{"id":79341,"date":"2018-12-20T00:00:50","date_gmt":"2019-02-01T06:26:29","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/79341\/"},"modified":"2019-02-01T14:26:30","modified_gmt":"2019-02-01T06:26:30","slug":"43647a5435","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/79341\/","title":{"rendered":"\u3010\u56de\u987e\u3011FDA\u3001EMA\u3001ICH\u548cCDE\u5bf9\u8d77\u59cb\u7269\u6599\u8981\u6c42\u7684\u5f02\u540c"},"content":{"rendered":"
\n

\"\u3010\u56de\u987e\u3011FDA\u3001EMA\u3001ICH\u548cCDE\u5bf9\u8d77\u59cb\u7269\u6599\u8981\u6c42\u7684\u5f02\u540c\"<\/p>\n

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 <\/p>\n

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 <\/p>\n

\n
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1. \u4e3a\u4ec0\u4e48\u8fdb\u884c\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9<\/strong><\/p>\n<\/section>\n<\/section>\n<\/fieldset>\n<\/section>\n


<\/p>\n

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 <\/p>\n

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 <\/p>\n

\n
\n
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\n

2. \u56fd\u5185\u5916\u5bf9\u8d77\u59cb\u7269\u6599\u9009\u62e9\u7684\u57fa\u672c\u8981\u6c42<\/strong><\/p>\n<\/section>\n<\/section>\n<\/fieldset>\n<\/section>\n


<\/p>\n

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 <\/p>\n

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 <\/p>\n

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 <\/p>\n

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 <\/p>\n

2005\u5e74CDE\u9881\u5e03\u7684\u300a\u5316\u5b66\u836f\u7269\u539f\u6599\u5236\u5907\u548c\u7ed3\u6784\u786e\u8bc1\u7814\u7a76\u6307\u5bfc\u539f\u5219\u300b\u4e2d\u89c4\u5b9a\u8d77\u59cb\u7269\u6599\u4e3a\uff1a\u8d28\u91cf\u7a33\u5b9a\u53ef\u63a7\uff0c\u5e94\u6709\u6765\u6e90\u3001\u6807\u51c6\u548c\u4f9b\u5e94\u5546\u7684\u68c0\u9a8c\u62a5\u544a\uff0c\u5fc5\u8981\u65f6\u5e94\u6839\u636e\u5236\u5907\u5de5\u827a\u5236\u5b9a\u5185\u63a7\u6807\u51c6\u30022015\u5e74CDE\u57f9\u8bad\u4e2d\u63d0\u5230\u8d77\u59cb\u7269\u6599\u9009\u62e9\u7684\u57fa\u672c\u539f\u5219\u4e3a\uff1a<\/p>\n

 <\/p>\n

1\uff09.\u786c\u662f\u539f\u6599\u836f\u7684\u91cd\u8981\u7ed3\u6784\u7ec4\u6210\u7247\u6bb5\uff0c\u53cd\u5e94\u8bd5\u5242\u4e0e\u6eb6\u5242\u4e0d\u5c5e\u4e8e\u8d77\u59cb\u7269\u6599\uff1b<\/p>\n

 <\/p>\n

2\uff09.\u539f\u6599\u836f\u751f\u4ea7\u5382\u5e94\u5bf9\u8d77\u59cb\u7269\u6599\u7684\u6742\u8d28\uff08\u5305\u62ec\u6b8b\u7559\u6eb6\u5242\u4e0e\u91cd\u91d1\u5c5e\u7b49\u6bd2\u6027\u6742\u8d28\uff09\u5168\u9762\u800c\u51c6\u786e\u7684\u4e86\u89e3\uff0c\u5728\u6b64\u57fa\u7840\u4e0a\u91c7\u7528\u9002\u5f53\u7684\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u63a7\u5236\uff0c\u5e76\u6839\u636e\u5404\u6742\u8d28\u5bf9\u540e\u7eed\u53cd\u5e94\u53ca\u7ec8\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\u5236\u5b9a\u5408\u7406\u7684\u9650\u5ea6\u8981\u6c42\uff1b<\/p>\n

