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\u7f8e\u56fdBrimrose<\/a> \u5e94\u7528<\/a><\/h3>\n

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\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u504f\u5dee\u53d1\u751f<\/h3>\n

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\n\u5bf9\u6bd4GMP\u4e2d\u8fd9\u4e24\u7c7b\u504f\u5dee\u7684\u63cf\u8ff0\uff0c\u53ef\u89c1\u5bf9\u4e8e\u5e38\u89c4\u504f\u5dee\u548c\u9a8c\u8bc1\u504f\u5dee\u7684\u7ba1\u7406\u8981\u6c42\u4e0d\u540c\uff0c\u5176\u5904\u7406\u65b9\u5f0f\u4e5f\u662f\u4e0d\u540c\u7684\u3002<\/p>\n

\u9a8c\u8bc1\u504f\u5dee\u4e0e\u5e38\u89c4\u504f\u5dee\u7684\u533a\u522b<\/h3>\n

\u53d1\u751f\u7684\u539f\u56e0\u4e0d\u540c<\/h4>\n

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\u5904\u7406\u65b9\u5f0f\u4e0d\u540c<\/h4>\n

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\n\u5e38\u89c4\u504f\u5dee\u9996\u5148\u8981\u5bf9\u5176\u5f71\u54cd\u6027\u505a\u51fa\u521d\u6b65\u5224\u65ad\uff0c\u6839\u636e\u5176\u5bf9\u8d28\u91cf\u7684\u5f71\u54cd\u8fdb\u884c\u5206\u7c7b\uff0c\u5982\u5f52\u4e3a\u5173\u952e\u504f\u5dee\u3001\u4e2d\u7b49\u504f\u5dee\u6216\u662f\u5fae\u5c0f\u504f\u5dee\u3002\u5bf9\u4e8e\u5fae\u5c0f\u504f\u5dee\uff0c\u6bd4\u5982\u5728\u4f7f\u7528\u4e4b\u524d\u53d1\u73b0\u4ed3\u5e93\u53d1\u9001\u4e86\u9519\u8bef\u7684\u7269\u6599\uff0c\u4ec5\u9700\u8981\u8bb0\u5f55\u548c\u89e3\u91ca\uff0c\u5e76\u4e14\u53ca\u65f6\u66f4\u6362\u7269\u6599\u4fee\u6b63\u9519\u8bef\u3002\u5bf9\u4e8e\u4e2d\u7b49\u504f\u5dee\u548c\u5173\u952e\u504f\u5dee\uff0c\u5e94\u8c03\u67e5\u5176\u53d1\u751f\u7684\u6839\u672c\u539f\u56e0\uff0c\u518d\u8bc4\u4f30\u504f\u5dee\u9020\u6210\u7684\u5f71\u54cd\uff0c\u5e76\u5efa\u7acb\u7ea0\u6b63\u548c\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\uff0c\u6279\u51c6\u540e\u5b8c\u6210\u7ea0\u6b63\u884c\u52a8\uff0c\u6700\u540e\u5b8c\u6210\u504f\u5dee\u62a5\u544a\u3002<\/p>\n

