{"id":84412,"date":"2019-04-15T00:00:50","date_gmt":"2019-04-17T03:12:54","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/84412\/"},"modified":"2019-04-17T11:12:54","modified_gmt":"2019-04-17T03:12:54","slug":"f386cbe401","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/84412\/","title":{"rendered":"2019 \u65b0\u5efaGMP\u5de5\u5382\u5de5\u7a0b\u7ba1\u7406\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u901a\u77e5"},"content":{"rendered":"
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\"2019<\/section>\n<\/section>\n<\/section>\n
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\u5404\u6709\u5173\u5355\u4f4d\uff1a<\/p>\n

\u81ea\u4ece\u6211\u56fd\u52a0\u5165ICH\u7ec4\u7ec7\u8d77\uff0cNMPA\u7684\u76f8\u5173\u6cd5\u89c4\uff0c\u65e0\u8bba\u662f\u6ce8\u518c\u8fd8\u662f\u4e34\u5e8a\u3001\u65e0\u8bba\u662f\u4e34\u5e8a\u524d\u8fd8\u662fGMP\uff0c\u90fd\u5728\u5411ICH\u53ca\u6b27\u7f8e\u5148\u8fdb\u6807\u51c6\u9760\u62e2\u3002\u5176\u4e2d\uff0c\u6295\u8d44\u6700\u5927\uff0c\u5f71\u54cd\u6700\u6df1\u8fdc\u7684\u7248\u5757\uff0c\u83ab\u8fc7\u4e8eGMP\u65b0\u5efa\/\u6539\u9020\u5382\u623f\u3002\u524d\u671f\u8bbe\u8ba1\u56fe\u7684\u4e0d\u6ce8\u610f\uff0c\u6216\u5de5\u7a0b\u7ba1\u7406\u7684\u6b20\u7f3a\uff0c\u76f4\u63a5\u5f71\u54cd\u5230\u4e86\u836f\u54c1\u662f\u5426\u80fd\u591f\u6b63\u5e38\u751f\u4ea7\uff0c\u5e76\u76f4\u63a5\u5173\u7cfb\u5230\u8ba4\u8bc1\u80fd\u5426\u901a\u8fc7\u3002\u65e0\u8bba\u662f\u65b0\u5382\u4ece\u96f6\u5f00\u59cb\u7684\u89c4\u5212\u3001\u4fee\u5efa\uff0c\u8fd8\u662f\u5bf9\u539f\u6709\u5382\u623f\u8fdb\u884c\u6539\u9020\uff0c\u8981\u8fbe\u5230\u7b26\u5408GXP\u5404\u9879\u6807\u51c6\uff0c\u662f\u9700\u8981\u7528\u79d1\u5b66\u7684\u65b9\u6cd5\u63a8\u52a8\u9879\u76ee\u5efa\u8bbe\uff0c\u53ca\u65f6\u5efa\u7acb\u9ad8\u6548\u7684\u9879\u76ee\u56e2\u961f\u6765\u7ba1\u7406\u9879\u76ee\u5168\u8fc7\u7a0b\u3002\u7531\u4e8e\u7f3a\u4e4f\u76f8\u5173\u7ecf\u9a8c\uff0c\u65b0\u5382\u5efa\u8bbe\u7684\u98ce\u9669\u7ba1\u7406\uff0c\u4e5f\u662f\u56fd\u5185\u5404\u836f\u5382\u9762\u4e34\u7684\u96be\u9898\u3002\u672c\u57f9\u8bad\u5c06\u4ece\u9879\u76ee\u7ba1\u7406\u51fa\u53d1\uff0c\u7ed3\u5408\u76f8\u5173\u7684\u6cd5\u89c4\u3001\u6307\u5357\u3001\u68c0\u67e5\u6307\u5bfc\u3001\u8fbe\u6807\u65b9\u9488\u6307\u5bfc\u7b49\u6807\u51c6\uff0c\u5bf9\u65b0\u5382\u5efa\u8bbe\u9879\u76ee\u8fdb\u884c\u5b9e\u64cd\u8bb2\u89e3\uff0c\u5e76\u91cd\u70b9\u5bf9\u9879\u76ee\u7ba1\u7406\u7684\u5168\u8fc7\u7a0b\u8fdb\u884c\u9610\u8ff0\uff0c\u76f8\u4fe1\u5bf9\u4e8e\u56fd\u5185\u5404\u836f\u5382\u7684\u8ba4\u8bc1\u76f8\u5173\u4eba\u5458\u3001\u57fa\u5efa\u9879\u76ee\u7ba1\u7406\u4eba\u5458\u3001QA\u4eba\u5458\u3001\u751f\u4ea7\u7ba1\u7406\u4eba\u5458\u3001\u751f\u4ea7\u6280\u672f\u4eba\u5458\u3001\u8d28\u91cf\u7ba1\u7406\u4eba\u5458\u3001\u9a8c\u8bc1\u4eba\u5458\u7b49\uff0c\u90fd\u4f1a\u662f\u5341\u5206\u6709\u5e2e\u52a9\u7684\u3002\u4e3a\u6b64\uff0c\u672c\u5355\u4f4d\u5b9a\u4e8e2019\u5e745\u670818\u65e5\u81f320\u65e5\u5728\u4e0a\u6d77\u5e02\u4e3e\u529e2019 \u65b0\u5efaGMP\u5de5\u5382\u5de5\u7a0b\u7ba1\u7406\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u3002\u6b22\u8fce\u76f8\u5173\u4eba\u5458\u79ef\u6781\u53c2\u52a0\uff0c\u6709\u5173\u57f9\u8bad\u4e8b\u9879\u901a\u77e5\u5982\u4e0b\uff1a<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e00\u3001\u57f9\u8bad\u65f6\u95f4\u5730\u70b9\uff1a<\/span><\/strong><\/p>\n

