{"id":42641,"date":"2021-06-25T10:40:04","date_gmt":"2021-06-25T08:40:04","guid":{"rendered":"https:\/\/kymos.com\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e6%89%b9%e6%ac%a1%e6%a3%80%e6%b5%8b%e4%b8%8e%e6%89%b9%e6%ac%a1%e6%94%be%e8%a1%8c\/"},"modified":"2026-07-08T11:40:46","modified_gmt":"2026-07-08T09:40:46","slug":"%e6%89%b9%e6%ac%a1%e6%a3%80%e6%b5%8b%e4%b8%8e%e6%89%b9%e6%ac%a1%e6%94%be%e8%a1%8c","status":"publish","type":"page","link":"https:\/\/kymos.com\/zh-hans\/%e6%9c%8d%e5%8a%a1%e9%a1%b9%e7%9b%ae\/cmc-%e5%88%86%e6%9e%90%e4%b8%8e%e8%b4%a8%e9%87%8f%e6%8e%a7%e5%88%b6\/%e6%89%b9%e6%ac%a1%e6%a3%80%e6%b5%8b%e4%b8%8e%e6%89%b9%e6%ac%a1%e6%94%be%e8%a1%8c\/","title":{"rendered":"\u6279\u6b21\u68c0\u6d4b\u4e0e\u6279\u6b21\u653e\u884c"},"content":{"rendered":"

\u6279\u6b21\u68c0\u6d4b\u4e0e\u6279\u6b21\u653e\u884c<\/h1><\/div>

\u9488\u5bf9\u5c0f\u5206\u5b50\u548c\u751f\u7269\u5236\u54c1\uff0c\u63d0\u4f9b\u7ecf GMP \u8ba4\u8bc1\u7684\u8fdb\u53e3\u3001\u6279\u6b21\u68c0\u6d4b\u548c\u6279\u6b21\u653e\u884c\u670d\u52a1\uff0c\u5e76\u914d\u5907\u591a\u540d\u53d7\u6743\u4eba (QP)\u3002<\/p>\n<\/div>

\u54a8\u8be2\u4e13\u5bb6<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>

Kymos \u96c6\u56e2\u63d0\u4f9b\u7ecf GMP \u8ba4\u8bc1\u7684\u8fdb\u53e3\u3001\u6279\u6b21\u68c0\u6d4b\u548c\u6279\u6b21\u653e\u884c\u670d\u52a1\u3002\u6211\u4eec\u62e5\u6709\u591a\u540d\u53d7\u6743\u4eba (QP)\uff0c\u662f\u4eba\u7528\u3001\u517d\u7528\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u836f\u7269 (IMP) \u8d28\u91cf\u63a7\u5236\u548c\u6279\u6b21\u8ba4\u8bc1\u7684\u8ba4\u8bc1\u8fdb\u53e3\u5546\u548c\u5236\u9020\u5546\uff08MIA \u6301\u6709\u8005\uff09\u3002 <\/span><\/p>\n

\u6211\u4eec\u5177\u5907\u5bf9\u65e0\u83cc\u3001\u975e\u65e0\u83cc\u53ca\u751f\u7269\u836f\u5242\u8fdb\u884c GMP \u6279\u6b21\u68c0\u6d4b\u548c\u6279\u6b21\u653e\u884c\u7684\u80fd\u529b\u3002\u6211\u4eec\u7684\u6279\u6b21\u68c0\u6d4b\u5ba2\u6237\u5927\u591a\u662f\u6765\u81ea\u672a\u7b7e\u7f72\u4e92\u8ba4\u534f\u8bae (MRA) \u56fd\u5bb6\/\u5730\u533a\u7684\u5168\u7403\u5236\u9020\u5546\uff0c\u4ed6\u4eec\u5e0c\u671b\u5c06\u4ea7\u54c1\u8fdb\u53e3\u5230\u6b27\u6d32\u7ecf\u6d4e\u533a (EEA)\u3002\u5728\u8fd9\u4e9b\u5730\u533a\uff0c\u6279\u6b21\u653e\u884c\u524d\u5fc5\u987b\u8fdb\u884c\u6279\u6b21\u68c0\u6d4b\u3002\u6211\u4eec\u7684\u670d\u52a1\u5305\u8fd8\u5305\u62ec\u4e3a\u8fd9\u4e9b\u5236\u9020\u5546\u63d0\u4f9b\u6279\u6b21\u653e\u884c\uff0c\u4f7f\u4ed6\u4eec\u80fd\u591f\u5c06\u4ea7\u54c1\u59d4\u6258\u7ed9\u6211\u4eec\uff0c\u76f4\u81f3\u4e0a\u5e02\u653e\u884c\u3002 <\/span><\/p>\n<\/div><\/div><\/div>

\"Quality<\/div><\/div><\/div><\/div>
\"Laboratory<\/div><\/div>

\u670d\u52a1\u9879\u76ee<\/p>\n<\/div>

<\/div><\/div>

\u6211\u4eec\u7684 GMP \u6279\u6b21\u68c0\u6d4b\u4e0e\u6279\u6b21\u653e\u884c\u89e3\u51b3\u65b9\u6848<\/b><\/h2><\/div>

<\/i><\/i><\/span>\u6211\u4eec\u7684\u7efc\u5408\u6279\u6b21\u68c0\u6d4b\u4e0e\u6279\u6b21\u653e\u884c\u670d\u52a1\u5305\u62ec\uff1a<\/span><\/a><\/h3><\/div>
\n