{"id":66668,"date":"2018-10-24T01:00:00","date_gmt":"2018-12-07T04:04:16","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/e38a4fcd64\/"},"modified":"2018-12-07T12:04:18","modified_gmt":"2018-12-07T04:04:18","slug":"e38a4fcd64","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/66668\/","title":{"rendered":"\u6700\u65b0\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u6cd5\u89c4\u8981\u6c42\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521719"},"content":{"rendered":"
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<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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1. \u4ec0\u4e48\u662f\u539f\u6599\u836f Active Pharmaceutical Ingredient\uff1f<\/strong><\/span><\/p>\n

ICH Q7A\u7684\u5b9a\u4e49\uff1a<\/p>\n

\u82f1\u6587\u76f4\u8bd1\uff1a\u6d3b\u6027\u836f\u7528\u6210\u5206\uff0c\u7f29\u5199\uff1aAPI<\/p>\n

\u65e8\u5728\u7528\u4e8e\u836f\u54c1\u5236\u9020\u4e2d\u7684\u4efb\u4f55\u4e00\u79cd\u7269\u8d28\u6216\u7269\u8d28\u7684\u6df7\u5408\u7269\uff0c\u800c\u4e14\u5728\u7528\u4e8e\u5236\u836f\u65f6\uff0c\u6210\u4e3a\u836f\u54c1\u7684\u4e00\u79cd\u6d3b\u6027\u6210\u5206\u3002\u6b64\u79cd\u7269\u8d28\u5728\u75be\u75c5\u7684\u8bca\u65ad\uff0c\u6cbb\u7597\uff0c\u75c7\u72b6\u7f13\u89e3\uff0c\u5904\u7406\u6216\u75be\u75c5\u7684\u9884\u9632\u4e2d\u6709\u836f\u7406\u6d3b\u6027\u6216\u5176\u5b83\u76f4\u63a5\u4f5c\u7528\uff0c\u6216\u8005\u80fd\u5f71\u54cd\u673a\u4f53\u7684\u529f\u80fd\u548c\u7ed3\u6784\u3002<\/p>\n

ICH Q7A\u7684\u5b9a\u4e49\uff1a<\/p>\n

\u7528\u6765\u8868\u793a\u4e2d\u95f4\u4f53\u6216\u539f\u6599\u836f\u7684\u751f\u4ea7\u4e2d\u8981\u7528\u7684\u8d77\u59cb\u7269\u6599\u3001\u8bd5\u5242\u548c\u6eb6\u5242\u7684\u901a\u7528\u4e13\u4e1a\u540d\u8bcd\u3002<\/p>\n


<\/strong><\/span>2\u3001\u4ec0\u4e48\u662f\u4e2d\u95f4\u4f53 Intermediate\uff1f<\/strong><\/span><\/p>\n

ICH Q7A\u7684\u5b9a\u4e49\uff1a<\/p>\n

\u539f\u6599\u836f\u5de5\u827a\u6b65\u9aa4\u4e2d\u4ea7\u751f\u7684\u3001\u5fc5\u987b\u7ecf\u8fc7\u8fdb\u4e00\u6b65\u5206\u5b50\u53d8\u5316\u6216\u7cbe\u5236\u624d\u80fd\u6210\u4e3a\u539f\u6599\u836f\u7684\u4e00\u79cd\u7269\u6599\u3002\u4e2d\u95f4\u4f53\u53ef\u4ee5\u5206\u79bb\u6216\u4e0d\u5206\u79bb\u3002<\/p>\n

(\u6ce8\uff1aICH Q7\u6307\u5357\u53ea\u6d89\u53ca\u8be5\u516c\u53f8\u5b9a\u4e49\u4e3a\u539f\u6599\u836f\u751f\u4ea7\u8d77\u59cb\u70b9\u4ee5\u540e\u751f\u4ea7\u7684\u4e2d\u95f4\u4f53\u3002)<\/p>\n


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

3\u3001\u4ec0\u4e48\u662f\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599 API Starting Material\uff1f<\/strong><\/span>
<\/p>\n

