>

\u201c\u4ee5\u4e66\u9762\u5f62\u5f0f\u9a8c\u8bc1\uff1a\u4e3a\u8bbe\u65bd\u3001\u7cfb\u7edf\u548c\u8bbe\u5907\u62df\u5b9a\u7684\u8bbe\u8ba1\u9002\u7528\u4e8e\u9884\u5b9a\u7528\u9014\u3002\u201d<\/p><\/div><\/div>

DQ \u4e4b\u524d\u7684\u98ce\u9669\u5206\u6790<\/h2>

\u5728\u8bbe\u8ba1\u786e\u8ba4\u4e4b\u524d\uff0c\u901a\u5e38\u4f1a\u5bf9\u9879\u76ee\u8fdb\u884c\u5168\u9762\u7684\u98ce\u9669\u5206\u6790\u3002\u5b83\u53ef\u4ee5\u5728\u8bbe\u8ba1\u4e4b\u524d\u63ed\u793a\u98ce\u9669\uff0c\u4ee5\u4fbf\u5728\u8bbe\u8ba1\u9636\u6bb5\u5c31\u5bf9\u5176\u52a0\u4ee5\u6743\u8861\u548c\u8003\u8651\u3002\u8fd9\u80fd\u786e\u4fdd\u9ad8\u5ea6\u7684\u5de5\u827a\u5b89\u5168\uff0c\u5e76\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u9884\u5148\u6392\u9664\u53ef\u80fd\u7684\u9519\u8bef\u6765\u6e90\u3002<\/p>

\u8bbe\u8ba1\u786e\u8ba4\u7684\u6b65\u9aa4<\/h2>
  1. 1<\/span>DQ \u8ba1\u5212<\/strong>\u7f16\u5236 DQ \u8ba1\u5212\u3002<\/span><\/li>
  2. 2<\/span>\u5de5\u4f5c\u65b9\u6cd5<\/strong>\u63cf\u8ff0\u5de5\u4f5c\u65b9\u6cd5\u3002<\/span><\/li>
  3. 3<\/span>\u4f5c\u4e1a\u6307\u5bfc\u4e66<\/strong>\u5236\u5b9a\u4f5c\u4e1a\u6307\u5bfc\u4e66\u3002<\/span><\/li>
  4. 4<\/span>\u7528\u6237\u9700\u6c42\u8bf4\u660e<\/strong>\u7f16\u5236 \u7528\u6237\u9700\u6c42\u8bf4\u660e<\/a> \u6216\u62db\u6807\u6587\u4ef6\u3002<\/span><\/li>
  5. 5<\/span>\u98ce\u9669\u5206\u6790<\/strong>\u7eb3\u5165\u98ce\u9669\u5206\u6790\u7ed3\u679c\u3002<\/span><\/li>
  6. 6<\/span>\u6279\u51c6<\/strong>\u53d6\u5f97\u59d4\u6258\u65b9\u7684\u6279\u51c6\u3002<\/span><\/li>
  7. 7<\/span>\u5ba1\u6838\u529f\u80fd\u89c4\u683c\u8bf4\u660e<\/strong>\u5c06\u4f9b\u5e94\u5546\u7684\u529f\u80fd\u89c4\u683c\u8bf4\u660e\u4e0e\u5df2\u6279\u51c6\u7684\u7528\u6237\u9700\u6c42\u8bf4\u660e\u8fdb\u884c\u6bd4\u5bf9\u3002<\/span><\/li>
  8. 8<\/span>\u5ba1\u6838\u7ed3\u6784\u8bbe\u8ba1<\/strong>\u6bd4\u5bf9\u6240\u63d0\u4ea4\u7684\u7ed3\u6784\u8bbe\u8ba1\u6587\u4ef6\u3002<\/span><\/li>
  9. 9<\/span>\u5ba1\u6838\u529f\u80fd<\/strong>\u5c06\u529f\u80fd\u63cf\u8ff0\uff08\u5305\u62ec \u63a7\u5236\u7cfb\u7edf<\/a> \uff09\u4e0e\u7528\u6237\u9700\u6c42\u8bf4\u660e\u8fdb\u884c\u6bd4\u5bf9\u3002<\/span><\/li>
  10. 10<\/span>\u6587\u4ef6\u8bb0\u5f55<\/strong>\u8bb0\u5f55\u5e76\u6279\u51c6\u5b9e\u65bd\u60c5\u51b5\u3002<\/span><\/li><\/ol>

    \u786e\u8ba4\u6d41\u7a0b\u6982\u89c8<\/h2>
    1. 1<\/span>RA \u2013 \u98ce\u9669\u5206\u6790<\/strong>\u5728\u8bbe\u8ba1\u5b9a\u578b\u4e4b\u524d\u8bc6\u522b\u5e76\u8bc4\u4f30\u98ce\u9669\u3002<\/span><\/li>
    2. 2<\/span>DQ \u2013 \u8bbe\u8ba1\u786e\u8ba4\uff08\u672c\u9875\uff09<\/strong>\u8bc1\u660e\u8bbe\u8ba1\u9002\u7528\u4e8e\u9884\u5b9a\u7528\u9014\u3002<\/span><\/li>
    3. 3<\/span>IQ \u2013 \u5b89\u88c5\u786e\u8ba4<\/a><\/strong>\u5bf9\u7167\u8ba2\u8d27\u6587\u4ef6\u68c0\u67e5\u5b89\u88c5\u60c5\u51b5\u3002<\/span><\/li>
    4. 4<\/span>OQ \u2013 \u8fd0\u884c\u786e\u8ba4<\/a><\/strong>\u68c0\u67e5\u9884\u5b9a\u7684\u8fd0\u884c\u529f\u80fd\u3002<\/span><\/li>
    5. 5<\/span>PQ \u2013 \u6027\u80fd\u786e\u8ba4<\/a><\/strong>\u8bc1\u660e\u8fd0\u884c\u4e2d\u8fbe\u5230\u6240\u8981\u6c42\u7684\u6027\u80fd\u3002<\/span><\/li><\/ol>
      \u7ee7\u7eed\u9605\u8bfb\uff1aIQ \u2013 \u5b89\u88c5\u786e\u8ba4 <\/i><\/a><\/div>

