{"id":96150,"date":"2019-05-07T00:00:50","date_gmt":"2019-05-17T07:59:05","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/96150\/"},"modified":"2019-05-17T15:59:06","modified_gmt":"2019-05-17T07:59:06","slug":"45968c8edf","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/96150\/","title":{"rendered":"\u3010\u597d\u6587\u63a8\u8350\u3011\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"white-space: normal;\"><span style=\"background-color: rgb(255, 172, 170);\">\u672a\u7ecf\u6388\u6743\uff0c\u4e0d\u5f97\u8f6c\u8f7d<\/span><br  \/><\/p>\n<p style=\"white-space: normal;text-align: center;\"><strong style=\"font-size: 20px;\">\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565<\/strong><br  \/><\/p>\n<p style=\"white-space: normal;text-align: center;\"><strong>Validation Strategy for Legacy Systems in Computerization of Pharmaceutical Industry<\/strong><\/p>\n<p style=\"text-align: center;\">\u8d75\u6668\u9633\uff0c\u6731\u5efa\u4f1f*<\/p>\n<p style=\"text-align: center;\">(\u7ec6\u80de\u5de5\u7a0b\u4e0e\u6297\u4f53\u836f\u7269\u6559\u80b2\u90e8\u5de5\u7a0b\u7814\u7a76\u4e2d\u5fc3\uff0c\u4e0a\u6d77\u4ea4\u901a\u5927\u5b66\u836f\u5b66\u9662\uff0c\u4e0a\u6d77 200240)<\/p>\n<section  label=\"Powered by 135editor.com\" style=\"white-space: normal;font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;\">\n<section class=\"_135editor\"     style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section>\n<section style=\"transform: rotate(0deg);\">\n<section style=\"padding-right: 2em;padding-left: 2em;transform: rotate(0deg);\">\n<section style=\"height: 3em;border-right: 2px solid rgb(36, 96, 142);border-left: 2px solid rgb(36, 96, 142);box-sizing: border-box;\"><\/section>\n<\/section>\n<section style=\"margin-top: -7px;display: flex;justify-content: space-between;align-items: flex-end;\">\n<section style=\"margin-left: 1.7em;\">\n<section   style=\"border-width: 2px;border-style: solid;border-color: rgb(142, 36, 96);width: 12px;height: 12px;background: rgb(36, 96, 142);border-radius: 100%;box-sizing: border-box;color: rgb(255, 255, 255);\"><\/section>\n<\/section>\n<section style=\"margin-right: 1.7em;\">\n<section   style=\"border-width: 2px;border-style: solid;border-color: rgb(142, 36, 96);width: 12px;height: 12px;background: rgb(36, 96, 142);border-radius: 100%;box-sizing: border-box;color: rgb(255, 255, 255);\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin-top: -10px;padding-right: 5px;padding-bottom: 20px;padding-left: 15px;box-sizing: border-box;\">\n<section style=\"padding-bottom: 8px;border-width: 1px;border-style: solid;border-color: rgb(51, 51, 51);background-color: rgb(36, 96, 142);color: rgb(255, 255, 255);box-sizing: border-box;\">\n<section style=\"margin-top: -10px;margin-right: 10px;margin-left: -10px;padding: 20px 10px 10px;border-width: 