{"id":645,"date":"2018-07-02T01:00:00","date_gmt":"2018-07-27T06:21:42","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/ich%e5%ae%a3%e5%b8%83%e5%bc%80%e5%a7%8b%e5%88%b6%e5%ae%9a%e4%b8%a4%e4%b8%aaich%e6%8c%87%e5%8d%97%ef%bc%9aq13%e5%92%8cq14\/"},"modified":"2018-07-27T14:21:42","modified_gmt":"2018-07-27T06:21:42","slug":"ich%e5%ae%a3%e5%b8%83%e5%bc%80%e5%a7%8b%e5%88%b6%e5%ae%9a%e4%b8%a4%e4%b8%aaich%e6%8c%87%e5%8d%97%ef%bc%9aq13%e5%92%8cq14","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/645\/","title":{"rendered":"ICH\u5ba3\u5e03\u5f00\u59cb\u5236\u5b9a\u4e24\u4e2aICH\u6307\u5357\uff1aQ13\u548cQ14"},"content":{"rendered":"
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\u56fd\u9645\u5408\u7406\u7528\u836f\u548cWHO\u516c\u62a5\u6c47\u7f16(2011)<\/h2>\n

\u4f5c\u8005\uff1a\u5510\u955c\u6ce2\u3000\u7b49\u7f16\u8457<\/p>\n<\/p><\/div>\n

\n
<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

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\u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001\u8d28\u91cf\u603b\u76d1\uff0c\u9a8c\u8bc1\u7ba1\u7406\u8d44\u6df1\u4e13\u5bb6\uff0c\u591a\u5bb6\u5236\u836f\u516c\u53f8\u987e\u95ee\uff0c\u836f\u5b66\u7855\u58eb\u3002\u56fd\u5bb6\u5de5\u827a\u6838\u5bf9\u672a\u96e8\u7ef8\u7f2a\u4e4b\u9645\uff0c\u6210\u529f\u89e3\u51b3\u4e86\u591a\u5bb6\u5728\u4ea7\u4ea7\u54c1\u5904\u65b9\u3001\u5de5\u827a\u95ee\u9898\u3002\u5904\u65b9\u5de5\u827a\u7684\u4e8c\u6b21\u5f00\u53d1\uff0c\u514d\u8d39\u54a8\u8be2\uff0c\u5168\u7a0b\u4fdd\u5bc6\u3002\u90ae\u7bb1\uff1a1193686015@qq.com\u3002<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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In a press release from 22 June the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future. The Assembly agreed to begin working on two new topics for ICH harmonisation:<\/span>
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ICH\u57286\u670822\u65e5\u7684\u65b0\u95fb\u7a3f\u4e2d\u5ba3\u5e03\u4ed6\u4eec\u5c06\u5f00\u59cb\u5236\u5b9a\u4e24\u4e2aICH\u6307\u5357\uff1a<\/span><\/p>\n


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– Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q14\/Q2(R2));<\/span><\/p>\n

\u5206\u6790\u7a0b\u5e8f\u5f00\u53d1\u548cQ2(R1)\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u7684\u4fee\u8ba2\uff08Q14\/Q2(R2)\uff09<\/span><\/p>\n

– Continuous manufacturing (Q13); <\/span><\/p>\n

\u8fde\u7eed\u751f\u4ea7\uff08Q13\uff09<\/span><\/p>\n


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The long anticipated revision of ICH Q2(R1) “Guideline on Validation of Analytical Procedures: Text and Methodology” has been approved and the work plan is scheduled to commence in Q3 2018. It is intended that the new guidelines will be consistent with ICH Q8(R2), Q9, Q10, Q11 and Q12 .<\/span><\/p>\n

\u5df2\u6279\u51c6\u5bf9ICH Q2\uff08R1\uff09\u201c\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6307\u5bfc\u539f\u5219\uff1a\u6b63\u6587\u548c\u65b9\u6cd5\u5b66\u201d\u8fdb\u884c\u8f83\u957f\u65f6\u95f4\u7684\u4fee\u8ba2\uff0c\u5de5\u4f5c\u8ba1\u5212\u5c06\u4e8e2018\u5e74\u7b2c3\u5b63\u5ea6\u5f00\u59cb\u3002\u9884\u671f\u65b0\u6307\u5357\u5c06\u4e0eICH Q8 \uff08R2\uff09\uff0cQ9\uff0cQ10\uff0cQ11\u548cQ12\u4e00\u81f4\u3002<\/span><\/p>\n

