{"id":59820,"date":"2018-11-20T01:00:00","date_gmt":"2018-12-07T02:49:39","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/58bdc2c250\/"},"modified":"2018-12-07T10:49:39","modified_gmt":"2018-12-07T02:49:39","slug":"58bdc2c250","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/59820\/","title":{"rendered":"\u3010\u57f9\u8bad\u4fe1\u606f\u3011\uff08\u5357\u4eac\uff09\u65b0\u6cd5\u89c4\u4e0bICH Q7\u8d28\u91cf\u6280\u672f\u8981\u6c42\u4e13\u9879\u63d0\u9ad8\u73ed"},"content":{"rendered":"
\n

\u200d<\/p>\n


<\/span><\/span><\/p>\n

\u5404\u6709\u5173\u5355\u4f4d\uff1a<\/span><\/strong> <\/span><\/strong><\/p>\n

    \u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u89c4\u5b9a\u56fd\u9645\u534f\u8c03\u4f1a(ICH)\u662f\u6b27\u76df\u3001\u65e5\u672c\u3001\u7f8e\u56fd\u4e09\u65b9\u836f\u54c1\u7ba1\u7406\u5f53\u5c40\u53ca\u4e09\u65b9\u5236\u836f\u4f01\u4e1a\u7ba1\u7406\u673a\u6784\uff0c\u4e8e1990\u5e74\u5171\u540c\u53d1\u8d77\uff0c\u5bf9\u4e09\u65b9\u56fd\u5bb6\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u89c4\u5b9a\u7684\u73b0\u5b58\u5dee\u5f02\u8fdb\u884c\u534f\u8c03\u7684\u56fd\u9645\u534f\u8c03\u7ec4\u7ec7\u30022017\u5e746\u6708CFDA\u52a0\u5165ICH\uff0c\u4e2d\u56fd\u6b63\u5f0f\u8fdb\u5165\u56fd\u9645\u76d1\u7ba1\u4f53\u7cfb\uff0c2018\u5e746\u67087\u65e5\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5ba3\u5e03\uff0c\u65e5\u672c\u5f53\u5730\u65f6\u95f46\u67087\u65e5\u4e0b\u53481\u70b930\u5206\uff0c\u5728\u65e5\u672c\u795e\u6237\u4e3e\u884c\u7684\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff092018\u5e74\u7b2c\u4e00\u6b21\u5927\u4f1a\u4e0a\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5f53\u9009\u4e3aICH\u7ba1\u7406\u59d4\u5458\u4f1a\u6210\u5458\u3002ICH\u7ba1\u59d4\u4f1a\u662fICH\u7684\u7ba1\u7406\u548c\u51b3\u7b56\u673a\u6784\uff0c\u52a0\u5165\u7ba1\u59d4\u4f1a\u4e0d\u4ec5\u6709\u5229\u4e8e\u52a9\u63a8\u6211\u56fd\u836f\u54c1\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\uff0c\u4e5f\u6709\u5229\u4e8e\u6269\u5927ICH\u89c4\u5219\u56fd\u9645\u5f71\u54cd\uff0c\u52a0\u5feb\u5b9e\u73b0\u836f\u54c1\u53ef\u53ca\u6027\uff0c\u63a8\u52a8\u4e2d\u5916\u533b\u836f\u4ea7\u4e1a\u4ea4\u6d41\uff0c\u662f\u4e00\u9879\u53cc\u8d62\u4e92\u5229\u7684\u5de5\u4f5c\u3002\u6b64\u6b21\uff0c\u56fd\u5bb6\u836f\u76d1\u5c40\u83b7\u5f97ICH\u7ba1\u59d4\u4f1a\u6210\u5458\u8d44\u683c\uff0c\u5f97\u5230ICH\u7ba1\u59d4\u4f1a\u548cICH\u5168\u4f53\u5927\u4f1a\u7684\u786e\u8ba4\u3002<\/span><\/strong><\/p>\n

