{"id":29642,"date":"2025-12-14T05:08:02","date_gmt":"2025-12-13T21:08:02","guid":{"rendered":"https:\/\/www.zdsztech.com\/blog\/gmp-production-management-5-key-steps\/"},"modified":"2025-12-14T05:08:02","modified_gmt":"2025-12-13T21:08:02","slug":"gmp-production-management-5-key-steps","status":"publish","type":"post","link":"https:\/\/www.zdsztech.com\/blog\/gmp-production-management-5-key-steps\/","title":{"rendered":"GMP\u751f\u4ea7\u7ba1\u7406\u600e\u4e48\u505a\uff1f\u63ed\u79d8\u9ad8\u6548\u7ba1\u7406\u76845\u5927\u5173\u952e\u6b65\u9aa4"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.zdsztech.com\/wp-content\/uploads\/2025\/12\/1765660081-87f94eb5164eb6efeb5a335a3243a644.jpeg\" alt=\"GMP\u751f\u4ea7\u7ba1\u7406\u600e\u4e48\u505a\uff1f\u63ed\u79d8\u9ad8\u6548\u7ba1\u7406\u76845\u5927\u5173\u952e\u6b65\u9aa4\"><\/p>\n<p>\u5728\u5236\u836f\u3001\u98df\u54c1\u53ca\u76f8\u5173\u751f\u547d\u79d1\u5b66\u9886\u57df\uff0cGMP\uff08Good Manufacturing 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Manual\uff09**\u7684\u5236\u5b9a\u3002\u8fd9\u4efd\u7eb2\u9886\u6027\u6587\u4ef6\u9700\u6e05\u6670\u9610\u8ff0\u516c\u53f8\u7684\u8d28\u91cf\u653f\u7b56\u3001\u5bf9GMP\u6cd5\u89c4\u7684\u627f\u8bfa\uff0c\u5e76\u6982\u8ff0\u6574\u4e2aQMS\u7684\u7ed3\u6784\u548c\u8303\u56f4\u3002\u5b83\u5411\u5185\u662f\u5168\u4f53\u5458\u5de5\u7684\u884c\u52a8\u6307\u5357\uff0c\u5411\u5916\u5219\u662f\u5411\u76d1\u7ba1\u673a\u6784\u548c\u5ba2\u6237\u5c55\u793a\u5408\u89c4\u80fd\u529b\u7684\u6743\u5a01\u8bc1\u660e\u3002<\/p>\n<p>\u5176\u6b21\uff0c\u57fa\u4e8e\u8d28\u91cf\u624b\u518c\uff0c\u9700\u8981\u5efa\u7acb\u4e00\u5957\u5c42\u7ea7\u5206\u660e\u3001\u76f8\u4e92\u5173\u8054\u7684<strong>\u7a0b\u5e8f\u6587\u4ef6\u4f53\u7cfb<\/strong>\u3002\u8fd9\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\uff1a<\/p>\n<ul>\n<li><strong>\u7ba1\u7406\u7c7bSOP<\/strong>\uff1a\u5982\u53d8\u66f4\u63a7\u5236\u3001\u504f\u5dee\u5904\u7406\u3001\u4f9b\u5e94\u5546\u5ba1\u8ba1\u3001\u5e74\u5ea6\u4ea7\u54c1\u8d28\u91cf\u56de\u987e\uff08APQR\uff09\u3001\u81ea\u68c0\u3001\u57f9\u8bad\u7ba1\u7406\u7b49\u3002<\/li>\n<li><strong>\u64cd\u4f5c\u7c7bSOP<\/strong>\uff1a\u8986\u76d6\u4ece\u539f\u8f85\u6599\u63a5\u6536\u3001\u4ed3\u50a8\u3001\u751f\u4ea7\u64cd\u4f5c\u3001\u8d28\u91cf\u68c0\u9a8c\u5230\u6210\u54c1\u653e\u884c\u7684\u6bcf\u4e00\u4e2a\u5177\u4f53\u6b65\u9aa4\u3002<\/li>\n<\/ul>\n<p>\u6700\u540e\uff0c\u6574\u4e2aQMS\u5fc5\u987b\u4ee5**\u201c\u6587\u4ef6\u5316\u201d<strong>\u548c<\/strong>\u201c\u8bb0\u5f55\u53ef\u8ffd\u6eaf\u201d**\u4e3a\u539f\u5219\u3002\u6240\u6709\u6d3b\u52a8\u90fd\u5fc5\u987b\u6709\u636e\u53ef\u67e5\uff0c\u6240\u6709\u8bb0\u5f55\u90fd\u5fc5\u987b\u53ca\u65f6\u3001\u51c6\u786e\u3001\u5b8c\u6574\u3002\u8fd9\u4e0d\u4ec5\u662f\u4e3a\u4e86\u5e94\u5bf9\u76d1\u7ba1\u5ba1\u8ba1\uff0c\u66f4\u662f\u4e3a\u4e86\u5728\u51fa\u73b0\u8d28\u91cf\u95ee\u9898\u65f6\uff0c\u80fd\u591f\u8fc5\u901f\u8ffd\u6eaf\u6e90\u5934\u3001\u754c\u5b9a\u5f71\u54cd\u8303\u56f4\u5e76\u91c7\u53d6\u6709\u6548\u7684\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u3002\u53ef\u4ee5\u8bf4\uff0c\u4e00\u4e2a\u6ca1\u6709\u88ab\u5b8c\u6574\u8bb0\u5f55\u7684\u6d3b\u52a8\uff0c\u5728GMP\u7684\u4e16\u754c\u91cc\u5c31\u7b49\u540c\u4e8e\u6ca1\u6709\u53d1\u751f\u3002\u5efa\u7acbQMS\uff0c\u5c31\u662f\u4e3a\u4f01\u4e1a\u7684\u751f\u4ea7\u8fd0\u8425\u88c5\u4e0a\u201c\u9ed1\u5323\u5b50\u201d\uff0c\u786e\u4fdd\u4e00\u5207\u5c3d\u5728\u638c\u63a7\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%BA%8C%E6%AD%A5%EF%BC%9A%E7%B2%BE%E7%BB%86%E5%8C%96%E4%BA%BA%E5%91%98%E3%80%81%E8%AE%BE%E5%A4%87%E4%B8%8E%E7%89%A9%E6%96%99%E7%AE%A1%E7%90%86\"><\/span>\u7b2c\u4e8c\u6b65\uff1a\u7cbe\u7ec6\u5316\u4eba\u5458