ICH Q7A \u5b9a\u4e49\uff1a<\/p>\n

\u662f\u6307\u4e00\u79cd\u539f\u6599\u3001\u4e2d\u95f4\u4f53\u6216API\uff0c\u7528\u6765\u751f\u4ea7\u4e00\u79cdAPI\uff0c\u5e76\u4ee5\u91cd\u8981\u7ed3\u6784\u7247\u6bb5\u7684\u5f62\u5f0f\u7ed3\u5408\u5230API\u7ed3\u6784\u4e2d\u3002API\u7684\u8d77\u59cb\u7269\u6599\u53ef\u80fd\u662f\u5728\u5e02\u573a\u4e0a\u6709\u552e\u3001\u80fd\u591f\u901a\u8fc7\u5408\u540c\u6216\u5546\u4e1a\u534f\u8bae\u4ece\u4e00\u4e2a\u6216\u591a\u4e2a\u4f9b\u5e94\u5546\u5904\u8d2d\u5f97\uff0c\u6216\u7531\u751f\u4ea7\u5382\u5bb6\u81ea\u5236\u3002API\u7684\u8d77\u59cb\u7269\u6599\u4e00\u822c\u6765\u8bf4\u6709\u660e\u786e\u7684\u5316\u5b66\u7279\u6027\u548c\u7ed3\u6784\u3002<\/p>\n

\u90a3\u4e48\uff0c\u5982\u4f55\u5b9a\u4e49\u201c\u91cd\u8981\u7ed3\u6784\u7247\u6bb5\u201d\uff1f<\/p>\n

\u662f\u6307\u5206\u5b50\u7ed3\u6784\u4e2d\u5bf9API\u5206\u5b50\u7684\u836f\u7406\u6d3b\u6027\u6709\u8d21\u732e\u6216\u662f\u6709\u91cd\u8981\u610f\u4e49\u7684\u90e8\u5206\uff08 ICH Q7A  US\u95ee\u4e0e\u7b54\uff09<\/p>\n

\u5b83\u5e38\u88ab\u7533\u62a5\u4eba\u9519\u8bef\u5730\u89e3\u91ca\u4e3a\u539f\u6599\u836f\u7ed3\u6784\u76f8\u8fd1\u7684\u7247\u6bb5\uff0c\u9002\u7528\u4e8e\u5bf9\u539f\u6599\u836f\u6700\u7ec8\u5206\u5b50\u7ed3\u6784\u6709\u8d21\u732e\u7684\u7269\u6599\uff0c\u4e0e\u8bd5\u5242\u3001\u50ac\u5316\u5242\u6216\u6eb6\u5242\u662f\u76f8\u5bf9\u7684\u3002(EMA \u9488\u5bf9ICH Q11\u53cd\u601d\u62a5\u544a \u6ce8\u91ca5)<\/p>\n


<\/p>\n

4\u3001API\u8d77\u59cb\u7269\u6599\u4e0eGMP\u9002\u7528\u8303\u56f4<\/strong><\/span><\/p>\n

\"\u6700\u65b0\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u6cd5\u89c4\u8981\u6c42\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521719\"<\/p>\n


<\/p>\n

5\u3001\u5de5\u827a\u6d41\u7a0b\u4e0e\u8d77\u59cb\u7269\u6599\u9009\u62e9<\/strong><\/span><\/p>\n

\"\u6700\u65b0\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u6cd5\u89c4\u8981\u6c42\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521719\"<\/p>\n

<\/span>6\u3001\u5de5\u827a\u6d41\u7a0b\u4e0e\u6ce8\u518c\u7533\u62a5\u8303\u56f4<\/strong><\/span><\/p>\n

\"\u6700\u65b0\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u6cd5\u89c4\u8981\u6c42\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521719\"<\/p>\n

<\/span>7\u3001\u4e3a\u4ec0\u4e48\u8981\u5173\u6ce8\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599<\/strong><\/span><\/p>\n

