{"id":75853,"date":"2019-01-20T00:00:50","date_gmt":"2019-02-01T05:49:50","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/75853\/"},"modified":"2019-02-01T13:49:50","modified_gmt":"2019-02-01T05:49:50","slug":"8c742a48d3","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/75853\/","title":{"rendered":"USP\u5206\u6790\u65b9\u6cd5\u7684\u751f\u547d\u5468\u671f"},"content":{"rendered":"
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2017<\/span>\u5e74\uff0cUSP\u4e3a\u62df\u8bae\u65b0\u7ae0\u8282\u53d1\u5e03\u4e86\u6807\u9898\u4e3a\u201c\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f<1220>\u201d \u7684\u6587\u7ae0\uff0c\u5176\u4e2d\u7684\u65b9\u6cd5\u4e0eICH Q8(R2)<\/span>\uff0cQ9<\/span>\uff0cQ10<\/span>\u548cQ11<\/span>\u6240\u8ff0\u7684\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1<\/span>\u7684\u6982\u5ff5\u76f8\u4e00\u81f4\u3002<\/span><\/p>\n

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\u4e00\u4e2a\u5206\u6790\u65b9\u6cd5<\/span><\/span><\/span>\u5fc5\u987b\u8bc1\u660e\u9002\u5408\u9884\u671f\u76ee\u7684\u3002\u5728\u5efa\u7acb\u65b9\u6cd5\u65f6\u8003\u8651\u5206\u6790\u65b9\u6cd5\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u662f\u5f88\u6709\u7528\u7684\uff0c\u5373\u8bbe\u8ba1\u3001\u5f00\u53d1\u3001\u786e\u8ba4\u548c\u6301\u7eed\u786e\u8ba4\u3002\u4ee5\u524d\u7684\u9a8c\u8bc1\u3001\u6838\u67e5\u548c\u65b9\u6cd5\u8f6c\u79fb\u7684\u6982\u5ff5\u5f3a\u8c03\u751f\u547d\u5468\u671f\u7684\u4e00\u4e2a\u90e8\u5206\uff0c\u4f46\u5e76\u6ca1\u6709\u91c7\u7528\u5168\u76d8\u773c\u5149\u6765\u8003\u8651\u3002\u6b64\u901a\u5219\u76ee\u7684\u662f\u66f4\u52a0\u5168\u9762\u5730\u8bf4\u660e\u6574\u4e2a\u65b9\u6cd5\u751f\u547d\u5468\u671f\u4ee5\u53ca\u5b9a\u4e49\u53ef\u80fd\u6709\u7528\u7684\u6982\u5ff5\u3002<\/span><\/p>\n


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\u4e3a\u4e86\u5728\u5206\u6790\u65b9\u6cd5\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f\u90fd\u80fd\u63d0\u4f9b\u4e00\u4e2a\u6574\u4f53\u7684\u65b9\u6cd5\uff0c\u53ef\u4ee5<\/span>\u4f7f\u7528\u4e00\u4e2a\u4e09\u9636\u6bb5\u7684\u6982\u5ff5\uff0c\u4e0e\u76ee\u524d<\/span>\u5de5\u827a\u9a8c\u8bc1<\/span><\/span><\/span>\u6280\u672f\u4fdd\u6301\u4e00\u81f4\uff1a<\/span><\/p>\n

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\u7b2c1<\/span>\u9636\u6bb5\uff1a\u65b9\u6cd5\u8bbe\u8ba1\u548c\u5f00\u53d1\uff08\u77e5\u8bc6\u6536\u96c6\u3001\u98ce\u9669\u8bc4\u4f30\u548c\u63a7\u5236\u3001\u5206\u6790\u63a7\u5236\u7b56\u7565\u3001\u77e5\u8bc6\u7ba1\u7406\u3001\u786e\u8ba4\u51c6\u5907\uff09<\/span><\/p>\n

\u7b2c2<\/span>\u9636\u6bb5\uff1a\u5206\u6790\u65b9\u6cd5\u6027\u80fd\u786e\u8ba4<\/span><\/p>\n

\u7b2c3<\/span>\u9636\u6bb5\uff1a\u6301\u7eed\u65b9\u6cd5\u6027\u80fd\u786e\u8ba4\uff08\u65e5\u5e38\u76d1\u6d4b\uff0c\u5206\u6790\u65b9\u6cd5\u53d8\u66f4\uff09<\/span><\/p>\n