\u3001\u8bbe\u5907\u4e0e\u7269\u6599\u7ba1\u7406<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728QMS\u6846\u67b6\u4e4b\u4e0b\uff0cGMP\u7ba1\u7406\u7684\u843d\u5730\u6267\u884c\u805a\u7126\u4e8e\u4e09\u5927\u6838\u5fc3\u8981\u7d20\uff1a\u4eba\u5458\uff08Man\uff09\u3001\u8bbe\u5907\uff08Machine\uff09\u548c\u7269\u6599\uff08Material\uff09\uff0c\u5373\u201c3M\u201d\u7ba1\u7406\u3002\u5bf9\u8fd9\u4e09\u8005\u7684\u7cbe\u7ec6\u5316\u7ba1\u63a7\u662f\u786e\u4fdd\u751f\u4ea7\u8fc7\u7a0b\u7a33\u5b9a\u3001\u4ea7\u54c1\u8d28\u91cf\u5747\u4e00\u7684\u5173\u952e\u3002<\/p>\n<p><strong>\u4eba\u5458\u7ba1\u7406<\/strong>\u662f\u91cd\u4e2d\u4e4b\u91cd\u3002GMP\u660e\u786e\u8981\u6c42\uff0c\u6240\u6709\u4ece\u4e8b\u751f\u4ea7\u548c\u8d28\u91cf\u7ba1\u7406\u7684\u4eba\u5458\u90fd\u5fc5\u987b\u5177\u5907\u76f8\u5e94\u7684\u8d44\u8d28\uff0c\u5e76\u63a5\u53d7\u6301\u7eed\u7684\u57f9\u8bad\u3002\u8fd9\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u5c97\u4f4d\u8d44\u8d28<\/strong>\uff1a\u4e3a\u6bcf\u4e2a\u5173\u952e\u5c97\u4f4d\u8bbe\u5b9a\u660e\u786e\u7684\u6559\u80b2\u80cc\u666f\u3001\u4e13\u4e1a\u6280\u80fd\u548c\u5de5\u4f5c\u7ecf\u9a8c\u8981\u6c42\u3002<\/li>\n<li><strong>\u57f9\u8bad\u4f53\u7cfb<\/strong>\uff1a\u5efa\u7acb\u8986\u76d6\u5168\u5458\u7684\u3001\u7cfb\u7edf\u7684\u57f9\u8bad\u8ba1\u5212\uff0c\u5185\u5bb9\u4e0d\u4ec5\u5305\u62ecGMP\u57fa\u7840\u77e5\u8bc6\uff0c\u66f4\u8981\u6db5\u76d6\u5177\u4f53\u5c97\u4f4d\u7684SOP\u64cd\u4f5c\u3001\u5b89\u5168\u89c4\u7a0b\u548c\u5e94\u6025\u9884\u6848\u3002\u6240\u6709\u57f9\u8bad\u5fc5\u987b\u6709\u8be6\u7ec6\u8bb0\u5f55\uff0c\u5e76\u5b9a\u671f\u8bc4\u4f30\u57f9\u8bad\u6548\u679c\u3002<\/li>\n<li><strong>\u5065\u5eb7\u4e0e\u536b\u751f<\/strong>\uff1a\u5236\u5b9a\u5e76\u6267\u884c\u4e25\u683c\u7684\u5458\u5de5\u5065\u5eb7\u6807\u51c6\u548c\u4e2a\u4eba\u536b\u751f\u8981\u6c42\uff0c\u9632\u6b62\u4eba\u5458\u6210\u4e3a\u6c61\u67d3\u6e90\uff0c\u8fd9\u5728\u65e0\u83cc\u751f\u4ea7\u7b49\u9ad8\u98ce\u9669\u9886\u57df\u5c24\u4e3a\u91cd\u8981\u3002<\/li>\n<\/ul>\n<p><strong>\u8bbe\u5907\u4e0e\u8bbe\u65bd\u7ba1\u7406<\/strong>\u65e8\u5728\u786e\u4fdd\u6240\u6709\u7528\u4e8e\u751f\u4ea7\u3001\u68c0\u9a8c\u548c\u4ed3\u50a8\u7684\u786c\u4ef6\u7cfb\u7edf\u59cb\u7ec8\u5904\u4e8e\u5408\u683c\u4e14\u53d7\u63a7\u7684\u72b6\u6001\u3002\u8fd9\u8981\u6c42\u4f01\u4e1a\u5efa\u7acb\u5b8c\u5584\u7684\u8bbe\u5907\u751f\u547d\u5468\u671f\u7ba1\u7406\u6d41\u7a0b\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u8bbe\u8ba1\u4e0e\u786e\u8ba4\uff08DQ\/IQ\/OQ\/PQ\uff09<\/strong>\uff1a\u65b0\u8bbe\u5907\u4ece\u9009\u578b\u8bbe\u8ba1\u5230\u5b89\u88c5\u3001\u8fd0\u884c\u53ca\u6027\u80fd\u786e\u8ba4\uff0c\u5fc5\u987b\u7ecf\u8fc7\u4e00\u7cfb\u5217\u4e25\u683c\u7684\u9a8c\u8bc1\uff0c\u8bc1\u660e\u5176\u6ee1\u8db3\u9884\u5b9a\u7528\u9014\u548cGMP\u8981\u6c42\u3002<\/li>\n<li><strong>\u7ef4\u62a4\u4e0e\u6821\u51c6<\/strong>\uff1a\u5236\u5b9a\u9884\u9632\u6027\u7ef4\u62a4\u8ba1\u5212\u548c\u5468\u671f\u6027\u6821\u51c6\u89c4\u7a0b\uff0c\u786e\u4fdd\u8bbe\u5907\u7cbe\u5ea6\u548c\u6027\u80fd\u7684\u6301\u7eed\u7a33\u5b9a\u3002\u6240\u6709\u7ef4\u62a4\u548c\u6821\u51c6\u6d3b\u52a8\u90fd\u5fc5\u987b\u8bb0\u5f55\u5728\u6848\u3002<\/li>\n<li><strong>\u6e05\u6d01\u4e0e\u72b6\u6001\u6807\u8bc6<\/strong>\uff1a\u5efa\u7acb\u8bbe\u5907\u6e05\u6d01SOP\uff0c\u5e76\u4f7f\u7528\u660e\u786e\u7684\u72b6\u6001\u6807\u8bc6\uff08\u5982\u201c\u5f85\u6e05\u6d01\u201d\u3001\u201c\u6e05\u6d01\u201d\u3001\u201c\u4f7f\u7528\u4e2d\u201d\uff09\uff0c\u9632\u6b62\u4ea4\u53c9\u6c61\u67d3\u548c\u8bef\u64cd\u4f5c\u3002<\/li>\n<\/ul>\n<p><strong>\u7269\u6599\u7ba1\u7406<\/strong>\u5219\u8d2f\u7a7f\u4e86\u4ece\u4f9b\u5e94\u5546\u5230\u6210\u54c1\u7684\u6574