 <\/p>\n

3\uff09. \u8d77\u59cb\u7269\u6599\u5e94\u6709\u7a33\u5b9a\u7684\u3001\u80fd\u6ee1\u8db3\u539f\u6599\u836f\u5927\u89c4\u6a21\u751f\u4ea7\u7684\u5546\u4e1a\u5316\u6765\u6e90\uff1b<\/p>\n

 <\/p>\n

4\uff09.\u8d77\u59cb\u7269\u6599\u4f9b\u5e94\u5546\u5e94\u6709\u5b8c\u5584\u7684\u751f\u4ea7\u4e0e\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\uff0c\u5e76\u4e0e\u539f\u6599\u836f\u751f\u4ea7\u5382\u5bb6\u6709\u826f\u597d\u7684\u6c9f\u901a\u4e0e\u534f\u4f5c\u5173\u7cfb\uff0c\u4fdd\u8bc1\u80fd\u59cb\u7ec8\u6309\u7167\u7edf\u4e00\u7684\u8981\u6c42\u751f\u4ea7\u7b26\u5408\u8981\u6c42\u7684\u8d77\u59cb\u7269\u6599\u3002<\/p>\n

 <\/p>\n

3.     \u5982\u4f55\u5bf9\u8d77\u59cb\u7269\u6599\u8fdb\u884c\u9009\u62e9<\/p>\n

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 <\/p>\n

1\uff09. \u5bf9\u539f\u6599\u836f\u8d28\u91cf\u5c5e\u6027\u5f71\u54cd\u8f83\u5c0f\u3002\u539f\u6599\u836f\u5408\u6210\u6b65\u9aa4\u7684\u957f\u77ed\u4e0e\u98ce\u9669\u4e4b\u95f4\u7684\u5173\u7cfb\uff0c\u9700\u8981\u8003\u8651\u539f\u6599\u836f\u7684\u7269\u7406\u6027\u8d28\u4ee5\u53ca\u6742\u8d28\u7684\u5f62\u6210\u3001\u8f6c\u5316\u548c\u6d88\u9664\u3002\u8d77\u59cb\u7269\u6599\u4e0e\u539f\u6599\u836f\u4e4b\u95f4\u5fc5\u987b\u6709\u591a\u4e2a\u5408\u6210\u6b65\u9aa4\uff0c\u4e2d\u95f4\u4f53\u672a\u8fdb\u884c\u5206\u79bb\u7eaf\u5316\u7684\u53cd\u5e94\u4e0d\u7b97\u505a\u5408\u6210\u6b65\u9aa4\u3002\u5408\u6210\u6b65\u9aa4\u5fc5\u987b\u6d89\u53ca\u5230\u5171\u4ef7\u952e\u7684\u5f62\u6210\u6216\u65ad\u88c2\uff0c\u7b80\u5355\u7684\u6210\u916f\u3001\u7682\u5316\u53cd\u5e94\u3001\u6210\u76d0\u3001\u91cd\u7ed3\u6676\u3001\u62c6\u5206\u6216\u8005\u7cbe\u5236\u4e0d\u4f5c\u4e3a\u5408\u6210\u6b65\u9aa4\uff0c\u539f\u6599\u836f\u7684\u5408\u6210\u5fc5\u987b\u6709\u4e24\u4e2a\u4ee5\u4e0a\u7684\u5408\u6210\u6b65\u9aa4\u3002\u5982\u679c\u6240\u62df\u5b9a\u7684\u8d77\u59cb\u7269\u6599\u662f\u4e00\u79cd\u539f\u6599\u836f\u6216\u8005\u5176\u5df2\u7ecf\u4f5c\u4e3a\u539f\u6599\u836f\u88ab\u6279\u51c6\u5e94\u7528\u4e8e\u4e0a\u5e02\u8bb8\u53ef\u7684\u5236\u5242\u4e2d\uff0c\u5219\u5bf9\u5176\u5408\u6210\u6b65\u9aa4\u6570\u4e0d\u505a\u8981\u6c42\u3002<\/p>\n

