{"id":18912,"date":"2018-07-23T01:00:00","date_gmt":"2018-08-08T01:07:36","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/%e7%bf%bb%e8%af%91%e5%8d%8f%e4%bd%9c-%e7%96%ab%e8%8b%97%e5%ae%8c%e6%95%b4%e7%94%9f%e5%91%bd%e5%91%a8%e6%9c%9f%e4%b9%8bqbd\/"},"modified":"2018-08-08T09:07:39","modified_gmt":"2018-08-08T01:07:39","slug":"%e7%bf%bb%e8%af%91%e5%8d%8f%e4%bd%9c-%e7%96%ab%e8%8b%97%e5%ae%8c%e6%95%b4%e7%94%9f%e5%91%bd%e5%91%a8%e6%9c%9f%e4%b9%8bqbd","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/18912\/","title":{"rendered":"\u7ffb\u8bd1\u534f\u4f5c\/\u75ab\u82d7\u5b8c\u6574\u751f\u547d\u5468\u671f\u4e4bQbD"},"content":{"rendered":"
\n

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QbD\uff0c\u5373\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1(Quality by Design)\uff0c\u8be5\u7406\u5ff5\u59cb\u6e90\u4e8e20\u4e16\u7eaa70\u5e74\u4ee3Toyota\u4e3a\u63d0\u9ad8\u6c7d\u8f66\u8d28\u91cf\u800c\u63d0\u51fa\u7684\u521b\u9020\u6027\u6982\u5ff5\uff0c\u5e76\u7ecf\u8fc7\u5728\u901a\u4fe1\u3001\u822a\u7a7a\u7b49\u9886\u57df\u7684\u53d1\u5c55\u9010\u6e10\u5f62\u6210\uff1b\u800c\u5bf9\u4e8e\u5236\u836f\u884c\u4e1a\uff0c\u8fd9\u4e00\u7406\u5ff5\u9996\u5148\u51fa\u73b0\u5728ICH Q8\u4e2d\u3002ICH Q8\u4e2d\u6307\u51fa\uff1a\u4ea7\u54c1\u7684\u8d28\u91cf\u65e0\u6cd5\u901a\u8fc7\u68c0\u9a8c\u8d4b\u4e88\uff0c\u800c\u662f\u901a\u8fc7\u8bbe\u8ba1\u8d4b\u4e88\u7684\u3002ICH Q6A\u4e2d\u5f3a\u8c03\u4e86\u8d28\u91cf\u6807\u51c6\u201cSpecifications\u201d\u7684\u89d2\u8272\uff1a\u8d28\u91cf\u6807\u51c6\u662f\u4e00\u9879\u91cd\u8981\u7684\u8d28\u91cf\u6307\u5f81\uff0c\u5b83\u7531\u751f\u4ea7\u5546\u63d0\u51fa\u548c\u8bba\u8bc1\uff0c\u7531\u7ba1\u7406\u673a\u6784\u6279\u51c6\u5e76\u4f5c\u4e3a\u6279\u51c6\u4ea7\u54c1\u7684\u4f9d\u636e\u3002\u56e0\u6b64\uff0c\u5176\u51b3\u5b9a\u6027\u4f5c\u7528\u7684\u662f\u751f\u4ea7\u5546\uff0c\u800c\u975eFDA\u7684\u6279\u51c6\u3002\u5b83\u4e3b\u8981\u5305\u62ec\u4ee5\u4e0b\u51e0\u4e2a\u6b65\u9aa4\uff1a<\/span><\/p>\n

\u2460\u786e\u5b9a\u76ee\u6807\u836f\u54c1\u8d28\u91cf\u6982\u51b5QTPP<\/span><\/p>\n

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<\/span><\/p>\n

\n
\n
\u6587\u732e\u76ee\u5f55<\/section>\n<\/section>\n<\/section>\n

<\/span><\/p>\n

1.MC-Vaccine \u5de5\u4f5c\u7ec4\u75c5\u4f8b\u7814\u7a76\u7b80\u4ecb<\/span><\/p>\n

2.\u76ee\u6807\u4ea7\u54c1\u7b80\u4ecb\uff0c\u98ce\u9669\u8bc4\u4f30\u4e0e\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/p>\n

3.\u63a7\u5236\u7b56\u7565\u90e8\u5206<\/span><\/p>\n

4.\u4e0a\u6e38\uff08\u591a\u7cd6\uff09\u90e8\u5206<\/span><\/p>\n

5.\u4e0a\u6e38\uff08\u75c5\u6bd2\u6837\u9897\u7c92\uff09\u90e8\u5206<\/span><\/p>\n