\u65f6\u95f4\uff1a2019\u5e74 5\u670818\u65e5-20\u65e5\uff08\u57f9\u8bad\u4e24\u5929\u300118\u65e5\u5168\u5929\u62a5\u5230\uff09<\/p>\n

\u5730\u70b9\uff1a\u4e0a\u6d77\u5e02\uff08\u5177\u4f53\u5730\u70b9\u3001\u62a5\u540d\u540e\u901a\u77e5\uff09<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e8c\u3001\u57f9\u8bad\u5bf9\u8c61\uff1a<\/span><\/strong><\/p>\n

1\u3001\u5236\u836f\u751f\u4ea7\u4f01\u4e1a\u4ece\u4e8b\u8d28\u91cf\u3001\u751f\u4ea7\u3001\u5de5\u7a0b\u3001\u8bbe\u5907\u7b49\u76f8\u5173\u4eba\u5458<\/p>\n

2\u3001\u76f8\u5173\u8bbe\u5907\u5382\u5bb6\u6280\u672f\u4eba\u5458\uff0c\u4ee5\u53ca\u5de5\u7a0b\u3001\u8bbe\u8ba1\u5355\u4f4d\u76f8\u5173\u4eba\u5458<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e09\u3001\u8bfe \u7a0b \u5b89 \u6392 \u8868<\/span><\/strong><\/p>\n

\u7b2c\u4e00\u5929<\/span><\/p>\n

09:00-12:00<\/span><\/p>\n

14:00-17:00<\/span><\/p>\n

\u4e00\u3001GMP\u65b0\u5382\u5efa\u8bbe<\/p>\n

1    2019\u5e74\u65b0\u5efacGMP\u5382\u623f\uff0c\u6211\u4eec\u9762\u4e34\u4ec0\u4e48\u6837\u7684\u6311\u6218\uff1f<\/p>\n

1.1  \u56fd\u5185\u5916\u65b0\u5382\u5efa\u8bbe\u76f8\u5173\u6cd5\u89c4\u4ecb\u7ecd<\/p>\n

