{"id":1765,"date":"2026-04-13T14:02:56","date_gmt":"2026-04-13T06:02:56","guid":{"rendered":"https:\/\/www.millibuff.com\/?p=1765"},"modified":"2026-04-13T14:02:56","modified_gmt":"2026-04-13T06:02:56","slug":"%e5%b0%8f%e7%89%9b%e6%9c%8d%e5%8a%a1-%e7%a8%bd%e6%9f%a5%e8%b4%a8%e6%8e%a7%ef%bc%9a%e7%b2%be%e5%87%86%e8%af%86%e5%88%ab%e6%89%a7%e8%a1%8c%e7%9b%b2%e5%8c%ba%ef%bc%8c%e4%b8%ba%e6%96%b0%e8%8d%af","status":"publish","type":"post","link":"https:\/\/www.millibuff.com\/?p=1765","title":{"rendered":"\u5c0f\u725b\u670d\u52a1 | \u7a3d\u67e5&\u8d28\u63a7\uff1a\u7cbe\u51c6\u8bc6\u522b\u6267\u884c\u76f2\u533a\uff0c\u4e3a\u65b0\u836f\u6ce8\u518c\u7533\u62a5\u4fdd\u9a7e\u62a4\u822a"},"content":{"rendered":"\n

\u5f53\u4e00\u6b3e\u521b\u65b0\u836f\u63a8\u8fdb\u81f3\u5173\u952e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\uff0c\u5411NMPA\/FDA\u7b49\u76d1\u7ba1\u673a\u6784\u63d0\u4f9b\u575a\u5b9e\u3001\u53ef\u9760\u7684\u79d1\u5b66\u8bc1\u636e\uff0c\u662f\u5404\u65b9\u5171\u540c\u7684\u76ee\u6807\u3002<\/p>\n\n\n\n

\u5728\u8fd9\u4e2a\u7531\u591a\u65b9\u53c2\u4e0e\u8005\u3001\u6d77\u91cf\u6570\u636e\u4e0e\u590d\u6742\u6267\u884c\u6d41\u7a0b\u4ea4\u7ec7\u7684\u7cfb\u7edf\u5de5\u7a0b\u4e2d\uff0c\u4efb\u4f55\u7ec6\u5c0f\u7684\u6267\u884c\u504f\u5dee\u4e0e\u6d41\u7a0b\u6f0f\u6d1e\uff0c\u90fd\u53ef\u80fd\u4f1a\u6210\u4e3a\u5f71\u54cd\u8bd5\u9a8c\u8fdb\u7a0b\u751a\u81f3\u963b\u788d\u7533\u62a5\u901a\u8fc7\u7684\u6f5c\u5728\u98ce\u9669\u3002<\/p>\n\n\n\n

\u5c24\u5176\u5728\u6ce8\u518c\u7533\u62a5\u7b49\u5173\u952e\u8282\u70b9\u524d\u540e\uff0c\u7533\u529e\u65b9\u5f80\u5f80\u9762\u4e34\u4e25\u5cfb\u7684\u5408\u89c4\u538b\u529b\u3002\u7531\u4e8e\u9879\u76ee\u56e2\u961f\u957f\u671f\u6df1\u5ea6\u53c2\u4e0e\u6267\u884c\uff0c\u81ea\u67e5\u65f6\u96be\u514d\u5b58\u5728”\u8eab\u5904\u5c40\u4e2d”\u7684\u89c6\u89d2\u5c40\u9650\uff1b\u5373\u4fbf\u53d1\u73b0\u95ee\u9898\uff0c\u4e5f\u5e38\u56e0\u7f3a\u4e4f\u4e13\u4e1a\u7684\u6307\u5bfc\uff0c\u96be\u4ee5\u5236\u5b9a\u51fa\u7b26\u5408\u76d1\u7ba1\u671f\u671b\u7684\u6574\u6539\u65b9\u6848\u3002\u9762\u5bf9\u8fd9\u4e9b\u5408\u89c4\u6311\u6218\uff0c\u5728\u5f53\u524d\u5e02\u573a\u73af\u5883\u4e0b\uff0c\u771f\u6b63\u80fd\u591f\u4e3a\u7533\u529e\u65b9\u521b\u9020\u4ef7\u503c\u7684\uff0c\u662f\u80fd\u591f\u7cbe\u51c6\u8bc6\u522b\u9690\u60a3\u3001\u63a8\u52a8\u6574\u6539\u843d\u5730\uff0c\u5e76\u6301\u7eed\u4f18\u5316\u9879\u76ee\u8d28\u91cf\u7ba1\u7406\u6d41\u7a0b\u7684\u4e13\u4e1a\u652f\u6301\u3002<\/p>\n\n\n\n