      \u6211\u4eec SEEFRIED Verfahrenstechnik GmbH<\/strong> \u5c06\u4e0e\u60a8\u5171\u540c\u7f16\u5236\u8bbe\u8ba1\u786e\u8ba4\u6587\u4ef6\u2014\u2014\u5305\u62ec\u7528\u6237\u9700\u6c42\u8bf4\u660e\u548c\u62db\u6807\u6587\u4ef6\u3002<\/p>

      \u5173\u4e8e\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\u7684\u5e38\u89c1\u95ee\u9898<\/h2>

      \u4ec0\u4e48\u662f\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\uff1f<\/h3>

      DQ \u662f\u4ee5\u4e66\u9762\u5f62\u5f0f\u8bc1\u660e\uff1a\u8bbe\u65bd\u3001\u7cfb\u7edf\u548c\u8bbe\u5907\u7684\u8ba1\u5212\u8bbe\u8ba1\u9002\u7528\u4e8e\u9884\u5b9a\u7528\u9014\uff08\u6b27\u76df GMP \u6307\u5357\u9644\u5f55 15\uff09\u3002<\/p>

      DQ \u5305\u62ec\u54ea\u4e9b\u6b65\u9aa4\uff1f<\/h3>

      \u5305\u62ec DQ \u8ba1\u5212\u3001\u5de5\u4f5c\u65b9\u6cd5\u63cf\u8ff0\u3001\u7528\u6237\u9700\u6c42\u8bf4\u660e\u6216\u62db\u6807\u6587\u4ef6\u3001\u7eb3\u5165\u98ce\u9669\u5206\u6790\u3001\u5c06\u529f\u80fd\u89c4\u683c\u8bf4\u660e\u3001\u7ed3\u6784\u8bbe\u8ba1\u6587\u4ef6\u548c\u529f\u80fd\u63cf\u8ff0\u4e0e\u7528\u6237\u9700\u6c42\u8bf4\u660e\u8fdb\u884c\u6bd4\u5bf9\uff0c\u4ee5\u53ca\u6587\u4ef6\u8bb0\u5f55\u548c\u6279\u51c6\u7b49\u3002<\/p>

      \u4e3a\u4ec0\u4e48\u98ce\u9669\u5206\u6790\u8981\u5728 DQ \u4e4b\u524d\u8fdb\u884c\uff1f<\/h3>

      \u5b83\u53ef\u4ee5\u5728\u8bbe\u8ba1\u4e4b\u524d\u8bc6\u522b\u98ce\u9669\uff0c\u4ee5\u4fbf\u5728\u8bbe\u8ba1\u4e2d\u52a0\u4ee5\u8003\u8651\u3002\u8fd9\u80fd\u63d0\u9ad8\u5de5\u827a\u5b89\u5168\uff0c\u5e76\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u9884\u5148\u6392\u9664\u9519\u8bef\u6765\u6e90\u3002<\/p>

      DQ \u4e4b\u540e\u5982\u4f55\u8fdb\u884c\uff1f<\/h3>

      DQ \u4e4b\u540e\u4f9d\u6b21\u8fdb\u884c\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u3001\u8fd0\u884c\u786e\u8ba4\uff08OQ\uff09\u548c\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u3002<\/p>

      \u8bf7\u8054\u7cfb\u6211\u4eec<\/h2>
      \u5982\u9700\u8bbe\u8ba1\u786e\u8ba4\u65b9\u9762\u7684\u54a8\u8be2\uff0c\u6b22\u8fce\u81f4\u7535 +49 4203 789492<\/a> \u6216\u53d1\u9001\u7535\u5b50\u90ae\u4ef6\u81f3 info@s-vt.net<\/a>.<\/div>
      \u53d1\u9001\u8be2\u4ef7<\/a>\u5168\u90e8\u670d\u52a1<\/a><\/div><\/div>

      \u66f4\u591a\u670d\u52a1<\/h2>
      \u89c4\u5212<\/span><\/i><\/a>\u57fa\u7840\u5de5\u7a0b\u8bbe\u8ba1<\/span><\/i><\/a>\u8bbe\u8ba1\u652f\u6301<\/span><\/i><\/a>\u91c7\u8d2d\u652f\u6301<\/span><\/i><\/a>\u5de5\u827a\u8bbe\u5907\u7528\u6237\u9700\u6c42\u8bf4\u660e\uff08URS\uff09<\/span><\/i><\/a>\u8fdb\u5ea6\u89c4\u5212\u4e0e\u63a7\u5236<\/span><\/i><\/a>\u65bd\u5de5\u76d1\u7406<\/span><\/i><\/a>IQ \u2013 \u5b89\u88c5\u786e\u8ba4<\/span><\/i><\/a>OQ \u2013 \u8fd0\u884c\u786e\u8ba4<\/span><\/i><\/a>PQ \u2013 \u6027\u80fd\u786e\u8ba4<\/span><\/i><\/a>\u5de5\u827a\u4f18\u5316<\/span><\/i><\/a><\/div>