{"id":29744,"date":"2021-09-18T15:06:43","date_gmt":"2021-09-18T07:06:43","guid":{"rendered":"\/\/www.fourforsale.com\/?p=29744"},"modified":"2021-09-18T15:06:45","modified_gmt":"2021-09-18T07:06:45","slug":"%e5%81%b6%e7%84%b6%e5%88%b0%e5%bf%85%e7%84%b6%ef%bc%8c%e4%be%9d%e7%8e%9b%e5%88%b6%e8%8d%af%e8%a1%8c%e4%b8%9a%e5%96%b7%e7%a0%81%e5%90%88%e8%a7%84%e9%aa%8c%e8%af%81%e5%8c%85","status":"publish","type":"post","link":"\/\/www.fourforsale.com\/archives\/29744","title":{"rendered":"\u5076\u7136\u5230\u5fc5\u7136\uff0c\u4f9d\u739b\u5236\u836f\u884c\u4e1a\u55b7\u7801\u5408\u89c4\u9a8c\u8bc1\u5305"},"content":{"rendered":"\n

\u9a8c\u8bc1\u5f71\u54cd\u7740\u5236\u836f\u751f\u4ea7\u7684\u6bcf\u4e00\u4e2a\u6d41\u7a0b\u548c\u7ec4\u4ef6\uff0c\u5305\u62ec\u673a\u5668\u3001\u7cfb\u7edf\u3001\u8bbe\u5907\u3002<\/p>\n\n\n\n

\u5728\u5982\u4eca\u7684\u4f9b\u5e94\u94fe\u4e2d\uff0c\u55b7\u7801\u673a<\/a><\/span>\u53ef\u4ee5\u8bf4\u662f\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u6700\u540e\u5173\u952e\u8981\u7d20\uff0c\u968f\u7740\u76d1\u7ba1\u590d\u6742\u6027\u7684\u589e\u52a0\uff0c\u4efb\u4f55\u4f01\u4e1a\u90fd\u4e0d\u80fd\u5ffd\u89c6\u8fd9\u4e2a\u5408\u89c4\u7684\u6700\u540e\u9636\u6bb5\u3002<\/p>\n\n\n\n

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

\u7136\u800c\uff0c\u8bb8\u591a\u4f01\u4e1a\u53ef\u80fd\u6ca1\u6709\u610f\u8bc6\u5230\u4ed6\u4eec\u7684\u55b7\u7801\u673a\u9a8c\u8bc1\u5305\u4e0d\u5b8c\u6574\uff0c\u56e0\u6b64\u4e0d\u7b26\u5408FDA\u7684\u76d1\u7ba1\u8981\u6c42\u3002\u7531\u4e8e\u4e0d\u5408\u89c4\u5e26\u6765\u76f8\u5f53\u5927\u7684\u98ce\u9669\u548c\u5f71\u54cd\uff0c\u4f9d\u739b\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u7ecf\u7406Bart Vansteenkiste\u6982\u8ff0\u4e86\u5236\u836f\u516c\u53f8\u5982\u4f55\u786e\u4fdd\u5176URS\u6db5\u76d6\u751f\u4ea7\u8fc7\u7a0b\u7684\u6700\u7ec8\u8981\u7d20\u3002<\/p>\n\n\n\n