\u57fa\u4e8e\u6b64\uff0c\u5c0f\u725b\u533b\u836f\u81f4\u529b\u4e8e\u63d0\u4f9b\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u8d28\u91cf\u4fdd\u8bc1\u670d\u52a1\uff0c\u540c\u65f6\u4e5f\u63d0\u4f9b\u534f\u52a9\u4f18\u5316\u5185\u90e8\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u652f\u6301\u670d\u52a1\uff0c\u63d0\u524d\u8bc6\u522b\u5e76\u6d88\u9664\u6ce8\u518c\u6838\u67e5\u98ce\u9669\u70b9\u3002\u6211\u4eec\u4ee5\u72ec\u7acb\u7684\u7b2c\u4e09\u65b9\u89c6\u89d2\u786e\u4fdd\u8bd5\u9a8c\u5408\u89c4\u6027\uff0c\u901a\u8fc7\u4e13\u4e1a\u62a5\u544a\u652f\u6491\u76d1\u7ba1\u6c9f\u901a\uff0c\u4ece\u800c\u5207\u5b9e\u964d\u4f4e\u9879\u76ee\u7684\u6ce8\u518c\u98ce\u9669\u3002<\/p>\n\n\n\n

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

PART 01
\u6838\u5fc3\u670d\u52a1<\/h2>\n\n\n\n

\u5c0f\u725b\u533b\u836f\u7a3d\u67e5\u56e2\u961f\u5728\u670d\u52a1\u8fc7\u7a0b\u4e2d\u4f1a\u6df1\u5165\u9879\u76ee\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5404\u5173\u952e\u8282\u70b9\uff0c\u9075\u5faaGCP\u7b49\u884c\u4e1a\u6807\u51c6\u89c4\u8303\uff0c\u56f4\u7ed5”\u53d1\u73b0\u95ee\u9898\u2014\u63a8\u52a8\u6574\u6539\u2014\u9884\u9632\u590d\u53d1”\u7684\u652f\u6301\u903b\u8f91\uff0c\u63d0\u4f9b\u4ee5\u4e0b\u6838\u5fc3\u670d\u52a1\uff1a<\/p>\n\n\n\n

1.\u5e7f\u6cdb\u7684\u7b2c\u4e09\u65b9\u7a3d\u67e5\u670d\u52a1\uff1a<\/h3>\n\n\n\n

\u5ba2\u89c2\u7684\u5408\u89c4\u8bc4\u4f30\u575a\u6301\u72ec\u7acb\u4e8e\u4e34\u5e8a\u8fd0\u8425\u7b49\u6267\u884c\u90e8\u95e8\u7684\u7b2c\u4e09\u65b9\u89c6\u89d2\uff0c\u4ee5\u5ba2\u89c2\u3001\u4e2d\u7acb\u7684\u7acb\u573a\u63d0\u4f9b\u5408\u89c4\u8bc4\u4f30\uff0c\u5e2e\u52a9\u7533\u529e\u65b9\u53ca\u9879\u76ee\u56e2\u961f\u7cfb\u7edf\u6392\u67e5\u5185\u90e8\u81ea\u67e5\u96be\u4ee5\u53d1\u73b0\u7684\u6f5c\u5728\u98ce\u9669\u3002<\/p>\n\n\n\n

1)\u5e7f\u6cdb\u7684\u670d\u52a1\u8303\u56f4<\/strong><\/p>\n\n\n\n

\u6db5\u76d6I-IV\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3001\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3001\u7814\u7a76\u6587\u6863\uff08TMF\uff09\u3001\u6570\u636e\u7ba1\u7406\u7b49\u9886\u57df\u7684\u7b2c\u4e09\u65b9\u7cfb\u7edf\u6027\u7a3d\u67e5\uff1b\u540c\u65f6\u5b9a\u5236\u5316\u63d0\u4f9b\u4f9b\u5e94\u5546\u7a3d\u67e5\u3001\u5b9e\u9a8c\u5ba4\u5ef6\u4f38\u7a3d\u67e5\uff0c\u4ee5\u53ca\u6ce8\u518c\u6838\u67e5\u51c6\u5907\u7b49\u652f\u6301\u3002<\/p>\n\n\n\n