\u5bf9\u4e8e\u5e38\u89c4\u504f\u5dee\u7684\u5904\u7406\uff0c\u9700\u8981\u4e00\u5957\u5b8c\u6574\u7684\u504f\u5dee\u7ba1\u7406\u4f53\u7cfb\u6765\u652f\u6491\uff0c\u5bf9\u4e0d\u540c\u5206\u7c7b\u7684\u504f\u5dee\u91c7\u53d6\u5bf9\u5e94\u7684\u5904\u7406\u6d41\u7a0b\u3002\u4f8b\u5982\uff0c\u6c34\u7cfb\u7edf\u8fdb\u884c\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u7b2c\u4e00\u9636\u6bb5\u65f6\u53d1\u73b0\u67d0\u7528\u6c34\u70b9\u5fae\u751f\u7269\u8d85\u6807\uff0c\u7531\u4e8e\u7b2c\u4e00\u9636\u6bb5\u7684\u6c34\u5c1a\u672a\u7528\u4e8e\u751f\u4ea7\uff0c\u56e0\u6b64\u4e0d\u9700\u8981\u6267\u884c\u751f\u4ea7\u4ea7\u54c1\u76f8\u5173\u7684\u7d27\u6025\u63aa\u65bd\uff1b\u7531\u4e8e\u5fae\u751f\u7269\u8d85\u6807\u4f1a\u5f71\u54cd\u672a\u6765\u4ea7\u54c1\u8d28\u91cf\uff0c\u56e0\u6b64\u8be5\u504f\u5dee\u5f52\u7c7b\u4e3a\u5173\u952e\u504f\u5dee\uff1b\u6b64\u65f6\u9700\u6210\u7acb\u504f\u5dee\u8c03\u67e5\u5c0f\u7ec4\u8fdb\u884c\u6839\u672c\u539f\u56e0\u7684\u8c03\u67e5\uff0c\u5e76\u4e14\u8bc4\u4f30\u504f\u5dee\u7684\u5f71\u54cd\uff0c\u8c03\u67e5\u539f\u56e0\u548c\u8bc4\u4f30\u5f71\u54cd\u53ef\u91c7\u7528\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7684\u65b9\u6cd5\uff0c\u5229\u7528\u98ce\u9669\u5206\u6790\u5de5\u5177\uff08\u5982\u9c7c\u9aa8\u56fe\u3001\u5931\u6548\u6a21\u5f0f\u5f71\u54cd\u5206\u6790\uff08FMEA\uff09\u7b49\uff09\u5f97\u51fa\u7ed3\u8bba\u3002\u57fa\u4e8e\u7ed3\u8bba\uff0c\u9700\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\u6765\u6d88\u9664\u504f\u5dee\u7684\u5f71\u54cd\uff0c\u5e76\u91c7\u53d6\u9884\u9632\u63aa\u65bd\u6765\u907f\u514d\u76f8\u540c\u7684\u504f\u5dee\u518d\u6b21\u53d1\u751f\u4ee5\u53ca\u6267\u884c\u540e\u7eed\u7684\u8ddf\u8e2a\u7a0b\u5e8f\u7b49\u3002<\/p>\n

\u53d1\u751f\u7684\u6982\u7387\u4e0d\u540c<\/h4>\n

\u5bf9\u4e8e\u4efb\u4f55\u5168\u65b0\u7684\u9a8c\u8bc1\u5bf9\u8c61\uff0c\u9a8c\u8bc1\u504f\u5dee\u4e3a\u72ec\u7acb\u4e8b\u4ef6\uff0c\u53ea\u4f1a\u5355\u6b21\u51fa\u73b0\uff0c\u56e0\u6b64\u9a8c\u8bc1\u504f\u5dee\u7684\u5904\u7406\u4e0d\u9700\u8981\u9884\u9632\u63aa\u65bd\u3002
\n\u5e38\u89c4\u504f\u5dee\u662f\u57fa\u4e8e\u67d0\u4e9b\u539f\u56e0\u53d1\u751f\u4e86\u4e0d\u8be5\u51fa\u73b0\u7684\u504f\u79bb\uff0c\u6709\u53ef\u80fd\u4f1a\u518d\u6b21\u51fa\u73b0\uff0c\u9700\u5728\u5f71\u54cd\u8bc4\u4f30\u65f6\u5206\u6790\u5176\u53d1\u751f\u7684\u53ef\u80fd\u6027\uff0c\u5e76\u9700\u8981\u901a\u8fc7\u9884\u9632\u63aa\u65bd\u6765\u964d\u4f4e\u5176\u53d1\u751f\u7684\u53ef\u80fd\u6027\uff0c\u4ece\u800c\u964d\u4f4e\u98ce\u9669\uff0c\u8fbe\u5230\u98ce\u9669\u63a7\u5236\u7684\u76ee\u7684\u3002
\n\u5173\u4e8e\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u7684\u9a8c\u8bc1\u504f\u5dee\u548c\u5e38\u89c4\u504f\u5dee\uff0c\u4e0b\u9762\u5c06\u4f1a\u7528\u4e24\u4e2a\u5b9e\u4f8b\u6765\u8fdb\u884c\u5177\u4f53\u5206\u6790\u3002<\/p>\n