A\u3001ICH\u6ce8\u518c\u6307\u5357\u8981\u6c42<\/strong><\/span><\/p>\n

1\uff09ICH Q7\uff0c\u539f\u6599\u836fGMP\u6307\u5357\uff0c2000\u5e7411\u670810\u65e5\u6279\u51c6\u5b9e\u65bd<\/p>\n

\u5b9a\u4e49\u4e86\u4ec0\u4e48\u662f\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\uff0c\u5e76\u89c4\u5b9a\u201c\u4ece\u8d77\u59cb\u7269\u6599\u7684\u5f15\u5165\u5f00\u59cb\uff0c\u4e2d\u95f4\u4f53\u548c\u539f\u6599\u836f\u7684\u751f\u4ea7\uff0c\u5e94\u9075\u5b88GMP\u7684\u89c4\u8303\u201d\u3002<\/p>\n

\u4f46\u8be5\u6587\u4ef6\u6ca1\u6709\u89c4\u5b9a\u5982\u4f55\u9009\u62e9\u8d77\u59cb\u7269\u6599\u3002<\/p>\n

2\uff09ICH Q11\uff0c\u539f\u6599\u836f\u7684\u5f00\u53d1\u548c\u751f\u4ea7\uff0c 2012\u5e745\u67081\u65e5\u6279\u51c6\u5b9e\u65bd<\/p>\n

\u5bf9\u5e94\u5982\u4f55\u9009\u62e9\u8d77\u59cb\u7269\u6599\u548c\u7533\u62a5\u65f6\u5e94\u63d0\u4ea4\u7684\u4fe1\u606f\u63d0\u4f9b\u4e86\u6307\u5bfc\u539f\u5219\u3002<\/p>\n


<\/p>\n

B\u3001\u6b27\u76df\u836f\u54c1\u6ce8\u518c\u6cd5\u89c4\u8981\u6c42<\/strong><\/span><\/p>\n

1\uff09CHEMISTRY OF ACTIVE SUBSTANCES\uff0c\u539f\u6599\u836f\u5316\u5b66\u6307\u5357\uff0c1987\u5e7410\u6708<\/p>\n

2\uff09CPMP\/QWP\/130\/96, Rev 1\uff0c\u65b0\u539f\u6599\u836f\u5316\u5b66\u6307\u5357\uff0c2003\u5e7412\u67081\u65e5<\/p>\n

3\uff09EMA\/CHMP\/QWP\/96664\/2015 \uff0c\u539f\u6599\u836f\u5316\u5b66\u6307\u5357(\u8349\u6848)(\u66ff\u4ee31\u548c2)\uff0c2015\u5e742\u670813\u65e5<\/p>\n

\u4e0a\u8ff0\u4e09\u4e2a\u6307\u5357\uff0c\u89c4\u5b9a\u4e86\u5e94\u5982\u4f55\u7f16\u5199\u539f\u6599\u836f\u7533\u62a5\u7684\u6280\u672f\u8d44\u6599(ASMF)\uff0c\u5305\u542b\u4e86\u8d77\u59cb\u7269\u6599\u5e94\u63d0\u4ea4\u54ea\u4e9b\u5185\u5bb9\u3002<\/p>\n

4\uff09 EMA\/448443\/2014\uff0c\u5316\u5b66\u539f\u6599\u836f\u751f\u4ea7\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u548c\u8bba\u8bc1\u8981\u6c42\u601d\u8003\uff0c2014\u5e749\u670812\u65e5\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08 EMA \uff09\u9488\u5bf9ICH Q11\u53d1\u5e03\u4e86\u8be5\u53cd\u601d\u62a5\u544a\uff0c\u4ee5\u6f84\u6e05EMA\u5bf9\u5982\u4f55\u9009\u62e9\u8d77\u59cb\u7269\u6599\u7684\u770b\u6cd5\u3002<\/p>\n