    \u76ee\u524d\u539f\u6599\u836f\u7f8e\u56fdFDA\u548c\u6b27\u6d32EDQM\u4ee5\u53ca\uff0cPIC\/S\u7ec4\u7ec7\u8fdb\u884c\u7684\u73b0\u573a\u68c0\u67e5\u7684\u6807\u51c6\u5747\u4e3aICH Q7\u7684\u8981\u6c42\uff0c\u4e3a\u4e86\u66f4\u597d\u5730\u7814\u7a76ICH\u6709\u5173\u6280\u672f\u6587\u4ef6\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u539f\u6599\u836fQ7\u7684\u8981\u6c42\uff0c\u6211\u5355\u4f4d\u5b9a\u4e8e2018\u5e7412\u670816\u65e5\u81f318\u65e5\u5728\u5357\u4eac\u5e02\u4e3e\u529e\u201cICH Q7\u2014\u8d28\u91cf\u6280\u672f\u4e13\u9879\u8981\u6c42\u63d0\u9ad8\u4e0e\u5b8c\u5584\u9ad8\u7ea7\u7814\u4fee\u73ed \u201d\uff0c\u5c4a\u65f6\u5c06\u9080\u8bf7\u6743\u5a01\u4e13\u5bb6\u5728\u4f1a\u4e0a\u4e0e\u5927\u5bb6\u5206\u4eab\u4ed6\u4eec\u7684\u77e5\u8bc6\u3001\u7ecf\u9a8c\u3001\u89c2\u5bdf\u3001\u8ba4\u8bc6\u7b49\u770b\u6cd5\u3002\u76f8\u5173\u4e8b\u9879\u5982\u4e0b\uff1a<\/span><\/strong><\/p>\n


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

\u4e00\u3001\u65f6\u95f4\u5730\u70b9<\/span><\/strong><\/p>\n

   \u4f1a\u8bae\u65f6\u95f4\uff1a2018\u5e7412\u670816\u65e5-18\u65e5\uff0816\u65e5\u5168\u5929\u62a5\u5230\uff09<\/span><\/strong><\/p>\n

   \u62a5\u5230\u5730\u70b9\uff1a\u5357\u4eac\u5e02\uff08\u5177\u4f53\u5730\u70b9\u57f9\u8bad\u524d\u4e24\u5468\u901a\u77e5\u62a5\u540d\u4f01\u4e1a\uff09<\/span><\/strong><\/p>\n

   <\/span><\/strong>\u652f\u6301\u5355\u4f4d\uff1a\u9752\u5c9b\u79d1\u521b\u76f8\u5bb9\u6027\u7814\u7a76\u4e2d\u5fc3\uff08\u9ad8\u5206\u5b50\u6750\u6599\u4e13\u5bb6\u5de5\u4f5c\u7ad9\uff09<\/span><\/strong><\/p>\n


<\/p>\n

\u4e8c\u3001\u4f1a\u8bae\u4e3b\u8981\u7814\u8ba8\u5185\u5bb9\u53ca\u4e3b\u8bb2\u8001\u5e08<\/span><\/p>\n

    \u5185\u5bb9\u8be6\u89c1\u9644\u4ef6\u4e00\uff08\u8bfe\u7a0b\u5b89\u6392\u8868<\/span>\uff09<\/span><\/p>\n