6.\u4e0b\u6e38\u90e8\u5206<\/span><\/p>\n

7.\u836f\u7269\u4ea7\u54c1\u90e8\u5206<\/span><\/p>\n

8.\u76d1\u7ba1\u90e8\u5206<\/span><\/p>\n

9.\u6267\u884c\u90e8\u5206<\/span><\/p>\n

10.\u8bb2QbD\u5e94\u7528\u4e8e\u6d3b\u75ab\u82d7\uff08A-VAX\uff09<\/span><\/p>\n

\n
\n
\u53c2\u4e0e\u6d41\u7a0b<\/section>\n<\/section>\n<\/section>\n


<\/span><\/p>\n

1.\u626b\u63cf\u4e0b\u65b9\u4e8c\u7ef4\u7801\u6216\u70b9\u51fb\u6587\u672b\u201c\u9605\u8bfb\u539f\u6587<\/span>\u201d\uff0c\u586b\u5199\u62a5\u540d\u767b\u8bb0\u8868\uff0c\u8bf7\u786e\u4fdd\u4fe1\u606f\u6b63\u786e\uff1b<\/span><\/p>\n

\"\u7ffb\u8bd1\u534f\u4f5c\/\u75ab\u82d7\u5b8c\u6574\u751f\u547d\u5468\u671f\u4e4bQbD\"<\/p>\n

2<\/span>.\u62a5\u540d\u7684\u8001\u5e08\u5c06\u6536\u5230\u4e00\u7bc7\u6d4b\u8bd5\u6587\u732e\u53ca\u7ffb\u8bd1\u8981\u6c42\uff08\u7ffb\u8bd1\u8981\u6c42\u89c1\u90ae\u7bb1\u6b63\u6587\uff0c\u6d4b\u8bd5\u6587\u7ae0\u89c1\u90ae\u7bb1\u9644\u4ef6\uff09\uff0c<\/span>\u6839\u636e\u7ffb\u8bd1\u7684\u7ed3\u679c\u9074\u9009\u53c2\u4e0e\u4eba\u5458\uff1b<\/span><\/span><\/p>\n

3.\u5efa\u7acb\u5fae\u4fe1\u7fa4\uff0c\u65b9\u4fbf\u5927\u5bb6\u7684\u6c9f\u901a\u4ea4\u6d41\uff1b<\/span><\/p>\n

4.\u7edf\u4e00\u5206\u53d1\u76f8\u5173\u7ffb\u8bd1\u6587\u4ef6\uff1b<\/span><\/p>\n

5.\u5b89\u6392\u53c2\u4e0e\u4eba\u5458\u5bf9\u7ffb\u8bd1\u4f5c\u54c1\u8fdb\u884c\u76f8\u4e92\u6821\u5bf9\uff1b<\/span><\/p>\n

6.\u5b8c\u6210\u540e\u7684\u8bd1\u6587\u4ec5\u63d0\u4f9b\u53c2\u4e0e\u8005\u5171\u4eab\u3002<\/span><\/p>\n

\u8bc6\u522b\u5fae\u4fe1\u4e8c\u7ef4\u7801\uff0c\u6dfb\u52a0\u751f\u7269\u5236\u54c1\u5708\u5c0f\u7f16\uff0c\u7b26\u5408\u6761\u4ef6\u8005\u5373\u53ef\u52a0\u5165\u751f\u7269\u5236\u54c1\u5708\u5fae\u4fe1\u7fa4\uff01<\/span><\/strong>
<\/p>\n

\u8bf7\u6ce8\u660e\uff1a\u59d3\u540d+\u7814\u7a76\u65b9\u5411\uff01<\/span><\/strong><\/span><\/p>\n

\"\u7ffb\u8bd1\u534f\u4f5c\/\u75ab\u82d7\u5b8c\u6574\u751f\u547d\u5468\u671f\u4e4bQbD\"<\/p>\n

<\/span>
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<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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<\/section>\n<\/section>\n
\n
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<\/span><\/strong><\/span>\u7248<\/section>\n<\/section>\n
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\u6743<\/section>\n<\/section>\n
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\u58f0<\/section>\n<\/section>\n
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\u660e<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

\u672c\u516c\u4f17\u53f7\u6240\u6709\u8f6c\u8f7d\u6587\u7ae0\u7cfb\u51fa\u4e8e\u4f20\u9012\u66f4\u591a\u4fe1\u606f\u4e4b\u76ee\u7684\uff0c\u4e14\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u4e0d\u5e0c\u671b\u88ab\u8f6c\u8f7d\u7684\u5a92\u4f53\u6216\u4e2a\u4eba\u53ef\u4e0e\u6211\u4eec\u8054\u7cfb(cbplib@163.com)\uff0c\u6211<\/span><\/span>\u4eec\u5c06\u7acb\u5373\u8fdb\u884c\u5220\u9664\u5904\u7406\u3002\u6240\u6709\u6587\u7ae0\u4ec5\u4ee3\u8868\u4f5c\u8005\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868\u672c\u7ad9\u7acb\u573a\u3002<\/span>
<\/p>\n

\"\u7ffb\u8bd1\u534f\u4f5c\/\u75ab\u82d7\u5b8c\u6574\u751f\u547d\u5468\u671f\u4e4bQbD\"<\/strong><\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u751f\u7269\u5236\u54c1\u5708 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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