5\uff09PA\/PH\/CEP (04) 2, 6R\uff0cCEP\u4fee\u8ba2\u548c\u66f4\u65b0\u8981\u6c42\u6307\u5357, EDQM\uff08\u6b27\u6d32\u836f\u5178\u59d4\u5458\u4f1a\uff09\u4e8e2014\u5e747\u6708\u53d1\u5e03\uff0c\u8f7d\u660e\u8d77\u59cb\u7269\u6599\u53d1\u751f\u53d8\u66f4\u5e94\u63d0\u4ea4\u54ea\u4e9b\u8d44\u6599\u3002<\/p>\n

6\uff09EDQM\u53d1\u5e03\u7684\u65b0CEP\u7533\u8bf710\u5927\u7f3a\u9677\uff0c\u7b2c1\u540d\uff0c\u8d77\u59cb\u7269\u6599\u8d44\u6599\u4fe1\u606f\u4e0d\u5145\u5206\uff08\u5408\u6210\u8def\u7ebf\uff0c\u6742\u8d28\u8c31\uff0c\u5982\u6709\u5173\u7269\u8d28\u3001\u8bd5\u5242\u3001\u6eb6\u5242\u3001\u50ac\u5316\u5242\uff0c\u643a\u5e26\u81f3\u6210\u54c1\u4e2d\u7684\u6742\u8d28\uff09\uff0c\u7b2c3\u540d\uff0c\u8d77\u59cb\u7269\u6599\u8d28\u91cf\u6807\u51c6\u4e0d\u5408\u9002\uff08\u7279\u522b\u6613\u643a\u5e26\u81f3\u6210\u54c1\u7684\u6709\u5173\u7269\u8d28\u548c\u6b8b\u7559\u6eb6\u5a92\uff09<\/p>\n


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

C\u3001FDA CMC\u6307\u5357\u8981\u6c42<\/strong><\/p>\n

1\uff09\u7f8e\u56fd\u7b2cII\u7c7b\u539f\u6599\u836fDMF\u5b8c\u6574\u6027\u8bc4\u4f30\uff0c2016\u5e742\u6708\uff0c\u7f8e\u56fdFDA\u53d1\u5e03\u7684\u884c\u4e1a\u6307\u5357\u4e2d\uff0c\u89c4\u5b9a\u4e86\u8d77\u59cb\u7269\u6599\u5e94\u63d0\u4f9b\u54ea\u4e9b\u8d44\u6599\uff08\u660e\u786e\u8981\u6c42\u6309\u7167ICH Q11\u539f\u5219\u9009\u62e9\u8d77\u59cb\u7269\u6599\uff0c\u5e76\u63d0\u4f9b\u7406\u7531\u9610\u8ff0\uff09<\/p>\n

2\uff09 FDA\u884c\u4e1a\u6307\u5357\uff0c\u5df2\u6279\u51c6\u4e0a\u5e02NDA\/ANDA\u7684\u5e74\u5ea6\u62a5\u544a\uff0c\u5bf9\u8d77\u59cb\u7269\u6599\u7684\u8d28\u91cf\u6807\u51c6\u548c\u5206\u6790\u65b9\u6cd5\u76f8\u5173\u7684\u53d8\u66f4\u5206\u7c7b\u6709\u89c4\u5b9a\u3002<\/p>\n


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

D\u3001<\/strong><\/span>WHO PQ\u6ce8\u518c\u8981\u6c42<\/strong><\/span><\/p>\n

1\uff09WHO TRS No.957 Annex 4\uff0cWHO APIMF\u6307\u5357\uff0c\u5305\u542b\u4e86\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u548c\u63a7\u5236\u5e94\u63d0\u4ea4\u7684\u8d44\u6599\u3002<\/p>\n