\n

\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f\u7684\u4e00\u4e2a\u57fa\u672c\u8981\u7d20\u662f\u5236\u8ba2\u4e00\u4e2a\u76ee\u6807\u8bf4\u660e\u5bf9\u5206\u6790\u65b9\u6cd5\u7684\u6027\u80fd\u8981\u6c42\u3002\u8fd9\u4e9b\u5728\u5206\u6790\u76ee\u6807\u6982\u51b5\uff08Analytical Target Profile<\/span>\uff0cATP<\/span>\uff09\u4e2d\u63cf\u8ff0\u7684\u8981\u6c42\u53ef\u4ee5\u770b\u4f5c\u662f\u7c7b\u4f3c\u4e8e\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5<\/span><\/span><\/span>\uff08Quality Target Product Profile<\/span>\uff0cQTPP<\/span>\uff09\u3002\u5206\u6790\u76ee\u6807\u6982\u51b5\uff08ATP<\/span>\uff09\u662f\u8bbe\u8ba1\u548c\u5f00\u53d1\u9636\u6bb5\u7684\u57fa\u7840\u3002\u6839\u636eUSP <1220><\/span>\u8349\u6848 , ATP<\/span>\u662f\u76ee\u6807\u6d4b\u91cf\u4e0d\u786e\u5b9a\u5ea6\uff08Target Measurement Uncertainty<\/span>\uff0cTMU<\/span>\uff09\u5206\u6790\u65b9\u6cd5\u4ea7\u751f\u7684\u53ef\u62a5\u544a\u503c\u6240\u8981\u6c42\u7684\u8d28\u91cf ,<\/span> \u5176\u4e2dTMU<\/span>\u662f\u5728\u4fdd\u8bc1\u9002\u5408\u9884\u671f\u76ee\u7684\u7684\u60c5\u51b5\u4e0b ,<\/span> \u53ef\u62a5\u544a\u7ed3\u679c\u7684\u6700\u5927\u4e0d\u786e\u5b9a\u5ea6\u3002<\/span><\/p>\n

\n

\u5206\u6790\u6280\u672f\u7684\u9009\u62e9\u5c06\u8003\u8651\u5f85\u6d4b\u7269\u6599\u7684\u5c5e\u6027\u548cATP<\/span>\u7684\u8981\u6c42\u3002\u5e94\u8003\u8651\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\uff0c\u4ee5\u4e86\u89e3\u4e0d\u540c\u68c0\u6d4b\u65b9\u6cd5\u53d8\u91cf\u5bf9\u62a5\u544a\u7ed3\u679c\u548c\u5fc5\u8981\u63a7\u5236\u63aa\u65bd\u7684\u6f5c\u5728\u5f71\u54cd\u3002\u53ef\u4ee5\u5229\u7528\u5b9e\u9a8c\u8bbe\u8ba1\uff08DOE<\/span><\/span>\uff09<\/span><\/span><\/span>\u7814\u7a76\u6765\u4e86\u89e3\u65b9\u6cd5\u53d8\u91cf\u5bf9\u62a5\u544a\u7ed3\u679c\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\n

\u5728\u8bbe\u8ba1\u548c\u5f00\u53d1\u9636\u6bb5\u7ed3\u675f\u65f6\uff0c\u5e94\u53d1\u5e03\u4e00\u4efd\u62a5\u544a ,<\/span> \u5176\u4e2d\u5305\u62ec\u8be5\u65b9\u6cd5\u8349\u6848\u5982\u4f55\u6ee1\u8db3ATP<\/span>\u7684\u8981\u6c42\u4ee5\u53ca\u8fd9\u4e9b\u5173\u952e\u68c0\u6d4b\u65b9\u6cd5\u53d8\u91cf\u6240\u9700\u7684\u65b9\u6cd5\u63a7\u5236\u3002\u6839\u636eUSP <1220><\/span>\u8349\u6848 ,<\/span> \u8fd9\u6837\u7684\u62a5\u544a\u5e94\u8be5\u662f\u6027\u80fd\u786e\u8ba4\u7684\u5148\u51b3\u6761\u4ef6 ,<\/span> \u5b83\u5c06\u786e\u4fdd\u8be5\u65b9\u6cd5\u751f\u6210\u7684\u62a5\u544a\u503c\u7b26\u5408ATP<\/span>\u6807\u51c6\uff08\u5728\u5c06\u4f7f\u7528\u8be5\u65b9\u6cd5\u7684\u73af\u5883\u4e2d\uff09\u3002<\/span><\/p>\n