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

1<\/span><\/h1>\n\n\n\n

\u5e02\u573a\u80cc\u666f<\/span><\/h1>\n\n\n\n

GMP\u8ba4\u8bc1\u662f\u4fdd\u8bc1\u8d28\u91cf\u7684\u57fa\u672c\u8981\u7d20\uff0c\u662f\u652f\u6491\u5236\u836f\u548c\u751f\u7269\u6280\u672f\u4ea7\u54c1\u548c\u5de5\u827a\u5b89\u5168\u7684\u57fa\u77f3\uff0c\u6700\u521d\u7531\u7f8e\u56fdFDA\u5236\u5b9a\uff0c\u73b0\u5728\u88ab\u6b27\u6d32EMA\u548c\u82f1\u56fdMHRA\u7b49\u5168\u7403\u76d1\u7ba1\u673a\u6784\u5e7f\u6cdb\u91c7\u7528\u3002\u8d8a\u6765\u8d8a\u591a\u7684\u56fd\u9645\u76d1\u7ba1\u673a\u6784\u4e5f\u7eb7\u7eb7\u6548\u4eff\uff0c\u5305\u62ec\u6fb3\u5927\u5229\u4e9a\u836f\u76d1\u5c40\u7b49\u3002\u6709\u5173\u836f\u54c1\u5e8f\u5217\u5316\u7684\u65b0\u76d1\u7ba1\u8981\u6c42\u5df2\u5728\u4fc4\u7f57\u65af\u751f\u6548(2020\u5e747\u67081\u65e5)\uff0c\u4e0d\u4e45\u5c06\u5728\u5df4\u897f\u548c\u5370\u5ea6\u5c3c\u897f\u4e9a\u751f\u6548(2021\u5e74)\uff0c\u8fd9\u5c06\u8fdb\u4e00\u6b65\u5f71\u54cd\u836f\u54c1\u4f9b\u5e94\u94fe\u3002<\/p>\n\n\n\n

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

\u4e0d\u5408\u89c4\u7684\u98ce\u9669\u5f88\u5927\uff0c\u5c3d\u7ba1\u96be\u4ee5\u8861\u91cf\u3002\u4ece\u6f5c\u5728\u7684\u76d1\u7ba1\u7f5a\u6b3e\u548c\u635f\u5931\u54c1\u724c\u58f0\u8a89\uff0c\u5230\u6682\u65f6\u88ab\u8feb\u5173\u95ed\u4e00\u6761\u5b8c\u6574\u7684\u751f\u4ea7\u7ebf\uff0c\u6ca1\u6709\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u7cfb\u7edf\u548c\u6d41\u7a0b\u53ef\u80fd\u4f1a\u5bf9\u4efb\u4f55\u4f01\u4e1a\u4ea7\u751f\u4e0d\u5229\u5f71\u54cd\u3002<\/p>\n\n\n\n

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

\u6bcf\u4e2a\u5236\u836f\u5236\u9020\u5546\u90fd\u5e94\u8be5\u4e86\u89e3GMP\u9a8c\u8bc1\u4ea7\u54c1\u548c\u6d41\u7a0b\u7684\u8981\u6c42\uff0c\u516c\u53f8\u5fc5\u987b\u6709\u6587\u4ef6\u8bc1\u660e\u5176\u90e8\u7f72\u7684\u6d41\u7a0b\u3001\u65b9\u6cd5\u3001\u6d4b\u8bd5\u3001\u6d3b\u52a8\u548c\u8bbe\u5907\u80fd\u591f\u53cd\u590d\u751f\u4ea7\u9884\u671f\u7684\u4ea7\u54c1\u3002\u56e0\u6b64\uff0c\u5fc5\u987b\u9a8c\u8bc1\u5236\u9020\u8fc7\u7a0b\u4e2d\u7684\u6bcf\u4e2a\u5173\u952e\u6b65\u9aa4\uff0c\u4ee5\u4fbf\u5728\u89c4\u5b9a\u6761\u4ef6\u4e0b\u6309\u9884\u671f\u6267\u884c\u3002<\/p>\n\n\n\n

\u4e0e\u9a8c\u8bc1\u76f8\u5173\u7684\u6587\u6863\u5305\u62ec\uff1a<\/h2>\n\n\n\n
  • \u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f(SOPs)<\/li><\/ul>\n\n\n\n
    • \u89c4\u683c<\/li><\/ul>\n\n\n\n
      • \u9a8c\u8bc1\u603b\u4f53\u89c4\u5212\uff08VMP\uff09<\/li><\/ul>\n\n\n\n
        • \u786e\u8ba4\u534f\u8bae\u548c\u62a5\u544a<\/li><\/ul>\n\n\n\n
          • \u9a8c\u8bc1\u534f\u8bae\u548c\u62a5\u544a<\/li><\/ul>\n\n\n\n