    \u674e\u8001\u5e08\uff1a<\/span><\/p>\n

    \u4e13\u6ce8\u4e8e\u4e2d\u56fd\u4e0e\u6b27\u7f8e\u533b\u836f\u6cd5\u89c4\uff0c\u7279\u522b\u662fGMP\u7b26\u5408\u6027\u7814\u7a76\u3001DMF\u548cCOS\/CEP\u6587\u4ef6\u7f16\u5199\u3001 FDA,EDQM\u73b0\u573a\u7b26\u5408\u6027\u68c0\u67e5\u3002\u7f16\u5199DMF\u548cCEP\u6587\u4ef6\u8d85\u8fc760\u4e2a\u6587\u4ef6\u3002\u5bf9\u4e8eDMF\u6587\u4ef6\u7f16\u5236\uff0cCEP\u6587\u4ef6\u7f16\u5236\u548cGMP\u53ca\u539f\u6599\u836fICH Q7\u6709\u6df1\u5165\u7684\u7814\u7a76\u3002\u4e3a\u6e56\u5357\u836f\u76d1\u5c40\u3001\u4e91\u5357\u7701\u836f\u76d1\u5c40\u7b49\u591a\u6b21\u57f9\u8bad\uff0cCFDA\u5916\u8058\u8bb2\u5e08\u3002\u5929\u6d25\u5927\u5b66\u5236\u836f\u5de5\u7a0b\u7855\u58eb\u73ed\u4e13\u804c\u8bb2\u5e08\u3002\u534f\u4f1a\u7279\u8058\u4e13\u5bb6\u3002<\/span><\/p>\n


<\/span>\u4e09\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/p>\n

     \u5236\u836f\u4f01\u4e1a\u3001\u7814\u7a76\u9662\uff08\u6240\uff09\u7b49\u76f8\u5173\u5355\u4f4d\u7684\u6ce8\u518c\u7ecf\u7406\/\u4e13\u5458\u3001QA\u7ecf\u7406\/\u4e3b\u7ba1\u3001QC\u7ecf\u7406\/\u4e3b\u7ba1\u3001\u57f9\u8bad\u4e3b\u7ba1\/\u4e13\u5458\u3001\u751f\u4ea7\u7ecf\u7406\/\u4e3b\u7ba1\/\u6280\u672f\u5458\u3001\u56fd\u9645\u8ba4\u8bc1\u534f\u8c03\u5458\/\u4e13\u5458\u3001\u6587\u4ef6\u7ba1\u7406\u5458\/\u4e13\u5458\u3001\u6cd5\u89c4\u4e8b\u52a1\u7ecf\u7406\/\u4e13\u5458\u3001\u5206\u6790\u7ecf\u7406\/\u4e13\u5458\u3001\u836f\u54c1\u6807\u51c6\u53d1\u5c55\u7ecf\u7406\/\u4e13\u5458\u3001\u56fd\u9645\u6ce8\u518c\u4e13\u5458\u3001\u751f\u4ea7\u90e8\u6280\u672f\u5de5\u7a0b\u5e08\u7b49\u3002<\/span><\/p>\n


<\/span>\u56db\u3001<\/span><\/strong>\u4f1a\u8bae\u8bf4\u660e<\/span><\/strong><\/p>\n

       1\u3001\u7406\u8bba\u8bb2\u89e3,\u5b9e\u4f8b\u5206\u6790,\u4e13\u9898\u8bb2\u6388,\u4e92\u52a8\u7b54\u7591.<\/span><\/p>\n

       2\u3001\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005\u7531\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66<\/span><\/p>\n

       3\u3001\u4f01\u4e1a\u9700\u8981\u5185\u8bad\u548c\u6307\u5bfc\uff0c\u8bf7\u4e0e\u4f1a\u52a1\u7ec4\u8054\u7cfb<\/span><\/p>\n

      <\/span><\/strong><\/p>\n

<\/span><\/strong>\u4e94\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/p>\n

       \u4f1a\u52a1\u8d39\uff1a2500\u5143\/\u4eba\uff1b\uff08\u4f1a\u52a1\u8d39\u5305\u62ec\uff1a\u57f9\u8bad\u3001\u7814\u8ba8\u3001\u8d44\u6599\u7b49\uff09\u3002\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/p>\n


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

\u516d\u3001\u8054\u7cfb\u65b9\u5f0f<\/span><\/strong><\/p>\n

        \u7535\u8bdd\uff1a15652565785         \u4f20 \u771f\uff1a010-63811998 <\/span><\/p>\n