\u504f\u5dee\u5b9e\u4f8b\u5206\u6790<\/h3>\n

\u5b9e\u4f8b\u4e00<\/h4>\n

\u67d0\u8bbe\u5907\u7528\u6237\u9700\u6c42\uff08URS\uff09\u4e2d\u8981\u6c42\u5176\u6e29\u5ea6\u7cbe\u5ea6\u4e0d\u5927\u4e8e0.5\u2005\u2103\uff0c\u6839\u636e\u5382\u5bb6\u6587\u4ef6\u63cf\u8ff0\uff0c\u8be5\u8bbe\u5907\u53ef\u63a7\u5236\u7cbe\u5ea6\u4e3a0.1\u2005\u2103\uff0c\u56e0\u6b64\u9a8c\u8bc1\u65b9\u6848\u4e2d\u8981\u6c42\u5176\u6e29\u5ea6\u7cbe\u5ea6\u4e0d\u5927\u4e8e0.1\u2005\u2103\uff0c\u9a8c\u8bc1\u65f6\u53d1\u73b0\u8be5\u8bbe\u5907\u53ea\u80fd\u8fbe\u52300.2\u2005\u2103\u7684\u7cbe\u5ea6\u3002
\n\u9996\u5148\u8bb0\u5f55\u504f\u5dee\uff0c\u5e76\u5206\u6790\u53d1\u751f\u504f\u5dee\u7684\u539f\u56e0\u3002
\n\u5982\u679c\u51fa\u73b0\u504f\u5dee\u7684\u539f\u56e0\u662f\u8fd9\u53f0\u8bbe\u5907\u672c\u8eab\u8fbe\u4e0d\u5230\u9a8c\u8bc1\u76ee\u6807\uff0c\u8be5\u504f\u5dee\u5373\u5c5e\u4e8e\u9a8c\u8bc1\u504f\u5dee\uff0c\u5e94\u6309\u7167\u9a8c\u8bc1\u504f\u5dee\u7684\u5904\u7406\u65b9\u5f0f\u53bb\u5904\u7406\u3002\u6b64\u65f6\u5e94\u91c7\u53d6\u7ea0\u6b63\u63aa\u65bd\uff0c\u6216\u8005\u5347\u7ea7\u9a8c\u8bc1\u65b9\u6848\uff0c\u6216\u8005\u6539\u53d8\u8bbe\u5907\u786c\u4ef6\uff0c\u6700\u7ec8\u9700\u4f7f\u4e24\u8005\u4e00\u81f4\uff0c\u8fdb\u800c\u5173\u95ed\u504f\u5dee\uff0c\u5b8c\u6210\u6574\u4e2a\u9a8c\u8bc1\u8fc7\u7a0b\u3002
\n\u5982\u679c\u51fa\u73b0\u504f\u5dee\u7684\u539f\u56e0\u662f\u6e29\u5ea6\u63a2\u5934\u635f\u574f\uff0c\u800c\u53c8\u56e0\u4e3a\u8d85\u51fa\u6821\u51c6\u65f6\u95f4\u6240\u4ee5\u6ca1\u6709\u88ab\u53d1\u73b0\uff0c\u5bfc\u81f4\u9a8c\u8bc1\u7ed3\u679c\u4e0d\u51c6\u786e\uff0c\u5373\u8bbe\u5907\u5b9e\u9645\u662f\u53ef\u6ee1\u8db3\u65b9\u6848\u4e2d\u7684\u7cbe\u5ea6\u8981\u6c42\uff0c\u4f46\u6d4b\u8bd5\u7ed3\u679c\u4e0d\u6ee1\u8db3\u8981\u6c42\uff0c\u8be5\u504f\u5dee\u5373\u5c5e\u4e8e\u5e38\u89c4\u504f\u5dee\u3002\u6b64\u65f6\u9700\u5bf9\u504f\u5dee\u8fdb\u884c\u5206\u7c7b\uff0c\u518d\u6267\u884c\u5bf9\u5e94\u7684\u6d41\u7a0b\u3002\u7ea0\u6b63\u63aa\u65bd\u662f\u7ef4\u4fee\u5e76\u7acb\u523b\u91cd\u65b0\u6821\u51c6\u6e29\u5ea6\u63a2\u5934\uff0c\u5e76\u4e14\u91cd\u65b0\u9a8c\u8bc1\uff1b\u9884\u9632\u63aa\u65bd\u662f\u5bf9\u8ba1\u91cf\u7ba1\u7406\u90e8\u95e8\u63d0\u51fa\u63d0\u524d\u6821\u51c6\u7684\u63a7\u5236\u8981\u6c42\uff0c\u5305\u62ec\u5347\u7ea7\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff08SOP\uff09\u3001\u4f7f\u7528\u8f6f\u4ef6\u5b9a\u671f\u63d0\u9192\u7b49\u3002<\/p>\n

