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\u3000\u3000 \u968f\u7740\u52a0\u5165WTO\u548c\u4e16\u754c\u7ecf\u6d4e\u4e00\u4f53\u5316\u8fdb\u7a0b\u7684\u52a0\u5feb\uff0c\u5728\u836f\u54c1\u8d38\u6613\u65b9\u9762\uff0c\u56fd\u5185\u4f01\u4e1a\u9010\u6b65\u8d70\u51fa\u56fd\u95e8\uff0c\u63a5\u53d7\u56fd\u9645\u7ade\u4e89\u548c\u6280\u672f\u58c1\u5792\u6311\u6218\u3002\u5728\u6b27\u6d32\u5e02\u573a\uff0c\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40 \uff08EDQM\uff09\u7684COS\u8bc1\u4e66\u662f\u56fd\u5185\u539f\u6599\u836f\u6210\u529f\u8fdb\u5165\u6b27\u6d32\u7684\u9996\u9009\u6ce8\u518c\u7a0b\u5e8f\u3002\u56e0\u6b64\u66f4\u591a\u5730\u4e86\u89e3\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\u7684\u7ba1\u7406\u7cfb\u7edf\u4ee5\u53caCOS\u8bc1\u4e66\u7684\u8981\u6c42\uff0c\u6210\u4e3a\u5f88\u591a\u4f01\u4e1a\u7684\u8feb \u5207\u9700\u8981\u3002<\/p>\n

\u3000\u3000\u6b27\u6d32\u7406\u4e8b\u4f1a\u4e0b\u5c5e\u7684EDQM\u662f\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\uff0c\u65e8\u5728\u4fdd\u8bc1\u5728\u6b27\u6d32\u751f\u4ea7\u548c\u9500\u552e\u7684\u836f\u54c1\u5177\u6709\u540c\u7b49\u4f18\u826f\u7684\u54c1\u8d28\uff0c\u540c\u65f6\u4fc3\u8fdb\u4e86\u8d44\u6e90\u7684\u8fdb\u4e00\u6b65\u96c6\u4e2d\u548c\u5171\u4eab\u3002<\/p>\n

\u3000\u3000EDQM\u662f\u5728\u6b27\u76df\u548c\u6b27\u6d32\u7406\u4e8b\u4f1a\u4e0d\u65ad\u7684\u5408\u4f5c\u4e2d\u5efa\u7acb\u548c\u53d1\u5c55\u8d77\u6765\u7684\uff0c\u5b83\u6709\u6548\u5730\u6ee1\u8db3\u4e86\u51cf\u5c11\u836f\u54c1\u81ea\u7531\u8d38\u6613\u4e2d\u7684\u6280\u672f\u58c1\u5792\u4ee5\u53ca\u5408\u7406\u4f7f\u7528\u516c\u5171\u5065\u5eb7\u8d44\u6e90\u7684\u9700\u8981\u3002<\/p>\n

\u3000\u3000\u4e0e\u6b27\u76df\u76f8\u6bd4\uff0c\u6b27\u6d32\u7406\u4e8b\u4f1a\u62e5\u6709\u66f4\u591a\u7684\u6210\u5458\u56fd\uff08\u73b0\u5728\u662f45\u4e2a\u6210\u5458\u56fd\uff0c\u4e0d\u4e45\u5c06\u53d8\u621046\u4e2a\uff09\uff0c\u8fd9\u610f\u5473\u7740\u6b27\u76df\u4ee5\u5916\u7684\u6b27\u6d32\u56fd\u5bb6\u53ef\u4ee5\u4e0e\u6b27\u76df\u56fd\u5bb6\u5e73\u7b49\u5730\u53c2\u4e0e\u836f\u54c1\u65b9\u9762\u7684\u5408\u4f5c\uff0c\u540c\u65f6\u4e5f\u63a8\u52a8\u4e86\u8fd9\u4e9b\u56fd\u5bb6\u52a0\u5165\u6b27\u76df\u7684\u8fdb\u7a0b\u3002<\/p>\n

1\u3001\u8fd9\u79cd\u5408\u4f5c\u901a\u5e38\u57fa\u4e8e\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n

A\u3001 \u56fd\u9645\u534f\u5546\u4f1a\u8bae\uff08\u7531\u6b27\u76df\u548c32\u4e2a\u6b27\u6d32\u6210\u5458\u56fd\u7b7e\u7f72\u7684\u6b27\u6d32\u836f\u5178\u534f\u5b9a\uff09<\/p>\n

\u5171\u540c\u4f53\u6cd5\uff08\u6b27\u76df\u6cd5\u89c4\u548c\u89e3\u91ca\uff09<\/p>\n

\u5176\u5b83\u7ea6\u5b9a\uff08\u6b27\u6d32\u7406\u4e8b\u4f1a\uff0c\u6b27\u76df\u59d4\u5458\u4f1a\u548c\u6b27\u6d32\u836f\u54c1\u8bc4\u5ba1\u5c40\uff08EMEA\uff09\u4e4b\u95f4\u7b7e\u7f72\u7684\uff09\uff1b<\/p>\n

B\u3001 \u81ea\u53d1\u7684\u6280\u672f\u56e2\u4f53\uff1a\u4ee5\u6b27\u6d32\u548c\u975e\u6b27\u6d32\u56fd\u5bb6\u7684\u89c2\u5bdf\u5458\u8eab\u4efd\uff0c\u63a8\u52a8\u6b27\u6d32\u836f\u54c1\u6807\u51c6\u4e0e\u5404\u56fd\u6cd5\u89c4\u4e4b\u95f4\u7684\u878d\u5408\u3002<\/p>\n

2\u3001\u6709\u5173\u5408\u4f5c\u5df2\u7ecf\u5728\u4ee5\u4e0b\u9886\u57df\u5f00\u5c55\uff1a<\/p>\n

A\u3001 \u6b27\u6d32\u836f\u5178\u6807\u51c6\uff08\u7ea61850\u4e2a\u4e13\u8bba\u548c280\u4e2a\u603b\u8bba\uff09\uff1b<\/p>\n

B\u3001 \u6b27\u6d32\u836f\u5178\u9002\u5e94\u6027\u8bc1\u4e66\u7a0b\u5e8f\uff0c\u8fd9\u4e00\u7a0b\u5e8f\u9002\u7528\u4e8e\u6240\u6709\u539f\u6750\u6599\u751f\u4ea7\u5546\uff1b<\/p>\n