        \u8054 \u7cfb \u4eba: \u5c1a  \u4e39          \u90ae \u7bb1\uff1a2331466365@qq.com<\/span><\/p>\n

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

    \u9644\u4ef6\u4e00\uff1a\u65e5\u7a0b\u5b89\u6392\u8868<\/span><\/p>\n

    \u9644\u4ef6\u4e8c\uff1a\u53c2\u4f1a\u62a5\u540d\u8868<\/span><\/p>\n

                             <\/span><\/span> <\/span><\/span>                        <\/span><\/span><\/p>\n

\u5317\u4eac\u534e\u590f\u51ef\u665f\u533b\u836f\u6280\u672f\u4e2d\u5fc3<\/span><\/strong><\/p>\n

                                   2018<\/span><\/strong>\u5e7411\u67088\u53f7<\/span><\/strong><\/p>\n

    <\/span>   <\/span><\/span><\/p>\n

\u9644\u4ef6\u4e00\uff1a\u65e5\u7a0b\u5b89\u6392<\/span><\/p>\n


<\/span><\/p>\n\n\n\n\n
\n

\u4e0a\u53489.00-12.00<\/span><\/strong><\/p>\n

\u4e0b\u5348<\/span><\/strong><\/p>\n

1.30-17.00<\/span><\/strong><\/p>\n<\/td>\n

\n

\u4e00\u3001ICH\u7ec4\u7ec7\u5efa\u7acb\u7684\u5386\u53f2\u53ca\u53d1\u5c55<\/span><\/strong><\/p>\n

ICH<\/span><\/strong>\u5386\u53f2\u56de\u987e\u4e0e\u6539\u9769 \u6210\u5458\u4e0e\u89c2\u5bdf\u5458<\/span><\/strong><\/p>\n

\u7ec4\u7ec7\u67b6\u6784\uff1a\u59d4\u5458\u4f1a\u3001\u4e13\u5bb6\u5de5\u4f5c\u7ec4\u53ca\u79d8\u4e66\u5904<\/span><\/strong><\/p>\n

ICH<\/span><\/strong>\u6307\u5bfc\u539f\u5219\u7684\u5236\u8ba2\u5b9e\u65bd\u7a0b\u5e8f  ICH\u73b0\u6709\u6307\u5bfc\u539f\u5219\u6982\u8ff0<\/span><\/strong><\/p>\n

\u4e8c\u3001<\/span><\/strong>Q7A <\/span><\/strong>\u836f\u7269\u6d3b\u6027\u6210\u5206\u7684GMP\u6307\u5357<\/span><\/strong><\/p>\n

1.<\/span><\/strong>ICH Q7<\/span><\/strong>\u7684\u91cd\u8981\u6027<\/span><\/strong><\/p>\n

1.1 FDA<\/span><\/strong>\u73b0\u573a\u68c0\u67e5\u4f9d\u636e\uff0c\u6807\u51c6\uff0c\u6d41\u7a0b\uff0c\u68c0\u67e5\u65f6\u95f4\uff0c\u68c0\u67e5\u7684\u8303\u56f4\uff1b<\/span><\/strong><\/p>\n

1.2 <\/span><\/strong>\u6b27\u76dfEDQM\u73b0\u573a\u68c0\u67e5\u4f9d\u636e\uff0c\u6807\u51c6\uff0c\u6d41\u7a0b\uff0c\u68c0\u67e5\u65f6\u95f4\uff0c\u68c0\u67e5\u7684\u8303\u56f4\uff1b<\/span><\/strong><\/p>\n

2.<\/span><\/strong>\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u548c\u754c\u5b9a\uff0c\u751f\u4ea7\u7684\u5b9a\u4e49\uff1b<\/span><\/strong><\/p>\n

3.<\/span><\/strong>QA<\/span><\/strong>\u90e8\u95e8\u7684\u804c\u8d23\uff0c\u5982\u4f55\u505a\u597dQA\u4eba\u5458\uff1b\u536b\u751f\u5065\u5eb7\u8981\u6c42<\/span><\/strong><\/p>\n