            2<\/span><\/h1>\n\n\n\n

            \u5173\u952e\u90e8\u5206<\/span><\/h1>\n\n\n\n

            \u8d34\u6807\u548c\u6807\u7b7e\u6253\u5370\u662f\u9a8c\u8bc1\u8fc7\u7a0b\u7684\u5173\u952e\u7ec4\u6210\u90e8\u5206\u30022018\u5e74\uff0c9%\u7684\u533b\u7597\u5668\u68b0\u53ec\u56de\u4e8b\u4ef6 \uff08\u4ee5\u53ca\u8d85\u8fc7 100 \u4e07\u53f0\u7684\u9000\u8d27\uff09\u662f\u7531\u4e8e\u6807\u7b7e\u95ee\u9898\u9020\u6210\u7684\uff0c\u6253\u5370\u9519\u8bef\u65e0\u7591\u662f\u4e00\u4e2a\u56e0\u7d20\u3002\u4f8b\u5982\uff0c\u50cf\u8272\u5e26\u6545\u969c\u8fd9\u6837\u7684\u7410\u788e\u95ee\u9898\u53ef\u80fd\u5bfc\u81f4\u5185\u5bb9\u4e22\u5931\u3001\u4e0d\u53ef\u8bfb\u6216\u88ab\u8bef\u89e3\u3002\u5f53\u6ca1\u6709\u68c0\u6d4b\u5230\u8fd9\u79cd\u60c5\u51b5\uff0c\u4ea7\u54c1\u5230\u8fbe\u4f9b\u5e94\u94fe\u65f6\uff0c\u5c31\u4f1a\u8fdd\u53cd\u6cd5\u89c4\uff0c\u5371\u53ca\u60a3\u8005\u7684\u5b89\u5168\u3002\u6b64\u5916\uff0c\u968f\u7740\u51c6\u65f6\u5236\u751f\u4ea7\u65b9\u5f0f\u7684\u589e\u52a0\uff0c\u4f01\u4e1a\u9700\u8981\u62e5\u6709\u53ef\u9760\u7684\u673a\u5236\u6765\u786e\u4fdd\u6279\u6b21\u5b8c\u6574\u6027\u3002\u4ee4\u4eba\u62c5\u5fc3\u7684\u662f\uff0c\u76f4\u5230\u76d1\u7ba1\u90e8\u95e8\u627e\u4e0a\u95e8\u524d\u5927\u591a\u6570\u4f01\u4e1a\u8fd8\u6ca1\u6709\u610f\u8bc6\u5230\u4ed6\u4eec\u7684\u55b7\u7801\u7cfb\u7edf\u4e0d\u5408\u89c4\u3002<\/p>\n\n\n\n

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

            \u53ef\u9760\u7684\u4f9b\u5e94\u5546\u4f1a\u79ef\u6781\u4e3b\u52a8\u5730\u786e\u4fdd\u7cfb\u7edf\u9a8c\u8bc1\uff0c\u68c0\u67e5\u7528\u6237\u9700\u6c42\u8bf4\u660e \uff08URS\uff09 \u4e2d\u8981\u6c42\u7684\u5185\u5bb9\u662f\u5426\u6b63\u786e\u4ea4\u4ed8\uff1b\u63d0\u4f9b\u98ce\u9669\u8bc4\u4f30\uff1b\u6d4b\u8bd5\u7b56\u7565\uff1b\u826f\u597d\u7684\u6587\u6863\u6807\u51c6\uff1b\u548c\u57f9\u8bad\u534f\u8bae\u3002\u7ecf\u8fc7GAMP V\u4e13\u4e1a\u57f9\u8bad\u7684\u4e13\u5bb6\u4f1a\u786e\u5207\u77e5\u9053\u5728\u836f\u54c1\u751f\u4ea7\u73af\u5883\u4e2d\u5b9e\u73b0\u9a8c\u8bc1\u9700\u8981\u4ec0\u4e48\uff0c\u5305\u62ec\u9a8c\u8bc1\u5176\u4ed6\u7cfb\u7edf\u7684\u96c6\u6210\uff08\u5982\u8d34\u6807\u673a\u6216ERP\u7cfb\u7edf\uff09”\uff0c\u5e76\u5c06\u63d0\u4f9b\u9a8c\u8bc1\u5305\u6765\u652f\u6301\u8fd9\u4e00\u70b9\u3002<\/p>\n\n\n\n