\u4e2a\u4f9b\u5e94\u94fe\u3002\u5176\u6838\u5fc3\u76ee\u6807\u662f\u786e\u4fdd\u6240\u7528\u7269\u6599\u7684\u6b63\u786e\u6027\u3001\u8d28\u91cf\u5408\u683c\u6027\u548c\u53ef\u8ffd\u6eaf\u6027\u3002\u5173\u952e\u63a7\u5236\u70b9\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u4f9b\u5e94\u5546\u7ba1\u7406<\/strong>\uff1a\u5efa\u7acb\u5408\u683c\u4f9b\u5e94\u5546\u6863\u6848\uff0c\u5bf9\u5176\u8fdb\u884c\u5ba1\u8ba1\u548c\u5b9a\u671f\u8bc4\u4f30\u3002<\/li>\n<li><strong>\u6536\u8d27\u4e0e\u53d6\u6837<\/strong>\uff1a\u5bf9\u6240\u6709\u8fdb\u5382\u7269\u6599\u8fdb\u884c\u4e25\u683c\u7684\u6838\u5bf9\u3001\u68c0\u67e5\u548c\u4ee3\u8868\u6027\u53d6\u6837\u3002<\/li>\n<li><strong>\u68c0\u9a8c\u4e0e\u653e\u884c<\/strong>\uff1a\u7269\u6599\u5fc5\u987b\u7ecfQC\u68c0\u9a8c\u5408\u683c\u5e76\u7531QA\u6279\u51c6\u653e\u884c\u540e\u65b9\u53ef\u6295\u5165\u4f7f\u7528\u3002<\/li>\n<li><strong>\u4ed3\u50a8\u4e0e\u53d1\u653e<\/strong>\uff1a\u9075\u5faa\u201c\u5148\u8fdb\u5148\u51fa\u201d\uff08FEFO\/FIFO\uff09\u539f\u5219\uff0c\u5728\u89c4\u5b9a\u7684\u6e29\u6e7f\u5ea6\u6761\u4ef6\u4e0b\u50a8\u5b58\uff0c\u5e76\u7cbe\u786e\u8bb0\u5f55\u53d1\u653e\u4fe1\u606f\uff0c\u786e\u4fdd\u6279\u6b21\u8ffd\u6eaf\u7684\u51c6\u786e\u65e0\u8bef\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%B8%89%E6%AD%A5%EF%BC%9A%E5%9B%BA%E5%8C%96%E4%B8%8E%E6%89%A7%E8%A1%8C%E6%A0%87%E5%87%86%E5%8C%96%E7%9A%84%E7%94%9F%E4%BA%A7%E6%B5%81%E7%A8%8B_SOP\"><\/span>\u7b2c\u4e09\u6b65\uff1a\u56fa\u5316\u4e0e\u6267\u884c\u6807\u51c6\u5316\u7684\u751f\u4ea7\u6d41\u7a0b (SOP)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5982\u679c\u8bf4QMS\u662fGMP\u7ba1\u7406\u7684\u201c\u5baa\u6cd5\u201d\uff0c\u90a3\u4e48\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff08Standard Operating Procedure, SOP\uff09\u5c31\u662f\u786e\u4fdd\u751f\u4ea7\u6d3b\u52a8\u7cbe\u51c6\u3001\u53ef\u91cd\u590d\u6267\u884c\u7684\u201c\u6cd5\u5f8b\u6761\u6587\u201d\u3002SOP\u7684\u672c\u8d28\uff0c\u662f\u5c06\u7ecf\u8fc7\u9a8c\u8bc1\u548c\u4f18\u5316\u7684\u6700\u4f73\u5b9e\u8df5\uff0c\u4ee5\u4e66\u9762\u5f62\u5f0f\u56fa\u5316\u4e0b\u6765\uff0c\u6d88\u9664\u56e0\u4e2a\u4eba\u7ecf\u9a8c\u3001\u4e60\u60ef\u6216\u60c5\u7eea\u6ce2\u52a8\u5e26\u6765\u7684\u4e0d\u786e\u5b9a\u6027\uff0c\u786e\u4fdd\u6bcf\u4e00\u6279\u4ea7\u54c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u90fd\u4e25\u683c\u4e00\u81f4\u3002<\/p>\n<p>SOP\u7684\u5236\u5b9a\u5fc5\u987b\u9075\u5faa**\u201c5W1H\u201d\u539f\u5219**\uff0c\u5373\u6e05\u6670\u8bf4\u660e\u201c\u505a\u4ec0\u4e48\uff08What\uff09\u201d\u3001\u201c\u4e3a\u4ec0\u4e48\u505a\uff08Why\uff09\u201d\u3001\u201c\u8c01\u6765\u505a\uff08Who\uff09\u201d\u3001\u201c\u4f55\u65f6\u505a\uff08When\uff09\u201d\u3001\u201c\u5728\u54ea\u91cc\u505a\uff08Where\uff09\u201d\u4ee5\u53ca\u201c\u5982\u4f55\u505a\uff08How\uff09\u201d\u3002\u4e00\u4efd\u9ad8\u8d28\u91cf\u7684SOP\u5e94\u5177\u5907\u4ee5\u4e0b\u7279\u5f81\uff1a<\/p>\n<ul>\n<li><strong>\u51c6\u786e\u6027\u4e0e\u5408\u89c4\u6027<\/strong>\uff1a\u5185\u5bb9\u5fc5\u987b\u5b8c\u5168\u7b26\u5408\u73b0\u884cGMP\u6cd5\u89c4\u548c\u4f01\u4e1a\u5185\u90e8\u7684\u8d28\u91cf\u6807\u51c6\u3002<\/li>\n<li><strong>\u53ef\u64cd\u4f5c\u6027<\/strong>\uff1a\u8bed\u8a00\u7b80\u7ec3\u3001\u6b65\u9aa4\u6e05\u6670\u3001\u65e0\u6b67\u4e49\uff0c\u4e00\u7ebf\u64cd\u4f5c\u4eba\u5458\u80fd\u591f\u8f7b\u677e\u7406\u89e3\u5e76\u51c6\u786e\u6267\u884c\u3002\u907f\u514d\u4f7f\u7528\u6a21\u7cca\u4e0d\u6e05\u7684\u8bcd\u6c47\uff0c\u5982\u201c\u9002\u91cf\u201d\u3001\u201c\u5c3d\u5feb\u201d\u7b49\u3002<\/li>\n<li><strong>\u5b8c\u6574\u6027<\/strong>\uff1a\u8986\u76d6\u64cd\u4f5c\u7684\u6bcf\u4e00\u4e2a\u5173\u952e\u6b65\u9aa4\uff0c\u5305\u62ec\u51c6\u5907\u5de