C\u3001 \u5b98\u65b9\u836f\u7269\u5b9e\u9a8c\u5ba4\u7f51\u7edc\uff08OMCL\uff09\uff1a\u8be5\u7f51\u7edc\u76ee\u524d\u5305\u62ec\u4e86\u6765\u81ea\u8fd140\u4e2a\u56fd\u5bb6\u7684100\u591a\u4e2a\u5408\u4f5c\u5b9e\u9a8c\u5ba4\u3002OMCL\u4fc3\u8fdb\u4e86\u6b27\u6d32\u56fd\u5bb6\u4e4b\u95f4\u836f\u7269\u68c0\u9a8c\u7ed3\u679c\u7684\u4e92\u8ba4\uff0c\u5e76\u4fdd\u8bc1\u5404\u56fd\u60a3\u8005\u53ef\u4ee5\u83b7\u5f97\u76f8\u540c\u8d28\u91cf\u7684\u836f\u54c1\u3002<\/p>\n

\u4e8c\u3001\u6b27\u6d32\u836f\u5178\u9002\u5e94\u6027\u8bc1\u4e66\uff08COS \/ CEP\uff09<\/span>
<\/p>\n

1\u3001\u7b80\u4ecb<\/p>\n

\u6b27\u6d32\u836f\u5178\u9002\u5e94\u6027\u8bc1\u4e66COS\u2014\u2014certificate of suitability to monograph of European Pharmacopoeia\u3002\u53c8\u79f0CEP\u8bc1\u4e66\u3002\u662f\u7531\u6210\u7acb\u4e8e1964\u5e74\u7684\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\u5373\u6b27\u6d32\u836f\u7269\u8d28\u91cf\u7406\u4e8b\u4f1a\uff08EDQM\uff09\u9881\u53d1\u7684\u7528\u4ee5\u8bc1\u660e\u539f\u6599\u836f\u54c1\u7684\u8d28\u91cf\u662f\u6309 \u7167\u6b27\u6d32\u836f\u5178\u6709\u5173\u4e13\u8bba\u63cf\u8ff0\u7684\u65b9\u6cd5\u4e25\u683c\u63a7\u5236\u7684\uff0c\u5176\u4ea7\u54c1\u8d28\u91cf\u7b26\u5408\u6b27\u6d32\u836f\u5178\u6807\u51c6\u7684\u4e00\u79cd\u8bc1\u4e66\u3002\u5b83\u662f\u968f\u7740\u6b27\u6d32\u5e02\u573a\u7684\u4e00\u4f53\u5316\u8fdb\u7a0b\u7684\u9010\u6b65\u53d1\u5c55\u800c\u4e8e1992\u5e74\u51fa\u73b0\u7684\uff0c\u5176\u76ee\u7684 \u5c31\u662f\u4e3a\u4e86\u51cf\u5c11\u751f\u4ea7\u5382\u5bb6\u548c\u6709\u5173\u8bc4\u5ba1\u673a\u6784\u7684\u5927\u91cf\u7684\u91cd\u590d\u6027\u5de5\u4f5c\uff0c\u4fc3\u8fdb\u6b27\u6d32\u836f\u54c1\u5e02\u573a\u7684\u4e00\u4f53\u5316\u8fdb\u7a0b\u3002\u4e0e\u7f8e\u56fdFDA\u5bf9\u539f\u6599\u836f\u54c1\u8981\u6c42\u7684\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09\u76f8\u6bd4\uff0c\u6b27\u6d32 COS\u8bc1\u4e66\u7533\u8bf7\u6587\u4ef6\u66f4\u6ce8\u91cd\u7684\u662f\u836f\u7269\u672c\u8eab\u7684\u6027\u8d28\uff0c\u5305\u62ec\u5316\u5b66\u7ed3\u6784\u53ca\u7ed3\u6784\u89e3\u6790\u3001\u5316\u5b66\u6027\u8d28\u3001\u6742\u8d28\u53ca\u5176\u9650\u5ea6\u3001\u8d28\u91cf\u63a7\u5236\u3001\u7a33\u5b9a\u6027\u548c\u5b89\u5168\u6027\u7814\u7a76\u7b49\u7b49\u3002\u8981\u53d6\u5f97\u6b64\u8bc1\u4e66\uff0c\u751f\u4ea7 \u5546\u9700\u8981\u63d0\u4ea4\u4e00\u4efd\u8be6\u7ec6\u7684\u6863\u6848\uff0c\u5176\u4e2d\u53ef\u80fd\u542b\u6709\u673a\u5bc6\u8d44\u6599\u3002\u6b64\u8bc1\u4e66\u7528\u6237\u8868\u660e\u901a\u8fc7\u5e94\u7528\u6b27\u6d32\u836f\u5178\u6709\u5173\u4e13\u8bba\uff0c\u53ca\u8bc1\u4e66\u4e0a\u6240\u5217\u51fa\u7684\u5fc5\u8981\u65b9\u6cd5\uff0c\u80fd\u591f\u68c0\u67e5\u836f\u7269\u539f\u6599\u548c\u8f85\u6599\u662f\u5426\u9002\u7528 \u4e8e\u836f\u54c1\u7684\u751f\u4ea7\uff0c\u4e5f\u5c31\u662f\u8bf4\uff0c\u4ece\u8fd9\u4e00\u7279\u5b9a\u65b9\u6cd5\uff08\u5305\u62ec\u539f\u6750\u6599\uff09\u751f\u4ea7\u7684\u836f\u7269\u4e2d\u7684\u6240\u6709\u53ef\u80fd\u6742\u8d28\u548c\u6c61\u67d3\u90fd\u80fd\u591f\u7531\u6709\u5173\u4e13\u8bba\u7684\u8981\u6c42\u5b8c\u5168\u63a7\u5236\u3002<\/p>\n

\u6b27\u6d32\u836f\u54c1\u8d28\u91cf\u7ba1\u7406\u5c40\uff08EDQM\uff09\u7684COS\u8bc1\u4e66\u7a0b\u5e8f\u662f\u57fa\u4e8e\u6b27\u6d32\u516c\u5171\u5065\u5eb7\u59d4\u5458\u4f1a\u90e8\u5206\u8868\u51b3\u901a\u8fc7\u7684 AP-CSP(93)4\u53f7\u51b3\u8bae\u800c\u4ea7\u751f\u7684\u3002COS\u8bc1\u4e66\u7684\u76ee\u7684\u662f\u8bc4\u4f30\u548c\u5224\u65ad\u4f7f\u7528\u6b27\u6d32\u836f\u5178\u4e13\u8bba\u63a7\u5236\u539f\u6599\u836f\u7684\u5316\u5b66\u7eaf\u5ea6\u3001\u5fae\u751f\u7269\u54c1\u8d28\u548c TSE\uff08Transmitting animal Spongiform Encephalopathy agent \u4f20\u64ad\u6027\u52a8\u7269\u6d77\u7ef5\u72b6\u8111\u75c5\u4f53\uff09\u98ce\u9669\u7684\u9002\u7528\u6027\u3002<\/p>\n