 <\/span><\/p>\n

The AQbD approach is very important to collect information in order to get an understanding and control of sources of variability of the analytical procedure by defining the control strategy.<\/span><\/p>\n

\u901a\u8fc7\u5b9a\u4e49\u63a7\u5236\u7b56\u7565\u4f7f\u7528AQbD\u65b9\u6cd5\u6765\u6536\u96c6\u4fe1\u606f\u4ee5\u5f97\u5230\u7684\u5206\u6790\u65b9\u6cd5\u7684\u53d8\u5f02\u6765\u6e90\u7684\u7406\u89e3\u548c\u63a7\u5236\u662f\u975e\u5e38\u91cd\u8981\u7684<\/span><\/p>\n

 <\/span><\/p>\n

Based on the Analytical Target Profile (ATP) the objective of the test and the quality parameters can be defined. By performing the validation (qualification) in the QbD concept, sufficient confidence can be achieved in order to consistently generate the analytical results that meet the ATP requirements.<\/span><\/p>\n

\u6839\u636e\u5206\u6790\u76ee\u6807\u6587\u4ef6\uff08ATP\uff09\uff0c\u53ef\u4ee5\u5b9a\u4e49\u6d4b\u8bd5\u76ee\u6807\u548c\u8d28\u91cf\u53c2\u6570\u3002\u901a\u8fc7\u6267\u884cQbD\u89c2\u5ff5\u7684\u9a8c\u8bc1\uff08\u786e\u8ba4\uff09\uff0c\u53ef\u4ee5\u83b7\u5f97\u8db3\u591f\u7684\u7f6e\u4fe1\u5ea6\uff0c\u4ee5\u59cb\u7ec8\u5982\u4e00\u5730\u751f\u6210\u7b26\u5408ATP\u8981\u6c42\u7684\u5206\u6790\u7ed3\u679c\u3002<\/span><\/p>\n

 <\/span><\/p>\n

So far there has been a lack of an Analytical Development Guideline, which the new ICH Development Guideline is supposed to compensate. Currently analytical procedures are mainly validated according to the classical validation parameters and  these procedures mainly focus on HPLC Methods. Therefore this ICH topic has a top priority for the pharmaceutical industry. It is expected that the Revision of the Q2 (R1) Guideline will help to implement new and innovative analytical methods.<\/span><\/p>\n

\u5230\u76ee\u524d\u4e3a\u6b62\uff0c\u7f3a\u4e4f\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u7684\u6307\u5357\uff0c\u65b0\u7684ICH\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u6307\u5357\u53ef\u4ee5\u5f25\u8865\u6b64\u7a7a\u767d\u3002\u76ee\u524d\u5206\u6790\u65b9\u6cd5\u4e3b\u8981\u6839\u636e\u7ecf\u5178\u9a8c\u8bc1\u53c2\u6570\u8fdb\u884c\u9a8c\u8bc1\uff0c\u5e76\u4e14\u8fd9\u4e9b\u7a0b\u5e8f\u4e3b\u8981\u96c6\u4e2d\u5728HPLC\u65b9\u6cd5\u3002\u56e0\u6b64\uff0c\u8fd9\u4e2aICH\u4e3b\u9898\u662f\u5236\u836f\u884c\u4e1a\u7684\u9996\u8981\u4efb\u52a1\u3002\u9884\u8ba1\u7b2c\u4e8c\u5b63\u5ea6\uff08R1\uff09\u6307\u5357\u7684\u4fee\u8ba2\u5c06\u5bf9\u65b0\u7684\u548c\u521b\u65b0\u7684\u5206\u6790\u65b9\u6cd5\u7684\u5b9e\u65bd\u6709\u6240\u5e2e\u52a9\u3002<\/span><\/p>\n