5\u4f5c\u3001\u6838\u5fc3\u64cd\u4f5c\u3001\u7ed3\u675f\u5de5\u4f5c\u3001\u8bb0\u5f55\u8981\u6c42\u4ee5\u53ca\u5f02\u5e38\u60c5\u51b5\u5904\u7406\u3002<\/li>\n<li><strong>\u7248\u672c\u53d7\u63a7<\/strong>\uff1a\u6240\u6709SOP\u90fd\u5fc5\u987b\u7ecf\u8fc7\u4e25\u683c\u7684\u8d77\u8349\u3001\u5ba1\u6838\u3001\u6279\u51c6\u6d41\u7a0b\uff0c\u5e76\u8fdb\u884c\u7248\u672c\u63a7\u5236\u3002\u73b0\u573a\u4f7f\u7528\u7684\u5fc5\u987b\u662f\u6700\u65b0\u751f\u6548\u7684\u7248\u672c\uff0c\u6240\u6709\u4f5c\u5e9f\u7684\u65e7\u7248\u6587\u4ef6\u90fd\u5e94\u53ca\u65f6\u56de\u6536\uff0c\u9632\u6b62\u8bef\u7528\u3002<\/li>\n<\/ul>\n<p>SOP\u7684\u751f\u547d\u529b\u5728\u4e8e<strong>\u4e25\u683c\u6267\u884c<\/strong>\u3002\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5f3a\u5927\u7684\u6267\u884c\u6587\u5316\u548c\u76d1\u7763\u673a\u5236\u3002\u7ba1\u7406\u5c42\u5e94\u53cd\u590d\u5f3a\u8c03\u201c\u6309SOP\u64cd\u4f5c\u201d\u662f\u4e0d\u53ef\u903e\u8d8a\u7684\u7ea2\u7ebf\u3002\u8d28\u91cf\u4fdd\u8bc1\uff08QA\uff09\u90e8\u95e8\u9700\u8981\u5bf9\u751f\u4ea7\u73b0\u573a\u8fdb\u884c\u5e38\u6001\u5316\u5de1\u68c0\uff0c\u76d1\u7763SOP\u7684\u6267\u884c\u60c5\u51b5\u3002\u4efb\u4f55\u504f\u79bbSOP\u7684\u64cd\u4f5c\u90fd\u5e94\u88ab\u89c6\u4e3a\u504f\u5dee\u8fdb\u884c\u7ba1\u7406\u3002<\/p>\n<p>\u4e0eSOP\u7d27\u5bc6\u76f8\u5173\u7684\u662f<strong>\u6279\u751f\u4ea7\u8bb0\u5f55\uff08Batch Production Record, BPR\uff09<\/strong>\u3002BPR\u662fSOP\u6267\u884c\u8fc7\u7a0b\u7684\u5b9e\u65f6\u201c\u4f34\u968f\u5f0f\u201d\u6587\u4ef6\uff0c\u5b83\u8be6\u7ec6\u8bb0\u5f55\u4e86\u7279\u5b9a\u6279\u6b21\u4ea7\u54c1\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\u3002\u64cd\u4f5c\u4eba\u5458\u5fc5\u987b\u5728\u5b8c\u6210\u6bcf\u4e00\u6b65\u64cd\u4f5c\u540e\uff0c\u7acb\u5373\u3001\u540c\u6b65\u5730\u586b\u5199BPR\uff0c\u8bb0\u5f55\u6240\u7528\u7269\u6599\u7684\u6279\u53f7\u3001\u64cd\u4f5c\u8d77\u6b62\u65f6\u95f4\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570\u3001\u64cd\u4f5c\u4eba\u53ca\u590d\u6838\u4eba\u7b7e\u540d\u7b49\u3002\u4e00\u4efd\u5b8c\u6574\u3001\u6e05\u6670\u3001\u51c6\u786e\u7684BPR\u662f\u8bc1\u660e\u8be5\u6279\u4ea7\u54c1\u7b26\u5408GMP\u8981\u6c42\u751f\u4ea7\u3001\u5b9e\u73b0\u5b8c\u5168\u53ef\u8ffd\u6eaf\u7684\u6838\u5fc3\u6cd5\u5f8b\u8bc1\u636e\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E5%9B%9B%E6%AD%A5%EF%BC%9A%E5%AE%9E%E6%96%BD%E4%B8%A5%E6%A0%BC%E7%9A%84%E8%B4%A8%E9%87%8F%E6%8E%A7%E5%88%B6%E4%B8%8E%E5%81%8F%E5%B7%AE%E7%AE%A1%E7%90%86\"><\/span>\u7b2c\u56db\u6b65\uff1a\u5b9e\u65bd\u4e25\u683c\u7684\u8d28\u91cf\u63a7\u5236\u4e0e\u504f\u5dee\u7ba1\u7406<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u8d28\u91cf\u63a7\u5236\uff08Quality Control, QC\uff09\u4e0e\u8d28\u91cf\u4fdd\u8bc1\uff08Quality Assurance, QA\uff09\u662f\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u9884\u5b9a\u8d28\u91cf\u6807\u51c6\u7684\u4e24\u4e2a\u5173\u952e\u804c\u80fd\uff0c\u5171\u540c\u6784\u6210\u4e86GMP\u7684\u8d28\u91cf\u76d1\u7763\u4f53\u7cfb\u3002QC\u4fa7\u91cd\u4e8e\u68c0\u9a8c\uff0c\u800cQA\u5219\u4fa7\u91cd\u4e8e\u4f53\u7cfb\u548c\u9884\u9632\u3002<\/p>\n<p>**\u4e25\u683c\u7684\u8d28\u91cf\u63a7\u5236\uff08QC\uff09**\u662f\u4ea7\u54c1\u8d28\u91cf\u7684\u201c\u5b88\u95e8\u5458\u201d\u3002\u5b83\u901a\u8fc7\u8d2f\u7a7f\u5168\u8fc7\u7a0b\u7684\u53d6\u6837\u548c\u68c0\u9a8c\uff0c\u4e3a\u4ea7\u54c1\u662f\u5426\u5408\u683c\u63d0\u4f9b\u5ba2\u89c2\u6570\u636e\u652f\u6301\u3002QC\u7684\u804c\u8d23\u4e3b\u8981\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u7269\u6599\u68c0\u9a8c<\/strong>\uff1a\u5bf9\u6240\u6709\u8fdb\u5382\u7684\u539f\u8f85\u6599\u3001\u5305\u88c5\u6750\u6599\u7b49\u8fdb\u884c\u9274\u522b\u3001\u542b\u91