\u8fd9\u4e00\u7a0b\u5e8f\u663e\u793a\u4e86\u5404\u90e8\u95e8\u4e4b\u95f4\u5178\u578b\u7684\u5408\u4f5c\u5173\u7cfb\uff0c\u5982CHMP\uff08\u4eba\u7528\u836f\u59d4\u5458\u4f1a\uff09,CVMP\uff08\u517d\u7528\u836f\u59d4\u5458 \u4f1a\uff09\u548c \u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\uff0c\u8fd9\u4e9b\u90e8\u95e8\u5728\u6307\u5bfc\u5de5\u4e1a\u754c\u7684\u540c\u65f6,\u5171\u540c\u52aa\u529b\u5bfb\u627e\u5b9e\u7528\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u5e76\u5728\u4e0d\u4f7f\u8bc4\u4f30\u7a0b\u5e8f\u590d\u6742\u5316\u7684\u524d\u63d0\u4e0b\u63d0\u9ad8\u8d28\u91cf\u4fdd\u8bc1\u3002\u8bc1\u4e66\u7ba1\u7406\u5904\u5df2\u7ecf\u660e\u786e\u8868\u793a\uff1a\u5bf9\u4e8e \u5df2\u6709\u6b27\u6d32\u836f\u5178\u6807\u51c6\u7684\u539f\u6599\u836f\u751f\u4ea7\u5546\uff0c\u5e94\u9009\u7528COS\u8bc1\u4e66\u7a0b\u5e8f\u3002<\/p>\n

\u7531\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\u5b98\u5458\u3001CHMP\/CVMP\u8054\u5408\u5de5\u4f5c\u7ec4\u3001CHMP\u751f\u7269\u6280\u672f\u5de5\u4f5c\u7ec4\u3001CVMP\u514d\u75ab \u4ea7\u54c1\u5de5\u4f5c\u7ec4\u3001\u8349\u836f\u4ea7\u54c1\u5de5\u4f5c\u7ec4\u548c\u6b27\u76df\u59d4\u5458\u4f1a\u4ee3\u8868\u3001EMEA\u3001EDQM\u7b49\u5171\u540c\u7ec4\u6210\u7684\u6307\u5bfc\u59d4\u5458\u4f1a\uff0c\u5728\u5b9e\u65bdCOS\u7a0b\u5e8f\u65f6\u8d2f\u5f7b\u4e86\u78cb\u5546\u3001\u534f\u8c03\u548c\u5408\u4f5c\u7684\u539f\u5219\uff0c\u6307\u5bfc\u59d4\u5458\u4f1a \u6bcf\u5e74\u4e3e\u884c\u4e00\u6b21\u4f1a\u8bae\uff0c\u4ee5\u4fdd\u6301\u6709\u5173\u8bb8\u53ef\u3001\u836f\u5178\u548c\u9002\u7528\u6027\u8bc1\u4e66\u653f\u7b56\u7684\u8fde\u8d2f\u6027\u3002<\/p>\n

\u9664\u4e86\u8d1f\u8d23\u653f\u7b56\u65b9\u9488\u7684\u6307\u5bfc\u59d4\u5458\u4f1a\uff0cEDQM\u8fd8\u9488\u5bf9\u5316\u5b66\u7269\u8d28\u548cTSE\u98ce\u9669\u7269\u8d28\u5206\u522b\u8bbe\u7acb\u4e86\u4e24\u4e2a\u6280\u672f\u987e\u95ee\u56e2\uff0c\u7531\u6587\u4ef6\u5ba1\u67e5\u4e13\u5bb6\u7ec4\u6210\u3002\u987e\u95ee\u56e2\u4e3b\u8981\u8d1f\u8d23\u5904\u7406\u8bc1\u4e66\u7533\u8bf7\u6587\u4ef6\u5ba1\u67e5\u5458\u63d0\u51fa\u7684\u4efb\u4f55\u6280\u672f\u6216\u79d1\u5b66\u95ee\u9898\u3002<\/p>\n

\u622a\u6b62\u52302004\u5e743\u6708\u5e95\uff0cEDQM\u5171\u9881\u53d1COS\u8bc1\u4e661520\u4efd\uff0c\u5176\u4e2d\u6709\u5173\u5316\u5b66\u836f\u54c1\u7684\u8bc1\u4e66970 \u4efd\uff0c\u536063.8%\u9700\u505aTSE\u98ce\u9669\u8bc4\u4f30\u7684\u751f\u7269\u539f\u6599\u8bc1\u4e66430\u4ef6\uff0c\u536028.28\uff05\uff0c\u4e24\u8005\u517c\u6709\u7684\uff08\u5373\u9700\u8981\u505aTSE\u98ce\u9669\u8bc4\u4f30\u7684\u5316\u5b66\u836f\u54c1\uff0943\u4ef6\uff0c\u53602.82%\uff0c\u88ab \u64a4\u9500\u7684\u8bc1\u4e6675\u4ef6\uff0c\u53604.93%\uff0c\u5b9e\u9645\u6709\u6548\u7684\u8bc1\u4e66\u603b\u6570\u4e3a1445\u4ef6\u3002\u4e2d\u56fd\u53ea\u670924\u5bb6\u5236\u836f\u4f01\u4e1a\u768445\u4ef6COS\u8bc1\u4e66\uff0c\u64a4\u95002\u4ef6\uff0c\u5b9e\u9645\u6709\u6548\u7684COS\u8bc1\u4e66\u4e3a43 \u4ef6\uff0c\u4ec5\u5360\u5168\u7403\u9881\u53d1\u8bc1\u4e66\u603b\u989d\u76842.97%\uff0c\u5168\u90e8\u96c6\u4e2d\u5728\u5316\u5b66\u836f\u54c1\u3002<\/p>\n

2\u3001COS\u8bc1\u4e66\u7684\u9002\u7528\u8303\u56f4<\/p>\n

COS\u8bc1\u4e66\u9002\u7528\u4e8e\u5df2\u6536\u5f55\u4e8e\u6b27\u6d32\u836f\u5178\u4e2d\u7684\u4ee5\u4e0b\u7269\u8d28\uff1a<\/p>\n