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\u6b27\u76dfGMP\/GDP\u6cd5\u89c4\u6c47\u7f16\uff08\u4e2d\u82f1\u6587\u5bf9\u7167\u7248\uff09<\/h2>\n

\u4f5c\u8005\uff1a???<\/p>\n<\/p><\/div>\n

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<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n

ICH Q12\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u6982\u5ff5\u7a3f\u5e26\u6765\u7684\u542f\u793a<\/span><\/h2>\n

2014\u5e749\u6708\uff0cICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management\uff08\u300a\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u6280\u672f\u548c\u6cd5\u89c4\u8003\u8651\u300b\uff09\u7684\u6982\u5ff5\u7a3f\u5b9a\u7a3f\u3002<\/span><\/p>\n


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\u4ece\u8fd9\u7bc7\u4ecb\u7ecd\u4e2d\uff0c<\/span>\u6211\u4eec\u77e5\u9053\u57282003\u5e74\uff0cICH\u786e\u5b9a\u4e86\u4e00\u4e2a\u8d28\u91cf\u613f\u666f<\/span>\uff1a\u5efa\u7acb\u4e00\u4e2a\u8d2f\u7a7f\u4e8e\u4ea7\u54c1\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u7edf\u4e00\u7684\u5236\u836f\u8d28\u91cf\u7cfb\u7edf\uff0c\u540c\u65f6\u5f3a\u8c03\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u548c\u79d1\u5b66\u7684\u7efc\u5408\u65b9\u6cd5\u3002ICH\u5df2\u7ecf\u9881\u5e03\u4e86\u51e0\u4e2a\u6307\u5357\uff08Q8\u2014Q11\uff09\u6765\u5b9e\u73b0\u8fd9\u4e2a\u613f\u666f\u3002\u800cICH Q8-11\u91cd\u70b9\u5728\u4e8e\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7684\u7814\u53d1\u9636\u6bb5\uff0c\u6240\u4ee5ICH \u5f00\u53d1<\/span>Q12\u7684\u76ee\u7684\u662f\u7740\u91cd\u4e8e\u751f\u547d\u5468\u671f\u7684\u5546\u4e1a\u751f\u4ea7\u9636\u6bb5<\/span>\u3002ICH Q10\u5f15\u8fdb\u4e86\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u548c\u77e5\u8bc6\u7ba1\u7406\u7684\u6982\u5ff5\uff0c\u5b83\u4eec\u662f\u63a8\u8fdb\u5668\uff0c\u901a\u8fc7\u63d0\u4f9b\u57fa\u4e8e\u79d1\u5b66\u548c\u98ce\u9669\u7684\u65b9\u6cd5\uff0c\u80fd\u591f\u4fc3\u8fdb\u4ea7\u54c1\u5b9e\u73b0\u3001\u7ef4\u6301\u63a7\u5236\u72b6\u6001\u3001\u5b9e\u73b0\u6301\u7eed\u6539\u8fdb\u3002ICH Q9 \u662f\u5173\u4e8e\u8d28\u91cf\u5206\u6790\u7ba1\u7406\u7684\uff0c\u4ecb\u7ecd\u4e86\u8fd9\u4e2a\u63a8\u8fdb\u5668\u7684\u7ec6\u8282\uff0c\u4f46\u5bf9\u4e8e\u77e5\u8bc6\u7ba1\u7406\u6d89\u53ca\u5185\u5bb9\u6bd4\u8f83\u5c11\u3002<\/span><\/p>\n


<\/p>\n

ICH Q10\u4ecb\u7ecd\u4e86\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e2d\u53d8\u66f4\u63a7\u5236\u7684\u6709\u9650\u7684\u4e00\u70b9\u4fe1\u606f\uff0c\u73b0\u5728\u770b\u6765\u76d1\u7ba1\u90e8\u95e8\u9700\u8981\u66f4\u591a\u7684\u4fe1\u606f\u6765\u5bf9\u53d8\u66f4\u8fdb\u884c\u7ba1\u7406\uff0c\u53ea\u6709\u8fd9\u6837\u4ed6\u4eec\u624d\u80fd\u591f\u66f4\u52a0\u7406\u89e3\u548c\u4fe1\u4efb\u53d8\u66f4\uff0c\u4ee5\u5b9e\u73b0\u6240\u8c13\u7684\u201c\u64cd\u4f5c\u7684\u7075\u6d3b\u6027\u201d\u3002<\/span><\/p>\n