2)\u5b8c\u6574\u7684\u6807\u51c6\u5316\u7a3d\u67e5\u6d41\u7a0b<\/strong>\u6211\u4eec\u8bbe\u8ba1\u4e86\u8986\u76d6\u7a3d\u67e5\u5168\u8fc7\u7a0b\u7684\u6807\u51c6\u5316\u6d41\u7a0b\uff0c\u786e\u4fdd\u7a3d\u67e5\u5de5\u4f5c\u7684\u7cfb\u7edf\u6027\u4e0e\u95ed\u73af\u7ba1\u7406\u3002\u670d\u52a1\u53ef\u7075\u6d3b\u8986\u76d6\u4ece\u7a3d\u67e5\u524d\u51c6\u5907\u4e0e\u98ce\u9669\u8bc4\u4f30\u3001\u73b0\u573a\/\u8fdc\u7a0b\u7a3d\u67e5\u3001\u7a3d\u67e5\u53d1\u73b0\u4e0e\u62a5\u544a\u64b0\u5199\uff0c\u5230 CAPA\uff08\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff09\u5ba1\u6838\u4e0e\u8ffd\u8e2a<\/strong>\u7684\u5168\u6d41\u7a0b\u73af\u8282\u3002<\/p>\n\n\n\n

2.QA\u652f\u6301\uff1a<\/h3>\n\n\n\n

\u5173\u952e\u8282\u70b9\u524d\u7684\u4e13\u9879\u9884\u8bc4\u4f30\u5728\u4e0a\u8ff0\u7cfb\u7edf\u6027\u7a3d\u67e5\u670d\u52a1\u7684\u57fa\u7840\u4e0a\uff0c\u5c0f\u725b\u533b\u836f\u8fd8\u9488\u5bf9\u9879\u76ee\u5173\u952e\u91cc\u7a0b\u7891\u4e0e\u9ad8\u98ce\u9669\u573a\u666f\u63d0\u4f9b\u4e13\u9879\u652f\u6301\uff0c\u534f\u52a9\u9879\u76ee\u56e2\u961f\u5e94\u5bf9\u7279\u5b9a\u5408\u89c4\u6311\u6218\u3002<\/p>\n\n\n\n

1\uff09\u56fd\u5bb6\u5c40\u73b0\u573a\u68c0\u67e5\u524d\u9884\u8bc4\u4f30\uff1a<\/strong>\u5bf9\u7167\u5b98\u65b9\u6838\u67e5\u5173\u6ce8\u91cd\u70b9\u4e0e\u8fc7\u5f80\u7f3a\u9677\u8d8b\u52bf\uff0c\u5bf9\u9879\u76ee\u8fdb\u884c\u7cfb\u7edf\u6027\u7684\u6a21\u62df\u6838\u67e5\uff0c\u534f\u52a9\u8bc4\u4f30\u8fce\u68c0\u72b6\u6001\u5e76\u6307\u5bfc\u6574\u6539\u3002<\/p>\n\n\n\n

2\uff09\u6570\u636e\u9501\u5e93\u524d\u4e13\u9879\u6392\u67e5\uff1a<\/strong>\u5728\u9501\u5e93\u7b49\u5173\u952e\u8282\u70b9\u524d\uff0c\u5bf9\u91cd\u70b9\u4e1a\u52a1\u6d41\u7a0b\u4e0e\u6838\u5fc3\u6570\u636e\u8fdb\u884c\u4e13\u9879\u8bc4\u4f30\uff0c\u534f\u52a9\u964d\u4f4e\u5173\u952e\u8d28\u91cf\u95ee\u9898\u9057\u7559\u7684\u98ce\u9669\u3002<\/p>\n\n\n\n

3\uff09\u5b9a\u5236\u5316\u9879\u76ee\u8d28\u63a7\uff1a<\/strong>\u9488\u5bf9\u7279\u6b8a\u9002\u5e94\u75c7\u6216\u590d\u6742\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u7ed3\u5408\u9879\u76ee\u7279\u70b9\u5236\u5b9a\u5e76\u6267\u884c\u66f4\u5177\u9488\u5bf9\u6027\u7684\u8d28\u63a7\u65b9\u6848\u3002<\/p>\n\n\n\n