cf\u3001\u7eaf\u5ea6\u7b49\u6307\u6807\u7684\u68c0\u6d4b\u3002<\/li>\n<li><strong>\u8fc7\u7a0b\u63a7\u5236\uff08IPC\uff09<\/strong>\uff1a\u5728\u751f\u4ea7\u7684\u5173\u952e\u8282\u70b9\uff08\u5982\u6df7\u5408\u5747\u5300\u5ea6\u3001\u538b\u7247\u786c\u5ea6\u3001\u534a\u6210\u54c1\u542b\u91cf\u7b49\uff09\u8fdb\u884c\u53d6\u6837\u5206\u6790\uff0c\u786e\u4fdd\u5de5\u827a\u8fc7\u7a0b\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u3002<\/li>\n<li><strong>\u6210\u54c1\u68c0\u9a8c<\/strong>\uff1a\u5bf9\u6700\u7ec8\u4ea7\u54c1\u8fdb\u884c\u5168\u9879\u68c0\u9a8c\uff0c\u5224\u65ad\u5176\u662f\u5426\u7b26\u5408\u6ce8\u518c\u6279\u51c6\u7684\u8d28\u91cf\u6807\u51c6\u3002<\/li>\n<li><strong>\u7a33\u5b9a\u6027\u8003\u5bdf<\/strong>\uff1a\u901a\u8fc7\u52a0\u901f\u53ca\u957f\u671f\u7a33\u5b9a\u6027\u8bd5\u9a8c\uff0c\u8bc4\u4f30\u4ea7\u54c1\u5728\u6709\u6548\u671f\u5185\u7684\u8d28\u91cf\u53d8\u5316\u8d8b\u52bf\uff0c\u4e3a\u786e\u5b9a\u6709\u6548\u671f\u548c\u50a8\u5b58\u6761\u4ef6\u63d0\u4f9b\u4f9d\u636e\u3002\u6240\u6709\u68c0\u9a8c\u6d3b\u52a8\u90fd\u5fc5\u987b\u4f9d\u636e\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u68c0\u9a8c\u65b9\u6cd5\u8fdb\u884c\uff0c\u4f7f\u7528\u7ecf\u8fc7\u6821\u51c6\u7684\u4eea\u5668\uff0c\u5e76\u4ea7\u751f\u8be6\u5c3d\u7684\u68c0\u9a8c\u8bb0\u5f55\u3002<\/li>\n<\/ul>\n<p>**\u4e3b\u52a8\u7684\u504f\u5dee\u7ba1\u7406\uff08Deviation Management\uff09**\u5219\u662f\u4f53\u73b0GMP\u7ba1\u7406\u6210\u719f\u5ea6\u7684\u91cd\u8981\u6807\u5fd7\u3002\u504f\u5dee\u662f\u6307\u4efb\u4f55\u504f\u79bb\u65e2\u5b9aSOP\u3001\u6807\u51c6\u6216\u89c4\u8303\u7684\u975e\u9884\u671f\u4e8b\u4ef6\u3002GMP\u8981\u6c42\u4f01\u4e1a\u5efa\u7acb\u4e00\u4e2a\u95ed\u73af\u7684\u504f\u5dee\u7ba1\u7406\u7cfb\u7edf\uff0c\u5176\u6838\u5fc3\u6d41\u7a0b\u5305\u62ec\uff1a<\/p>\n<ol>\n<li><strong>\u53ca\u65f6\u53d1\u73b0\u4e0e\u62a5\u544a<\/strong>\uff1a\u9f13\u52b1\u4efb\u4f55\u5458\u5de5\u5728\u53d1\u73b0\u504f\u5dee\u540e\u7b2c\u4e00\u65f6\u95f4\u4e0a\u62a5\u3002<\/li>\n<li><strong>\u7acb\u5373\u8bc4\u4f30\u4e0e\u5904\u7406<\/strong>\uff1aQA\u548c\u76f8\u5173\u90e8\u95e8\u9700\u8fc5\u901f\u8bc4\u4f30\u504f\u5dee\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u6f5c\u5728\u5f71\u54cd\uff0c\u5e76\u91c7\u53d6\u7d27\u6025\u63aa\u65bd\uff08\u5982\u6682\u505c\u751f\u4ea7\u3001\u9694\u79bb\u7269\u6599\u7b49\uff09\u3002<\/li>\n<li><strong>\u6df1\u5165\u7684\u6839\u672c\u539f\u56e0\u8c03\u67e5\uff08Root Cause Analysis\uff09<\/strong>\uff1a\u4e0d\u80fd\u6b62\u6b65\u4e8e\u8868\u9762\u73b0\u8c61\uff0c\u800c\u5e94\u8fd0\u7528\u9c7c\u9aa8\u56fe\u30015W\u5206\u6790\u6cd5\u7b49\u5de5\u5177\uff0c\u6df1\u6316\u5bfc\u81f4\u504f\u5dee\u53d1\u751f\u7684\u7cfb\u7edf\u6027\u3001\u6839\u672c\u6027\u539f\u56e0\u3002<\/li>\n<li><strong>\u5236\u5b9a\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09<\/strong>\uff1a\u9488\u5bf9\u6839\u672c\u539f\u56e0\uff0c\u5236\u5b9a\u6709\u6548\u7684\u7ea0\u6b63\u63aa\u65bd\uff08\u89e3\u51b3\u5f53\u524d\u95ee\u9898\uff09\u548c\u9884\u9632\u63aa\u65bd\uff08\u9632\u6b62\u672a\u6765\u518d\u53d1\uff09\u3002CAPA\u5fc5\u987b\u5177\u4f53\u3001\u53ef\u6267\u884c\u3001\u6709\u8d1f\u8d23\u4eba\u548c\u5b8c\u6210\u65f6\u9650\u3002<\/li>\n<li><strong>\u6709\u6548\u6027\u8bc4\u4f30<\/strong>\uff1a\u5728CAPA\u5b9e\u65bd\u540e\uff0c\u9700\u5728\u4e00\u6bb5\u65f6\u95f4\u540e\u56de\u987e\u5176\u6709\u6548\u6027\uff0c\u786e\u8ba4\u95ee\u9898\u662f\u5426\u5f97\u5230\u6839\u9664\u3002<\/li>\n<\/ol>\n<p>\u4e00\u4e2a\u5f3a\u5927\u7684\u504f\u5dee\u7ba1\u7406\u4f53\u7cfb\uff0c\u80fd\u5c06\u770b\u4f3c\u8d1f\u9762\u7684\u201c\u5dee\u9519\u201d\u8f6c\u5316\u4e3a\u6301\u7eed\u6539\u8fdb\u7684\u5b9d\u8d35\u673a\u4f1a\uff0c\u4e0d\u65ad\u52a0\u56fa\