{"id":57005,"date":"2018-09-29T01:00:00","date_gmt":"2018-09-30T02:21:51","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e7%be%8e%e5%9b%bd%e6%ac%a7%e7%9b%9f%e5%a4%a7%e9%9d%a2%e7%a7%af%e7%a6%81%e6%ad%a2%e8%bf%9b%e5%8f%a3%e5%8d%8e%e6%b5%b7%e4%ba%a7%e5%93%81\/"},"modified":"2018-09-30T10:21:52","modified_gmt":"2018-09-30T02:21:52","slug":"%e7%be%8e%e5%9b%bd%e6%ac%a7%e7%9b%9f%e5%a4%a7%e9%9d%a2%e7%a7%af%e7%a6%81%e6%ad%a2%e8%bf%9b%e5%8f%a3%e5%8d%8e%e6%b5%b7%e4%ba%a7%e5%93%81","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57005\/","title":{"rendered":"\u7f8e\u56fd\u6b27\u76df\u5927\u9762\u79ef\u7981\u6b62\u8fdb\u53e3\u534e\u6d77\u4ea7\u54c1"},"content":{"rendered":"
\n

\u7ee7\u7f8e\u56fd FDA \u4e8e 9 \u6708 20 \u65e5\u53d1\u5e03\u9488\u5bf9\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u7684\u68c0\u67e5 483 \u4e4b\u540e\uff0cFDA \u4e0e\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09\u4e8e 9 \u6708 28 \u65e5\u5206\u522b\u53d1\u5e03\u5e7f\u6cdb\u7684\u8fdb\u53e3\u7981\u4ee4\u548c\u4e0d\u5408\u89c4\u62a5\u544a\uff0c\u91c7\u53d6\u6269\u5927\u8303\u56f4\u7684\u7981\u6b62\u8fdb\u53e3\u3001\u53d6\u7f14\u4e0a\u5e02\u8bb8\u53ef\u7b49\u4e25\u5389\u63aa\u65bd\u3002\u800c\u8fd9\u4e00\u7cfb\u5217\u884c\u52a8\u4e4b\u540e\u53ef\u80fd\u7684\u76d1\u7ba1\u548c\u5546\u4e1a\u540e\u679c\u6709\u54ea\u4e9b\uff1f\u5bf9\u884c\u4e1a\u66f4\u6df1\u8fdc\u7684\u5f71\u54cd\u53c8\u662f\u4ec0\u4e48\uff1f\u4e0b\u9762\u6211\u4eec\u6765\u5206\u6790\u4e00\u4e0b\u3002<\/span><\/p>\n

\u5546\u4e1a\u548c\u6c11\u4e8b\u8bc9\u8bbc\u540e\u679c<\/strong><\/span><\/p>\n

\u7f2c\u6c99\u5766\u53ec\u56de\u8303\u56f4\u5e7f\u6cdb\uff0c\u800c\u8fdb\u53e3\u7981\u4ee4\u52a0\u5267\u4e86\u6b64\u95ee\u9898\u3002\u9996\u5148\uff0c\u8fd9\u79cd\u7ecf\u786e\u8ba4\u7684\u4e25\u91cd\u4ea7\u54c1\u8d28\u91cf\u95ee\u9898\u548c\u5e7f\u6cdb\u7684\u53ec\u56de\u5c06\u81f3\u5c11\u5bf9\u534e\u6d77\u4f5c\u4e3a API \u751f\u4ea7\u5546\u7684\u58f0\u8a89\u4ea7\u751f\u91cd\u5927\u5f71\u54cd\u3002\u8fd8\u53ef\u80fd\u5bfc\u81f4\u534e\u6d77\u5ba2\u6237\u7684\u5546\u4e1a\u8bc9\u8bbc\/\u7d22\u8d54\u3002\u6b64\u5916\uff0c\u534e\u6d77\u53ca\u5176\u5ba2\u6237\u53ef\u80fd\u4f1a\u6210\u4e3a\u5168\u7403\u4ea7\u54c1\u8d23\u4efb\u8bc9\u8bbc\/\u7d22\u8d54\u7684\u76ee\u6807\uff0c\u800c\u6700\u7ec8\u539f\u544a\u548c\u534e\u6d77\u7684\u5ba2\u6237\u90fd\u5c06\u628a\u4ea7\u54c1\u8d23\u4efb\u7d22\u8d54\u91cd\u70b9\u653e\u5728\u534e\u6d77\u8eab\u4e0a\u3002\u5728\u7f8e\u56fd\u548c\u6b27\u6d32\uff0c\u5df2\u7ecf\u9488\u5bf9\u6210\u54c1\u5236\u5242\u751f\u4ea7\u5546\u63d0\u8d77\u4e86\u4e0e\u7f2c\u6c99\u5766\u76f8\u5173\u7684\u4ea7\u54c1\u8d23\u4efb\u8bc9\u8bbc\u3002<\/span><\/p>\n