<\/p>\n

F\u3001\u56fd\u5185\u836f\u653f\u6ce8\u518c\u8981\u6c42<\/strong><\/span><\/p>\n

1\uff09\u65b0\u6ce8\u518c\u5206\u7c7b4\u30015.2\u7c7b\u7533\u62a5\u8d44\u6599\u8981\u6c42(\u8bd5\u884c)- CTD\u6307\u5357\uff0c\u4e2d\u56fd\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff0c2016\u5e74\u7b2c80\u53f7\u901a\u544a\u7684\u9644\u4ef6\uff0c\u66f4\u65b0\u7ec6\u5316\u4e86\u8d77\u59cb\u7269\u6599\u5e94\u63d0\u4ea4\u8d44\u6599\u7684\u89c4\u5b9a\uff0c\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u5e94\u7b26\u5408ICH Q11\u548c\u6b27\u76df\u7684\u76f8\u5173\u8981\u6c42\u3002<\/p>\n

2\uff09CDE \u5ba1\u6838\u7f3a\u9677\uff1a<\/p>\n

S2.1\u662f\u5426\u4e3a\u7c97\u54c1\u7cbe\u5236\u5236\u5907\u539f\u6599\u836f\uff0c<\/p>\n

S2.2\u662f\u5426\u91c7\u7528\u6e38\u79bb\u9178\/\u78b1\u7ecf\u4e00\u6b65\u6210\u76d0\u7cbe\u5236\u5236\u5907\u539f\u6599\u836f\uff0c<\/p>\n

S2.3 I\u7c7b\u6eb6\u5242\u7684\u4f7f\u7528\u662f\u5426\u662f\u5fc5\u987b\u7684<\/p>\n

2\uff09CDE \u5ba1\u6838\u7f3a\u9677\uff1a<\/p>\n

2.4.1\u662f\u5426\u63d0\u4f9b\u4e86\u91cd\u8981\u8d77\u59cb\u7269\u6599\u7684\u5236\u5907\u5de5\u827a<\/p>\n

2.4.2\u662f\u5426\u5236\u8ba2\u4e86\u91cd\u8981\u8d77\u59cb\u7269\u6599\u7684\u5185\u63a7\u6807\u51c6<\/p>\n


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

8\u3001\u5982\u4f55\u9009\u62e9\u8d77\u59cb\u7269\u6599\uff1f<\/strong><\/span>
<\/p>\n

8.1CDE\u89c2\u70b9-\u53d7\u7406\u6280\u672f\u8981\u6c42<\/span>
<\/p>\n

\uff082015\u5e74CDE\u57f9\u8badPPT- \u5bf9\u201c\u5316\u5b66\u4eff\u5236\u836f\u54c1\u53d7\u7406\u6280\u672f\u8981\u6c42\u201d\u76f8\u5173\u8981\u70b9\u7684\u89e3\u6790 \u2013\u674e\u7709\uff09<\/p>\n

\u2460 \u5217\u51fa\u6240\u6709\u8d77\u59cb\u7269\u6599\u5e76\u63d0\u4f9b\u751f\u4ea7\u5546\u4fe1\u606f\uff0c\u5305\u62ec\u8d77\u59cb\u7269\u6599\u751f\u4ea7\u5546\u540d\u79f0\u3001\u8054\u7cfb\u65b9\u5f0f\u548c\u751f\u4ea7\u5730\u70b9\u3002<\/p>\n

\u2461 \u5bf9\u8d77\u59cb\u7269\u6599\u9009\u62e9\u7684\u5408\u7406\u6027\u8fdb\u884c\u8ba8\u8bba\u5e76\u63d0\u4f9b\u76f8\u5173\u652f\u6301\u6027\u4fe1\u606f\u3002<\/p>\n

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\"\u6700\u65b0\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u6cd5\u89c4\u8981\u6c42\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u539f\u8f85\u5305\u7cfb\u521719\"<\/p>\n

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1. \u4ec0\u4e48\u662f\u539f\u6599\u836f Active Pharmaceutical Ingredient\uff1f ICH Q7A\u7684\u5b9a\u4e49\uff1a […]<\/p>\n","protected":false},"author":1,"featured_media":66669,"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\/66668"}],"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=66668"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66668\/revisions"}],"predecessor-version":[{"id":66676,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66668\/revisions\/66676"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/66669"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=66668"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=66668"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=66668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}