1px;border-style: solid;border-color: rgb(51, 51, 51);background-color: rgb(254, 254, 254);box-sizing: border-box;\">\n<section class=\"135brush\"  style=\"padding: 10px 5px;font-size: 14px;line-height: 1.75em;color: rgb(36, 96, 142);box-sizing: border-box;\">\n<p><strong>\u6458\u8981\uff1a<\/strong>\u968f\u7740\u533b\u836f\u5de5\u4e1a\u8bbe\u5907\u7684\u81ea\u52a8\u5316\u3001\u4fe1\u606f\u5316\u7a0b\u5ea6\u8d8a\u6765\u8d8a\u9ad8\uff0c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u4e86\u66f4\u597d\u7684\u64cd\u4f5c\u4fdd\u8bc1\uff0c\u4e5f\u63d0\u9ad8\u4e86\u751f\u4ea7\u7684\u6548\u7387\u548c\u6536\u76ca\u7387\u3002\u56e0\u6b64\uff0c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u8fc7\u7a0b\u4e2d\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u5408\u89c4\u6027\u5df2\u6210\u4e3a\u533b\u836f\u5de5\u4e1a\u4f9d\u4eceGMP \u6cd5\u89c4\u7684\u91cd\u8981\u8981\u6c42\u3002\u672c\u6587\u901a\u8fc7\u5206\u6790\u7814\u7a76\uff0c\u5bf9\u6211\u56fd\u4f01\u4e1a\u5728GMP \u9644\u5f5511\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u300b\u6b63\u5f0f\u5b9e\u65bd\u4e4b\u524d\u5df2\u7ecf\u4f7f\u7528\u7684\u9057\u7559\u7cfb\u7edf\u7684\u5408\u89c4\u6027\u95ee\u9898\uff0c\u63d0\u51fa\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\uff0c\u4ee5\u5dee\u8ddd\u5206\u6790\u6cd5\u9a8c\u8bc1\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565\u3002\u540c\u65f6\u7ed3\u5408\u7b14\u8005\u5b9e\u8df5\u9879\u76ee\u201cA \u516c\u53f8\u5728\u7ebf\u7c92\u5b50\u76d1\u63a7\u7cfb\u7edf\u7684\u9a8c\u8bc1\u201d\u6765\u8bf4\u660e\u5982\u4f55\u5bf9\u4f01\u4e1a\u7684\u9057\u7559\u7cfb\u7edf\u8fdb\u884c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u3002<\/p>\n<p><strong>\u5173\u952e\u8bcd\uff1a<\/strong>\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\uff1b\u9057\u7559\u7cfb\u7edf\uff1b\u98ce\u9669\u7ba1\u7406\uff1b\u5dee\u8ddd\u5206\u6790<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"white-space: normal;text-align: center;\"><br  \/><\/p>\n<section style=\"padding: 10px;white-space: normal;font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;max-width: 100%;line-height: 2em;word-wrap: break-word;word-break: normal;text-align: center;color: rgb(254, 254, 254);background-color: rgb(123, 154, 181);transform: rotateZ(0deg);\"><span class=\"135brush\"  style=\"color: rgb(255, 255, 255);\">\u4ee5\u4e0b\u4e3a\u6587\u7ae0\u8282\u9009<\/span><\/section>\n<p style=\"margin-top: -1px;white-space: normal;font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;\"><img class=\"\"      style=\"width: 558px;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/10-1558079946.png\" alt=\"\u3010\u597d\u6587\u63a8\u8350\u3011\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565\" title=\"\u3010\u597d\u6587\u63a8\u8350\u3011\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565\"  \/><\/p>\n<p style=\"text-indent: 2em;\">\u968f\u7740\u73b0\u4ee3\u8ba1\u7b97\u673a\u6280\u672f\u3001\u81ea\u52a8\u5316\u6280\u672f\u3001\u4fe1\u606f\u6280\u672f\u7684\u98de\u901f\u53d1\u5c55\uff0c\u533b\u836f\u5de5\u4e1a\u4f01\u4e1a\u7684\u8bbe\u5907\u8d8a\u6765\u8d8a\u8d8b\u4e8e\u73b0\u4ee3\u5316\u3001\u81ea\u52a8\u5316\u548c\u4fe1\u606f\u5316[1]\u3002\u4e3a\u4e86\u63d0\u9ad8\u5de5\u4f5c\u6548\u7387\uff0c\u51cf\u5c11\u4eba\u4e3a\u9519\u8bef\uff0c\u63d0\u9ad8\u4ea7\u54c1\u8d28\u91cf\uff0c\u8d8a\u6765\u8d8a\u591a\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u88ab\u5236\u836f\u4f01\u4e1a\u5728\u4ea7\u54c1\u751f\u4ea7\u7684\u5404\u4e2a\u73af\u8282\u4e2d\u4f7f\u7528\u3002\u56e0\u6b64\uff0c\u4e0eGMP \u76f8\u5173\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u5408\u89c4\u6027\u4e5f\u6210\u4e3aGMP\u6cd5\u89c4\u7684\u91cd\u8981\u8981\u6c42\u30022015 \u5e7412 \u67081 \u65e5\uff0cGMP \u7684\u9644\u5f5511\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u300b\u6b63\u5f0f\u751f\u6548\u5b9e\u65bd\u3002\u5bf9\u4e8e\u8be5\u9644\u5f55\u6b63\u5f0f\u751f\u6548\u5b9e\u65bd\u524d\uff0c\u5404\u5236\u836f\u4f01\u4e1a\u5df2\u7ecf\u4f7f\u7528\u7684\u9057\u7559\u7cfb\u7edf\u5982\u4f55\u80fd\u8fbe\u5230\u6cd5\u89c4\u8981\u6c42\u8fd9\u4e00\u95ee\u9898\uff0c\u6211\u56fd\u5e76\u65e0\u5177\u4f53\u7684\u6cd5\u89c4\u6216\u6307\u5357\u6307\u5bfc\u3002\u8fd9\u5bfc\u81f4\u5f88\u591a\u4f01\u4e1a\u5bf9\u4e8e\u8be5\u95ee\u9898\u4ecd\u7136\u5904\u4e8e\u8ff7\u832b\u4e4b\u4e2d\u3002<\/p>\n<p style=\"text-indent: 2em;\">\u672c\u6587\u4ece\u56fd\u5185\u5916\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u7684\u6cd5\u89c4\u53ca\u6307\u5357\u51fa\u53d1\uff0c\u7ed3\u5408\u6b27\u76df(EU) \u548c\u4e16\u754c\u536b\u751f\u7ec4\u7ec7(WHO) \u5bf9\u9057\u7559\u7cfb\u7edf\u9a8c\u8bc1\u7b56\u7565\u7684\u5efa\u8bae\uff0c\u901a\u8fc7\u5206\u6790\u6211\u56fd\u73b0\u9636\u6bb5\u9057\u7559\u7cfb\u7edf\u5b58\u5728\u7684\u95ee\u9898\uff0c\u5bf9\u6211\u56fd\u9057\u7559\u7cfb\u7edf\u7684\u5408\u89c4\u6027\u53ca\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\uff0c\u6309\u7167\u56fd\u5185\u76f8\u5173GMP \u7684\u8981\u6c42\uff0c\u4ee5\u53ca\u826f\u597d\u81ea\u52a8\u5316\u751f\u4ea7\u5b9e\u8df5\u6307\u5357\u7b2c5 \u7248(Good Automation Manufactory Practise 5\uff0cGAMP5) \u7684\u9a8c\u8bc1\u8981\u6c42\uff0c\u63d0\u51fa\u57fa\u4e8e\u98ce\u9669\u7ba1\u7406\uff0c\u4ee5\u5dee\u8ddd\u5206\u6790\u6cd5\u9a8c\u8bc1\u9057\u7559\u7cfb\u7edf\u7684\u65b0\u7b56\u7565\u3002\u5e0c\u671b\u80fd\u5bf9\u6709\u6b64\u7591\u60d1\u7684\u4f01\u4e1a\u6709\u6240\u5e2e\u52a9\u3002<\/p>\n<p><strong>1 \u76f8\u5173\u6982\u5ff5<\/strong><\/p>\n<p><strong>1.1 \u8ba1\u7b97\u673a\u5316\u7cfb\u7edf<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>1.2 \u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u9a8c\u8bc1<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>1.3 \u9057\u7559\u7cfb\u7edf<\/strong><\/p>\n<p><strong>2 \u9057\u7559\u7cfb\u7edf\u9a8c\u8bc1\u65b9\u6cd5\u7814\u7a76<\/strong><\/p>\n<p><strong>2.1 \u56fd\u5916\u9057\u7559\u7cfb\u7edf\u76f8\u5173\u6307\u5357\u6216\u6cd5\u89c4<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>2.2 \u9057\u7559\u7cfb\u7edf\u5b58\u5728\u7684\u95ee\u9898<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>2.3 \u9a8c\u8bc1\u65b9\u6cd5\u7814\u7a76<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3 \u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u5408\u89c4\u6027\u7b56\u7565<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.1 \u9057\u7559\u7cfb\u7edf\u7684\u8bc6\u522b<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.2 \u7cfb\u7edf\u5206\u7c7b\u53ca\u6e05\u5355<\/strong><\/p>\n<p><strong>3.3 \u7cfb\u7edf\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p><strong>3.3.1 \u4e1a\u52a1\u5f71\u54cd\u6027\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.3.2 \u7cfb\u7edf\u7535\u5b50\u6570\u636e\/ \u7535\u5b50\u7b7e\u540d\u9002\u7528\u6027\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.4 \u57fa\u4e8e\u98ce\u9669\u7ba1\u7406\u7684\u5dee\u8ddd\u5206\u6790<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.5 \u786e\u5b9a\u9a8c\u8bc1\u8ba1\u5212<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.6 \u9a8c\u8bc1<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.7 \u5f25\u8865\u540e\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>3.8 \u5b8c\u6210\u6700\u7ec8\u9a8c\u8bc1\u62a5\u544a<\/strong><\/p>\n<p><strong>4 \u4ee5\u5728\u7ebf\u7c92\u5b50\u76d1\u63a7\u7cfb\u7edf\u4e3a\u4f8b\uff0c\u8be6\u89e3\u5982\u4f55\u9a8c\u8bc1\u9057\u7559<\/strong><strong>\u7cfb\u7edf<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.1 \u7cfb\u7edf\u7684\u8bc6\u522b\u3001\u5206\u7c7b\u53ca\u6e05\u5355<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.2 \u7cfb\u7edf\u8bc4\u4f30<\/strong><\/p>\n<p><strong>4.3 \u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u7684\u5dee\u8ddd\u5206\u6790<\/strong><\/p>\n<p><strong>4.3.1 \u9a8c\u8bc1\u6587\u4ef6\u5dee\u8ddd\u5206\u6790\u53ca\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.3.2 \u6570\u636e\u53ef\u9760\u6027\u5dee\u8ddd\u5206\u6790\u53ca\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.3.3 \u7ba1\u7406\u89c4\u7a0b\u5dee\u8ddd\u5206\u6790\u53ca\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.4 \u786e\u5b9a\u9a8c\u8bc1\u8ba1\u5212<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.5 \u9a8c\u8bc1\u7684\u5b9e\u65bd<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.6 \u5f25\u8865\u540e\u98ce\u9669\u8bc4\u4f30<\/strong><\/p>\n<p style=\"white-space: normal;\"><strong>4.7 \u5b8c\u6210\u6700\u7ec8\u9a8c\u8bc1\u62a5\u544a<\/strong><\/p>\n<p><strong>5 \u603b\u7ed3<\/strong><\/p>\n<p