\u2014\u5408\u6210\u6216\u63d0\u53d6\u7684\u6709\u673a\u6216\u65e0\u673a\u7269\uff08\u539f\u6599\u836f\u6216\u836f\u7528\u8f85\u6599\uff09\uff1b<\/p>\n

\u2014\u901a\u8fc7\u53d1\u9175\u83b7\u5f97\u7684\u975e\u76f4\u63a5\u57fa\u56e0\u4ea7\u7269\uff0c\u5373\u5fae\u751f\u7269\u7684\u4ee3\u8c22\u4ea7\u7269\uff0c\u65e0\u8bba\u8be5\u5fae\u751f\u7269\u662f\u5426\u7ecf\u8fc7\u4f20\u7edf\u65b9\u6cd5<\/p>\n

\u6216r-DNA\u6280\u672f\u4fee\u9970\uff1b<\/p>\n

\u2014\u5177\u6709\u4f20\u64ad\u52a8\u7269\u6d77\u7ef5\u72b6\u8111\u75c5\uff08TSE\uff09\u5371\u9669\u7684\u4ea7\u54c1\uff08\u6ce8\uff1a\u6b64\u7c7b\u4ea7\u54c1\u53ef\u5355\u72ec\u7533\u8bf7COS\u8bc1\u4e66\u6216\u8fdb\u884c<\/p>\n

TSE\u5371\u9669\u6027\u8bc4\u4f30\uff0c\u4e5f\u53ef\u4e24\u9879\u5171\u540c\u7533\u8bf7\uff09\u3002<\/p>\n

COS\u8bc1\u4e66\u4e0d\u9002\u7528\u4e8e\u76f4\u63a5\u57fa\u56e0\u4ea7\u7269\uff08\u86cb\u767d\u8d28\uff09\uff0c\u6e90\u4e8e\u4eba\u7c7b\u7ec4\u7ec7\u7684\u4ea7\u54c1\u3001\u75ab\u82d7\u3001\u8840\u6db2\u5236\u54c1\u7b49\u3002<\/p>\n

3\u3001COS\u8bc1\u4e66\u4ea7\u751f\u7684\u80cc\u666f\u3001\u53d1\u5c55\u4e0e\u73b0\u72b6<\/p>\n

\u7531\u4e8e\u6709\u7740\u4f17\u591a\u7684\u4eba\u53e3\u53ca\u53d1\u8fbe\u7684\u7ecf\u6d4e\uff0c\u6b27\u6d32\u662f\u4e16\u754c\u4e0a\u5de8\u5927\u7684\u836f\u54c1\u6d88\u8017\u5730\u533a\uff0c\u540c\u65f6\u4e5f\u662f\u5411\u5916\u8f93\u51fa\u836f\u7269\u5236\u5242 \u7684\u6700\u5927\u5730\u533a\u3002\u4e0e\u7f8e\u56fd\u4e00\u6837\uff0c\u51fa\u4e8e\u5bf9\u81ea\u8eab\u8d44\u6e90\u548c\u73af\u4fdd\u7684\u8003\u8651\uff0c\u51b3\u5927\u591a\u6570\u6b27\u6d32\u56fd\u5bb6\u4e25\u683c\u63a7\u5236\u539f\u6599\u836f\u7684\u751f\u4ea7\u89c4\u6a21\u3002\u6b27\u6d32\u5236\u836f\u5de5\u4e1a\u53d1\u8fbe\u800c\u4e14\u5386\u53f2\u60a0\u4e45\uff0c\u96c6\u4e2d\u4e86\u5f88\u591a\u4e16\u754c\u4e3b\u8981\u8de8 \u56fd\u5236\u836f\u4f01\u4e1a\uff0c\u6210\u4e3a\u4e16\u754c\u4e0a\u5411\u5916\u8f93\u51fa\u836f\u54c1\u5236\u5242\u6700\u591a\u7684\u5730\u533a\u3002\u968f\u7740\u6b27\u6d32\u9010\u6e10\u4e00\u4f53\u5316\uff0c\u6b27\u76df\u7248\u56fe\u4e0d\u65ad\u6269\u5927,\u4f5c\u4e3a\u4e00\u4e2a\u6574\u4f53\uff0c\u5b83\u6b63\u6210\u4e3a\u4e16\u754c\u4e0a\u6700\u5927\u7684\u539f\u6599\u836f\u8fdb\u53e3\u5e02\u573a\u4e4b\u4e00\uff0c\u4e5f \u662f\u6211\u56fd\u4f17\u591a\u539f\u6599\u836f\u751f\u4ea7\u5382\u5bb6\u7684\u91cd\u8981\u76ee\u6807\u5e02\u573a\u3002<\/p>\n

\u7531\u4e8e\u6b27\u6d32\u56fd\u5bb6\u4e00\u822c\u8f83\u5c0f\uff0c\u7ecf\u6d4e\u5e02\u573a\u4e00\u4f53\u5316\u4e00\u76f4\u662f\u5927\u52bf\u6240\u8d8b, \u8fdb\u7a0b\u5728\u4e0d\u65ad\u52a0\u901f\u3002\u65e9\u57281964\u5e74\uff0c\u6b27\u76df\u5c31\u6210\u7acb\u4e86\u7edf\u4e00\u7684\u516c\u5171\u536b\u751f\u59d4\u5458\u4f1a\uff08Public Health Committee\uff09\u548c\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a(Committee of European Pharmacopoeia)\uff0c\u9881\u5e03\u4e86\u5728\u6240\u6709\u6210\u5458\u56fd\u5185\u90fd\u5177\u6709\u6cd5\u5f8b\u6548\u529b\u7684\u6b27\u6d32\u836f\u5178\u3002\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\u4e5f\u7531\u6700\u521d\u7684\u516b\u4e2a\u6210\u5458\u56fd\u53d1\u5c55\u5230\u73b0\u5728\u4e09\u5341\u4e00\u4e2a\u6210\u5458\u56fd\uff0c\u5305\u62ec\uff1a\u5965 \u5730\u5229\u3001\u6bd4\u5229\u65f6\u3001\u6ce2\u9ed1\u3001\u514b\u7f57\u5730\u4e9a\u3001\u585e\u6d66\u8def\u65af\u3001\u6377\u514b\u5171\u548c\u56fd\u3001\u4e39\u9ea6\u3001\u82ac\u5170\u3001\u6cd5\u56fd\u3001\u5fb7\u56fd\u3001\u5e0c\u814a\u3001\u5308\u7259\u5229\u3001\u51b0\u5c9b\u3001\u7231\u5c14\u5170\u3001\u610f\u5927\u5229\u3001\u5362\u68ee\u5821\u3001\u8377\u5170\u3001\u632a\u5a01\u3001\u8461\u8404\u7259\u3001\u65af\u6d1b \u4f10\u514b\u5171\u548c\u56fd\u3001\u65af\u6d1b\u6587\u5c3c\u4e9a\u3001\u897f\u73ed\u7259\u3001\u745e\u5178\u3001\u745e\u58eb\u3001\u524d\u5357\u65af\u62c9\u592b\u8054\u76df\u3001\u571f\u8033\u5176\u3001\u82f1\u56fd\u7b49\uff0c\u57fa\u672c\u4e0a\u6db5\u76d6\u4e86\u6b27\u6d32\u7684\u4e3b\u8981\u56fd\u5bb6\u3002\u5728\u516c\u5171\u536b\u751f\u59d4\u5458\u4f1a\u548c\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\u7684\u534f\u8c03\u548c \u89c4\u8303\u4e0b\uff0c\u8fd1\u51e0\u5e74\u6b27\u6d32\u7684\u533b\u836f\u7ba1\u7406\u4f53\u5236\u548c\u6cd5\u89c4\u53d1\u751f\u4e86\u660e\u663e\u7684\u53d8\u5316\u3002\u5bf9\u6210\u5458\u56fd\u4ee5\u5916\u7684\u533b\u836f\u4ea7\u54c1\u8fdb\u5165\u6210\u5458\u56fd\u5e02\u573a\u7684\u7ba1\u5236\u653f\u7b56\u4e5f\u505a\u51fa\u4e86\u76f8\u5e94\u7684\u8c03\u6574\u3002<\/p>\n