3.\u4f53\u7cfb\u5efa\u8bbe\u4e0e\u57f9\u8bad\uff1a<\/h3>\n\n\n\n

\u9a71\u52a8\u8d28\u91cf\u7ba1\u7406\u6301\u7eed\u4f18\u5316\u4ece\u88ab\u52a8\u5e94\u5bf9\u68c0\u67e5\u8f6c\u5411\u4e3b\u52a8\u8d28\u91cf\u7ba1\u7406\uff0c\u5e2e\u52a9\u7533\u529e\u65b9\u53ca\u7814\u7a76\u673a\u6784\u63d0\u5347\u9879\u76ee\u6267\u884c\u7684\u6574\u4f53\u89c4\u8303\u6027\u3002<\/p>\n\n\n\n

1\uff09GCP\u4e13\u4e1a\u57f9\u8bad\u4e0e\u7b54\u7591\uff1a<\/strong>\u9488\u5bf9\u4e34\u5e8a\u6267\u884c\u4e2d\u7684\u5408\u89c4\u7591\u96be\u70b9\uff0c\u63d0\u4f9b\u6cd5\u89c4\u89e3\u8bfb\u4e0e\u5b9e\u64cd\u6307\u5bfc\uff0c\u5e2e\u52a9\u9879\u76ee\u56e2\u961f\u51c6\u786e\u7406\u89e3\u5e76\u843d\u5b9e\u76d1\u7ba1\u8981\u6c42\u3002<\/p>\n\n\n\n

2\uff09\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\u652f\u6301\uff1a<\/strong>\u57fa\u4e8e\u7cfb\u7edf\u6027\u7684\u7a3d\u67e5\u53d1\u73b0\u4e0e\u884c\u4e1a\u6700\u4f73\u5b9e\u8df5\uff0c\u4e3a\u7533\u529e\u65b9\u63d0\u4f9b\u5185\u90e8\u4e34\u5e8a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u642d\u5efa\u6216\u4f18\u5316\u5efa\u8bae\uff0c\u63a8\u52a8 CAPA \u7406\u5ff5\u843d\u5730\uff0c\u51cf\u5c11\u540c\u7c7b\u95ee\u9898\u91cd\u590d\u51fa\u73b0\u3002<\/p>\n\n\n\n

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

PART 02
\u56e2\u961f\u4e0e\u7ecf\u9a8c\u80cc\u4e66<\/h2>\n\n\n\n

\u5ba2\u89c2\u3001\u4e25\u8c28\u7684\u7a3d\u67e5\u548c\u8d28\u63a7\uff0c\u5efa\u7acb\u5728\u957f\u671f\u7684\u884c\u4e1a\u79ef\u7d2f\u4e0e\u5b9e\u6218\u7ecf\u9a8c\u4e4b\u4e0a\u3002<\/p>\n\n\n\n

1.\u4e30\u5bcc\u7684\u4e34\u5e8a\u4e0eGCP\u7ba1\u7406\u7ecf\u9a8c<\/strong>
\u5c0f\u725b\u533b\u836f\u6838\u5fc3\u56e2\u961f\u62e5\u6709\u591a\u5e74\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u548c\u8d28\u91cf\u7ba1\u7406\u5de5\u4f5c\u7ecf\u9a8c\uff0c\u5bf9\u4e34\u5e8a\u8fd0\u8425\u6d41\u7a0b\u4e0e\u8d28\u91cf\u4f53\u7cfb\u5177\u6709\u6df1\u523b\u7684\u5b9e\u8df5\u6d1e\u5bdf\u3002<\/p>\n\n\n\n

2.\u524d\u6cbf\u6cd5\u89c4\u8ffd\u8e2a\u4e0e\u89e3\u8bfb\u80fd\u529b<\/strong>
\u5c0f\u725b\u533b\u836f\u56e2\u961f\u6301\u7eed\u8ddf\u8e2a NMPA\u3001FDA\u3001EMA \u7b49\u76d1\u7ba1\u673a\u6784\u7684\u6cd5\u89c4\u66f4\u65b0\u4e0e\u6838\u67e5\u52a8\u6001\uff0c\u786e\u4fdd\u7a3d\u67e5\u6807\u51c6\u4e0e\u6700\u65b0\u76d1\u7ba1\u671f\u671b\u4fdd\u6301\u4e00\u81f4\u3002<\/p>\n\n\n\n