style=\"text-indent: 2em;\">\u672c\u6587\u9488\u5bf9\u6211\u56fd\u5236\u836f\u4f01\u4e1a\u9057\u7559\u7cfb\u7edf\u9a8c\u8bc1\u53ef\u80fd\u5b58\u5728\u7684\u4e0d\u5408\u89c4\u95ee\u9898\uff0c\u4ece\u56fd\u5185\u5916\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u7684\u6cd5\u89c4\u53ca\u6307\u5357\u51fa\u53d1\uff0c\u7ed3\u5408EU \u548cWHO \u5bf9\u9057\u7559\u7cfb\u7edf\u9a8c\u8bc1\u7b56\u7565\u7684\u5efa\u8bae\uff0c\u63d0\u51fa\u4e00\u5957\u9a8c\u8bc1\u9057\u7559\u7cfb\u7edf\u7684\u5408\u89c4\u6027\u7b56\u7565\u3002\u8be5\u7b56\u7565\u6709\u52a9\u4e8e\u7cbe\u51c6\u627e\u5230\u7cfb\u7edf\u4e0e\u5408\u89c4\u8981\u6c42\u7684\u5dee\u8ddd\uff0c\u4e14\u901a\u8fc7\u8d2f\u7a7f\u5168\u8fc7\u7a0b\u7684\u98ce\u9669\u8bc4\u4f30\u5bfb\u627e\u6700\u9002\u5408\u5f25\u8865\u5dee\u8ddd\u7684\u63aa\u65bd\uff0c\u6700\u540e\u901a\u8fc7\u63aa\u65bd\u53ca\u518d\u6b21\u98ce\u9669\u8bc4\u4f30\u5c06\u98ce\u9669\u6d88\u9664\u6216\u964d\u81f3\u53ef\u63a5\u53d7\u7684\u6c34\u5e73\u3002\u4ee5 A \u516c\u53f8\u5728GMP \u9644\u5f5511 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border-box;\">\n<p>\u4f5c\u8005\u7b80\u4ecb\uff1a\u8d75\u6668\u9633(1988\u2014)\uff0c\u5973\uff0c\u7855\u58eb\u7814\u7a76\u751f\uff0c\u4e13\u4e1a\u65b9\u5411\uff1a\u5236\u836f\u5de5\u7a0b\u3002<\/p>\n<p>\u901a\u4fe1\u8054\u7cfb\u4eba\uff1a\u6731\u5efa\u4f1f(1956\u2014)\uff0c\u7537\uff0c\u6559\u6388\uff0c\u535a\u58eb\u751f\u5bfc\u5e08\uff0c\u4ece\u4e8b\u751f\u7269\u6280\u672f\u5236\u7a76\u4e0e\u5f00\u53d1\u3002<\/p>\n<p>Tel\uff1a021-34208024<\/p>\n<p>E-mail\uff1ajianweiz@sjtu.edu.cn<\/p>\n<\/section>\n<\/section>\n<section style=\"white-space: normal;font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;display: -webkit-flex;justify-content: flex-end;\">\n<section style=\"margin-top: -30px;margin-right: -12px;\">\n<section style=\"width: 65px;\"><img class=\"\"      style=\"width: 65px;display: block;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/2-1558079946.png\" alt=\"\u3010\u597d\u6587\u63a8\u8350\u3011\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565\" title=\"\u3010\u597d\u6587\u63a8\u8350\u3011\u533b\u836f\u5de5\u4e1a\u7684\u8ba1\u7b97\u673a\u5316\u8fc7\u7a0b\u4e2d\u9057\u7559\u7cfb\u7edf\u7684\u9a8c\u8bc1\u7b56\u7565\"  \/><\/section>\n<\/section>\n<\/section>\n<section  label=\"Powered by 135editor.com\" style=\"white-space: normal;font-size: 16px;font-family: \u5fae\u8f6f\u96c5\u9ed1;\">\n<section class=\"_135editor\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: right;box-sizing: border-box;\">\n<section  style=\"max-width: 100%;vertical-align: middle;display: inline-block;width: 111.111px;box-sizing: border-box;overflow: hidden !important;\"><img class=\"\"      style=\"vertical-align: middle;width: 111.111px;box-sizing: border-box;\" 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