            \u66f4\u91cd\u8981\u7684\u662f\uff0c\u516c\u53f8\u7684\u55b7\u7801\u7cfb\u7edf\u7684\u539f\u7406\u80fd\u591f\u7ecf\u5f97\u8d77\u5ba1\u8ba1\u3002\u90a3\u4e48\uff0c\u4e3a\u4ec0\u4e48\u8981\u628a\u9a8c\u8bc1\u8fc7\u7a0b\u6700\u540e\u90e8\u5206\u7684\u5408\u89c4\u6027\u7559\u7ed9\u5076\u7136\u5462\uff1f<\/p>\n\n\n\n

            \"\"<\/figure><\/div>\n","protected":false},"excerpt":{"rendered":"

            \u9a8c\u8bc1\u5f71\u54cd\u7740\u5236\u836f\u751f\u4ea7\u7684\u6bcf\u4e00\u4e2a\u6d41\u7a0b\u548c\u7ec4\u4ef6\uff0c\u5305\u62ec\u673a\u5668\u3001\u7cfb\u7edf\u3001\u8bbe\u5907\u3002 \u5728\u5982\u4eca\u7684\u4f9b\u5e94\u94fe\u4e2d\uff0c\u55b7\u7801\u673a\u53ef\u4ee5\u8bf4\u662f\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u6700\u540e\u5173\u952e\u8981\u7d20\uff0c\u968f\u7740\u76d1\u7ba1\u590d\u6742\u6027\u7684\u589e\u52a0\uff0c\u4efb\u4f55\u4f01\u4e1a\u90fd\u4e0d\u80fd\u5ffd\u89c6\u8fd9\u4e2a\u5408\u89c4\u7684\u6700\u540e\u9636\u6bb5\u3002 \u7136\u800c\uff0c\u8bb8\u591a\u4f01\u4e1a\u53ef\u80fd\u6ca1\u6709\u610f\u8bc6\u5230\u4ed6\u4eec\u7684\u55b7\u7801\u673a\u9a8c\u8bc1\u5305\u4e0d\u5b8c\u6574\uff0c\u56e0\u6b64\u4e0d\u7b26\u5408FDA\u7684\u76d1\u7ba1\u8981\u6c42\u3002\u7531\u4e8e\u4e0d\u5408\u89c4\u5e26\u6765\u76f8\u5f53\u5927\u7684\u98ce\u9669\u548c\u5f71\u54cd\uff0c\u4f9d\u739b\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u7ecf\u7406Bart Vansteenkiste\u6982\u8ff0\u4e86\u5236\u836f\u516c\u53f8\u5982\u4f55\u786e\u4fdd\u5176URS\u6db5\u76d6\u751f\u4ea7\u8fc7\u7a0b\u7684\u6700\u7ec8\u8981\u7d20\u3002 1 \u5e02\u573a\u80cc\u666f GMP\u8ba4\u8bc1\u662f\u4fdd\u8bc1\u8d28\u91cf\u7684\u57fa\u672c\u8981\u7d20\uff0c\u662f\u652f\u6491\u5236\u836f\u548c\u751f\u7269\u6280\u672f\u4ea7\u54c1\u548c\u5de5\u827a\u5b89\u5168\u7684\u57fa\u77f3\uff0c\u6700\u2026<\/p>\n","protected":false},"author":9,"featured_media":29742,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[],"class_list":["post-29744","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/posts\/29744"}],"collection":[{"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/comments?post=29744"}],"version-history":[{"count":0,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/posts\/29744\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/media\/29742"}],"wp:attachment":[{"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/media?parent=29744"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/categories?post=29744"},{"taxonomy":"post_tag","embeddable":true,"href":"\/\/www.fourforsale.com\/wp-json\/wp\/v2\/tags?post=29744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}