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class=\"wp-block-paragraph\">\u70ba\u4e86\u5438\u5f15\u66f4\u591a\u570b\u969b\u88fd\u85e5\u4f01\u696d\u6295\u8cc7\uff0c\u5370\u5ea6\u65bc2005\u5e74\u5f15\u5165\u4e86\u201c\u7522\u54c1\u5c08\u5229\u5236\u5ea6\u201d\u3002\u5f88\u591a\u5370\u5ea6\u7684\u751f\u7522\u5546\u6539\u9020\u4e86\u81ea\u5df1\u7684\u751f\u7522\u5ee0\uff0c\u5370\u5ea6\u6210\u70ba\u64c1\u6709\u6700\u591a\u7d93\u904eFDA\u3001\u6b50\u6d32\u85e5\u54c1\u8cea\u91cf\u548c\u5065\u5eb7\u4fdd\u969c\u5c40\uff08EDQM\uff09\uff0c\u4ee5\u53ca\u5176\u4ed6\u7ba1\u7406\u6a5f\u69cb\u6aa2\u9a57\u85e5\u5ee0\u7684\u570b\u5bb6\u4e4b\u4e00\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u65b0\u52a0\u5761<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u65b0\u52a0\u5761\u5728\u88fd\u85e5\u696d\u4e2d\u627f\u64d4\u7684\u7fa9\u52d9\u548c\u6295\u8cc7\u4f7f\u5176\u6210\u70ba\u7b2c\u4e8c\u5927\u767c\u9054\u4e9e\u6d32\u570b\u5bb6\uff0c\u50c5\u6b21\u65bc\u65e5\u672c\u3002\u65b0\u52a0\u5761\u4ee5\u5176\u4f5c\u70ba\u5168\u7403\u88fd\u85e5\u4f01\u696d\u7684\u6230\u7565\u751f\u7522\u57fa\u5730\uff0c\u53ca\u5176\u5c65\u884c\u5168\u7403\u6cd5\u898f\u7684\u80fd\u529b\u800c\u8457\u7a31\u3002\u5728\u904e\u53bb\u5e7e\u5e74\u4e2d\uff0c\u65b0\u52a0\u5761\u570b\u5167\u5e02\u5834\u4fdd\u6301\u5065\u5eb7\u7684\u767c\u5c55\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u99ac\u4f86\u897f\u4e9e<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2001\u5e743\u6708\uff0c\u99ac\u4f86\u897f\u4e9e\u63a5\u53d7\u4e86\u201c\u570b\u969b\u91ab\u85e5\u54c1\u7a3d\u67e5\u5354\u7d04\u7d44\u7e54\u201d\uff08PIC\/S\uff09\u5c0d\u99ac\u4f86\u897f\u4e9e\u570b\u5bb6\u85e5\u54c1\u7ba1\u7406\u5c40\uff08NPCB\uff09\u7ba1\u7406\u7684GMP\u6aa2\u9a57\u8207\u8a31\u53ef\u9ad4\u7cfb\u9032\u884c\u7684\u8a55\u4f30\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b64\u6b21\u8a55\u4f30\u986f\u793a\u56e0\u5176\u5617\u8a66\u8207\u570b\u969b\u6a19\u6e96\u63a5\u8ecc\uff0c\u99ac\u4f86\u897f\u4e9e\u7684\u9ad4\u4fc2\u5e7e\u4e4e\u6eff\u8db3\u5c0dPIC\/S\u6210\u54e1\u570b\u7684\u8981\u6c42\u3002\u4f46\u56e0\u70ba\u7f3a\u4e4f\u5c08\u9580\u6280\u8853\uff0c\u6b64\u6b21GMP\u5be9\u6838\u7684\u6df1\u5ea6\u5c1a\u6709\u6b20\u7f3a\u3002 NPCB\u5f9e\u6b64\u81f4\u529b\u65bc\u57f9\u8a13\u5c08\u696d\u9818\u57df\u548c\u6aa2\u9a57\u65b9\u9762\u7684GMP\u5be9\u6838\u54e1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u99ac\u4f86\u897f\u4e9e\u65bc2002\u5e74\u6210\u70baPIC\/S\u6210\u54e1\uff0c\u70ba\u5b8c\u5168\u6eff\u8db3\u6839\u64da\u7576\u524d\u4e16\u754c\u885b\u751f\u7d44\u7e54\uff08WHO\uff09\u570b\u969b\u85e5\u54c1\u5408\u4f5c\u76e3\u6e2c\u4e2d\u5fc3\u7ba1\u7406\u7684PIC\/S\u5