{"id":97378,"date":"2024-10-26T14:34:57","date_gmt":"2024-10-26T06:34:57","guid":{"rendered":"https:\/\/www.073980.com\/?p=97378"},"modified":"2024-10-26T14:34:59","modified_gmt":"2024-10-26T06:34:59","slug":"gmp%e8%ae%a4%e8%af%81%e6%98%af%e4%bb%80%e4%b9%88%e6%84%8f%e6%80%9d","status":"publish","type":"post","link":"https:\/\/www.073980.com\/97378.htm","title":{"rendered":"GMP\u8ba4\u8bc1\u662f\u4ec0\u4e48\u610f\u601d?"},"content":{"rendered":"\n

\u5728\u5f53\u4eca\u8fd9\u4e2a\u6ce8\u91cd\u54c1\u8d28\u4e0e\u5b89\u5168\u7684\u793e\u4f1a\uff0cGMP(Good Manufacturing Practices)\u8ba4\u8bc1\u5df2\u6210\u4e3a\u5236\u836f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\u7684\u751f\u4ea7\u4f01\u4e1a\u4e0d\u53ef\u6216\u7f3a\u7684\u91cd\u8981\u6807\u8bc6\u3002GMP\u8ba4\u8bc1\u4e0d\u4ec5\u4ee3\u8868\u7740\u4f01\u4e1a\u5728\u751f\u4ea7\u7ba1\u7406\u548c\u8d28\u91cf\u63a7\u5236\u65b9\u9762\u8fbe\u5230\u4e86\u56fd\u9645\u5148\u8fdb\u6c34\u5e73\uff0c\u66f4\u662f\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u548c\u5b89\u5168\u6027\u7684\u6709\u529b\u4fdd\u969c\u3002<\/p>\n\n\n\n

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

GMP\u8ba4\u8bc1\u7684\u5b9a\u4e49\u4e0e\u80cc\u666f<\/h2>\n\n\n\n

GMP\u8ba4\u8bc1\uff0c\u5373\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u8ba4\u8bc1\uff0c\u662f\u82f1\u6587Good Manufacturing Practice\u7684\u7f29\u5199\uff0c\u4e2d\u6587\u542b\u4e49\u4e3a\u201c\u826f\u597d\u751f\u4ea7\u89c4\u8303\u201d\u3002\u5b83\u662f\u7531\u4e16\u754c\u536b\u751f\u7ec4\u7ec7(WHO)\u5236\u5b9a\u7684\u6307\u5bfc\u98df\u7269\u3001\u836f\u54c1\u3001\u533b\u7597\u4ea7\u54c1\u751f\u4ea7\u548c\u8d28\u91cf\u7ba1\u7406\u7684\u6cd5\u89c4\uff0c\u4e5f\u662f\u4e00\u5957\u9002\u7528\u4e8e\u5236\u836f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\u7684\u5f3a\u5236\u6027\u6807\u51c6\u3002\u65b0\u4fee\u8ba2\u7684\u300a\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u54c1\u7ba1\u7406\u6cd5\u300b\u660e\u786e\u89c4\u5b9a\uff0c\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u5fc5\u987b\u6309\u7167\u56fd\u52a1\u9662\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u4f9d\u6cd5\u5236\u5b9a\u7684\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u7ec4\u7ec7\u751f\u4ea7\uff0c\u5e76\u901a\u8fc7GMP\u8ba4\u8bc1\u73b0\u573a\u68c0\u67e5\uff0c\u624d\u80fd\u786e\u4fdd\u836f\u54c1\u7684\u8d28\u91cf\u4e0e\u5b89\u5168\u3002<\/p>\n\n\n\n

GMP\u8ba4\u8bc1\u7684\u6838\u5fc3\u8981\u6c42<\/h2>\n\n\n\n

GMP\u8ba4\u8bc1\u7684\u6838\u5fc3\u5728\u4e8e\u786e\u4fdd\u836f\u54c1\u6216\u98df\u54c1\u7b49\u4ea7\u54c1\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u8d28\u91cf\u53ef\u63a7\uff0c\u4ece\u800c\u4fdd\u969c\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u5b83\u8981\u6c42\u4f01\u4e1a\u4ece\u539f\u6599\u91c7\u8d2d\u3001\u4eba\u5458\u57f9\u8bad\u3001\u8bbe\u65bd\u8bbe\u5907\u3001\u751f\u4ea7\u8fc7\u7a0b\u3001\u5305\u88c5\u8fd0\u8f93\u3001\u8d28\u91cf\u63a7\u5236\u7b49\u591a\u4e2a\u65b9\u9762\u8fbe\u5230\u56fd\u5bb6\u89c4\u5b9a\u7684\u536b\u751f\u8d28\u91cf\u8981\u6c42\u3002\u5177\u4f53\u6765\u8bf4\uff0cGMP\u8ba4\u8bc1\u7684\u6838\u5fc3\u8981\u6c42\u5305\u62ec\uff1a<\/p>\n\n\n\n