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\u539f\u6599\u836f\u6b27\u7f8e\u6587\u4ef6\u6ce8\u518c\u53ca\u6b27\u76df\u975e\u65e0\u83cc\u539f\u6599\u836fGMP\u5b9e\u6218\u6307\u5357<\/h2>\n

\u4f5c\u8005\uff1a\u6ed5\u6653\u989c, \u5b8b\u8f89\u4e3b\u7f16<\/p>\n<\/p><\/div>\n

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<\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

<\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

\u4e8e\u662f\uff0cICH Q12\u5728\u4ee5\u4e0b\u65b9\u9762\u8fdb\u884c\u4e86\u7edf\u4e00\u89c4\u5b9a\uff1a<\/span><\/p>\n


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Regulatory Dossier\u6cd5\u89c4\u6ce8\u518c<\/span><\/p>\n


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\u672c\u6307\u5357\u4e2d\u5f00\u53d1\u4e86\u4e00\u4e2a\u7edf\u4e00\u7684\u65b9\u6cd5\u7528\u4e8e\u201c\u6cd5\u89c4\u627f\u8bfa\u201d\uff0c\u8fd9\u4e2a\u65b9\u6cd5\u6709\u52a9\u4e8e\u6279\u51c6\u540e\u53d8\u66f4\uff1b<\/span><\/p>\n

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    \u6307\u5357\u4e2d\u5217\u51fa\u4e86\u6ce8\u518c\u8d44\u6599\u4e2d\u7528\u4e8e\u6cd5\u89c4\u8bc4\u4f30\u548c\u68c0\u67e5\u6240\u5fc5\u987b\u7684\u7ec6\u8282\u548c\u4fe1\u606f\uff0c\u4ee5\u4fbf\u4e8e\u521b\u5efa\u66f4\u4fbf\u5229\u7684\u6279\u51c6\u540e\u53d8\u66f4\u7ba1\u7406\u7684\u4f53\u7cfb\uff1b<\/span><\/p>\n<\/li>\n

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    \u5236\u836f\u8d28\u91cf\u4f53\u7cfb<\/span><\/p>\n<\/li>\n

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    \u672c\u6307\u5357\u57fa\u4e8e\u4ea7\u54c1\u3001\u5de5\u827a\u548c\/\u6216\u4e34\u5e8a\u77e5\u8bc6\uff0c\u4e3a\u7edf\u4e00\u7684\u57fa\u4e8e\u98ce\u9669\u7684\u53d8\u66f4\u7ba1\u7406<\/span>\u4f53\u7cfb\u5efa\u7acb\u6807\u51c6\uff0c<\/span>\u4ee5\u4fbf\u9ad8\u6548\u8bc4\u4f30\u53d8\u66f4\u5bf9\u4ea7\u54c1\u8d28\u91cf\u3001\u5b89\u5168\u3001\u529f\u6548\u7684\u5f71\u54cd<\/span>\u3002<\/p>\n<\/li>\n

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    \u52a0\u5f3a\u77e5\u8bc6\u7ba1\u7406\uff0c\u4fdd\u8bc1\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\u77e5\u8bc6\u7684\u8fde\u7eed\u6027\u3002<\/span><\/p>\n<\/li>\n

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    \u6279\u51c6\u540e\u53d8\u66f4\u7ba1\u7406\u65b9\u6848<\/span><\/p>\n<\/li>\n

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    \u5f15\u5165\u6279\u51c6\u540e\u7ba1\u7406\u65b9\u6848\u7684\u6982\u5ff5\u53ef\u4ee5\u6709\u52a9\u4e8e\u4f60\u4e3b\u52a8\u7684\u8bc6\u522b\u6279\u51c6\u540e\u53d8\u66f4\u3001\u786e\u5b9a\u7533\u62a5\u673a\u5236\u548c\u6cd5\u89c4\u90e8\u95e8\u5bf9\u6b64\u7684\u8bc4\u4f30\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u4e3a\u6279\u51c6\u540e\u53d8\u66f4\u7ba1\u7406\u65b9\u6848\u5efa\u7acb\u6807\u51c6\u4ee5\u4fbf\u4e8e\u5404\u5730\u533a\u91c7\u7528\u3002<\/span><\/p>\n<\/li>\n