u4f01\u4e1a\u7684\u8d28\u91cf\u9632\u7ebf\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%BA%94%E6%AD%A5%EF%BC%9A%E5%88%A9%E7%94%A8%E6%95%B0%E5%AD%97%E5%8C%96%E5%B7%A5%E5%85%B7%E5%AE%9E%E7%8E%B0GMP%E7%AE%A1%E7%90%86%E7%9A%84%E6%8C%81%E7%BB%AD%E4%BC%98%E5%8C%96\"><\/span>\u7b2c\u4e94\u6b65\uff1a\u5229\u7528\u6570\u5b57\u5316\u5de5\u5177\u5b9e\u73b0GMP\u7ba1\u7406\u7684\u6301\u7eed\u4f18\u5316<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u4f20\u7edf\u7684GMP\u7ba1\u7406\u6a21\u5f0f\u4e2d\uff0c\u4f01\u4e1a\u4e25\u91cd\u4f9d\u8d56\u7eb8\u8d28\u6587\u4ef6\u548c\u4eba\u5de5\u6d41\u7a0b\u3002\u5806\u79ef\u5982\u5c71\u7684SOP\u3001BPR\u548c\u5404\u7c7b\u8bb0\u5f55\uff0c\u4e0d\u4ec5\u7ba1\u7406\u6210\u672c\u9ad8\u6602\uff0c\u66f4\u5e26\u6765\u4e86\u6570\u636e\u5b64\u5c9b\u3001\u8ffd\u6eaf\u56f0\u96be\u3001\u6548\u7387\u4f4e\u4e0b\u548c\u6613\u4e8e\u51fa\u9519\u7b49\u8bf8\u591a\u75db\u75db\u3002\u968f\u7740\u6570\u5b57\u5316\u6d6a\u6f6e\u7684\u5230\u6765\uff0c\u5229\u7528\u73b0\u4ee3\u4fe1\u606f\u6280\u672f\u5de5\u5177\u5bf9GMP\u7ba1\u7406\u4f53\u7cfb\u8fdb\u884c\u5347\u7ea7\uff0c\u5df2\u6210\u4e3a\u4f01\u4e1a\u4ece\u201c\u5408\u89c4\u201d\u8fc8\u5411\u201c\u5353\u8d8a\u201d\u7684\u5fc5\u7136\u9009\u62e9\u3002<\/p>\n<p>\u6570\u5b57\u5316\u5de5\u5177\uff0c\u7279\u522b\u662f\u50cf**\u300c\u652f\u9053\u5e73\u53f0\u300d**\u8fd9\u7c7b\u7075\u6d3b\u3001\u53ef\u6269\u5c55\u7684\u65e0\u4ee3\u7801\/\u4f4e\u4ee3\u7801\u5e73\u53f0\uff0c\u4e3a\u89e3\u51b3GMP\u7ba1\u7406\u7684\u4e0a\u8ff0\u75db\u70b9\u63d0\u4f9b\u4e86\u5f3a\u6709\u529b\u7684\u89e3\u51b3\u65b9\u6848\u3002\u5b83\u4eec\u80fd\u591f\u5c06\u590d\u6742\u7684GMP\u6d41\u7a0b\u8981\u6c42\uff0c\u8f6c\u5316\u4e3a\u7ebf\u4e0a\u5316\u3001\u81ea\u52a8\u5316\u3001\u667a\u80fd\u5316\u7684\u7ba1\u7406\u5e94\u7528\uff0c\u5b9e\u73b0\u7ba1\u7406\u7684\u8d28\u53d8\u3002<\/p>\n<p><strong>1. \u6587\u4ef6\u4e0e\u8bb0\u5f55\u7ba1\u7406\u7684\u6570\u5b57\u5316\uff1a<\/strong><span class=\"xintheme_keyword_link\"><a href=\"https:\/\/www.zdsztech.com\/engine\" target=\"_blank\" title=\"\u65e0\u4ee3\u7801\u5e73\u53f0\">\u65e0\u4ee3\u7801\u5e73\u53f0<\/a><\/span>\u53ef\u4ee5\u901a\u8fc7\u5176\u5f3a\u5927\u7684<strong>\u8868\u5355\u5f15\u64ce<\/strong>\uff0c\u5c06\u5404\u7c7b\u7eb8\u8d28\u8bb0\u5f55\uff08\u5982\u6279\u751f\u4ea7\u8bb0\u5f55BPR\u3001\u6e05\u6d01\u8bb0\u5f55\u3001\u57f9\u8bad\u8bb0\u5f55\u7b49\uff09\u5feb\u901f\u8f6c\u5316\u4e3a\u7ed3\u6784\u5316\u7684\u7535\u5b50\u8868\u5355\u3002\u64cd\u4f5c\u4eba\u5458\u53ef\u4ee5\u5728\u5e73\u677f\u6216PC\u7aef\u5b9e\u65f6\u586b\u5199\uff0c\u6570\u636e\u81ea\u52a8\u4fdd\u5b58\u81f3\u4e91\u7aef\u6570\u636e\u5e93\u3002\u8fd9\u4e0d\u4ec5\u6d88\u9664\u4e86\u624b\u5199\u8bb0\u5f55\u7684\u6a21\u7cca\u548c\u9519\u8bef\uff0c\u66f4\u91cd\u8981\u7684\u662f\uff0c\u6240\u6709\u6570\u636e\u90fd\u5177\u5907\u4e86\u53ef\u641c\u7d22\u3001\u53ef\u7edf\u8ba1\u3001\u53ef\u8ffd\u6eaf\u7684\u7279\u6027\u3002\u901a\u8fc7<strong>\u6253\u5370\u6a21\u677f<\/strong>\u529f\u80fd\uff0c\u53ef\u4ee5\u4e00\u952e\u751f\u6210\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u7684\u3001\u5e26\u6709\u7535\u5b50\u7b7e\u540d\u7684\u89c4\u8303\u5316\u62a5\u544a\u3002<\/p>\n<p><strong>2. \u6d41\u7a0b\u6267\u884c\u7684\u81ea\u52a8\u5316\u4e0e\u6807\u51c6\u5316\uff1a<\/strong>\u5229\u7528\u5e73\u53f0\u7684<strong>\u6d41\u7a0b\u5f15\u64ce<\/strong>\uff0c\u53ef\u4ee5\u5c06\u53d8\u66f4\u63a7\u5236\u3001\u504f\u5dee\u7ba1\u7406\u3001CAPA\u3001\u4f9b\u5e94\u5546\u51c6\u5165\u7b49\u590d\u6742\u7684\u8de8\u90e8\u95e8\u5ba1\u6279\u6d41\u7a0b\u56fa\u5316\u5230\u7cfb\u7edf\u4e2d\u3002\u5f53\u4e00\u4e2a\u504f\u5dee\u88ab\u53d1\u8d77\u65f6\uff0c\u7cfb\u7edf\u4f1a\u81ea\u52a8\u6309\u7167\u9884\u8bbe\u89