\u5b9e\u4f8b\u4e8c<\/h4>\n

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\n\u9996\u5148\u8bb0\u5f55\u504f\u5dee\uff0c\u67e5\u627e\u539f\u56e0\u3002\u5982\u53d1\u73b0\u662f\u7531\u4e8e\u5e03\u70b9\u65f6\u4eba\u5458\u64cd\u4f5c\u4e0d\u89c4\u8303\uff0c\u63a2\u5934\u76f4\u63a5\u63a5\u89e6\u5230\u4e86\u8154\u4f53\u91d1\u5c5e\u90e8\u5206\uff0c\u5bfc\u81f4\u5bfc\u70ed\u5f02\u5e38\uff0c\u5c5e\u4e8e\u5e38\u89c4\u504f\u5dee\uff0c\u5904\u7406\u65b9\u5f0f\u9996\u5148\u8fdb\u884c\u5f71\u54cd\u8bc4\u4f30\uff0c\u518d\u73b0\u573a\u7ea0\u6b63\uff0c\u91cd\u65b0\u6446\u653e\u62ac\u5934\uff0c\u4f7f\u4e4b\u53ea\u80fd\u63a5\u89e6\u88c5\u8f7d\u7269\u800c\u4e0d\u63a5\u89e6\u91d1\u5c5e\u8154\u4f53\uff0c\u6700\u540e\u63d0\u51fa\u9884\u9632\u63aa\u65bd\uff0c\u4f8b\u5982\u5bf9\u63a2\u5934\u6446\u653e\u8fdb\u884c\u66f4\u4e3a\u6807\u51c6\u5316\u7684\u57f9\u8bad\u7b49\u7b49\u3002
\n\u5982\u679c\u9020\u6210\u504f\u5dee\u7684\u539f\u56e0\u662f\u6ee1\u8f7d\u65f6\u653e\u7f6e\u7684\u7269\u6599\u592a\u591a\u6216\u8005\u6446\u653e\u65b9\u5f0f\u4e0d\u5408\u7406\uff0c\u5373\u662f\u7531\u4e8e\u88c5\u8f7d\u91cf\u6216\u88c5\u8f7d\u65b9\u5f0f\u7684\u4e0d\u786e\u5b9a\u5f15\u8d77\u7684\uff0c\u5c5e\u4e8e\u9a8c\u8bc1\u504f\u5dee\u3002\u7ea0\u6b63\u63aa\u65bd\u4e3a\u66f4\u6539\u9a8c\u8bc1\u65b9\u6848\uff0c\u4f7f\u7528\u65b0\u7684\u88c5\u8f7d\u91cf\u6216\u88c5\u8f7d\u65b9\u5f0f\u91cd\u65b0\u8fdb\u884c\u70ed\u5206\u5e03\u9a8c\u8bc1\u3002\u91cd\u65b0\u9a8c\u8bc1\u65f6\u6216\u8bb8\u4f9d\u7136\u4e0d\u80fd\u8fbe\u5230\u8981\u6c42\uff0c\u5c31\u9700\u8981\u591a\u6b21\u8c03\u6574\u591a\u6b21\u9a8c\u8bc1\u6700\u7ec8\u786e\u5b9a\u5176\u88c5\u8f7d\u91cf\u4e0e\u88c5\u8f7d\u65b9\u5f0f\u4f7f\u5176\u6e29\u5ea6\u5206\u5e03\u5747\u5300\uff0c\u624d\u80fd\u5b8c\u6210\u6b64\u6b21\u9a8c\u8bc1\u3002