  • \n

    \u9f13\u52b1QbD\u7528\u4e8e\u6279\u51c6\u540e\u53d8\u66f4\u7ba1\u7406\u65b9\u6848\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


    <\/p>\n

    ICH Q12\u53ef\u80fd\u5b9e\u73b0\u4ee5\u4e0b\u76ee\u6807\uff1a<\/span><\/p>\n


    <\/p>\n

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      \u7edf\u4e00\u53d8\u66f4\u7ba1\u7406\uff0c\u53ef\u4ee5\u4f7f\u4f01\u4e1a\u548c\u76d1\u7ba1\u8005\u5728\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u5185\u66f4\u597d\u7684\u7ba1\u7406CMC\u53d8\u66f4\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u4fbf\u4e8e\u5b9e\u73b0\u57fa\u4e8e\u98ce\u9669\u7684\u6cd5\u89c4\u76d1\u7ba1\u548c\u5bf9\u8bc4\u4f30\u53ca\u68c0\u67e5\u7684\u8d44\u6e90\u4f18\u5316\u3002<\/span><\/p>\n<\/li>\n

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      \u6709\u52a9\u4e8e\u4f01\u4e1a\u91c7\u7528\u7b80\u5355\u3001\u7edf\u4e00\u7684\u65b9\u6cd5\u7ef4\u6301\u5e76\u66f4\u65b0\u6ce8\u518c\u8d44\u6599\u6765\u4fdd\u8bc1\u7b26\u5408\u6027\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u52a0\u5f3a\u524d\u77bb\u6027\u7684\u53d8\u66f4\u7ba1\u7406\u7684\u6cd5\u89c4\u5de5\u5177\u7684\u4f7f\u7528\uff08\u4f8b\u5982\uff0c\u6279\u51c6\u540e\u53d8\u66f4\u7ba1\u7406\u8ba1\u5212\uff08PACM\uff09\uff0cPACM\u65b9\u6848\/\u76f8\u5bb9\u6027\u65b9\u6848\uff09\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u901a\u8fc7\u5bf9\u6279\u51c6\u540e\u53d8\u66f4\u8fdb\u884c\u6709\u7b56\u7565\u7684\u7ba1\u7406\u6709\u52a9\u4e8e\u4fdd\u8bc1\u4ea7\u54c1\u5de5\u827a\u7684\u7a33\u5b9a\u6027\uff0c\u53ef\u4ee5\u51cf\u5c11\u7531\u4e8e\u751f\u4ea7\u548c\u8d28\u91cf\u95ee\u9898\u5bfc\u81f4\u7684\u836f\u7269\u77ed\u7f3a\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u6709\u52a9\u4e8e\u751f\u4ea7\u5de5\u827a\u548c\u63a7\u5236\u7b56\u7565\u7684\u6301\u7eed\u6539\u8fdb\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u6709\u52a9\u4e8e\u63d0\u9ad8\u751f\u4ea7\u6548\u7387\u3002<\/span><\/p>\n<\/li>\n

    • \n

      \u6709\u52a9\u4e8e\u5f15\u5165\u521b\u65b0\u548cPACM\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n

      \n
      \n
      \n
      \n
      <\/figure>\n
      \n
      \n

      \u6b27\u76df\u98df\u54c1\u6cd5<\/h2>\n

      \u4f5c\u8005\uff1a\uff08\u610f\uff09\u8def\u6613\u5409\u00b7\u67ef\u65af\u5854\u6258\uff08Luigi Costato\uff09\u3001\uff08\u610f\uff09\u8d39\u8fea\u5357\u591a\u00b7\u963f\u5c14\u5f7c\u65af\u5c3c\uff08Ferdinando Albisinni\uff09<\/p>\n<\/p><\/div>\n