\u4eba\u5458\u8981\u6c42<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5177\u5907\u76f8\u5e94\u7684\u4eba\u5458\u8d44\u8d28\u548c\u6280\u672f\u80fd\u529b\uff0c\u5efa\u7acb\u5065\u5168\u7684\u4eba\u5458\u57f9\u8bad\u548c\u8003\u6838\u5236\u5ea6\uff0c\u786e\u4fdd\u5458\u5de5\u80fd\u591f\u80dc\u4efb\u5404\u81ea\u7684\u5de5\u4f5c\u5c97\u4f4d\u3002<\/p>\n\n\n\n

\u751f\u4ea7\u73af\u5883<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u7b26\u5408GMP\u8981\u6c42\u7684\u6d01\u51c0\u751f\u4ea7\u73af\u5883\uff0c\u5305\u62ec\u6d01\u51c0\u8f66\u95f4\u3001\u7a7a\u6c14\u51c0\u5316\u7cfb\u7edf\u3001\u6e29\u6e7f\u5ea6\u63a7\u5236\u7cfb\u7edf\u7b49\uff0c\u4ee5\u4fdd\u8bc1\u836f\u54c1\u7684\u8d28\u91cf\u7a33\u5b9a\u6027\u3002<\/p>\n\n\n\n

\u539f\u6750\u6599\u91c7\u8d2d<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u4e25\u683c\u7684\u539f\u6750\u6599\u91c7\u8d2d\u5236\u5ea6\uff0c\u5bf9\u4f9b\u5e94\u5546\u8fdb\u884c\u5ba1\u8ba1\u548c\u7b5b\u9009\uff0c\u5e76\u5bf9\u539f\u6750\u6599\u8fdb\u884c\u68c0\u9a8c\u548c\u786e\u8ba4\uff0c\u786e\u4fdd\u6240\u7528\u539f\u6750\u6599\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u3002<\/p>\n\n\n\n

\u751f\u4ea7\u8fc7\u7a0b<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u79d1\u5b66\u7684\u751f\u4ea7\u8fc7\u7a0b\u63a7\u5236\u548c\u7ba1\u7406\u5236\u5ea6\uff0c\u5305\u62ec\u5de5\u827a\u6d41\u7a0b\u56fe\u3001\u64cd\u4f5c\u89c4\u7a0b\u3001\u751f\u4ea7\u8bb0\u5f55\u7b49\uff0c\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u7684\u7a33\u5b9a\u6027\u548c\u53ef\u63a7\u6027\u3002<\/p>\n\n\n\n

\u8d28\u91cf\u63a7\u5236<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u4e25\u683c\u7684\u8d28\u91cf\u63a7\u5236\u5236\u5ea6\uff0c\u5bf9\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u5404\u4e2a\u73af\u8282\u8fdb\u884c\u5168\u9762\u7684\u8d28\u91cf\u68c0\u6d4b\u548c\u76d1\u63a7\uff0c\u5e76\u5efa\u7acb\u5b8c\u5584\u7684\u8d28\u91cf\u8ffd\u6eaf\u4f53\u7cfb\uff0c\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u3002<\/p>\n\n\n\n

\u4ea7\u54c1\u50a8\u5b58\u548c\u8fd0\u8f93<\/strong>\uff1a\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5b8c\u5584\u7684\u4ea7\u54c1\u50a8\u5b58\u548c\u8fd0\u8f93\u5236\u5ea6\uff0c\u5305\u62ec\u6e29\u6e7f\u5ea6\u63a7\u5236\u3001\u9632\u6c61\u67d3\u63aa\u65bd\u3001\u8fd0\u8f93\u65b9\u5f0f\u7b49\uff0c\u786e\u4fdd\u4ea7\u54c1\u7684\u8d28\u91cf\u7a33\u5b9a\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n\n\n\n

GMP\u8ba4\u8bc1\u7684\u91cd\u8981\u6027<\/h2>\n\n\n\n

GMP\u8ba4\u8bc1\u5bf9\u4e8e\u5236\u836f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\u7684\u751f\u4ea7\u4f01\u4e1a\u6765\u8bf4\u5177\u6709\u6781\u5176\u91cd\u8981\u7684\u610f\u4e49\u3002\u5b83\u4e0d\u4ec5\u5173\u4e4e\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\uff0c\u8fd8\u5f71\u54cd\u7740\u4f01\u4e1a\u7684\u5f62\u8c61\u3001\u4fe1\u8a89\u548c\u5e02\u573a\u7ade\u4e89\u529b\u3002\u5177\u4f53\u6765\u8bf4\uff0cGMP\u8ba4\u8bc1\u7684\u91cd\u8981\u6027\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n\n\n\n