c4\u5219\uff0c\u5c06\u4efb\u52a1\u6d41\u8f6c\u7ed9\u6307\u5b9a\u7684\u8c03\u67e5\u4eba\u3001\u5ba1\u6838\u4eba\u3001\u6279\u51c6\u4eba\uff0c\u5e76\u5168\u7a0b\u8bb0\u5f55\u6bcf\u4e2a\u8282\u70b9\u7684\u5904\u7406\u610f\u89c1\u548c\u8017\u65f6\u3002\u8fd9\u786e\u4fdd\u4e86\u6d41\u7a0b\u7684\u521a\u6027\u6267\u884c\uff0c\u675c\u7edd\u4e86\u7ebf\u4e0b\u6d41\u7a0b\u53ef\u80fd\u51fa\u73b0\u7684\u201c\u8df3\u6b65\u201d\u6216\u201c\u9057\u5fd8\u201d\uff0c\u5927\u5927\u63d0\u5347\u4e86\u534f\u540c\u6548\u7387\u3002<\/p>\n<p><strong>3. \u8d28\u91cf\u6570\u636e\u7684\u5b9e\u65f6\u76d1\u63a7\u4e0e\u5206\u6790\uff1a<\/strong>\u6240\u6709\u901a\u8fc7\u7cfb\u7edf\u6536\u96c6\u7684\u8d28\u91cf\u6570\u636e\uff0c\u5982IPC\u68c0\u9a8c\u7ed3\u679c\u3001\u73af\u5883\u76d1\u6d4b\u6570\u636e\u3001\u8bbe\u5907\u8fd0\u884c\u53c2\u6570\u7b49\uff0c\u90fd\u53ef\u4ee5\u901a\u8fc7<strong>\u62a5\u8868\u5f15\u64ce<\/strong>\uff0c\u4ee5\u53ef\u89c6\u5316\u7684\u65b9\u5f0f\u5448\u73b0\u5728\u6570\u636e\u770b\u677f\u4e0a\u3002\u7ba1\u7406\u8005\u53ef\u4ee5\u5b9e\u65f6\u76d1\u63a7\u751f\u4ea7\u7ebf\u7684\u8d28\u91cf\u72b6\u6001\uff0c\u4e00\u65e6\u51fa\u73b0\u53c2\u6570\u8d85\u6807\u6216\u5f02\u5e38\u8d8b\u52bf\uff0c<strong>\u89c4\u5219\u5f15\u64ce<\/strong>\u53ef\u4ee5\u81ea\u52a8\u89e6\u53d1\u9884\u8b66\uff0c\u901a\u8fc7\u77ed\u4fe1\u3001\u90ae\u4ef6\u6216\u7cfb\u7edf\u6d88\u606f\u901a\u77e5\u76f8\u5173\u4eba\u5458\uff0c\u5b9e\u73b0\u4ece\u201c\u4e8b\u540e\u8865\u6551\u201d\u5230\u201c\u4e8b\u4e2d\u5e72\u9884\u201d\u7684\u8f6c\u53d8\u3002<\/p>\n<p><strong>4. 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class=\"ez-toc-section\" id=\"%E7%BB%93%E8%AF%AD%EF%BC%9A%E4%BB%8E%E5%90%88%E8%A7%84%E5%88%B0%E5%8D%93%E8%B6%8A%EF%BC%8C%E6%9E%84%E5%BB%BA%E9%9D%A2%E5%90%91%E6%9C%AA%E6%9D%A5%E7%9A%84GMP%E7%AE%A1%E7%90%86%E4%BD%93%E7%B3%BB\"><\/span>\u7ed3\u8bed\uff1a\u4ece\u5408\u89c4\u5230\u5353\u8d8a\uff0c\u6784\u5efa\u9762\u5411\u672a\u6765\u7684GMP\u7ba1\u7406\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u603b\u7ed3\u800c\u8a00\uff0c\u9ad8\u6548\u7684GMP\u751f\u4ea7\u7ba1\u7406\u5e76\u975e\u4e00\u8e74\u800c\u5c31\uff0c\u5b83\u662f\u4e00\u4e2a\u52a8\u6001\u4e14\u6301\u7eed\u4f18\u5316\u7684\u8fc7\u7a0b\u3002\u4ece\u6784\u5efa\u5168\u9762\u7684QMS\u4f53\u7cfb\u84dd\u56fe\uff0c\u5230\u7cbe\u7ec6\u5316\u7ba1\u63a7\u4eba\u5458\u3001\u8bbe\u5907\u4e0e\u7269\u6599\u4e09\u5927\u8981\u7d20\uff0c\u518d\u5230\u56fa\u5316\u5e76\u4e25\u683c\u6267\u884c\u6807\u51c6\u5316\u7684SOP\u6d41\u7a0b\uff0c\u4ee5\u53ca\u5b9e\u65bd\u4e25\u5bc6\u7684\u8d28\u91cf\u63a7\u5236\u4e0e\u504f\u5dee\u7ba1\u7406\uff0c\u8fd9\u4e94\u5927\u5173\u952e\u6b65\u9aa4\u73af\u73af\u76f8\u6263\uff0c\u5171\u540c\u6784\u7b51\u4e86\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u7684\u575a\u56fa\u9632\u7ebf\u3002<\/p>\n<p>\u5728\u6570\u5b57\u5316\u65f6\u4ee3\uff0c\u4ec5\u4ec5\u505c\u7559\u5728\u7eb8\u9762\u5408\u89c4\u5df2\u8fdc\u8fdc\u4e0d\u591f\u3002\u4f01\u4e1a\u51b3\u7b56\u8005\u5fc5\u987b\u8ba4\u8bc6\u5230\uff0c\u501f\u52a9\u5982**\u300c\u652f\u9053\u5e73\u53f0\u300d**\u8fd9\u7c7b\u7075\u6d3b\u3001\u53ef\u6269\u5c55\u7684\u65e0\u4ee3\u7801\u5de5\u5177\uff0c\u662f\u63a8\u52a8GMP\u7ba1\u7406\u4ece\u88ab\u52a8\u5408\u89c4\u8d70\u5411\u4e3b\u52a8\u5353\u8d8a\u7684\u5173\u952e\u5f15\u64ce\u3002\u8fd9\u4e9b\u5de5\u5177\u4e0d\u4ec5\u80fd\u5e2e\u52a9\u4f01\u4e1a\u9ad8\u6548\u3001\u4f4e\u6210\u672c\u5730\u843d\u5730\u590d\u6742\u7684GMP\u8981\u6c42\uff0c\u66f4\u80fd\u5c06\u8d28\u91cf\u7ba1\u7406\u6d41\u7a0b\u5185\u5316\u4e3a\u4f01\u4e1a\u7684\u6838\u5fc3\u6570\u636e\u8d44\u4ea7\u548c\u8fd0\u8425\u7ade\u4e89\u529b\u3002\u8fd9\u4e0d\u4ec5\u662f\u4e00\u9879\u6280\u672f\u6295\u8d44\uff0c\u66f4\u662f\u5bf9\u4f01\u4e1a\u672a\u6765\u53ef\u6301\u7eed\u53d1\u5c55\u7684\u6218\u7565\u5e03\u5c40\u3002<\/p>\n<p>\u7acb\u5373\u4e86\u89e3\u5982\u4f55\u5229\u7528\u300c\u652f\u9053\u5e73\u53f0\u300d\u6784\u5efa\u60a8\u7684\u4e13\u5c5eGMP\u7ba1\u7406\u7cfb\u7edf\uff0c\u3010<a