      \n
      <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

      <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

      \u57282014\u5e743\u6708\uff0cFDA\u516c\u5e03\u4e86\u4e00\u4efd\u6307\u5357CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports\uff08\u300a\u5e94\u5728\u5e74\u62a5\u4e2d\u8bb0\u8f7d\u7684CMC\u6279\u51c6\u540e\u751f\u4ea7\u53d8\u66f4\u300b\uff09\uff0c\u6587\u4e2d\u5c06\u6279\u51c6\u540e\u53d8\u66f4\u5206<\/span>\u4e3a\u4e09\u7c7b\uff1a\u91cd\u5927\u53d8\u66f4\u3001\u4e2d\u7b49\u53d8\u66f4\u3001\u5fae\u5c0f\u53d8\u66f4\u3002\u5982\u679c\u53d8\u66f4\u88ab\u8ba4\u4e3a\u662f\u91cd\u5927\u53d8\u66f4\uff0c\u5219\u7533\u8bf7\u4eba\u5fc5\u987b\u63d0\u4ea4\u53d8\u66f4\u81f3FDA\uff0c\u5e76\u5728\u6536\u5230FDA\u5bf9NDA\u6216ANDA\u7684\u6279\u51c6\u540e\u624d\u80fd\u5c06\u53d8\u66f4\u540e\u5de5\u827a\u751f\u4ea7\u7684\u4ea7\u54c1\u7528\u4e8e\u9500\u552e\uff08\u4e5f\u79f0\u4e3a\u9884\u6279\u51c6\u589e\u8865PAS\uff09\u3002\u5982\u679c\u53d8\u66f4\u88ab\u8ba4\u4e3a\u662f\u4e2d\u7b49\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u5728\u4ea7\u54c1\u9500\u552e\u524d30\u5929\u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\uff08CBE-30\u589e\u8865\uff09\uff0c\u6216\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u5728\u9500\u552e\u540c\u65f6\u63d0\u4ea4\u53d8\u66f4\u7533\u8bf7\uff08CBE-0\u589e\u8865\uff09\u3002\u5982\u679c\u53d8\u66f4\u88ab\u8ba4\u4e3a\u662f\u5fae\u5c0f\u7684\uff0c\u5219\u7533\u8bf7\u4eba\u53ef\u4ee5\u76f4\u63a5\u8fdb\u884c\u53d8\u66f4\uff0c\u4f46\u5fc5\u987b\u5728\u53d8\u66f4\u5f53\u5e74\u7684\u5e74\u62a5\u4e2d\u901a\u77e5FDA\u3002\u5e76\u4e14\u5b83\u5728\u9644\u5f55A\u3001B\u4e2d\u8be6\u7ec6\u5217\u4e3e\u4e86\u5f88\u591a\u5c5e\u4e8e\u5fae\u5c0f\u53d8\u66f4\u7684\u4f8b\u5b50\uff0c\u4f8b\u5982\u5728\u5df2\u6279\u51c6\u7684\u7533\u8bf7\u4e2d\u6307\u5b9a\u4e86\u4e00\u4e2a\u975e\u6d3b\u6027\u6210\u5206\u7684\u4f9b\u5e94\u5546\uff0c\u8981\u53d8\u66f4\u81f3\u4e00\u4e2a\u65b0\u7684\u4f9b\u5e94\u5546\uff0c\u975e\u6d3b\u6027\u6210\u4efd\u7684\u8d28\u91cf\u6807\u51c6\u4fdd\u6301\u4e0d\u53d8\uff1b\u5bf9\u5728\u7533\u62a5\u4e2d\u5df2\u6279\u51c6\u7684\u65e0\u83cc\u4ea7\u54c1\u751f\u4ea7\u573a\u6240\u8fdb\u884c\u7ed3\u6784\u6027\u6539\u9020\uff0c\u4e14\u4e0d\u5f71\u54cd\u751f\u4ea7\u533a\u57df\u6216\u65e0\u83cc\u4fdd\u8bc1\uff0c\u5bf9\u4ea7\u54c1\u8d28\u91cf\u6216\u8d28\u91cf\u6807\u51c6\u4e0d\u8fdb\u884c\u53d8\u66f4\u3002<\/span><\/p>\n