\u8fdb\u4e00\u6b65 FDA \u76d1\u7ba1\u540e\u679c<\/strong><\/span><\/p>\n

\u6839\u636e FDA \u6700\u8fd1\u7684\u68c0\u67e5\u7ed3\u679c\uff0cFDA \u53ef\u80fd\u91c7\u53d6\u8fdb\u4e00\u6b65\u884c\u52a8\uff1a
1. FDA \u7684\u68c0\u67e5\u7ed3\u679c\u548c\u8fdb\u53e3\u7981\u4ee4\u7684\u53d1\u5e03\u5f88\u53ef\u80fd\u4f1a\u5411\u534e\u6d77\u7b7e\u53d1\u8b66\u544a\u4fe1\u3002\u65e0\u8bba\u662f\u5173\u95ed\u8fdb\u53e3\u7981\u4ee4\u8fd8\u662f\u8b66\u544a\u4fe1\u90fd\u53ef\u80fd\u9700\u8981\u6570\u5e74\u65f6\u95f4\u3002\u518d\u6b64\u4e4b\u524d\uff0cFDA \u5c06\u4e0d\u4f1a\u6279\u51c6\u4ee5\u534e\u6d77\u4f5c\u4e3a API \u6765\u6e90\u7684\u4efb\u4f55\u7533\u8bf7\u3002<\/span><\/p>\n

2. FDA \u7684\u68c0\u67e5\u7ed3\u679c\u53ef\u80fd\u5bfc\u81f4\u6c38\u4e45\u7981\u4ee4\u5408\u610f\u5224\u51b3\u3002\u867d\u7136\u5728\u6d77\u5916\u573a\u5730\u6d89\u53ca GMP \u8fdd\u89c4\u7684\u60c5\u51b5\u5f88\u5c11\u89c1\uff0c\u4f46\u5982\u679c\u68c0\u67e5\u7ed3\u679c\u663e\u793a\u9700\u8981\u91c7\u53d6\u6b64\u7c7b\u884c\u52a8\uff0cFDA \u53ef\u80fd\u4f1a\u5bfb\u6c42\u7981\u6b62\u5728\u534e\u6d77\u7684\u751f\u4ea7\u6d3b\u52a8\u3002FDA \u4e4b\u524d\u66fe\u91c7\u53d6\u8fc7\u6b64\u7c7b\u884c\u52a8\uff0c\u4f8b\u5982\u9488\u5bf9 Ranbaxy \u548c Maquet\u3002\u5982\u679c FDA \u8003\u8651\u5408\u610f\u5224\u51b3\uff0c\u5219\u534e\u6d77\u7684\u7f8e\u56fd\u516c\u53f8\u5c06\u518d\u6b21\u6210\u4e3a\u8be5\u884c\u52a8\u7ba1\u8f96\u6743\u7684\u6839\u636e\u3002<\/span><\/p>\n