\n

\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7684\u7b2c3<\/span>\u9636\u6bb5\uff08\u6301\u7eed\u65b9\u6cd5\u6027\u80fd\u786e\u8ba4\uff09\u5e94\u8bc1\u660e\u8be5\u65b9\u6cd5\u6301\u7eed\u9002\u5408\u9884\u671f\u76ee\u7684 ,<\/span> \u5373\u6301\u7eed\u6309\u7167ATP<\/span>\u7684\u8981\u6c42\u4ea4\u8d27\u3002\u8fd9\u662f\u901a\u8fc7\u4f8b\u884c\u76d1\u6d4b\u548c\u8bc4\u4f30\u53ef\u80fd\u5f71\u54cd\u8be5\u65b9\u6cd5\u7684\u4efb\u4f55\u201c\u53d8\u66f4\u201d\u6765\u786e\u5b9a\u7684\uff0c\u65e0\u8bba\u662f\u65b9\u6cd5\u672c\u8eab\u8fd8\u662f\u65b9\u6cd5\u6240\u652f\u6301\u7684\u7269\u6599\/<\/span>\u5de5\u827a\u3002<\/span><\/p>\n

\n

\u53c2\u8003\u8d44\u6599\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

1. <\/span><\/span> General Chapter Prospectus: <1220> The Analytical Procedure Lifecycle http:\/\/www.uspnf.com\/notices\/1220-analytical-procedure-lifecycle<\/span><\/span><\/p>\n

 <\/span><\/p>\n

2. <\/span><\/span> Proposed New USP General Chapter: The Analytical Procedure Lifecycle <1220>http:\/\/www.uspnf.com\/sites\/default\/files\/usp_pdf\/EN\/USPNF\/revisions\/s201784.pdf<\/span><\/span><\/p>\n

3. <\/span><\/span> Got Life?<\/span> \u2013 Check Out the Analytical Procedure Lifecycle http:\/\/www.lachmanconsultants.com\/2018\/05\/got-life-check-out-the-analytical-procedure-lifecycle\/<\/span><\/span><\/span><\/p>\n<\/p>\n

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\u58f0\u660e<\/span><\/strong>\uff1a\u672c\u6587\u4ec5\u4f9b\u5206\u4eab\u4e4b\u7528\uff0c\u7248\u6743\u5c5e\u4e8e\u539f\u4f5c\u8005\u3002\u5982\u6d89\u53ca\u7248\u6743\u95ee\u9898\uff0c\u8bf7\u4e0e\u5c0f\u7f16\u8054\u7cfb\u6211\u4eec\u4f1a\u59a5\u5584\u5904\u7406\u3002<\/span><\/span><\/p>\n

\n

<\/span><\/strong>\u56fd\u9645\u901a\u7528\u6280\u672f\u8981\u6c42\u4e0b\u7684\u836f\u54c1\u8d28\u91cf\u7814\u7a76<\/span><\/strong>\u4e0e\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f\u7ba1\u7406<\/span><\/span><\/strong>\u7814\u8ba8\u4f1a<\/span><\/span><\/strong><\/strong><\/span><\/p>\n<\/h2>\n

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\uff08\u4e00\uff09\u836f\u54c1\u8d28\u91cf\u7814\u7a76\u6cd5\u89c4<\/span><\/strong><\/p>\n

\u4e00\u3001ICH\u6307\u5bfc\u539f\u5219\u548c\u8d28\u91cf\u7814\u7a76\u7533\u62a5\u7b56\u7565<\/span><\/strong><\/p>\n

1.\u836f\u7269\u8d28\u91cf\u5206\u6790\u7684\u5173\u6ce8\u70b9\uff08\u4e2a\u6027\u95ee\u9898\u548c\u5171\u6027\u95ee\u9898\uff09<\/span><\/p>\n

2.\u4e3a\u4ec0\u4e48\u8981\u5b66\u4e60ICH\u7cfb\u5217\u6307\u5bfc\u539f\u5219\uff08ICH\u6307\u5bfc\u539f\u5219\u5728\u836f\u7269\u7814\u53d1\u4e2d\u7684\u5e94\u7528\uff09<\/span><\/p>\n