1995\u5e74\u963f\u59c6\u65af\u7279\u4e39\u6761\u7ea6\uff08Treaty of Amsterdam\uff09\u751f\u6548\u4ee5\u540e\uff0c\u6b27\u76df\u6210\u7acb\u4e86\u4e13\u95e8\u7684\u836f\u7269\u8bc4\u5ba1\u673a\u6784\u2014\u2014\u6b27\u6d32\u836f\u7269\u8bc4\u5ba1\u5c40\uff08EMEA\uff0cEuropean Agency for the Evaluation of Medicinal Product\uff09\u3002EMEA\u5c06\u5236\u5242\u836f\u54c1\u4e0a\u5e02\u7684\u6838\u51c6\uff08Marketing Authorization\uff09\u7a0b\u5e8f\u5206\u6210\u4e24\u79cd\uff0c\u5373”\u96c6\u4e2d\u7533\u8bf7”\u548c”\u4e92\u8ba4\u7533\u8bf7”\u3002\u8fd9\u4e24\u79cd\u7533\u8bf7\u7684\u76ee\u7684\u5c31\u662f\u4e3a\u4e86\u6d88\u9664\u5404\u6210\u5458\u56fd\u4e4b\u95f4\u7684\u4e0a\u5e02\u6838\u51c6\u7ed3\u679c\u4e92\u4e0d\u627f\u8ba4\u73b0\u8c61\uff0c\u51cf\u5c11 \u6709\u5173\u5f53\u5c40\u548c\u751f\u4ea7\u4f01\u4e1a\u7684\u91cd\u590d\u6027\u5de5\u4f5c\uff0c\u6d88\u9664\u6210\u5458\u56fd\u4e4b\u95f4\u7684\u836f\u54c1\u8d38\u6613\u969c\u788d\uff0c\u4fc3\u8fdb\u5e02\u573a\u7684\u4e00\u4f53\u5316\u3002\u8fd9\u4e24\u79cd\u7533\u8bf7\u7a0b\u5e8f\u7684\u7ed3\u679c\u662f\uff1a\u4e00\u4e2a\u836f\u54c1\u7684\u4e0a\u5e02\u7533\u8bf7\u4e00\u65e6\u83b7\u5f97\u6279\u51c6\uff0c\u5c06\u81ea\u52a8\u6216 \u901a\u8fc7\u4e00\u5b9a\u7a0b\u5e8f\u5728\u6b27\u76df\u6240\u6709\u7684\u6210\u5458\u56fd\u4e0a\u5e02\u3002<\/p>\n

4\u3001\u83b7\u5f97COS\u8bc1\u4e66\u7684\u7a0b\u5e8f<\/p>\n

a\uff0e \u751f\u4ea7\u5382\u5bb6\u6216\u7533\u8bf7\u4ee3\u7406\u673a\u6784\u901a\u8fc7\u94f6\u884c\u5411\u8ba4\u8bc1\u79d8\u4e66\u5904\u6c47\u53bb\u8bc1\u4e66\u7533\u8bf7\u7684\u6709\u5173\u8d39\u7528\uff0c\u5e76\u5c06\u5b8c\u6210\u7684\u7533\u8bf7\u8868\u683c\u548c\u836f\u7269\u6863\u6848\uff08Dossier\uff09\u4e00\u5e76\u9012\u4ea4\u7ed9\u6b27\u6d32\u836f\u7269\u8d28\u91cf\u7406\u4e8b\u4f1a\uff08EDQM\uff09\u7684\u8ba4\u8bc1\u79d8\u4e66\u5904\u3002<\/p>\n

b\uff0e \u8ba4\u8bc1\u79d8\u4e66\u5904\u6536\u5230\u7533\u8bf7\u6587\u4ef6\u540e\uff0c\u5728\u4e00\u5b9a\u671f\u9650\u5185\u5c06\u5b89\u6392\u8bc4\u5ba1\u3002\u8bc4\u5ba1\u7531\u8ba4\u8bc1\u79d8\u4e66\u5904\u6307\u5b9a\u7684\u8bc4\u5ba1\u59d4\u5458\u5c0f\u7ec4\uff08\u5fc5\u8981\u65f6\u4e5f\u53ef\u7531\u76f8\u5173\u7684\u6280\u672f\u987e\u95ee\u59d4\u5458\u4f1a\uff09\u6765\u5b8c\u6210\uff0c\u4ee5\u7ed9\u51fa\u662f\u5426\u53ef\u4ee5\u9881\u53d1COS\u8bc1\u4e66\u7684\u7ed3\u8bba\u3002<\/p>\n

c\uff0e \u7ed3\u679c\u901a\u77e5\uff1a\u8ba4\u8bc1\u79d8\u4e66\u5904\u91c7\u53d6\u5fc5\u8981\u7684\u65b9\u5f0f\u5c06\u6587\u4ef6\u8bc4\u5ba1\u7ed3\u679c\u53ca\u662f\u5426\u53ef\u4ee5\u9881\u53d1COS\u8bc1\u4e66\u7684\u7ed3\u8bba\u544a\u4e4b\u7533\u8bf7\u4eba\u3002<\/p>\n