\u504f\u5dee\u7ba1\u7406\u8981\u6c42\uff1b\u53d8\u66f4\u63a7\u5236\u8981\u6c42\uff1b\u5e74\u5ea6\u8d28\u91cf\u56de\u987e\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

4.<\/span><\/strong>\u5382\u623f\u8bbe\u65bd\u7684\u57fa\u672c\u8981\u6c42\uff0c\u516c\u7528\u5de5\u7a0b\u7684\u8bbe\u8ba1\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

4.1 <\/span><\/span><\/strong>\u7a7a\u8c03\u51c0\u5316\u7cfb\u7edf\u7684\u8bbe\u8ba1\u8981\u6c42\uff0c\u9a8c\u8bc1\uff1b<\/span><\/strong><\/p>\n

4.2 <\/span><\/span><\/strong>\u7eaf\u5316\u6c34\u548c\u6ce8\u5c04\u7528\u6c34\u7684\u8bbe\u8ba1\u8981\u6c42\uff0c\u98ce\u9669\u8bc4\u4f30\u548c\u9a8c\u8bc1\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

4.3 <\/span><\/span><\/strong>\u538b\u7f29\u7a7a\u6c14\u7cfb\u7edf\u7684\u8bbe\u8ba1\u8981\u6c42\uff0c\u98ce\u9669\u8bc4\u4f30\u548c\u9a8c\u8bc1\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

5.<\/span><\/strong>\u8bbe\u5907\u7ba1\u7406\u7684\u8981\u6c42<\/span><\/strong><\/p>\n

\u8bbe\u8ba1\u4e0e\u7ed3\u6784\u8981\u6c42\uff1b\u8bbe\u5907\u7684\u9884\u9632\u7ef4\u62a4\u4fdd\u517b\u8981\u6c42\uff1b\u6821\u9a8c\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u8bbe\u5907\u7684\u6e05\u6d01\u53ca\u6e05\u6d01\u9a8c\u8bc1\u8981\u6c42\uff1b\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7ba1\u7406\u548c\u9a8c\u8bc1\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

6.<\/span><\/strong>\u6587\u4ef6\u548c\u8bb0\u5f55\u7ba1\u7406<\/span><\/strong><\/p>\n

\u5982\u679c\u505a\u5230\u7b26\u5408cGMP\u8981\u6c42\u7684\u6587\u4ef6\u548c\u8bb0\u5f55\uff1b<\/span><\/strong><\/p>\n

\u6587\u4ef6\u548c\u8bb0\u5f55\u7684\u7f16\u7801\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u6587\u4ef6\u548c\u8bb0\u5f55\u7684\u4fdd\u5b58\u6761\u4ef6\u548c\u65f6\u95f4\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u8bb0\u5f55\u7684\u586b\u5199\u89c4\u8303\uff1b<\/span><\/strong><\/p>\n

\u6570\u636e\u5b8c\u6574\u6027\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

7.<\/span><\/strong>\u7269\u6599\u7ba1\u7406\u7684\u8981\u6c42<\/span><\/strong><\/p>\n

\u7269\u6599\u7684\u9a8c\u6536\uff0c\u53f0\u79e4\u7684\u65e5\u6821\u9a8c\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4ed3\u5e93\u7684\u866b\u5bb3\u63a7\u5236\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4ed3\u5e93\u7684\u53d6\u6837\u8981\u6c42\uff0c\u53d6\u6837\u95f4\u7684\u8bbe\u8ba1\u53ca\u89c4\u8303\uff1b<\/span><\/strong><\/p>\n

\u4ed3\u5e93\u7684\u65e5\u5e38\u6e29\u6e7f\u5ea6\u63a7\u5236\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4ed3\u5e93\u7684\u53d1\u6599\uff0c\u8d27\u4f4d\u5361\uff0c\u73b0\u573a\u72b6\u6001\u6807\u8bc6\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4e0d\u5408\u683c\u54c1\u5e93\u7684\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e0a\u53489.00-12.00<\/span><\/strong><\/p>\n