1.2  \u5382\u623f\u6539\u9020\u9879\u76ee\u4ecb\u7ecd<\/p>\n

1.3  \u65b0\u5efa\u5382\u623f\u7684\u98ce\u9669\u5206\u6790\uff0c\u5982\u4f55\u5224\u65ad\u6295\u5165\u6536\u76ca\u6bd4\u3001<\/p>\n

1.4  2019\u73af\u4fdd\u6311\u6218<\/p>\n

2    \u4ec0\u4e48\u662f\u6ee1\u8db3GEP\u8981\u6c42\u7684\u5de5\u7a0b\u5efa\u8bbe<\/p>\n

2.1  \u4ec0\u4e48\u662fGEP 2.2GEP\u76f8\u5173\u6982\u5ff5\u4ecb\u7ecd<\/p>\n

2.2  GEP\u5404\u9636\u6bb5\u6587\u4ef6\u4f53\u7cfb\u7ba1\u7406\u8981\u6c42<\/p>\n

2.3  GEP\u751f\u547d\u5468\u671fLifecycle Management\u7ba1\u7406\u65b9\u5f0f\u548c\u5de5\u5177<\/p>\n

\u4e8c\u3001\u65b0\u5382\u5efa\u8bbe\u751f\u547d\u5468\u671f\u7ba1\u7406<\/p>\n

1    \u542f\u52a8\u9879\u76ee<\/p>\n

1.1  \u65b0\u5efaGMP\u9879\u76ee\u7684\u7acb\u9879\u8003\u8651\uff08\u65f6\u95f4\u3001\u82b1\u8d39\u53ca\u8d28\u91cf\uff09<\/p>\n

1.2  GMP\u9879\u76ee\u8fc7\u7a0b\u4e2d\uff0c\u7814\u53d1\u5de5\u827a\u7684\u652f\u6301<\/p>\n

1.3  GMP\u7acb\u9879\u9636\u6bb5\uff0cGMP\u7248\u5757\u4eba\u5458\u7684\u914d\u5907<\/p>\n

1.4  \u4f9b\u5e94\u5546\u5982\u4f55\u9009\u62e9\u548c\u7b5b\u9009<\/p>\n

2    \u5de5\u7a0b\u8bbe\u8ba1<\/p>\n

2.1  \u4ec0\u4e48\u662f\u6982\u5ff5\u8bbe\u8ba1\u3001\u521d\u6b65\u8bbe\u8ba1\u548c\u8bbe\u8ba1\u5ba1\u6838<\/p>\n

2.2  \u8be6\u7ec6\u8bbe\u8ba1\u7684\u5173\u6ce8 2.3\u8bbe\u5907\u8fc7\u7a0b\u4e2d\u7684GMP\u8003\u8651\u8981\u70b9<\/p>\n

\u4e3b\u8bb2\u8001\u5e08\uff1a\u5434\u8001\u5e08 \u8d44\u6df1\u4e13\u5bb6  \u957f\u671f\u5728\u8de8\u56fd\u4f01\u4e1a\u5de5\u4f5c\uff0c\u5386\u4efb\u9a8c\u8bc1\u7ecf\u7406\uff0c\u5de5\u7a0b\u90e8\u7ecf\u7406\uff0cQA \u603b\u76d1\uff0c\u5de5\u827a\u603b\u76d1\u3002 \u53c2\u4e0e\u7684\u9879\u76ee\u5f88\u591a\u901a\u8fc7\u4e86EU, FDA \u7684GMP \u5ba1\u8ba1\uff0c\u6709\u774020\u591a\u5e74\u7684\u5236\u836f\u884c\u4e1a\u5de5\u7a0b\u9879\u76ee\u7ba1\u7406\u7ecf\u9a8c\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u7b2c\u4e8c\u5929<\/span><\/p>\n

09:00-12:00<\/span><\/p>\n

13:30-16:30<\/span><\/p>\n

\u4e09\u3001\u65b0\u5382\u5efa\u8bbe\u751f\u547d\u5468\u671f\u7ba1\u7406<\/p>\n

1    \u9879\u76ee\u65bd\u5de5\u53ca\u5b89\u88c5<\/p>\n

1.1  \u9879\u76ee\u603b\u5305\u548c\u5206\u5305\u7684\u533a\u522b\u548c\u6536\u76ca\u8003\u8651<\/p>\n