3. FDA \u7684\u68c0\u67e5\u7ed3\u679c\u8fd8\u53ef\u80fd\u5bfc\u81f4\u5211\u4e8b\u8d77\u8bc9\u3002\u5982\u679c\u6709\u4fe1\u606f\u8868\u660e\u516c\u53f8\u5df2\u610f\u8bc6\u5230\u7f2c\u6c99\u5766 API \u4e2d NDMA \u7684\u5b58\u5728\u5e76\u7ee7\u7eed\u9500\u552e\u8be5\u4ea7\u54c1\uff0c\u6216\u5bf9\u8868\u660e\u5b58\u5728\u6742\u8d28\u7684\u8bc1\u636e\u89c6\u800c\u4e0d\u89c1\uff0cFDA \u5c06\u66f4\u503e\u5411\u4e8e\u8003\u8651\u5211\u4e8b\u8d77\u8bc9\u3002\u5982\u679c FDA \u8003\u8651\u63d0\u8d77\u5211\u4e8b\u8bc9\u8bbc\uff0c\u534e\u6d77\u7f8e\u56fd\u516c\u53f8\u5c06\u518d\u6b21\u6210\u4e3a\u8bc9\u8bbc\u7684\u7ba1\u8f96\u6743\u6839\u636e\u3002EMA \u548c FDA \u6700\u521d\u5747\u8868\u793a NDMA \u6742\u8d28\u662f\u610f\u6599\u5916\u7684\u975e\u6545\u610f\u7684\uff0c\u5982\u679c\u6700\u8fd1\u7684\u68c0\u67e5\u8bc1\u5b9e\u786e\u5b9e\u5982\u6b64\uff0c\u90a3\u4e48\u5c06\u4f1a\u964d\u4f4e\u653f\u5e9c\u53d1\u8d77\u5211\u4e8b\u8bc9\u8bbc\u7684\u53ef\u80fd\u6027\u3002<\/span><\/p>\n

\u5bf9\u884c\u4e1a\u7684\u5f71\u54cd<\/strong><\/span><\/p>\n

\u534e\u6d77\u7f2c\u6c99\u5766 API \u4e2d\u53d1\u73b0\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u5728\u7ed3\u6784\u4e0a\u4e0e\u7f2c\u6c99\u5766\u5e76\u65e0\u5173\u7cfb\uff0c\u800c\u7edd\u5927\u591a\u6570 HPLC \u7a33\u5b9a\u6027\u6307\u793a\u65b9\u6cd5\u90fd\u65e8\u5728\u68c0\u6d4b\u548c\u5b9a\u91cf\u4e0e\u4e3b\u8981\u5206\u6790\u7269\u5316\u5b66\u76f8\u5173\u7684\u201c\u76f8\u5173\u7269\u8d28\u201d\u3002\u9274\u4e8e\u4eba\u7c7b\u751f\u4ea7\u4e86\u6570\u767e\u79cd\u5c0f\u5206\u5b50 API\uff0c\u800c\u5176\u4e2d\u8bb8\u591a\u662f\u901a\u8fc7\u591a\u6b65\u5408\u6210\u8def\u5f84\u751f\u4ea7\u7684\uff0c\u56e0\u6b64\u603b\u5171\u6709\u8d85\u8fc7\u5343\u79cd\u5316\u5b66\u5408\u6210 API\u3002 \u8fd9\u6837\u770b\u6765\uff0c\u6709\u4eba\u5076\u7136\u4ea7\u751f\u4e0e API \u65e0\u5316\u5b66\u76f8\u5173\u6027\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u53ea\u662f\u65f6\u95f4\u95ee\u9898\u3002\u867d\u7136\u4e5f\u5b58\u5728\u4e0e API \u5316\u5b66\u76f8\u5173\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u88ab\u68c0\u6d4b\u5e76\u63a7\u5236\u7684\u5b9e\u4f8b\u3002\u4f46\u5982\u679c\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u6781\u5c11\u91cf\u7684\u5b58\u5728\u4e14\u4e0e API \u6ca1\u6709\u5316\u5b66\u76f8\u5173\u6027\uff0c\u5219\u901a\u5e38\u4e0d\u4f1a\u5728 API \u4e2d\u68c0\u6d4b\u5230\u3002<\/span><\/p>\n