 <\/p>\n

2\uff09. \u662f\u5426\u6709\u5145\u8db3\u7684\u624b\u6bb5\u5bf9\u5176\u8d28\u91cf\u8fdb\u884c\u63a7\u5236\u3002\u5305\u62ec\u662f\u5426\u80fd\u591f\u5efa\u7acb\u4e00\u5957\u63a7\u5236\u8d77\u59cb\u7269\u6599\u6742\u8d28\uff08\u5305\u62ec\u6b8b\u7559\u6eb6\u5242\u3001\u57fa\u56e0\u6bd2\u3001\u8bd5\u5242\u3001\u50ac\u5316\u5242\u3001\u91cd\u91d1\u5c5e\u7b49\uff09\u7684\u5206\u6790\u65b9\u6cd5\u3002\u8d77\u59cb\u7269\u6599\u53ca\u5176\u6742\u8d28\u4e0d\u5e94\u8be5\u6210\u4e3a\u539f\u6599\u836f\u6742\u8d28\u7684\u91cd\u8981\u6765\u6e90\uff0c\u5206\u6790\u65b9\u6cd5\u5e94\u8be5\u80fd\u591f\u8ffd\u8e2a\u5728\u540e\u7eed\u5de5\u827a\u6b65\u9aa4\u4e2d\u8fd9\u4e9b\u6742\u8d28\u53ca\u5176\u884d\u751f\u7269\u7684\u53bb\u5411\u53ca\u53bb\u9664\u3002\u4ece\u8d28\u91cf\u63a7\u5236\u7684\u89d2\u5ea6\u8003\u8651\uff0c\u8d77\u59cb\u7269\u6599\u7684\u5316\u5b66\u7ed3\u6784\u5e94\u5f53\u5bb9\u6613\u4e0e\u5176\u5f02\u6784\u4f53\u6216\u8005\u7c7b\u4f3c\u7269\u76f8\u533a\u522b\u3002\u7ed3\u6784\u590d\u6742\u7684\u5316\u5408\u7269\uff08\u5982\u542b\u6709\u591a\u4e2a\u624b\u578b\u4e2d\u5fc3\u7684\u5316\u5408\u7269\uff09\uff0c\u4e00\u822c\u9700\u8981\u901a\u8fc7\u590d\u6742\u7684\u5408\u6210\u5de5\u827a\u5236\u5b9a\uff0c\u5176\u589e\u52a0\u4e86\u539f\u6599\u836f\u7684\u8d28\u91cf\u98ce\u9669\uff0c\u6545\u62df\u5b9a\u7684\u8d77\u59cb\u7269\u6599\u7684\u5316\u5b66\u7ed3\u6784\u4e2d\u80fd\u591f\u5f62\u6210\u5f02\u6784\u4f53\u6216\u7c7b\u4f3c\u7269\u7684\u7ed3\u6784\u548c\u5b98\u80fd\u56e2\u4e0d\u6613\u8fc7\u591a\uff0c\u4ee5\u5229\u4e8e\u5bf9\u5176\u8fdb\u884c\u8d28\u91cf\u63a7\u5236\u3002<\/p>\n

 <\/p>\n

3\uff09. \u5982\u679c\u539f\u6599\u836f\u751f\u4ea7\u5de5\u827a\u6709\u591a\u4e2a\u652f\u94fe\uff0c\u5219\u6bcf\u4e2a\u652f\u94fe\u8ffd\u6eaf\u81f3\u5176\u4f7f\u7528\u8d77\u59cb\u7269\u6599\u90fd\u9002\u7528ICH Q7\u7684GMP\u6761\u6b3e\u3002\u5728GMP\u6761\u4ef6\u4e0b\u5b9e\u65bd\u751f\u4ea7\u6b65\u9aa4\u548c\u9002\u5f53\u7684\u63a7\u5236\u7b56\u7565\u4e00\u8d77\u4e3a\u539f\u6599\u836f\u8d28\u91cf\u63d0\u4f9b\u4fdd\u8bc1\u3002<\/p>\n