      <\/p>\n

      \u53cd\u89c2\u56fd\u5185\u53d8\u66f4\u7684\u7ba1\u7406\uff0c\u300a\u836f\u54c1\u6ce8\u518c\u7ba1\u7406\u529e\u6cd5\u300b\u9644\u4ef64\u662f\u56fd\u5185\u8865\u5145\u7533\u8bf7\u76ee\u524d\u4e3b\u8981\u4f9d\u636e\u7684\u6cd5\u89c4\uff0c\u5b83\u53ea\u5206\u5217\u4e86\u56fd\u5bb6\u5c40\u548c\u7701\u5c40\u5ba1\u6279\u7684\u8865\u5145\u7533\u8bf7\u4e8b\u9879\uff0c\u5185\u5bb9\u592a\u8fc7\u6982\u8981\uff0c\u4f8b\u5982\u4e14\u7075\u6d3b\u6027\u5dee\uff0c\u5b9e\u65bd\u8d77\u6765\u7a0b\u5e8f\u7e41\u7410\u3001\u5468\u671f\u5f88\u957f\u3002\u8fd9\u4e2a\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u4e5f\u5f71\u54cd\u4e86\u4f01\u4e1a\u7684\u6301\u7eed\u6539\u8fdb\u4ee5\u53ca\u5b9e\u9645\u5de5\u827a\u4e0e\u6ce8\u518c\u8d44\u6599\u7684\u7b26\u5408\u6027\u3002\u6211\u4eec\u4e5f\u5f88\u671f\u5f85\u65b0\u7684\u300a\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\u5728\u8fd9\u65b9\u9762\u6709\u6240\u6539\u8fdb\u3002<\/span><\/p>\n

      \n
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      <\/figure>\n
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      \u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e662017 2017\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u540c\u6b65\u9898\u5e93 \u4e2d\u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\uff08\u4e00\uff09 \u6267\u4e1a\u836f\u5e08 2017\u5e74\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e66<\/h2>\n

      \u4f5c\u8005\uff1a\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u7814\u7a76\u7ec4<\/p>\n<\/p><\/div>\n

      \n
      <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

      <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n

      \n
      \n
      \n
      \n
      <\/figure>\n
      \n
      \n

      \u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e662017 2017\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u540c\u6b65\u9898\u5e93 \u4e2d\u836f\u5b66\u4e13\u4e1a\u77e5\u8bc6\uff08\u4e8c\uff09 \u6267\u4e1a\u836f\u5e08 2017\u5e74\u6267\u4e1a\u836f\u5e08\u8003\u8bd5\u7528\u4e66<\/h2>\n

      \u4f5c\u8005\uff1a\u56fd\u5bb6\u6267\u4e1a\u836f\u5e08\u8d44\u683c\u8003\u8bd5\u7814\u7a76\u7ec4<\/p>\n<\/p><\/div>\n

      \n
      <\/span>\u5f53\u5f53 <\/span> \t\t\t\t\t\t\t\t\t \u5e7f\u544a<\/span> \t\t\t\t\t\t\t\t\t <\/div>\n

      <\/i>\u8d2d\u4e70<\/span><\/span> <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<\/section>\n


      <\/p>\n

      \n

      \u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5236\u836f\u5de5\u7a0b\u8bba\u575b <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      \u56fd\u9645\u5408\u7406\u7528\u836f\u548cWHO\u516c\u62a5\u6c47\u7f16(2011) \u4f5c\u8005\uff1a\u5510\u955c\u6ce2\u3000\u7b49\u7f16\u8457 \u5f53\u5f53 \u5e7f\u544a \u8d2d\u4e70 \u5916\u8d44\u5927\u578b\u5236\u836f\u516c\u53f8\u6280\u672f\u3001\u7814\u53d1\u3001 […]<\/p>\n","protected":false},"author":1,"featured_media":646,"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\/645"}],"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=645"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/645\/revisions"}],"predecessor-version":[{"id":647,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/645\/revisions\/647"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/646"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=645"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=645"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=645"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}