\u53d1\u751f\u5728\u534e\u6d77\u8eab\u4e0a\u7684\u4e8b\u662f\u4e0d\u5e78\u7684\uff0c\u901a\u5e38\u7814\u53d1\u4e2d\u7684\u5c3d\u804c\u8c03\u67e5\u4e0d\u4e00\u5b9a\u80fd\u627e\u5230\u8fd9\u79cd\u65e0\u5173\u7269\u8d28\u7684\u75d5\u8ff9\u3002 \u5f88\u660e\u663e\u8fd9\u4e00\u4e8b\u4ef6\u5bf9\u4e8e FDA \u548c EMA \u6765\u8bf4\u90fd\u662f\u610f\u6599\u5916\u7684\uff0c\u4ed6\u4eec\u73b0\u5728\u5df2\u5c06\u5bf9 N-\u4e9a\u785d\u57fa\u7c7b\u6742\u8d28\u7684\u68c0\u6d4b\u6269\u5c55\u5230\u5176\u5b83\u6c99\u5766\u7c7b\u836f\u7269\u3002\u56e0\u6b64\uff0c\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u534e\u6d77\u4f3c\u4e4e\u662f\u4e2a\u53d7\u5bb3\u8005\uff0c\u5c3d\u7ba1\u6709\u5173\u534e\u6d77\u662f\u4f55\u65f6\u4ee5\u53ca\u5982\u4f55\u53d1\u73b0\u8be5\u6742\u8d28\u7684\u5b8c\u6574\u6545\u4e8b\u4ecd\u4e0d\u5f97\u800c\u77e5\u3002<\/span><\/p>\n

\u5728\u6b64\u4e4b\u524d\uff0c\u534e\u6d77\u5df2\u7ecf\u6709\u4e00\u4e9b\u6709\u5173\u8d28\u91cf\u95ee\u9898\u7684 FDA \u68c0\u67e5\u4e0d\u826f\u62a5\u544a\u548c\u8b66\u544a\u4fe1\uff0c\u4f46\u5230\u76ee\u524d\u4e3a\u6b62\uff0c483 \u548c\u8b66\u544a\u4fe1\u4e2d\u6ca1\u6709\u4e00\u5c01\u6d89\u53ca\u7f2c\u6c99\u5766\u4e2d\u6742\u8d28\u95ee\u9898\u3002 \u6211\u4eec\u5e76\u4e0d\u4e86\u89e3\u6545\u4e8b\u7684\u5168\u90e8\uff0c\u4f46\u8fd9\u5728\u5982\u6b64\u5e7f\u6cdb\u7684\u8fdb\u53e3\u7981\u4ee4\u91cc\u9762\u662f\u5426\u5b58\u5728 FDA \u607c\u7f9e\u6210\u6012\u7684\u6210\u5206\uff1f\u516c\u4f17\u671f\u671b FDA \u9632\u6b62\u53ef\u80fd\u7684\u81f4\u764c\u6742\u8d28\u8fdb\u5165\u836f\u54c1\u4f9b\u5e94\u94fe\u3002<\/span><\/p>\n

\u81f3\u4e8e\u540e\u679c\uff0cFDA \u73b0\u5728\u5c06\u4f1a\u671f\u671b API \u751f\u4ea7\u5546\u5f00\u5c55\u66f4\u591a\u7684\u5de5\u827a\u8c03\u67e5\uff0c\u5e76\u4e14\u53ef\u80fd\u5bf9\u7ed3\u6784\u4e0d\u76f8\u5173\u6742\u8d28\u8fdb\u884c\u66f4\u5e7f\u6cdb\u7684\u68c0\u6d4b\uff0c\u8fd9\u5c06\u5bf9 API \u751f\u4ea7\u5546\u9020\u6210\u91cd\u5927\u8d1f\u62c5\uff0c\u5e76\u4e0d\u53ef\u907f\u514d\u7684\u4f1a\u589e\u52a0\u6210\u672c\u3002\u800c\u60a3\u8005\u5c06\u662f\u6700\u7ec8\u627f\u62c5\u8005\u3002\u800c\u6839\u636e\u4e4b\u524d\u76d1\u7ba1\u90e8\u95e8\u4f30\u8ba1\u7684\u7f2c\u6c99\u5766\u4e2d\u6742\u8d28\u7684\u764c\u75c7\u7ec8\u751f\u98ce\u9669\u4ec5\u4e3a\u4e94\u5343\u5206\u4e4b\u4e00\uff0c\u786e\u5b9e\u662f\u975e\u5e38\u4f4e\u7684\u98ce\u9669\u3002<\/span><\/p>\n

<\/p>\n

\u7f8e\u56fd FDA \u5c06\u534e\u6d77\u5217\u5165\u8fdb\u53e3\u7981\u4ee4<\/strong><\/span><\/p><\/blockquote>\n