1.2  \u4f9b\u5e94\u5546\u5982\u4f55\u62db\u6807<\/p>\n

1.3  \u8bbe\u8ba1\u8fc7\u7a0b\u7684\u5173\u952e\u8981\u70b9<\/p>\n

2    cGMP\u9a8c\u8bc1<\/p>\n

2.1  \u8c03\u8bd5\u540c\u9a8c\u8bc1\u5de5\u4f5c\u7684\u91cd\u5408\u4e0e\u6574\u5408<\/p>\n

2.2 \u6b27\u7f8e\u9a8c\u8bc1\u5468\u671f\u7ba1\u7406\u4e0e\u56fd\u5185\u7684\u4e0d\u540c<\/p>\n

\u56db\u3001\u5c06\u9879\u76ee\u7ba1\u7406\u5e94\u7528\u4e8e\u65b0\u5382\u5efa\u8bbe<\/p>\n

1    \u4ec0\u4e48\u662f\u9879\u76ee\u7ba1\u7406\u53ca\u5173\u952e\u8981\u7d20<\/p>\n

1.1  \u9879\u76ee\u7ba1\u7406\u7684\u6574\u4f53\u8003\u91cf\u3001\u4ef7\u503c\u7ba1\u7406<\/p>\n

1.2  \u6848\u4f8b\uff1a\u5982\u4f55\u62c6\u5206\u9879\u76ee\u5de5\u4f5c\u7ed3\u6784WBS<\/p>\n

2    \u9879\u76ee\u56e2\u961f\u5efa\u8bbe<\/p>\n

2.1  \u9879\u76ee\u56e2\u961f\u4eba\u5458\u7684\u804c\u8d23\u3001\u57f9\u8bad 2.2\u5982\u4f55\u8fdb\u884c\u9879\u76ee\u8fc7\u7a0b\u6c9f\u901a<\/p>\n

3    \u9879\u76ee\u8fdb\u5ea6\u7ba1\u7406<\/p>\n

3.1  \u56fd\u5185\u65b0\u5382\u9879\u76ee\u7ecf\u5e38\u51fa\u73b0\u7684\u8fdb\u5ea6\u95ee\u9898<\/p>\n

3.2  \u6848\u4f8b\uff1a\u8fdb\u5ea6\u8ddf\u8e2a\u5de5\u5177\u5b66\u4e60<\/p>\n

3.3  \u9879\u76ee\u4ea7\u751f\u7684\u6587\u4ef6\u5982\u4f55\u7ba1\u7406\u53ca\u79ef\u6dc0<\/p>\n

\u4e3b\u8bb2\u8001\u5e08\uff1a\u5019\u8001\u5e08 \u5728\u5236\u836f\u548c\u751f\u7269\u5236\u836f\u884c\u4e1a\u6709\u4e8c\u5341\u591a\u5e74\u7684\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u5341\u5e74\u5927\u578b\u533b\u836f\u9879\u76ee\u9879\u76ee\u7ecf\u7406\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u6210\u529f\u6267\u884c\u4e86\u4e0a\u6d77\u7f57\u6c0f\u3001\u62dc\u8033\u3001\u897f\u5b89\u6768\u68ee\u3001\u6df1\u5733\u8d5b\u8bfa\u83f2\u5df4\u65af\u5fb7\u3001\u4e0a\u6d77\u8bfa\u534e\u3001\u82cf\u5dde\u8f89\u745e\u7b49\u8de8\u56fd\u516c\u53f8\u7684\u56fd\u5185\u76f8\u5173\u9879\u76ee\uff0c\u7ecf\u9a8c\u4e30\u5bcc\u3002\u534f\u4f1a\u7279\u8058\u4e13\u5bb6<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u56db\u3001\u57f9\u8bad\u5f62\u5f0f<\/span><\/strong><\/p>\n