\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u4e0e\u5b89\u5168<\/strong>\uff1a\u901a\u8fc7GMP\u8ba4\u8bc1\u7684\u4f01\u4e1a\uff0c\u5176\u751f\u4ea7\u8fc7\u7a0b\u3001\u8d28\u91cf\u63a7\u5236\u3001\u4eba\u5458\u57f9\u8bad\u7b49\u65b9\u9762\u90fd\u5f97\u5230\u4e86\u4e25\u683c\u628a\u5173\uff0c\u80fd\u591f\u751f\u4ea7\u51fa\u66f4\u52a0\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u4ea7\u54c1\uff0c\u4ece\u800c\u4fdd\u969c\u6d88\u8d39\u8005\u7684\u6743\u76ca\u3002<\/p>\n\n\n\n

\u63d0\u5347\u4f01\u4e1a\u5f62\u8c61\u4e0e\u4fe1\u8a89<\/strong>\uff1a\u83b7\u5f97GMP\u8ba4\u8bc1\u7684\u4f01\u4e1a\uff0c\u610f\u5473\u7740\u5176\u751f\u4ea7\u7ba1\u7406\u548c\u8d28\u91cf\u63a7\u5236\u6c34\u5e73\u8fbe\u5230\u4e86\u56fd\u9645\u5148\u8fdb\u6c34\u5e73\u3002\u8fd9\u4e0d\u4ec5\u6709\u52a9\u4e8e\u63d0\u5347\u4f01\u4e1a\u7684\u6574\u4f53\u5f62\u8c61\uff0c\u8fd8\u80fd\u591f\u589e\u5f3a\u4f01\u4e1a\u7684\u5e02\u573a\u4fe1\u8a89\uff0c\u4e3a\u4f01\u4e1a\u8d62\u5f97\u66f4\u591a\u6d88\u8d39\u8005\u7684\u4fe1\u4efb\u548c\u8ba4\u53ef\u3002<\/p>\n\n\n\n

\u589e\u5f3a\u5e02\u573a\u7ade\u4e89\u529b<\/strong>\uff1a\u5728\u5e02\u573a\u7ade\u4e89\u65e5\u76ca\u6fc0\u70c8\u7684\u4eca\u5929\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u4f01\u4e1a\u5f00\u59cb\u91cd\u89c6GMP\u8ba4\u8bc1\u3002\u83b7\u5f97GMP\u8ba4\u8bc1\u7684\u4f01\u4e1a\u5728\u53c2\u4e0e\u5e02\u573a\u7ade\u4e89\u65f6\u5177\u6709\u66f4\u5927\u7684\u4f18\u52bf\uff0c\u80fd\u591f\u66f4\u5bb9\u6613\u5730\u83b7\u5f97\u5408\u4f5c\u4f19\u4f34\u548c\u6d88\u8d39\u8005\u7684\u9752\u7750\u3002<\/p>\n\n\n\n

\u4fc3\u8fdb\u4f01\u4e1a\u53ef\u6301\u7eed\u53d1\u5c55<\/strong>\uff1aGMP\u8ba4\u8bc1\u4e0d\u4ec5\u5173\u6ce8\u4ea7\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\uff0c\u8fd8\u5f3a\u8c03\u4f01\u4e1a\u7684\u73af\u5883\u4fdd\u62a4\u3001\u793e\u4f1a\u8d23\u4efb\u7b49\u65b9\u9762\u3002\u901a\u8fc7GMP\u8ba4\u8bc1\u7684\u4f01\u4e1a\u80fd\u591f\u66f4\u597d\u5730\u5b9e\u73b0\u7ecf\u6d4e\u6548\u76ca\u548c\u793e\u4f1a\u6548\u76ca\u7684\u53cc\u8d62\uff0c\u4e3a\u4f01\u4e1a\u7684\u53ef\u6301\u7eed\u53d1\u5c55\u5960\u5b9a\u575a\u5b9e\u57fa\u7840\u3002<\/p>\n\n\n\n

GMP\u8ba4\u8bc1\u7684\u7533\u8bf7\u4e0e\u6d41\u7a0b<\/h2>\n\n\n\n

GMP\u8ba4\u8bc1\u7684\u7533\u8bf7\u548c\u6d41\u7a0b\u76f8\u5bf9\u590d\u6742\uff0c\u4f46\u53ea\u8981\u6309\u7167\u89c4\u5b9a\u7684\u6b65\u9aa4\u8fdb\u884c\uff0c\u4f01\u4e1a\u5c31\u80fd\u591f\u987a\u5229\u901a\u8fc7\u8ba4\u8bc1\u3002\u4e00\u822c\u6765\u8bf4\uff0cGMP\u8ba4\u8bc1\u7684\u7533\u8bf7\u6d41\u7a0b\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u6b65\u9aa4\uff1a<\/p>\n\n\n\n