\u7f8e\u56fd FDA \u4e8e 9 \u6708 28 \u65e5\u5c06\u534e\u6d77\u836f\u4e1a\u5217\u5165\u8fdb\u53e3\u7981\u4ee4\u540d\u5355\uff0c\u4ee5\u5728\u539f\u6599\u836f\uff08API\uff09\u751f\u4ea7\u5546\u5b8c\u5168\u786e\u5b9a\u662f\u5982\u4f55\u5c06\u6742\u8d28\u5f15\u5165\u5230\u5176 API \u5e76\u4fee\u590d\u5176\u8d28\u91cf\u4f53\u7cfb\u671f\u95f4\u4fdd\u62a4\u7f8e\u56fd\u60a3\u8005\u3002\u8fdb\u53e3\u7981\u4ee4\u5c06\u963b\u6b62\u534e\u6d77\u836f\u4e1a\u751f\u4ea7\u7684\u6240\u6709 API \u4ee5\u53ca\u4f7f\u7528\u534e\u6d77 API \u7684\u6210\u54c1\u5236\u5242\u5408\u6cd5\u8fdb\u5165\u7f8e\u56fd\u3002<\/span><\/p>\n

FDA \u63d0\u9192\u751f\u4ea7\u5546\u6709\u8d23\u4efb\u5f00\u53d1\u548c\u4f7f\u7528\u5408\u9002\u7684\u65b9\u6cd5\u6765\u68c0\u6d4b\u6742\u8d28\uff0c\u5305\u62ec\u5728\u53d8\u66f4\u751f\u4ea7\u5de5\u827a\u4e4b\u65f6\u3002\u5982\u679c\u751f\u4ea7\u5546\u68c0\u6d4b\u5230\u65b0\u7684\u6216\u66f4\u9ad8\u6c34\u5e73\u7684\u6742\u8d28\uff0c\u5e94\u5145\u5206\u8bc4\u4f30\u6742\u8d28\u5e76\u91c7\u53d6\u63aa\u65bd\u786e\u4fdd\u4ea7\u54c1\u5bf9\u60a3\u8005\u662f\u5b89\u5168\u7684\u3002<\/span><\/p>\n

\u6b27\u76df\u5bf9\u534e\u6d77\u53d1\u5e03\u4e0d\u5408\u89c4\u62a5\u544a<\/strong><\/span><\/p><\/blockquote>\n

\u6b27\u76df\u76d1\u7ba1\u673a\u6784\u4e0e EDQM \u5408\u4f5c\u68c0\u67e5\u53d1\u73b0\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u5728\u4e34\u6d77\u7684\u5ddd\u5357\u751f\u4ea7\u7f2c\u6c99\u5766\u7684\u5de5\u5382\u6ca1\u6709\u9075\u5b88 GMP\u3002\u56e0\u6b64\uff0c\u5df2\u53d1\u5e03\u5173\u4e8e\u7f2c\u6c99\u5766\u751f\u4ea7\u7684\u4e0d\u5408\u89c4\u58f0\u660e\uff0c\u5e76\u4e14\u8be5\u573a\u5730\u4e0d\u518d\u88ab\u8bb8\u53ef\u751f\u4ea7\u7528\u4e8e\u6b27\u76df\u836f\u54c1\u7684\u7f2c\u6c99\u5766\uff08\u53ca\u5176\u4e2d\u95f4\u4f53\uff09\u3002\u8fd9\u610f\u5473\u7740\u7981\u6b62\u5728\u6b27\u76df\u7684\u4e0a\u5e02\u8bb8\u53ef\u4eba\u4f7f\u7528\u6765\u81ea\u8be5\u573a\u5730\u7684\u7f2c\u6c99\u5766\u7528\u4e8e\u836f\u54c1\u751f\u4ea7\u3002<\/span><\/p>\n