3.\u771f\u5b9e\u98ce\u9669\u573a\u666f\u7684\u5e94\u5bf9\u79ef\u7d2f<\/strong>
\u5728\u5404\u7c7b\u521b\u65b0\u836f\u53ca\u590d\u6742\u8bd5\u9a8c\u8bbe\u8ba1\u7684\u8d28\u63a7\u9879\u76ee\u4e2d\uff0c\u56e2\u961f\u6301\u7eed\u79ef\u7d2f\u5e76\u66f4\u65b0\u98ce\u9669\u573a\u666f\u5e93\uff0c\u5c06\u5b9e\u6218\u8ba4\u77e5\u8f6c\u5316\u4e3a\u7a3d\u67e5\u5de5\u4f5c\u4e2d\u7684\u7cbe\u51c6\u5224\u65ad\u3002
\u4f8b\u5982\uff0c\u5728\u7532\u82ef\u78fa\u9178\u591a\u7eb3\u975e\u5c3c\u7247\u7532\u72b6\u817a\u764cIII\u671f\u8bd5\u9a8c\u7b2c\u4e09\u65b9\u4e13\u4e1a\u7a3d\u67e5\u670d\u52a1\u4e2d\uff0c\u8be5\u9879\u76ee\u5177\u6709\u591a\u4e2d\u5fc3\u5e76\u53d1\u3001\u6267\u884c\u8282\u594f\u5feb\u7684\u7279\u70b9\uff0c\u4e14\u590d\u6742\u7684\u5b89\u5168\u6027\u6570\u636e\u7ba1\u7406\u4e0e\u7597\u6548\u8bc4\u4f30\u5bf9\u7a3d\u67e5\u5de5\u4f5c\u63d0\u51fa\u4e86\u6781\u9ad8\u8981\u6c42\u3002<\/em>\u5c0f\u725b\u7a3d\u67e5\u56e2\u961f\u57281\u4e2a\u6708\u5185\u5b8c\u6210\u4e86\u8de8\u8d8a10\u4e2a\u7701\u4efd\u3001\u5171\u8ba112\u5bb6\u4e2d\u5fc3\u7684\u5168\u9762\u7a3d\u67e5\uff0c\u6700\u7ec8\u8be5\u9879\u76ee\u5728\u540e\u7eed\u7684\u5b98\u65b9\u68c0\u67e5\u4e0e\u5ba1\u8bc4\u4e2d\u5b9e\u73b0\u4e86”0\u91cd\u5927\u7f3a\u9677\uff0c\u5ba1\u8bc4\u5168\u901a\u8fc7”\u3002<\/em><\/p>\n\n\n\n

PART 03
\u7ed3\u8bed<\/h2>\n\n\n\n

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1)\u5c0f\u725b\u4e34\u7814 | \u7814\u53d1\u671f\u95f4\u5b89\u5168\u6027\u66f4\u65b0\u62a5\u544a\uff08DSUR\uff09\u7cfb\u7edf\u6027\u6307\u5357\uff1a\u4ece\u6cd5\u89c4\u6846\u67b6\u5230\u5b9e\u64cd\u8981\u70b9\u5168\u89e3\u6790<\/a><\/p>\n\n\n\n

2)\u5c0f\u725b\u4e34\u7814 | 2025\u7248GCP\u5f81\u6c42\u610f\u89c1\u7a3f\u6765\u4e86\uff01\u4f60\u7684\u5de5\u4f5c\u5c06\u6709\u54ea\u4e9b\u53d8\u5316\uff1f<\/a><\/p>\n\n\n\n

3)\u5c0f\u725b\u4e34\u7814 | BE\u7814\u7a76\u4e0d\u662f”\u505a\u8fc7”\u5c31\u80fd”\u505a\u597d”\u2014\u65b0\u7248\u300a\u5316\u5b66\u4eff\u5236\u836f\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u8d28\u91cf\u98ce\u9669\u8bc4\u4f30\u6307\u5bfc\u539f\u5219\u300b<\/a><\/p>\n\n\n\n

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\u90d1\u603b\u76d1<\/strong>\u8054\u7cfb\u7535\u8bdd\uff1a<\/strong>13758291914<\/strong>\uff08\u5fae\u4fe1\u540c\u53f7\uff09 <\/strong>\u5546\u52a1\u90ae\u7bb1\uff1a<\/strong>zym@millibuff.com<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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