236\u5b9a\u7684GMP\u6cd5\u898f\u7684\u85e5\u54c1\u751f\u7522\u5546\u9812\u767c\u8a31\u53ef\u8b49\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u99ac\u4f86\u897f\u4e9e\u8a3b\u518a\u7684\u85e5\u54c1\u6a19\u7c64\u6216\u5305\u88dd\u4e0a\u5370\u6709\u4e00\u500b\u8a3b\u518a\u7de8\u865f\uff0c\u4ee5PBKO\u6216MAL\u958b\u59cb\u8b49\u660e\u5176\u8cea\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6aa2\u9a57\u7d50\u679c\u5408\u683c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u53f0\u7063<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7531\u885b\u751f\u7f72\u7d44\u5efa\u7684\u53f0\u7063\u85e5\u653f\u5c40\uff08BPA\uff09\u7ba1\u7406\u53f0\u7063\u7684\u85e5\u54c1\u884c\u696d\u3002 GMP\u8981\u6c42\u7d93\u904e\u5e7e\u6b21\u4fee\u6539\u548c\u589e\u88dc\u5f8c\uff0c\u65bc20\u4e16\u7d0080\u5e74\u4ee3\u9996\u6b21\u88fd\u5b9a\u3002 GMP\u88fd\u85e5\u6a5f\u69cb\u6bcf\u5169\u5e74\u63a5\u53d7\u4e00\u6b21\u7ba1\u7406\u6a5f\u69cb\u7684\u6aa2\u9a57\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2007\u5e74\uff0c\u70ba\u4e86\u4f7f\u570b\u5167\u7684\u88fd\u85e5\u6d3b\u52d5\u66f4\u52a0\u5438\u5f15\u570b\u969b\u85e5\u54c1\u4f01\u696d\uff0c\u53f0\u7063\u7b56\u7565\u5be9\u6838\u59d4\u54e1\u6703\u6c7a\u5b9a\u4fee\u6539\u85e5\u54c1\u8a3b\u518a\u6cd5\u898f\u3002\u885b\u751f\u7f72\u76ee\u524d\u6b63\u5728\u5be6\u65bd\u4fee\u6539\u5f8c\u7684\u6cd5\u898f\uff0c\u8981\u6c42\u53f0\u7063\u7684\u85e5\u54c1\u751f\u7522\u5546\u81ea2009\u5e74\u8d77\u9075\u5b88\u6b50\u76df\u7684PIC\/S\u6a19\u6e96\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u97d3\u570b<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u8207\u7f8e\u570b\u7c3d\u8a02\u4e86\u81ea\u7531\u8cbf\u6613\u5354\u5b9a\u3001\u7d93\u6b77\u4e86\u7d93\u6fdf\u7684\u5feb\u901f\u589e\u9577\u4e4b\u5f8c\uff0c\u97d3\u570b\u7684\u85e5\u54c1\u5e02\u5834\u6210\u70ba\u7e7c\u65e5\u672c\u3001\u4e2d\u570b\u548c\u5370\u5ea6\u4e4b\u5f8c\u4e9e\u592a\u5730\u5340\u6700\u5177\u5438\u5f15\u529b\u7684\u5e02\u5834\u4e4b\u4e00\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8d8a\u5357\u3001\u83f2\u5f8b\u8cd3\u548c\u6cf0\u570b<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8d8a\u5357\u3001\u83f2\u5f8b\u8cd3\u548c\u6cf0\u570b\u90fd\u662f\u201c\u6771\u5357\u4e9e\u570b\u5bb6\u806f\u76df\u201d\uff08ASEAN\uff09\u6210\u54e1\u570b\uff0c\u4ea6\u9075\u5b88ASEAN