\u8fd9\u4e00\u884c\u52a8\u662f\u7ee7\u4eca\u5e74 7 \u6708\u4efd\u7684\u4ea7\u54c1\u53ec\u56de\u4ee5\u53ca\u968f\u540e\u6682\u505c\u534e\u6d77\u7f2c\u6c99\u5766\u7684 CEP\u4e4b\u540e\uff08\u7b26\u5408\u6b27\u6d32\u8d28\u91cf\u68c0\u6d4b\u6807\u51c6\u7684\u8bc1\u4e66\uff09\u5f00\u5c55\u7684\u3002\u7531\u4e8e N-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff08NDMA\uff09\u7684\u5b58\u5728\uff0c\u5df2\u7ecf\u7981\u6b62\u5728\u6b27\u76df\u4f9b\u5e94\u8be5\u516c\u53f8\u7684\u7f2c\u6c99\u5766\u3002\u8fd9\u6b21\u6b27\u6d32\u68c0\u67e5\u91cd\u70b9\u662f\u7f2c\u6c99\u5766\u7684\u751f\u4ea7\uff0c\u4e8e 2018 \u5e74 9 \u6708\u5b8c\u6210\uff0c\u53d1\u73b0\u4e86\u534e\u6d77\u836f\u4e1a\u7684\u591a\u4e2a\u7f3a\u9677\uff0c\u5305\u62ec\u516c\u53f8\u5bf9\u4e8e\u5176\u7f2c\u6c99\u5766\u4e2d\u5b58\u5728 NDMA \u4ee5\u53ca\u53e6\u4e00\u6742\u8d28 N-\u4e9a\u785d\u57fa\u4e8c\u4e59\u80fa\uff08NDEA\uff09\u5f00\u5c55\u8c03\u67e5\u7684\u65b9\u6cd5\u7f3a\u9677\u3002<\/span><\/p>\n

EudraGMDP \u7f51\u7ad9\u4e0a\u516c\u5e03\u4e86\u6709\u5173\u534e\u6d77\u7f2c\u6c99\u5766\u751f\u4ea7\u7684\u4e0d\u5408\u89c4\u58f0\u660e\u3002<\/span><\/p>\n

\u8be5\u573a\u5730\u6700\u8fd1\u4e5f\u63a5\u53d7\u4e86\u7f8e\u56fd FDA \u7684\u68c0\u67e5\uff0cFDA \u5df2\u53d1\u5e03\u8fdb\u53e3\u7981\u4ee4\uff0c\u963b\u6b62\u6d59\u6c5f\u534e\u6d77\u5ddd\u5357\u5de5\u5382\u751f\u4ea7\u7684\u6240\u6709\u539f\u6599\u836f\u4ee5\u53ca\u6240\u6709\u542b\u6709\u8fd9\u4e9b\u539f\u6599\u836f\u7684\u836f\u54c1\u8fdb\u5165\u7f8e\u56fd\u3002\u4e0e\u6b27\u76df\u7684\u53ec\u56de\u884c\u52a8\u76f8\u4f3c\uff0cFDA \u5c1a\u672a\u5ba3\u5e03\u9664\u5df2\u91c7\u53d6\u63aa\u65bd\u7684\u7f2c\u6c99\u5766\u836f\u54c1\u7684\u5176\u5b83\u4ea7\u54c1\u7684\u53ec\u56de\u3002<\/span><\/p>\n

EMA \u548c\u6b27\u76df\u56fd\u5bb6\u76d1\u7ba1\u673a\u6784\u6b63\u5728\u79ef\u6781\u8003\u8651\u6240\u6709\u53ef\u7528\u8bc1\u636e\uff0c\u5305\u62ec\u6b27\u6d32\u548c\u7f8e\u56fd\u7684\u68c0\u67e5\u7ed3\u679c\uff0c\u4f5c\u4e3a\u8bc4\u4f30\u6d59\u6c5f\u534e\u6d77\u751f\u4ea7\u573a\u5730\u8fd9\u4e00\u6301\u7eed\u8fc7\u7a0b\u7684\u4e00\u90e8\u5206\u3002\u8fd9\u5c06\u51b3\u5b9a\u8be5\u573a\u5730\u751f\u4ea7\u7684\u5176\u5b83\u539f\u6599\u836f\u662f\u5426\u9700\u8981\u91c7\u53d6\u8fdb\u4e00\u6b65\u6b27\u76df\u884c\u52a8\u3002<\/span><\/p>\n