3.\u836f\u7269\u8d28\u91cf\u63a7\u5236\u4e2d\u5206\u6790\u65b9\u6cd5\u5728\u836f\u54c1\u751f\u547d\u5468\u671f\u4e2d\u7684\u53d8\u5316<\/span><\/p>\n

\u4e8c\u3001\u56fd\u5185\u5916\u836f\u5178\u548c\u5206\u6790\u76f8\u5173\u6cd5\u89c4\u89e3\u8bfb<\/span><\/strong><\/p>\n

1.\u300a\u4e2d\u56fd\u836f\u5178\u300b2020\u7248\u7684\u4fee\u6539\u53d8\u5316<\/span> <\/span>2.USP\u4e2d\u7684\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f\u7ba1\u7406\u7b80\u4ecb<\/span><\/p>\n

\uff08\u4e8c\uff09\u6742\u8d28\u7814\u7a76\u7b56\u7565<\/span><\/strong><\/p>\n

1\u4e00\u822c\u6742\u8d28\u9650\u5ea6\u62df\u5b9a\u7684\u57fa\u672c\u601d\u8def\u4e0e\u7b56\u7565\u53ca\u6848\u4f8b\u5206\u6790<\/span><\/span><\/p>\n

2\u8b66\u793a\u7ed3\u6784\u3001\u57fa\u56e0\u6bd2\u6027\u6742\u8d28\u7814\u7a76\u601d\u8def\u53ca\u63a7\u5236\u7b56\u7565<\/span><\/span><\/p>\n

3\u5143\u7d20\u6742\u8d28\u7814\u7a76\u601d\u8def\u53ca\u63a7\u5236\u7b56\u7565<\/span><\/span><\/p>\n

\uff08\u4e09\uff09<\/span><\/strong>\u836f\u54c1\u7814\u53d1\u4e0e\u8d28\u91cf\u63a7\u5236\u4e2d\u5e38\u89c1\u95ee\u9898\u5206\u6790<\/span><\/strong><\/p>\n

\u4e00\u3001\u53d6\u6837\u7684\u4ee3\u8868\u6027\u548c\u5747\u4e00\u6027\u95ee\u9898<\/span><\/strong><\/p>\n

\u4e8c\u3001\u6807\u51c6\u54c1\u3001\u5bf9\u7167\u54c1\u5728\u836f\u54c1\u7814\u53d1\u4e0e\u8d28\u91cf\u63a7\u5236\u7684\u8981\u6c42<\/span><\/strong><\/p>\n

\u4e09\u3001\u8d28\u91cf\u6807\u51c6\u5236\u5b9a\u95ee\u9898<\/span><\/strong><\/p>\n

1.\u8d28\u91cf\u6807\u51c6\u4e0e\u7a33\u5b9a\u6027\u6570\u636e\u8bc4\u4ef7\uff08<\/span>Q1E<\/span>\uff09\u4e0e\u5206\u6790\u65b9\u6cd5\uff08<\/span>Q2<\/span>\uff09\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/span><\/p>\n

2.\u8d28\u91cf\u6807\u51c6\u4e0e\u4e0e\u6742\u8d28\u8c31\u7814\u7a76\uff08<\/span>Q3<\/span>\uff09\u4ee5\u53ca\u836f\u5178\u65b9\u6cd5\uff08<\/span>Q4<\/span>\uff09\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/span><\/p>\n

\uff08\u56db\uff09\u5206\u6790\u6570\u636e\u5bf9\u4e8e\u836f\u54c1\u8d28\u91cf\u548c\u836f\u7269\u7814\u53d1\u7684\u91cd\u8981\u6027<\/span><\/strong><\/p>\n

1.\u65b0\u5f62\u52bf\u4e0b\u9700\u8981\u53ef\u9760\u7684\u5206\u6790\u6570\u636e\u7684\u7d27\u8feb\u6027<\/span><\/span><\/p>\n

2.\u5982\u4f55\u505a\u5230\u5206\u6790\u6570\u636e\u7684\u771f\u5b9e\u3001\u89c4\u8303\u548c\u53ef\u9760\uff1f<\/span><\/span><\/p>\n