GMP\u898f\u5247\u3002\u4f46\u56e0\u70ba\u6c92\u6709\u7d71\u4e00\u7684\u6aa2\u9a57\u6a19\u6e96\uff0c\u5176\u5408\u683c\u7a0b\u5ea6\u53ea\u80fd\u548c\u9075\u5b88\u6b50\u76df\u53ca\u7f8e\u570b\u6a19\u6e96\u7684\u570b\u5bb6\u9032\u884c\u908a\u969b\u6bd4\u8f03\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8d8a\u5357\u88fd\u85e5\u696d\u7684\u767c\u5c55\u4ecd\u820a\u8655\u65bc\u521d\u7d1a\u968e\u6bb5\u3002\u8d8a\u5357\u885b\u751f\u90e8\u70ba\u4e86\u80fd\u5920\u5728\u570b\u969b\u5e02\u5834\u4e0a\u722d\u5f97\u4e00\u5e2d\u4e4b\u5730\uff0c\u6b63\u5728\u6295\u8cc7\u4ee5\u6eff\u8db3\u85e5\u54c1\u7684GMP\u8981\u6c42\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2007\u5e745\u6708\u7684\u4e00\u4efd\u8abf\u67e5\u5831\u544a\u7a31\uff0c\u5168\u7403\u85e5\u54c1\u5e02\u5834\u548c\u83f2\u5f8b\u8cd3\u751f\u7269\u6280\u8853\u884c\u696d\u5728\u672a\u4f86\u4e94\u5e74\u6709\u671b\u6301\u7e8c\u589e\u9577\u3002 2007\u5e74\uff0c\u745e\u5178\u7684Pharmadule\u8207\u83f2\u5f8b\u8cd3Servac\u7c3d\u8a02\u5408\u540c\u5efa\u7acb\u4e00\u500b\u72c2\u72ac\u75c5\u75ab\u82d7\u751f\u7522\u5ee0\u5bb6\u3002 Sanofi \u2013Aventis\u7684\u5b50\u516c\u53f8Winthrop Pharmaceuticals\u4e5f\u5728\u5bbf\u52d9\u7701\u958b\u8a2d\u4e86\u5206\u652f\u6a5f\u69cb\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6cf0\u570b\u4ecd\u820a\u662f\u4e9e\u6d32\u88fd\u85e5\u696d\u767c\u5c55\u6700\u5177\u6311\u6230\u6027\u7684\u5730\u5340\u4e4b\u4e00\uff0c\u5168\u4e16\u754c\u7684\u516c\u53f8\u90fd\u8981\u7d93\u904e\u6cf0\u570b\u653f\u5e9c\u7684\u5f37\u5236\u6027\u8a31\u53ef\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u64daBusiness Monitor International\u4eca\u5e742\u6708\u7684\u4e00\u4efd\u5831\u544a\u7a31\uff0c\u5883\u5916\u6295\u8cc7\u98a8\u96aa\u548c\u9650\u5236\u5f71\u97ff\u4e86\u65b0\u7522\u54c1\u4e0a\u5e02\uff0c\u540c\u6642\u59a8\u7919\u4e86\u5916\u5546\u76f4\u63a5\u6295\u8cc7\uff0c\u56e0\u6b64\u6cf0\u570b\u5e02\u5834\u7684\u767c\u5c55\u9810\u671f\u53ef\u80fd\u975e\u5e38\u7de9\u6162\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EMEA\u8207FDA\u5728\u4e9e\u6d32\u63a1\u7528\u7684GMP\u6aa2\u9a57\u65b9\u6cd5<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>EMEA<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u64da2007\u5e741\u6708\u767c\u884c\u7684EMEA\u6587\u4ef6\uff08EMEA\/INS\/GMP\/23022\/2007\uff09\uff0c\u4e0d\u5728EMEA\u7bc4\u570d\u5167\u7684400\u7a2eAPI\u8207\u6210\u54c1\u4f9b\u61c9\u5546\u65bc1995\u81f32005\u5e74\u9593\u63a5\u53d7\u4e86\u6aa2\u9a57\u3002\u6aa2\u9a57\u986f\u793a\u5b58\u57288785\u9ede\u7f3a\u9677\uff0c\u5176\u4e2d138\uff081.57%\uff09\u500b\u975e\u5e38\u56b4\u91cd\uff0c977\uff0811.12%\uff09\u500b\u8f03\u70ba\u56b4\u91cd\uff0c\u53e6\u59167670\uff0887.31%\uff09\u4e00\u822c\u56b4\u91cd\u3002\u6bcf\u6b21\u6aa2\u9a57\u4e2d\u767c\u73fe\u7684\u7f3a\u9677\u5e73\u5747\u6578\u70ba22\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6700\u5e38\u898b\u768415\u7a2e\u7f3a\u9677\u5206\u5225\u662f\uff1a<\/p>\n\n\n\n<ul 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