\n\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u88c5\u8f7d\u91cf\u548c\u88c5\u8f7d\u65b9\u5f0f\u662f\u5df2\u786e\u5b9a\u7684\u6807\u51c6\uff0c\u5982\u679c\u8bbe\u5907\u4f7f\u7528\u4e00\u5e74\u540e\u8fdb\u884c\u518d\u9a8c\u8bc1\u65f6\u53d1\u73b0\u6ee1\u8f7d\u70ed\u5206\u5e03\u4e0d\u5747\u5300\uff0c\u6b64\u65f6\u7684\u504f\u5dee\u4e3a\u5e38\u89c4\u504f\u5dee\uff0c\u9700\u6309\u7167\u5e38\u89c4\u504f\u5dee\u7684\u5904\u7406\u65b9\u5f0f\u8fdb\u884c\u8c03\u67e5\u3001\u98ce\u9669\u5206\u6790\u3001\u7ea0\u6b63\u9884\u9632\u63aa\u65bd\u7b49\u3002<\/p>\n

\u5b9e\u4f8b\u5bf9\u6bd4\u7ed3\u8bba<\/h4>\n

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\u603b\u7ed3<\/h3>\n

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\u3010\u53c2\u8003\u6587\u732e\u3011<\/strong>
\n[1] ICH Q7\uff0cGood Manufacturing Practice Guide for Active Pharmaceutical Ingredients\uff0c2000.11.
\n[2] EU Legislation\u2013EudraLex\uff0cVolume 4-Guidelines for good manufacturing practices for medicinal products for human and veterinary use\uff0c2015.03.
\n[3] EU Legislation\u2013EudraLex\uff0cVolume 4-Guidelines for good manufacturing practices for medicinal products for human and veterinary use\uff0cAnnex 15 Qualification and Validation\uff0c2015.10.
\n[3] \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\uff0c2011.03.
\n[4] \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff082010\u5e74\u4fee\u8ba2\uff09\uff0c\u9644\u5f55\uff0c\u786e\u8ba4\u4e0e\u9a8c\u8bc1\uff0c2015.12.
\n[5] \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u8ba4\u8bc1\u7ba1\u7406\u4e2d\u5fc3\uff0c\u836f\u54c1GMP\u6307\u5357\uff0c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c2011.08.
\n[6] \u8bc6\u6797\u7f51\u7ad9\uff0cIPEM\u8bb2\u4e49\uff0c\u53d8\u66f4\u548c\u504f\u5dee\u7ba1\u7406\u4ee5\u53caCAPA\uff0c2018.08\uff0chttp:\/\/lib.shilinx.com.<\/p>\n

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