href=\"https:\/\/user.zdsztech.com\/toWorkbench?index=2\">\u514d\u8d39\u8bd5\u7528\uff0c\u5728\u7ebf\u76f4\u63a5\u8bd5\u7528<\/a>\u3011\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%85%B3%E4%BA%8EGMP%E7%94%9F%E4%BA%A7%E7%AE%A1%E7%90%86%E7%9A%84%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\"><\/span>\u5173\u4e8eGMP\u751f\u4ea7\u7ba1\u7406\u7684\u5e38\u89c1\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_%E5%AE%9E%E6%96%BDGMP%E7%AE%A1%E7%90%86%E5%AF%B9%E4%B8%AD%E5%B0%8F%E4%BC%81%E4%B8%9A%E6%9D%A5%E8%AF%B4%E6%88%90%E6%9C%AC%E6%98%AF%E5%90%A6%E8%BF%87%E9%AB%98%EF%BC%9F\"><\/span>1. \u5b9e\u65bdGMP\u7ba1\u7406\u5bf9\u4e2d\u5c0f\u4f01\u4e1a\u6765\u8bf4\u6210\u672c\u662f\u5426\u8fc7\u9ad8\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u521d\u671f\u6295\u5165\u786e\u5b9e\u5b58\u5728\uff0c\u5305\u62ec\u8bbe\u65bd\u6539\u9020\u3001\u8bbe\u5907\u9a8c\u8bc1\u3001\u4f53\u7cfb\u5efa\u7acb\u548c\u4eba\u5458\u57f9\u8bad\u7b49\u3002\u4f46\u957f\u671f\u6765\u770b\uff0cGMP\u662f\u964d\u4f4e\u98ce\u9669\u3001\u63d0\u5347\u8d28\u91cf\u3001\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u7684\u5fc5\u8981\u6295\u8d44\u3002\u4e0d\u5408\u89c4\u5bfc\u81f4\u7684\u53ec\u56de\u3001\u7f5a\u6b3e\u751a\u81f3\u505c\u4ea7\u7684\u635f\u5931\u8fdc\u8d85\u521d\u671f\u6295\u5165\u3002\u6b64\u5916\uff0c\u53ef\u4ee5\u5206\u9636\u6bb5\u5b9e\u65bd\uff0c\u5e76\u5229\u7528\u50cf\u300c\u652f\u9053\u5e73\u53f0\u300d\u8fd9\u7c7b\u9ad8\u6027\u4ef7\u6bd4\u7684\u6570\u5b57\u5316\u5de5\u5177\uff0c\u80fd\u4ee5\u8fdc\u4f4e\u4e8e\u4f20\u7edf\u8f6f\u4ef6\u7684\u6210\u672c\uff08\u6210\u672c\u964d\u4f4e50-80%\uff09\u5feb\u901f\u5b9e\u73b0\u6d41\u7a0b\u7684\u6570\u5b57\u5316\u7ba1\u7406\uff0c\u5927\u5e45\u964d\u4f4e\u8fd0\u8425\u548c\u6587\u4ef6\u7ba1\u7406\u6210\u672c\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_GMP%E8%AE%A4%E8%AF%81%E9%9C%80%E8%A6%81%E5%A4%9A%E9%95%BF%E6%97%B6%E9%97%B4%EF%BC%9F%E4%B8%BB%E8%A6%81%E6%B5%81%E7%A8%8B%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\"><\/span>2. GMP\u8ba4\u8bc1\u9700\u8981\u591a\u957f\u65f6\u95f4\uff1f\u4e3b\u8981\u6d41\u7a0b\u662f\u4ec0\u4e48\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u65f6\u95f4\u56e0\u4f01\u4e1a\u57fa\u7840\u3001\u4ea7\u54c1\u7c7b\u578b\u548c\u8ba4\u8bc1\u673a\u6784\u800c\u5f02\uff0c\u901a\u5e38\u9700\u89816\u523018\u4e2a\u6708\u3002\u4e3b\u8981\u6d41\u7a0b\u5305\u62ec\uff1a1) \u6210\u7acb\u9879\u76ee\u7ec4\uff0c\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\uff1b2) \u786c\u4ef6\u6539\u9020\u4e0e\u8bbe\u5907\u786e\u8ba4\uff1b3) \u5efa\u7acb\u5e76\u5b8c\u5584QMS\u6587\u4ef6\u4f53\u7cfb\uff1b4) \u5168\u5458\u57f9\u8bad\u4e0eSOP\u8bd5\u8fd0\u884c\uff1b5) \u5f00\u5c55\u81f3\u5c11\u8fde\u7eed\u4e09\u6279\u7684\u5de5\u827a\u9a8c\u8bc1\uff1b6) \u63d0\u4ea4\u8ba4\u8bc1\u7533\u8bf7\uff0c\u63a5\u53d7\u5b98\u65b9\u73b0\u573a\u5ba1\u8ba1\uff1b7) \u9488\u5bf9\u5ba1\u8ba1\u53d1\u73b0\u7684\u7f3a\u9677\u9879\u8fdb\u884c\u6574\u6539\uff08CAPA\uff09\uff1b8) \u83b7\u5f97\u8ba4\u8bc1\u8bc1\u4e66\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_%E7%94%9F%E4%BA%A7%E8%BF%87%E7%A8%8B%E4%B8%AD%E5%87%BA%E7%8E%B0%E5%81%8F%E5%B7%AE%EF%BC%88Deviation%EF%BC%89%E5%BA%94%E8%AF%A5%E5%A6%82%E4%BD%95%E5%A4%84%E7%90%86%EF%BC%9F\"><\/span>3. \u751f\u4ea7\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u504f\u5dee\uff08Deviation\uff09\u5e94\u8be5\u5982\u4f55\u5904\u7406\uff1f<span 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