3.OOS\/OOA \u53ca\u504f\u5dee\u6848\u4f8b\u5206\u6790<\/span><\/span><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a\u5468\u7acb\u6625  \u5468\u8001\u5e08\u5728\u836f\u54c1\u68c0\u9a8c\u4e00\u7ebf\u5de5\u4f5c\u4e09\u5341\u591a\u5e74\uff0c\u66fe\u4efb\u5317\u4eac\u5e02\u836f\u54c1\u68c0\u9a8c\u6240\u6297\u751f\u7d20\u5ba4\u4e3b\u4efb\u3001\u751f\u5316\u5b9e\u9a8c\u5ba4\u4e3b\u4efb\u53ca\u6240\u957f\u52a9\u7406\u3002\u7b2c\u4e5d\u3001\u5341\u5c4a\u836f\u5178\u59d4\u5458\u4f1a\u59d4\u5458\u3001\u56fd\u5bb6\u5c40CDE<\/span>\u4eff\u5236\u836f\u7acb\u5377\u5ba1\u67e5\u7ec4\u6210\u5458\uff0c\u5317\u4eac\u5e02\u4e0a\u5e02\u540e\u836f\u54c1\u5b89\u5168\u6027\u76d1\u6d4b\u4e0e\u518d\u8bc4\u4ef7\u4e13\u5bb6\u5e93\u4e13\u5bb6\uff0c<\/span>CFDA<\/span>\u7b49\u591a\u4e2a\u673a\u6784\u5ba1\u8bc4\u4e13\u5bb6\u5e93\u4e13\u5bb6\u3002<\/span><\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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\uff08\u4e94\uff09\u5206\u6790\u65b9\u6cd5\u751f\u547d\u5468\u671f\u5168\u8fc7\u7a0b\u7684\u7ba1\u7406<\/span><\/strong><\/p>\n

\u4e00\u3001\u5206\u6790\u65b9\u6cd5\u7684\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1QbD<\/span>\u7684\u91cd\u8981\u5173\u8282<\/span><\/span><\/strong><\/p>\n

\u4e8c\u3001\u4e0d\u540c\u9636\u6bb5\u7684\u65b9\u6cd5\u9a8c\u8bc1<\/span><\/strong><\/p>\n

1\u4e13\u5c5e\u6027\u4e0e\u964d\u89e3\u8bd5\u9a8c\u7684\u5e38\u89c1\u95ee\u9898   <\/span>2<\/span><\/span>\u7ebf\u6027\u4e0e\u8303\u56f4\u8bd5\u9a8c\u7684\u5e38\u89c1\u95ee\u9898<\/span><\/p>\n

3\u4e0d\u540c\u542b\u91cf\u6d4b\u5b9a\u6cd5\u51c6\u786e\u5ea6\u63a5\u53d7\u6807\u51c6 4<\/span>\u7cbe\u5bc6\u5ea6\u7684\u505a\u6cd5\u548c\u8bc4\u4f30<\/span><\/p>\n

5\u68c0\u6d4b\u9650\u548c\u5b9a\u91cf\u9650\u7684\u505a\u6cd5\u548c\u8bc4\u4f30   6\u7cfb\u7edf\u9002\u7528\u6027\u7684\u505a\u6cd5\u548c\u8bc4\u4f30<\/span><\/p>\n

7\u56de\u6536\u7387\u7684\u505a\u6cd5\u548c\u8bc4\u4f30           8\u65b9\u6cd5\u8010\u7528\u6027\u7684\u505a\u6cd5\u548c\u8bc4\u4f30<\/span><\/p>\n

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\u4f1a\u52a1\u8d39\uff1a<\/span><\/span>2500<\/span>\u5143<\/span>\/\u4eba<\/span>\uff08<\/span><\/span>\u542b<\/span>2\u5929\u5348\u9910<\/span>\uff09<\/span><\/span>\u3002<\/span><\/span>\u4f4f<\/span><\/span>\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/span><\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u56db\u3001\u8054\u7cfb\u65b9\u5f0f<\/span> <\/span><\/span><\/strong><\/p>\n

\u8054<\/span> \u7cfb<\/span> \u4eba\uff1a\u6f58\u6613<\/span>      panyi2010@126.com   <\/span><\/span><\/strong><\/p>\n

  \u7535  \u8bdd\uff1a13522766753 \uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

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