 <\/p>\n

4\uff09. \u8d77\u59cb\u7269\u6599\u5e94\u8be5\u5177\u6709\u660e\u786e\u7684\u5316\u5b66\u7279\u6027\u548c\u5316\u5b66\u7ed3\u6784\u3002\u6ca1\u6709\u5206\u79bb\u51fa\u7684\u4e2d\u95f4\u4f53\u4e00\u822c\u4e0d\u80fd\u8003\u8651\u4f5c\u4e3a\u8d77\u59cb\u7269\u6599\u3002\u8d77\u59cb\u7269\u6599\u7684\u540d\u79f0\u3001\u5316\u5b66\u7ed3\u6784\u3001\u5316\u5b66\u548c\u7269\u7406\u7279\u5f81\u4e0e\u6027\u8d28\uff0c\u4ee5\u53ca\u6742\u8d28\u8c31\u5e94\u6709\u8be6\u7ec6\u7684\u8bf4\u660e\u3002<\/p>\n

 <\/p>\n

5\uff09. \u8d77\u59cb\u7269\u6599\u5e94\u8be5\u662f\u539f\u6599\u836f\u7684\u201c\u91cd\u8981\u7ed3\u6784\u7247\u6bb5\u201d\u3002\u201c\u91cd\u8981\u7ed3\u6784\u7247\u6bb5\u201d\u662f\u6307\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\uff0c\u5e38\u88ab\u7533\u62a5\u4eba\u9519\u8bef\u5730\u89e3\u91ca\u4e3a\u539f\u6599\u836f\u7ed3\u6784\u76f8\u8fd1\u3002<\/p>\n

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6\uff09. \u8d77\u59cb\u7269\u6599\u4f9b\u5e94\u5546\u5e94\u6709\u5b8c\u5584\u7684\u751f\u4ea7\u4e0e\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\uff0c\u80fd\u591f\u4fdd\u8bc1\u653e\u5927\u5de5\u827a\u7a33\u5b9a\u5e76\u6ee1\u8db3\u4e34\u5e8a\u5b9e\u9a8c\u5bf9\u539f\u6599\u836f\u7684\u9700\u6c42\u3002<\/p>\n