\u4e0b\u5348<\/span><\/strong><\/p>\n

1.30-17.00<\/span><\/strong><\/p>\n<\/td>\n

\n

8.<\/span><\/strong>\u751f\u4ea7\u548c\u8fc7\u7a0b\u63a7\u5236\u8981\u6c42<\/span><\/strong><\/p>\n

\u751f\u4ea7\u6279\u53f7\u7684\u7ba1\u7406\uff0c\u5982\u4f55\u786e\u5b9a\u751f\u4ea7\u65e5\u671f\uff1b<\/span><\/strong><\/p>\n

\u751f\u4ea7\u5173\u952e\u64cd\u4f5c\u7684\u5b9a\u4e49\u548c\u65e5\u5e38\u7ba1\u7406\uff0c\u73b0\u573a\u786c\u4ef6\u7684\u8981\u6c42\uff1a<\/span><\/strong><\/p>\n

\u79f0\u91cf\uff0c\u914d\u6599\uff0c\u79bb\u5fc3\uff0c\u5e72\u71e5\uff0c\u6df7\u5408\u7b49\u64cd\u4f5c\uff1b<\/span><\/strong><\/p>\n

\u751f\u4ea7\u65f6\u9650\u8981\u6c42\uff1b\u8fc7\u7a0b\u53d6\u6837\u548c\u8fc7\u7a0b\u63a7\u5236\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4e2d\u95f4\u4f53\u548cAPI\u7684\u6279\u6df7\u5408\uff1b\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u7684\u63aa\u65bd<\/span><\/strong><\/p>\n

9.<\/span><\/strong>\u5305\u88c5\u548c\u8d34\u7b7e\u7684\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u5982\u4f55\u8fdb\u884c\u5206\u5305\u88c5\uff1b<\/span><\/strong><\/p>\n

\u81ea\u5236\u6807\u7b7e\u5982\u4f55\u7ba1\u7406\uff0c\u551b\u5934\u5982\u4f55\u63a7\u5236\uff1b<\/span><\/strong><\/p>\n

\u5206\u88c5\u64cd\u4f5c\u7684\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

10.<\/span><\/strong>\u4e2d\u95f4\u4f53\u548c\u539f\u6599\u836f\u7684\u9500\u552e\u7ba1\u7406<\/span><\/strong><\/p>\n

11.<\/span><\/strong>\u5b9e\u9a8c\u5ba4QC\u7cfb\u7edf\u8981\u6c42<\/span><\/strong><\/p>\n

\u53d6\u6837\u8981\u6c42\uff1b\u6837\u54c1\u7ba1\u7406\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u8d28\u91cf\u6807\u51c6\u7684\u5236\u5b9a\uff1b<\/span><\/strong><\/p>\n

OOS\u3001OOT\u7684\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u68c0\u9a8c\u62a5\u544a\u5355\u7ba1\u7406COA\u683c\u5f0f\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u7a33\u5b9a\u6027\u8bd5\u9a8c\u8981\u6c42\uff0c\u786c\u4ef6\u548c\u8bb0\u5f55\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u7559\u6837\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u6807\u51c6\u54c1\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u5fae\u751f\u7269\u68c0\u9a8c\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

\u4eba\u5458\u57f9\u8bad\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

12.<\/span><\/strong>\u9a8c\u8bc1\u8981\u6c42\uff08\u5de5\u827a\u9a8c\u8bc1\u8981\u6c42\uff1b\u6e05\u6d01\u9a8c\u8bc1\u8981\u6c42\uff1b\uff09<\/span><\/strong><\/p>\n

13.<\/span><\/strong>\u8fd4\u5de5\u548c\u91cd\u52a0\u5de5<\/span><\/strong><\/p>\n