5\u3001COS\u8bc1\u4e66\u7684\u4fee\u8ba2<\/p>\n

a\u3001 \u4e0e\u7b2c\u4e94\u7248\u6b27\u6d32\u836f\u5178\uff082004\u5e746\u6708\u51fa\u7248\u53d1\u884c\uff09\u76f8\u5173\u7684\u4fee\u8ba2<\/p>\n

COS\u8bc1\u4e66\u662f\u8bc1\u660e\u5bf9\u5df2\u751f\u6548\u7684\u6b27\u6d32\u836f\u5178\u7684\u4e13\u8bba\u6216\u603b\u8bba\u7684\u9002\u5e94\u6027\uff0c\u56e0\u6b64\u5fc5\u8981\u65f6\u5e94\u8be5\u6839\u636e\u836f\u5178\u589e\u8865\u672c\u6216\u65b0 \u7248\u836f\u5178\u7684\u8981\u6c42\u8fdb\u884c\u76f8\u5e94\u7684\u4fee\u8ba2\u3002\u57fa\u4e8e\u6b27\u6d32\u836f\u5178\u7b2c\u4e94\u7248\u7684\u5185\u5bb9\uff0cEDQM\u5c06\u4f1a\u5bf9\u5df2\u6388\u4e88\u8bc1\u4e66\u8fdb\u884c\u5fc5\u8981\u7684\u4fee\u8ba2\u3002\u8bc1\u4e66\u6301\u6709\u4eba\u6709\u8d23\u4efb\u5411\u8be5\u539f\u6599\u836f\u7684\u4f7f\u7528\u5546\u63d0\u4f9b\u4fee\u8ba2\u7684\u8bc1\u4e66\uff1b \u800c\u4e0a\u5e02\u8bb8\u53ef\u7684\u6301\u6709\u4eba\u6709\u8d23\u4efb\u5411\u8bb8\u53ef\u673a\u6784\u63d0\u4ea4\u76f8\u5e94\u7684\u4fee\u8ba2\u7533\u8bf7\u6587\u4ef6\u3002<\/p>\n

\u6709\u5173\u4fee\u8ba2\u7a0b\u5e8f\u7684\u5177\u4f53\u5185\u5bb9\u5c06\u5728\u8fd1\u671f\u516c\u5e03\uff0c\u57fa\u672c\u8981\u6c42\u5982\u4e0b\uff1a<\/p>\n

\u2015\u2015COS\u8bc1\u4e66\u5c06\u4f1a\u6839\u636e\u5f53\u524d\u7248\u672c\u7684\u836f\u5178\u548c\u76f8\u5173\u589e\u8865\u52a0\u4ee5\u66f4\u65b0\uff0c\u5e76\u4f7f\u7528\u65b0\u7684\u6807\u8bc6\u548c\u8bc1\u4e66\u7eb8\uff1b<\/p>\n

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b\u3001 \u4e0e\u53d8\u5316\u6709\u5173\u7684\u4fee\u8ba2<\/p>\n

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1\u3001\u5b9a\u4e49<\/p>\n

\u6b27\u6d32\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08EDMF\uff0c\u5373 European Drug Master File\uff09\u662f\u836f\u54c1\u5236\u5242\u7684\u5236\u9020\u5546\u4e3a\u53d6\u5f97\u4e0a\u5e02\u8bb8\u53ef\u800c\u5fc5\u987b\u5411\u6ce8\u518c\u5f53\u5c40\u63d0\u4ea4\u7684\u5173\u4e8e\u5728\u5236\u5242\u4ea7\u54c1\u4e2d\u6240\u4f7f\u7528\u7684\u539f\u6599\u836f\u7684\u57fa\u672c\u60c5\u51b5\u7684\u652f\u6301\u6027\u6280\u672f\u6587\u4ef6\u3002\u53c8\u79f0\u539f\u6599\u836f\u4e3b\u6587\u4ef6\u6863\u6848 \uff08ASMF\uff09\u3002\u5b83\u7684\u7533\u8bf7\u5fc5\u987b\u4e0e\u4f7f\u7528\u8be5\u539f\u6599\u836f\u7684\u5236\u5242\u7684\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u540c\u65f6\u8fdb\u884c\u3002\u5f53\u539f\u6599\u836f\u7269\u7684\u751f\u4ea7\u5382\u5bb6\uff08ASM\uff0c\u5373 The Active Substance Manufacturer\uff09\u4e0d\u662f\u836f\u54c1\u5236\u5242\u4e0a\u5e02\u8bb8\u53ef\u8bc1\u7684\u7533\u8bf7\u4eba\u65f6\uff0c\u4e5f\u5c31\u662f\u8bf4\u5f53\u5236\u5242\u751f\u4ea7\u5382\u5bb6\u4f7f\u7528\u5176\u5b83\u5382\u5bb6\u751f\u4ea7\u7684\u539f\u6599\u836f\u7269\u751f\u4ea7\u5236\u5242\u65f6\uff0c\u4e3a\u4e86\u4fdd\u62a4\u539f\u6599\u836f\u7269\u7684\u751f\u4ea7\u53ca \u8d28\u91cf\u7ba1\u7406\u7b49\u65b9\u9762\u6709\u4ef7\u503c\u7684\u6280\u672f\u673a\u5bc6\u800c\u7531\u539f\u6599\u836f\u7269\u7684\u751f\u4ea7\u5382\u5bb6\u63d0\u4ea4\u7ed9\u6b27\u6d32\u5b98\u65b9\u673a\u6784\u7684\u6587\u4ef6\u3002\u5206\u4e3a\u516c\u5f00\u90e8\u5206\u548c\u4fdd\u5bc6\u90e8\u5206\u3002\u4e0e\u7f8e\u56fdFDA\u7684DMF\u6db5\u6982\u836f\u54c1\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b CMC\uff08Chemistry, Manufacturing and Control\uff09\u4e0d\u540c\uff0c\u6b27\u6d32DMF\u5219\u4e3b\u8981\u5f3a\u8c03\u7b2c\u4e00\u4e2aC\uff0c\u5373Chemistry\u3002\u5177\u4f53\u7684\u8bf4\uff0cEDMF \u7684\u4e3b\u8981\u5185\u5bb9\u662f\u836f\u7269\u53ca\u5176\u76f8\u5173\u6742\u8d28\u7684\u5316\u5b66\uff0c\u5305\u62ec\u5316\u5b66\u7ed3\u6784\u53ca\u7ed3\u6784\u89e3\u6790\u3001\u5316\u5b66\u6027\u8d28\u3001\u6742\u8d28\u53ca\u5176\u9650\u5ea6\u3001\u6742\u8d28\u68c0\u67e5\u7b49\u7b49\u3002<\/p>\n