1\u3001\u7406\u8bba\u8bb2\u89e3,\u5b9e\u4f8b\u5206\u6790,\u4e13\u9898\u8bb2\u6388,\u4e92\u52a8\u7b54\u7591.<\/p>\n

2\u3001\u5b8c\u6210\u5168\u90e8\u57f9\u8bad\u8bfe\u7a0b\u8005\u7531\u534f\u4f1a\u9881\u53d1\u57f9\u8bad\u8bc1\u4e66<\/p>\n

3\u3001\u4f01\u4e1a\u9700\u8981GMP\u5185\u8bad\u548c\u6307\u5bfc\uff0c\u8bf7\u4e0e\u4f1a\u52a1\u7ec4\u8054\u7cfb<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e94\u3001\u57f9\u8bad\u8d39\u7528<\/span><\/strong><\/p>\n

\u4f1a\u52a1\u8d39\uff1a2500\u5143\/\u4eba\uff08\u4f1a\u52a1\u8d39\u5305\u62ec\uff1a\u57f9\u8bad\u3001\u7814\u8ba8\u3001\u8bc1\u4e66\u3001\u8d44\u6599\u7b49\uff09\uff1b\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002\u57f9\u8bad\u8d39\u53ef\u73b0\u573a\u4ea4\u7eb3\u6216\u63d0\u524d\u6c47\u6b3e<\/p>\n

\u6ce8\u660e\u4e0a\u6d77\u5382\u623f\u57f9\u8bad\u8d39<\/p>\n

\u6307\u5b9a\u94f6\u884c\u6c47\u6b3e\u81f3\uff1a
\u6237  \u540d\uff1a\u5317\u4eac\u90a6\u51ef\u4f01\u4e1a\u7ba1\u7406\u54a8\u8be2\u6709\u9650\u516c\u53f8
\u5f00\u6237\u884c\uff1a\u4e2d\u56fd\u5de5\u5546\u94f6\u884c\u5317\u4eac\u7389\u6cc9\u8def\u652f\u884c
\u8d26  \u53f7\uff1a020 006 300 920 005 0454 <\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u516d\u3001\u5408\u4f5c\u8d5e\u52a9<\/span><\/strong><\/p>\n

\u62db\u52df\u5408\u4f5c\u8d5e\u52a9\u5355\u4f4d\uff0c\u63d0\u4f9b\u4f01\u4e1a\u5c55\u4f4d\u3001\u5f62\u8c61\u5c55\u793a\u7b49\uff0c\u53ef\u81f4\u7535\u8be6\u8c08\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u626b\u63cf\u6216\u8bc6\u522b\u4e8c\u7ef4\u7801\u5373\u53ef\u5728\u7ebf\u62a5\u540d<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u62a5\u540d\u54a8\u8be2\uff1a<\/span><\/strong><\/p>\n

\u674e\u5a1f13641150050 \u5fae\u4fe1\u540c\u53f7 <\/span><\/p>\n

QQ\u54a8\u8be2; 2736812589  <\/span><\/p>\n

\u672c\u6b21\u4f1a\u8bae\u9650\u989d150\u5bb6\u4f01\u4e1a\u53c2\u52a0\uff0c\u6b22\u8fce\u53d1\u9001\u516c\u53f8\u540d\u79f0+\u59d3\u540d+\u7535\u8bdd<\/strong>\u9884\u767b\u8bb0\u3002\u77ed\u4fe1\u3001\u5fae\u4fe1\u3001\u90ae\u4ef6\u62a5\u540d\u767b\u8bb0\u3002<\/span><\/p>\n

\u7ec4\u56e2\u62a5\u540d\u53ef\u4eab\u53d7\u4f18\u60e0 \u6b22\u8fce\u54a8\u8be2\u62a5\u540d<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u70b9\u51fb\u67e5\u9605 <\/span><\/strong>2019<\/span>\u5236\u836f\u57f9\u8bad\u901a\u77e5<\/span><\/a><\/span><\/strong><\/span><\/em><\/p>\n

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