\u5728\u6d59\u6c5f\u534e\u6d77\u7f2c\u6c99\u5766\u4e2d\u68c0\u6d4b\u5230 NDMA\uff08\u4e00\u79cd\u53ef\u80fd\u7684\u81f4\u764c\u7269\uff09\u5bfc\u81f4\u4e86\u6b27\u76df\u8303\u56f4\u5185\u5bf9\u7f2c\u6c99\u5766\u836f\u54c1\u7684\u5ba1\u67e5 , \u968f\u540e\u5ba1\u67e5\u6269\u5c55\u5230\u5176\u5b83\u6c99\u5766\u7c7b\u836f\u3002\u8be5\u5ba1\u67e5\u4ecd\u5728\u8fdb\u884c\u4e2d\u3002EMA \u5c06\u7ee7\u7eed\u4e0e\u6b27\u76df\u5404\u56fd\u76d1\u7ba1\u673a\u6784\u3001\u56fd\u9645\u5408\u4f5c\u4f19\u4f34\u4ee5\u53ca EDQM \u5408\u4f5c\uff0c\u968f\u7740\u83b7\u5f97\u66f4\u591a\u4fe1\u606f\u4e0d\u65ad\u5411\u516c\u4f17\u66f4\u65b0\u8fdb\u5c55\u3002<\/span><\/p>\n

EudraGMDP \u4e0d\u5408\u89c4\u62a5\u544a<\/strong><\/span><\/p>\n

\u53d1\u5e03\u673a\u6784\uff1a\u610f\u5927\u5229\u836f\u76d1\u5c40<\/span><\/p>\n

\u7b2c\u4e09\u90e8\u5206 \u4e0d\u7b26\u5408\u9879<\/strong><\/span><\/p>\n

EMA\/EDQM \u8054\u5408\u68c0\u67e5\u662f\u5728 NDMA\/NDEA \u7f2c\u6c99\u5766\u6c61\u67d3\u95ee\u9898\u7684\u80cc\u666f\u4e0b\u5f00\u5c55\u7684\u201c\u6709\u56e0\u201d\u68c0\u67e5\u3002\u68c0\u67e5\u53d1\u73b0 9 \u4e2a\u201c\u4e3b\u8981\u201d\u7f3a\u9677\uff0c8 \u4e2a\u201c\u5176\u5b83\u201d\u7f3a\u9677\u3002\u4e3b\u8981\u7f3a\u9677\u89c1\u4e8e\u4ee5\u4e0b\u9886\u57df\uff1a
1. \u5728\u7f2c\u6c99\u5766 NDMA\/NDEA \u80cc\u666f\u5f00\u5c55\u7684\u8c03\u67e5\u663e\u793a\u51fa\u660e\u663e\u7f3a\u9677\uff1b
2. \u516c\u53f8\u5728 2018 \u5e74 7 \u6708\/ 8 \u6708\u95f4\u5f00\u5c55\u7684\u4f18\u5316\u7f2c\u6c99\u5766\u5de5\u827a\u7684\u5f00\u53d1\/\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u6267\u884c\u7684\u98ce\u9669\u8bc4\u4f30\u4e0d\u4ee4\u4eba\u6ee1\u610f\uff1b\u6b64\u5916 , \u516c\u53f8\u6ca1\u6709\u8ba4\u8bc6\u5230\u9700\u8981\u5236\u5b9a\u63a7\u5236\u7b56\u7565\u6765\u964d\u4f4e\u4f18\u5316\u540e\u5de5\u827a\u5e26\u6765\u7684\u65b0\u98ce\u9669\uff1b
3. 2011\/2012 \u5e74\u95f4\u4fee\u8ba2\u7684\u7f2c\u6c99\u5766\u5de5\u827a\u7814\u53d1\u4e2d\u6709\u591a\u4e2a\u95ee\u9898\u3002\u6ce8\u610f\uff1a\u5f15\u5165\u6b64\u6b21\u4fee\u8ba2\u5de5\u827a\u7684\u53d8\u66f4\u5bfc\u81f4\u4e86 NDMA \u6742\u8d28\u7684\u5f62\u6210\uff1b
4. \u4e0e\u6295\u8bc9\u5904\u7406\u6709\u5173\u7684\u89c2\u5bdf\u9879\uff0c\u5177\u4f53\u5173\u6ce8 NDMA \u6c61\u67d3\u95ee\u9898\uff1b
5. \u8d85\u6807\uff08OOS\uff09\u7ed3\u679c\u7684\u7ba1\u7406\uff1b
6. \u53ec\u56de\u7ba1\u7406\uff1a\u672a\u6b63\u5f0f\u542f\u52a8\u53ec\u56de\u6765\u7ba1\u7406\u4e0e\u53d7\u6c61\u67d3\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u6709\u5173\u7684\u884c\u52a8\uff1b
7. \u8fd4\u5de5\/\u6df7\u5408\u64cd\u4f5c , \u5305\u62ec\u8fd4\u5de5\/\u6df7\u5408\u65e0\u6599\u7684\u53ef\u8ffd\u6eaf\u6027\uff1b
8. \u4e0e GC-FID \u5206\u6790\u6709\u5173\u7684\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\uff1b
9. \u5728 2018 \u5e74 7 \u6708\/ 8 \u6708\u4f18\u5316\u540e\u7684\u65b0\u5de5\u827a\u751f\u4ea7\u7684\u7f2c\u6c99\u5766\u6279\u6b21\u7684 GC-MS \u5206\u6790\u4e2d\u68c0\u6d4b\u5230\u7684\u672a\u77e5\u5cf0\u8c03\u67e5\u4e0d\u5145\u5206\u3002<\/span><\/p>\n