\u8fd4\u5de5\u8981\u6c42\uff1b\u6bcd\u6db2\u5904\u7406\u8981\u6c42\uff1b\u56de\u6536\u6eb6\u5242\u8981\u6c42\uff1b\u56de\u6536\u6bcd\u6db2\u7684\u8981\u6c42\u53ca\u6ce8\u518c\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

14.<\/span><\/strong>\u5408\u540c\u751f\u4ea7\u5546\u548c\u5408\u540c\u5b9e\u9a8c\u5ba4\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

15.<\/span><\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u7528API\u7684\u7279\u6b8a\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n

ICH QA<\/span><\/strong>\u7cfb\u7edf\u7684\u95ee\u9898\u4e0e\u56de\u7b54\u3002<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u9644\u4ef6\u4e8c\uff1a<\/span><\/strong><\/p>\n

\u65b0\u6cd5\u89c4\u4e0bICH Q7-\u8d28\u91cf\u6280\u672f\u4e13\u9879\u8981\u6c42\u63d0\u9ad8\u4e0e\u5b8c\u5584\u9ad8\u7ea7\u7814\u4fee\u73ed–\u56de\u6267\u8868\uff08<\/span><\/strong>\u56e0\u53c2\u4f1a\u540d\u989d\u6709\u9650\u8bf7\u5c3d\u5feb\u56de\u6267\uff09<\/span><\/span><\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u5355\u4f4d\u540d\u79f0<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u90ae \u7f16<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

\u901a\u8baf\u5730\u5740<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

\u8054 \u7cfb \u4eba<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u90e8  \u95e8<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u804c\u79f0<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

\u624b   \u673a<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u7535  \u8bdd<\/span><\/p>\n<\/td>\n

<\/td>\n\n

\u4f20\u771f<\/span><\/p>\n<\/td>\n

<\/td>\n<\/tr>\n
\n

\u53c2\u4f1a \u4ee3  \u8868 \u767b\u8bb0<\/span><\/p>\n<\/td>\n

\n

\u59d3 \u540d<\/span><\/p>\n<\/td>\n

\n

\u6027 \u522b<\/span><\/p>\n<\/td>\n

\n

\u804c\u52a1\/\u79f0<\/span><\/p>\n<\/td>\n

\n

 <\/span>\u624b   \u673a<\/span><\/p>\n<\/td>\n

\n

      <\/span>\u7535 \u5b50 \u90ae \u7bb1<\/span><\/p>\n<\/td>\n<\/tr>\n

<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/td>\n<\/tr>\n
\n

\u4f4f\u5bbf\u8981\u6c42\uff1a  \u5355\u95f4\u25a1<\/strong>    \u5408\u4f4f\u25a1<\/strong>   \u4e0d\u7528\u5b89\u6392\u25a1<\/strong>     <\/span><\/p>\n<\/td>\n

\n

\u662f\u5426\u9700\u8981\u5c55\u4f4d\uff1a \u662f\u25cb \u5426\u25cb<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53d1\u7968\u4e8b\u5b9c<\/span><\/p>\n<\/td>\n

\n

\u53d1\u7968\u5355\u4f4d\u540d\u79f0:<\/span><\/p>\n

\u589e\u503c\u7a0e\u666e\u7968\u7eb3\u7a0e\u4eba\u8bc6\u522b\u53f7\uff1a<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53d1\u7968\u9879\u76ee\uff1a   \u25a1\u57f9\u8bad\u8d39     \u25a1\u4f1a\u52a1\u8d39<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9700\u4e86\u89e3\u7684\u95ee\u9898\uff1a<\/span><\/strong><\/p>\n

1<\/span><\/strong>\u3001<\/span><\/strong><\/p>\n

2<\/span><\/strong>\u3001<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u6307\u5b9a\u6536\u6b3e\u8d26\u6237\uff1a<\/span><\/strong><\/p>\n

\u6237  \u540d\uff1a\u5317\u4eac\u665f\u52cb\u708e\u56fd\u9645\u4f1a\u8bae\u670d\u52a1\u4e2d\u5fc3<\/span><\/strong><\/p>\n