\u51c6\u5907\u7533\u8bf7\u6750\u6599<\/strong>\uff1a\u4f01\u4e1a\u9700\u8981\u9009\u62e9\u7b26\u5408\u8d44\u8d28\u3001\u4fe1\u8a89\u826f\u597d\u7684\u8ba4\u8bc1\u673a\u6784\uff0c\u5e76\u63d0\u4ea4\u7533\u8bf7\u6750\u6599\u3002\u7533\u8bf7\u6750\u6599\u901a\u5e38\u5305\u62ecGMP\u624b\u518c\u3001\u5de5\u827a\u6d41\u7a0b\u56fe\u3001\u8bbe\u5907\u6e05\u5355\u3001\u4eba\u5458\u57f9\u8bad\u8bb0\u5f55\u3001\u4ea7\u54c1\u68c0\u9a8c\u8bb0\u5f55\u7b49\u3002<\/p>\n\n\n\n

\u73b0\u573a\u5ba1\u6838<\/strong>\uff1a\u8ba4\u8bc1\u673a\u6784\u4f1a\u6d3e\u51fa\u5ba1\u6838\u5458\u8fdb\u884c\u73b0\u573a\u5ba1\u6838\uff0c\u5305\u62ec\u8bbe\u5907\u3001\u751f\u4ea7\u8f66\u95f4\u3001\u5de5\u827a\u6d41\u7a0b\u3001\u4eba\u5458\u57f9\u8bad\u7b49\u591a\u4e2a\u65b9\u9762\u3002\u5ba1\u6838\u5458\u4f1a\u8bb0\u5f55\u5ba1\u6838\u7ed3\u679c\u5e76\u63d0\u51fa\u6539\u8fdb\u7684\u5efa\u8bae\u3002<\/p>\n\n\n\n

\u6574\u6539\u4e0e\u590d\u5ba1<\/strong>\uff1a\u6839\u636e\u5ba1\u6838\u7ed3\u679c\u548c\u6539\u8fdb\u5efa\u8bae\uff0c\u4f01\u4e1a\u9700\u8981\u8fdb\u884c\u5fc5\u8981\u7684\u6574\u6539\u548c\u6539\u8fdb\u3002\u6574\u6539\u5b8c\u6210\u540e\uff0c\u8ba4\u8bc1\u673a\u6784\u4f1a\u6d3e\u51fa\u5ba1\u6838\u5458\u5bf9\u6574\u6539\u60c5\u51b5\u8fdb\u884c\u590d\u5ba1\uff0c\u4ee5\u786e\u5b9a\u6574\u6539\u662f\u5426\u5230\u4f4d\u3002<\/p>\n\n\n\n

\u9881\u53d1\u8bc1\u4e66<\/strong>\uff1a\u8ba4\u8bc1\u673a\u6784\u786e\u8ba4\u6574\u6539\u5230\u4f4d\u540e\uff0c\u4f1a\u9881\u53d1GMP\u8ba4\u8bc1\u8bc1\u4e66\u3002\u4f01\u4e1a\u83b7\u5f97\u8bc1\u4e66\u540e\uff0c\u9700\u8981\u6309\u7167GMP\u7684\u8981\u6c42\u6301\u7eed\u8fdb\u884c\u751f\u4ea7\u548c\u7ba1\u7406\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u8d28\u91cf\u7684\u7a33\u5b9a\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n\n\n\n

GMP\u8ba4\u8bc1\u662f\u5236\u836f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\u751f\u4ea7\u4f01\u4e1a\u4e0d\u53ef\u6216\u7f3a\u7684\u91cd\u8981\u6807\u8bc6\u3002\u5b83\u4e0d\u4ec5\u5173\u4e4e\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\uff0c\u8fd8\u5f71\u54cd\u7740\u4f01\u4e1a\u7684\u5f62\u8c61\u3001\u4fe1\u8a89\u548c\u5e02\u573a\u7ade\u4e89\u529b\u3002\u901a\u8fc7\u9075\u5faaGMP\u8ba4\u8bc1\u7684\u8981\u6c42\u548c\u6ce8\u610f\u4e8b\u9879\uff0c\u4f01\u4e1a\u53ef\u4ee5\u786e\u4fdd\u4ea7\u54c1\u8d28\u91cf\u7b26\u5408\u56fd\u5bb6\u548c\u884c\u4e1a\u6807\u51c6\uff0c\u4fdd\u969c\u6d88\u8d39\u8005\u7684\u6743\u76ca\uff0c\u4ece\u800c\u4fc3\u8fdb\u4f01\u4e1a\u7684\u53ef\u6301\u7eed\u53d1\u5c55\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

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