NCA \u5efa\u8bae\/\u91c7\u53d6\u7684\u63aa\u65bd\uff1a<\/strong><\/span><\/p>\n

\u8981\u6c42\u4e0a\u5e02\u8bb8\u53ef\u53d8\u66f4\uff1a<\/strong> \u5bf9\u4e0a\u5e02\u8bb8\u53ef\u4eba\u7684\u884c\u52a8\u5e94\u7531\u76f8\u5e94\u8bb8\u53ef\u673a\u6784\u8bc4\u4f30\uff0c\u5e94\u5305\u62ec\u7531\u88ab\u68c0\u67e5\u516c\u53f8\u751f\u4ea7\u7684\u7f2c\u6c99\u5766\u548c\u7f2c\u6c99\u5766\u4e2d\u95f4\u4f53\u7684\u4e0a\u5e02\u8bb8\u53ef\u3002<\/span><\/p>\n

\u53ec\u56de\u5df2\u653e\u884c\u6279\u6b21\uff1a<\/strong> \u542b\u6709\u8be5\u516c\u53f8\u751f\u4ea7\u7684\u7f2c\u6c99\u5766\u539f\u6599\u836f\u7684\u4ea7\u54c1\u7684\u53ec\u56de\u5df2\u5728\u6b27\u76df\u5f00\u5c55<\/span><\/p>\n

\u7981\u6b62\u4f9b\u5e94\uff1a<\/strong> \u516c\u53f8\u5df2\u88ab\u7981\u6b62\u5411\u6b27\u76df\u5e02\u573a\u4f9b\u5e94\u7f2c\u6c99\u5766<\/span><\/p>\n

\u6682\u505c\u6216\u540a\u9500 CEP\uff08\u7531 EDQM \u91c7\u53d6\u7684\u884c\u52a8\uff09\uff1a<\/strong> \u7f2c\u6c99\u5766\u7684 CEP 2010-072 \u5df2\u6682\u505c\u3002\u5efa\u8bae\u8003\u8651\u4e0e\u88ab\u68c0\u67e5\u516c\u53f8\u4f5c\u4e3a\u4e2d\u95f4\u4f53\u751f\u4ea7\u5546\u7684\u5176\u5b83\u7f2c\u6c99\u5766 CEP \u76f8\u5173\u7684\u884c\u52a8<\/span><\/p>\n

\u5176\u5b83\uff1a<\/strong> \u5efa\u8bae\u4e5f\u7981\u6b62\u5411\u6b27\u76df\u5e02\u573a\u4f9b\u5e94\u7f2c\u6c99\u5766\u4e2d\u95f4\u4f53<\/span><\/p>\n

\u9644\u52a0\u8bf4\u660e\uff1a<\/strong>\u6709\u56e0\u68c0\u67e5\u4e3b\u8981\u9488\u5bf9\u7f2c\u6c99\u5766\uff0c\u56e0\u6b64\u8be5\u4e0d\u5408\u89c4\u58f0\u660e\u4ec5\u9650\u4e8e\u6b64 API\u3002<\/span><\/p>\n


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

\u4f5c\u8005\uff1a\u8bc6\u6797-Pepper\uff0c\u8bc6\u6797-Aspen
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\u53c2\u8003\u8d44\u6599<\/strong><\/span><\/p>\n