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\u5728\u8bba\u8ff0\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u65f6\uff0c\u8981\u91c7\u7528\u9002\u5f53\u7684\u79d1\u5b66\u539f\u7406\u8fdb\u884c\u8bba\u8ff0\uff0c\u8003\u8651\u6574\u4e2a\u5408\u6210\u65b9\u6cd5\u548c\u63a7\u5236\u7b56\u7565\uff0c\u7ed3\u5408\u4e0a\u8ff0\u6240\u6709\u5404\u7c7b\u539f\u5219\uff0c\u800c\u975e\u4ec5\u4e25\u683c\u9075\u5faa\u5355\u4e2a\u539f\u5219\u3002\u901a\u5e38\uff0c\u7533\u62a5\u4eba\/\u751f\u4ea7\u5546\u4f1a\u9009\u62e9\u5c11\u6570\u51e0\u4e2a\u6807\u51c6\uff0c\u4f7f\u7528\u5b83\u4eec\u5bf9\u8d77\u59cb\u7269\u6599\u7684\u9009\u62e9\u8fdb\u884c\u8bba\u8ff0\uff0c\u4f8b\u5982\uff0c\u201c\u5316\u5408\u7269X\u7279\u6027\u6e05\u695a\uff0c\u88ab\u5206\u79bb\uff0c\u5177\u6709\u6e05\u695a\u7684\u5316\u5b66\u7279\u6027\u548c\u7ed3\u6784\uff0c\u6210\u4e3a\u539f\u6599\u836f\u7684\u91cd\u8981\u7ed3\u6784\u7247\u65ad\uff0c\u56e0\u6b64\u6839\u636eICH Q11\u5b83\u88ab\u9009\u62e9\u4f5c\u4e3a\u8d77\u59cb\u7269\u6599\u201d\u3002\u8fd9\u6837\u7684\u8bba\u8ff0\u4e0d\u591f\u5168\u9762\uff0c\u56e0\u6b64\u4e0d\u4f1a\u88ab\u63a5\u53d7\u3002\u4ec5\u4ec5\u53ea\u6709\u63a7\u5236\u7b56\u7565\u7684\u8bdd\uff0c\u662f\u4e0d\u8db3\u4ee5\u4f5c\u4e3a\u8d77\u59cb\u7269\u6599\u7684\u8bba\u8bc1\u4f9d\u636e\u7684\u3002\u540c\u6837\uff0c\u5408\u6210\u8def\u7ebf\u5f88\u957f\u5e76\u4e0d\u80fd\u5f25\u8865\u5f88\u5dee\u7684\u63a7\u5236\u7b56\u7565\u3002<\/p>\n

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\u53c2\u8003\u6587\u732e\uff1a<\/p>\n


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\uff3b1\uff3dICH\uff0e Harmonized tripartiteguideline Q7 : good manufacturing practice guide foractive pharmaceutical ingredients<\/span><\/p>\n

\uff3b2\uff3dFDA\uff0e Guidance for industrydrug substance chemistry\uff0cmanufacturing\uff0cand controlsinformation ( draft guidance\uff0cwithdrawn )<\/span><\/p>\n

\uff3b3\uff3dFDA\uff0eGuideline forsubmitting supporting documentation in drugapplications for the manufacture ofdrug substances<\/span><\/p>\n

\uff3b4\uff3dICH\uff0e Harmonized tripartiteguideline Q11: development and manufactureof drug substances (chemical entities andbiotechnological\/biological entitie<\/span><\/p>\n

\uff3b5\uff3dEDQM\uff0e Top ten deficienciesfound after first assessment of newapplications in 2011 .<\/span><\/p>\n

\uff3b6\uff3dEMA\uff0e Guideline on thechemistry of new active substances\uff0e<\/span><\/p>\n

\uff3b7\uff3dCDE\uff0e\u5316\u5b66\u836f\u7269\u539f\u6599\u836f\u5236\u5907\u548c\u7ed3\u6784\u786e\u8bc1\u7814\u7a76\u7684\u6280\u672f\u6307\u5bfc\u539f\u5219\uff0e<\/span><\/p>\n

\uff3b8\uff3dCDE\uff0e\u300a\u5316\u5b66\u836f\u7269\u539f\u6599\u5236\u5907\u548c\u7ed3\u6784\u786e\u8bc1\u7814\u7a76\u6307\u5bfc\u539f\u5219\u300b<\/span><\/p>\n

\uff3b9\uff3dCDE\uff0e\u300a\u5316\u5b66\u836f\u54c1\u65b0\u6ce8\u518c\u5206\u7c7b\u7533\u62a5\u8d44\u6599\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\uff082016\u5e74\u7b2c80\u53f7\u6587\uff09<\/span><\/p>\n

\uff3b10\uff3d\u738b\u5b8f\u4eae\u7b49\uff0e\u5316\u5b66\u5408\u6210\u539f\u6599\u836f\u8d77\u59cb\u7269\u6599\u56fd\u5185\u5916\u76f8\u5173\u8981\u6c42\u7684\u6bd4\u8f83<\/span><\/p>\n


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\u5185\u5bb9\u6765\u6e90\uff1a\u7f51\u7edc\uff0c\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


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