2\u3001EDMF\u5206\u4e3a\u4e24\u90e8\u5206\uff1a<\/p>\n

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3\u3001EDMF\u7684\u9002\u7528\u8303\u56f4\uff1a<\/p>\n

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4\u3001EDMF\u7684\u53d8\u52a8\u548c\u66f4\u65b0<\/p>\n

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5\u3001EDMF\u7684\u9012\u4ea4\u7a0b\u5e8f<\/p>\n

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6\u3001EDMF\u7684\u8bc4\u4f30<\/p>\n

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\u6210\u7acb\u8be5\u7ec4\u7ec7\u7684\u76ee\u7684\uff1a\uff08\uff11\uff09\u5bf9\u4e09\u65b9\u6210\u5458\u56fd\u4e4b\u95f4\u4eba\u7528\u836f\u7269\u6ce8\u518c\u6280\u672f\u8981\u6c42\u901a\u8fc7\u56fd\u9645\u534f\u8c03\u53d6\u5f97\u4e00\u81f4\u3002\uff08\uff12\uff09 \u5bf9\u65b0\u7a76\u5f00\u53d1\u6280\u672f\u6807\u51c6\u8fdb\u884c\u6539\u8fdb\u4e0e\u9769\u65b0\u4ee5\u671f\u63d0\u9ad8\u7814\u7a76\u8d28\u91cf\u3002\uff08\uff13\uff09\u8282\u7ea6\u4eba\u529b\u3001\u52a8\u7269\u3001\u7269\u8d44\u7b49\u8d44\u6e90,\u7f29\u77ed\u7814\u7a76\u5f00\u53d1\u5468\u671f,\u8282\u7ea6\u7ecf\u8d39\u5f00\u652f\u3002\uff08\uff14\uff09\u63d0\u9ad8\u65b0\u7a76\u3001\u5f00 \u53d1\u3001\u6ce8\u518c\u3001\u4e0a\u5e02\u7684\u6548\u7387,\u4e3a\u63a7\u5236\u75be\u75c5\u63d0\u4f9b\u66f4\u591a\u66f4\u597d\u7684\u65b0\u836f\u3002<\/p>\n

\u516d\u3001CTD\u6587\u4ef6\u7b80\u4ecb<\/p>\n

\u3000\u3000\u968f\u7740\u7531\u7f8e\u56fd\uff0c\u6b27\u6d32\u548c\u65e5\u672c\u4e09\u65b9\u53d1\u8d77\u7684\u56fd\u9645\u534f\u8c03\u4f1a\u8bae\uff08International Conference of Harmonization\uff0c\u7b80\u79f0ICH\uff09\u7684\u8fdb\u7a0b\uff0c\u5728\u4e0a\u8ff0\u4e09\u4e2a\u5730\u533a\u5bf9\u4e8e\u5728\u4eba\u7528\u836f\u7533\u8bf7\u6ce8\u518c\u7684\u6280\u672f\u8981\u6c42\u65b9\u9762\u5df2\u7ecf\u53d6\u5f97\u4e86\u76f8\u5f53\u5927\u7684\u534f\u8c03\u7edf\u4e00\uff0c\u4f46\u76f4\u5230\u76ee\u524d\u4e3a\u6b62\uff0c\u5404\u56fd \u5bf9\u4e8e\u6ce8\u518c\u7533\u8bf7\u6587\u4ef6\u4ecd\u7136\u6ca1\u6709\u4e00\u4e2a\u7edf\u4e00\u7684\u683c\u5f0f\u3002\u6bcf\u4e2a\u56fd\u5bb6\u5bf9\u4e8e\u63d0\u4ea4\u7684\u6280\u672f\u62a5\u544a\u7684\u7ec4\u7ec7\u53ca\u6587\u4ef6\u4e2d\u603b\u7ed3\u548c\u8868\u683c\u7684\u5236\u4f5c\u90fd\u6709\u81ea\u5df1\u7684\u8981\u6c42\u3002\u5728\u65e5\u672c\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u51c6\u5907\u4e00\u4e2a\u6982\u8981\u6765 \u4ecb\u7ecd\u6280\u672f\u65b9\u9762\u7684\u4fe1\u606f\uff1b\u5728\u6b27\u6d32\u5219\u5fc5\u987b\u63d0\u4ea4\u4e13\u5bb6\u62a5\u544a\u548c\u8868\u683c\u5f0f\u7684\u603b\u7ed3\uff1b\u800c\u7f8e\u56fdFDA\u5bf9\u4e8e\u65b0\u836f\u7533\u8bf7\u7684\u683c\u5f0f\u548c\u5185\u5bb9\u4e5f\u6709\u81ea\u5df1\u7684\u6307\u5357\u3002\u4e3a\u89e3\u51b3\u8fd9\u4e9b\u95ee\u9898\uff0cICH\u51b3\u5b9a\u91c7\u7528\u7edf \u4e00\u7684\u683c\u5f0f\u6765\u89c4\u8303\u5404\u4e2a\u5730\u533a\u7684\u6ce8\u518c\u7533\u8bf7\uff0c\u5e76\u57282003\u5e747\u6708\u8d77\u9996\u5148\u5728\u6b27\u6d32\u5b9e\u884c\u3002\u8fd9\u5c31\u662f\u4e0b\u9762\u8981\u5411\u5927\u5bb6\u4ecb\u7ecd\u7684\u5e38\u89c4\u6280\u672f\u6587\u4ef6\uff08CTD\uff09\u3002<\/p>\n

\u3000\u3000CTD\u6587\u4ef6\u662f\u56fd\u9645\u516c\u8ba4\u7684\u6587\u4ef6\u7f16\u5199\u683c\u5f0f\uff0c\u7528\u6765\u5236\u4f5c\u4e00\u4e2a\u5411\u836f\u54c1\u6ce8\u518c\u673a\u6784\u9012\u4ea4\u7684\u7ed3\u6784\u5b8c\u5584\u7684\u6ce8\u518c\u7533\u8bf7\u6587\u4ef6\uff0c\u5171\u7531\u4e94\u4e2a\u6a21\u5757\u7ec4\u6210\uff0c\u6a21\u57571\u662f\u5730\u533a\u7279\u5f02\u6027\u7684\uff0c\u6a21\u57572\u30013\u30014\u548c5\u5728\u5404\u4e2a\u5730\u533a\u662f\u7edf\u4e00\u7684\u3002<\/p>\n