\u5f00\u6237\u884c\uff1a\u4e2d\u56fd\u5de5\u5546\u94f6\u884c\u5317\u4eac\u7389\u6cc9\u8def\u652f\u884c<\/span><\/strong><\/p>\n

\u8d26  \u53f7\uff1a020 006 301 920  003 3830  <\/span><\/strong><\/p>\n

\u6c47\u6b3e\u8bf7\u6ce8\u660e:\u5357\u4eacICH Q7-\u8d28\u91cf\u6280\u672f\u6ce8\u518c\u8d39<\/span><\/strong><\/p>\n<\/td>\n

\n

\u7b7e\u540d\/\u76d6\u7ae0\uff1a<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

\u65e5   \u671f\uff1a<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

1<\/span>\u3001\u8bf7\u60a8\u51c6\u786e\u586b\u5199\u4e0a\u8868\u5404\u9879\u4fe1\u606f,\u4ee5\u4fbf\u4f1a\u52a1\u7ec4\u5236\u4f5c\u4ee3\u8868\u8bc1\u7b49\u76f8\u5173\u4f1a\u8bae\u8d44\u6599\u3002<\/span><\/p>\n

2<\/span>\u3001\u8bf7\u60a8\u5728\u56de\u4f20\u6b64\u786e\u8ba4\u8868\u540e<\/span><\/strong>3<\/span><\/strong>\u4e2a\u5de5\u4f5c\u65e5\u5185\u529e\u7406\u4ed8\u6b3e\u3002<\/span><\/strong><\/p>\n

3<\/span>\u3001\u8bf7\u60a8\u4ed8\u6b3e\u540e\u628a\u6c47\u6b3e\u5e95\u5355\u56de\u4f20\u81f3<\/span>010<\/span>\uff0d<\/span>81312217<\/span>\uff0c\u6b3e\u5230\u540e\u6211\u4eec\u4f1a\u7ed9\u60a8\u51fa\u5177\u6b63\u5f0f\u4f1a\u8bae\u7528\u589e\u503c\u7a0e\u666e\u901a\u53d1\u7968<\/strong>\u3002<\/span><\/p>\n

4<\/span>\u3001\u6211\u4eec\u5728\u4f1a\u8bae\u53ec\u5f00\u524d\u4e00\u5468\u5de6\u53f3\u7ed9\u60a8\u53d1\u7b2c\u4e8c\u8f6e\u62a5\u5230\u901a\u77e5\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7535<\/span><\/strong>    <\/span><\/span><\/strong>\u8bdd<\/span><\/strong>\uff1a<\/span><\/strong> 15652565785  <\/span><\/strong><\/span>\u4f20<\/span><\/strong><\/span><\/strong>\u771f<\/span><\/strong>\uff1a<\/span><\/strong> 010-63811998 <\/span><\/strong><\/span><\/p>\n

\u8054<\/span><\/strong> \u7cfb \u4eba:   <\/span><\/span><\/strong>\u5c1a  <\/span><\/strong>\u4e39<\/span><\/strong>          <\/span><\/strong><\/span>\u90ae<\/span><\/strong> \u7bb1\uff1a<\/span><\/span><\/strong>2331466365@qq.com<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u200d<\/span><\/p>\n

\u200d<\/span><\/p>\n

\u200d<\/span><\/p>\n

\u200d<\/span><\/p>\n

\u200d<\/span><\/p>\n

\u200d<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u200d \u5404\u6709\u5173\u5355\u4f4d\uff1a      \u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u89c4\u5b9a\u56fd\u9645\u534f\u8c03\u4f1a(ICH)\u662f […]<\/p>\n","protected":false},"author":1,"featured_media":59821,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59820"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=59820"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59820\/revisions"}],"predecessor-version":[{"id":59822,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59820\/revisions\/59822"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/59821"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=59820"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=59820"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=59820"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}