\u6a21\u57571\uff1a\u884c\u653f\u4fe1\u606f\u548c\u6cd5\u89c4\u4fe1\u606f<\/p>\n

\u3000\u3000\u672c\u6a21\u5757\u5305\u62ec\u90a3\u4e9b\u5bf9\u5404\u5730\u533a\u7279\u6b8a\u7684\u6587\u4ef6\uff0c\u4f8b\u5982\u7533\u8bf7\u8868\u6216\u5728\u5404\u5730\u533a\u88ab\u5efa\u8bae\u4f7f\u7528\u7684\u6807\u7b7e\uff0c\u5176\u5185\u5bb9\u548c\u683c\u5f0f\u53ef\u4ee5\u7531\u6bcf\u4e2a\u5730\u533a\u7684\u76f8\u5173\u6ce8\u518c\u673a\u6784\u6765\u6307\u5b9a\u3002<\/p>\n

\u6a21\u57572\uff1aCTD\u6587\u4ef6\u6982\u8ff0<\/p>\n

\u3000\u3000\u672c\u6a21\u5757\u662f\u5bf9\u836f\u7269\u8d28\u91cf\uff0c\u975e\u4e34\u5e8a\u548c\u4e34\u5e8a\u5b9e\u9a8c\u65b9\u9762\u5185\u5bb9\u7684\u9ad8\u5ea6\u603b\u7ed3\u6982\u62ec\uff0c\u5fc5\u987b\u7531\u5408\u683c\u7684\u548c\u6709\u7ecf\u9a8c\u7684\u4e13\u5bb6\u6765\u62c5\u4efb\u6587\u4ef6\u7f16\u5199\u5de5\u4f5c\u3002<\/p>\n

\u6a21\u57573\uff1a\u8d28\u91cf\u90e8\u5206<\/p>\n

\u3000\u3000\u6587\u4ef6\u63d0\u4f9b\u836f\u7269\u5728\u5316\u5b66\u3001\u5236\u5242\u548c\u751f\u7269\u5b66\u65b9\u9762\u7684\u5185\u5bb9\u3002<\/p>\n

\u6a21\u57574\uff1a\u975e\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/p>\n

\u3000\u3000\u6587\u4ef6\u63d0\u4f9b\u539f\u6599\u836f\u548c\u5236\u5242\u5728\u6bd2\u7406\u5b66\u548c\u836f\u7406\u5b66\u8bd5\u9a8c\u65b9\u9762\u7684\u5185\u5bb9\u3002<\/p>\n

\u6a21\u57575\uff1a\u4e34\u5e8a\u7814\u7a76\u62a5\u544a<\/p>\n

\u3000\u3000\u6587\u4ef6\u63d0\u4f9b\u5236\u5242\u5728\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u9762\u7684\u5185\u5bb9\u3002<\/p>\n

\u5728CTD\u6587\u4ef6\u4e2d\uff0c\u9700\u8981\u539f\u6599\u836f\u5382\u5bb6\u63d0\u4ea4\u7684\u53ea\u662f\u5728\u6a21\u57572\u6574\u4f53\u8d28\u91cf\u6982\u8ff0\uff08The Quality Overall Summary\uff0c\u5373QOS\uff09\u90e8\u5206\u548c\u6a21\u57573\u8d28\u91cf\uff08Quality\uff09\u90e8\u5206\u4e2d\u6d89\u53ca\u539f\u6599\u836f\u7684\u5316\u5b66\u6027\u8d28\u3001\u751f\u4ea7\u5de5\u827a\u548c\u8d28\u91cf\u63a7\u5236\u7b49\u65b9\u9762\u7684\u57fa\u672c\u6570\u636e\u548c\u8d44\u6599\u3002\u5728\u6574\u4f53\u8d28\u91cf\u6982\u8ff0 \u4e2d\u539f\u6599\u836f\u5382\u5bb6\u63d0\u4f9b\u7684\u8d44\u6599\u5e94\u8be5\u80fd\u591f\u4f7f\u8d28\u91cf\u8bc4\u5ba1\u59d4\u5458\u5bf9\u6a21\u57573\u7684\u76f8\u5173\u5185\u5bb9\u6709\u4e00\u4e2a\u5927\u81f4\u7684\u4e86\u89e3\u3002<\/p>\n

\u3000\u3000\u5728\u63d0\u4ea4CTD\u6587\u4ef6\u65f6\uff0c\u540c\u6837\u4e3a\u4e86\u4fdd\u62a4\u539f\u6599\u836f\u751f\u4ea7\u5382\u5bb6\u7684\u6280\u672f\u673a\u5bc6\u800c\u9700\u8981\u7531\u7533\u8bf7\u4eba\u914d\u5408\u539f\u6599\u836f\u751f\u4ea7 \u5382\u5bb6\u7684\u8d1f\u8d23\u4eba\u5355\u72ec\u63d0\u4ea4\u4e00\u4efd\u7b26\u5408\u6b27\u6d32CTD\u683c\u5f0f\u7684\u4fdd\u5bc6\u6587\u4ef6\uff0c\u4ee5\u786e\u4fdd\u6240\u6709\u6ce8\u518c\u7533\u8bf7\u8981\u6c42\u7684\u76f8\u5173\u8d44\u6599\u76f4\u63a5\u63d0\u4f9b\u7ed9\u6709\u5173\u5f53\u5c40\uff0c\u8fd9\u4e2a\u4fdd\u5bc6\u6587\u4ef6\u5305\u62ec\u6a21\u57573\u4e2d\u5173\u4e8e\u751f\u4ea7\u5de5\u827a\u7684 \u8be6\u7ec6\u63cf\u8ff0\uff0c\u751f\u4ea7\u8fc7\u7a0b\u7684\u8d28\u91cf\u63a7\u5236\uff0c\u5de5\u827a\u9a8c\u8bc1\u548c\u6570\u636e\u8bc4\u4ef7\u7684\u5185\u5bb9\u3002\u6b64\u5916\uff0c\u8fd8\u9700\u8981\u5355\u72ec\u63d0\u4f9b\u4e00\u4e2a\u6574\u4f53\u8d28\u91cf\u6982\u8ff0\uff0c\u5176\u5185\u5bb9\u4e0d\u5728\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u5404\u90e8\u5206\u5185\u3002\u6574\u4e2a\u4fdd\u5bc6\u6587\u4ef6\u5fc5 \u987b\u7b26\u5408CTD\u7684\u683c\u5f0f\u8981\u6c42\u3002<\/p>\n


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

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