{"id":75979,"date":"2018-12-10T00:00:50","date_gmt":"2019-02-01T05:51:00","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/75979\/"},"modified":"2019-02-01T13:51:00","modified_gmt":"2019-02-01T05:51:00","slug":"94fe857eed","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/75979\/","title":{"rendered":"\u836f\u54c1\u6ce8\u518c\u73b0\u573a\u3001\u751f\u4ea7\u73b0\u573a\u7f3a\u9677\u6c47\u603b\uff1a\u7814\u53d1\u8fc7\u7a0bGMP\u6267\u884c\u4e0d\u8db3\uff0c\u8d28\u91cf\u4f53\u7cfb\u8584\u5f31"},"content":{"rendered":"
\n

2017\u5e74\u73b0\u573a\u68c0\u67e5\u53d1\u73b0\u7684\u95ee\u9898\u4e2d\uff0c\u7533\u62a5\u8d44\u6599\u4e0d\u771f\u5b9e\u3001\u6570\u636e\u65e0\u6cd5\u6eaf\u6e90\u7b49\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\u5df2\u4e0d\u518d\u7a81\u51fa\u3002\u8fd9\u4e0e2017\u5e74\u5ea6\u6ce8\u518c\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u4efb\u52a1\u5927\u90e8\u5206\u901a\u8fc7\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6838\u67e5\u3001\u4f01\u4e1a\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u5bf9\u6570\u636e\u53ef\u9760\u6027\u95ee\u9898\u666e\u904d\u63d0\u9ad8\u91cd\u89c6\u6709\u4e00\u5b9a\u5173\u7cfb\u3002\u4f46\u662f\uff0c\u6279\u51c6\u4e0a\u5e02\u524d\u836f\u54c1GMP\u7b26\u5408\u6027\u95ee\u9898\u8f83\u591a\uff0c\u8bf4\u660e\u4f01\u4e1a\u5728\u836f\u54c1\u7814\u53d1\u8fc7\u7a0b\u4e2d\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5efa\u8bbe\u6bd4\u8f83\u8584\u5f31\uff0c\u5bf9\u836f\u54c1GMP\u7684\u7b26\u5408\u6027\u5173\u6ce8\u4e0d\u591f\u30022017\u5e74\u5ea6\u53d1\u73b0\u4f01\u4e1a\u5b58\u5728\u7814\u53d1\u8fc7\u7a0b\u4e2d\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u6267\u884c\u4e0d\u8db3\u3001\u504f\u5dee\u53ca\u8d85\u6807\u8c03\u67e5\u4e0d\u5145\u5206\u3001\u5de5\u827a\u9a8c\u8bc1\u4e0d\u79d1\u5b66\u7b49\u95ee\u9898\u3002\u5177\u4f53\u5982\u4e0b\uff1a<\/span><\/p>\n

\n

\uff08\u4e00\uff09\u4e2d\u8bd5\u6216\u6280\u672f\u8f6c\u79fb\u8fc7\u7a0b\u4e2d\u836f\u54c1GMP\u89c4\u8303\u6267\u884c\u4e0d\u8db3<\/span><\/p>\n

\n

\u76ee\u524d\u5927\u591a\u6570\u4f01\u4e1a\u5df2\u610f\u8bc6\u5230\u4ece\u7814\u53d1\u5230\u751f\u4ea7\u7684\u6280\u672f\u8f6c\u79fb\u9700\u8981\u8fdb\u884c\u8d28\u91cf\u7ba1\u7406\uff0c\u4f46\u4ecd\u5b58\u5728\u4e0d\u8db3\u3002\u4e2a\u522b\u4f01\u4e1a\u4ecd\u672a\u5c06\u6b64\u8fc7\u7a0b\u7eb3\u5165\u836f\u54c1GMP\u4f53\u7cfb\u4e4b\u4e2d\uff0c\u5b58\u5728\u4eba\u5458\u804c\u8d23\u4e0d\u6e05\u3001\u751f\u4ea7\u90e8\u95e8\u5bf9\u54c1\u79cd\u5de5\u827a\u77e5\u8bc6\u7406\u89e3\u4e0d\u591f\u3001\u7814\u53d1\u90e8\u95e8\u5b9e\u65bd\u5de5\u827a\u9a8c\u8bc1\u672a\u5b8c\u5168\u9075\u5faa\u836f\u54c1GMP\u89c4\u5b9a\u7b49\u73b0\u8c61\u3002<\/span><\/p>\n

\n

\uff08\u4e8c\uff09\u504f\u5dee\u3001\u8d85\u6807\u7ed3\u679c\u8c03\u67e5\u4e0d\u5145\u5206 <\/span><\/p>\n

\n

\u5b58\u5728\u5bf9\u504f\u5dee\u3001\u8d85\u6807\u7ed3\u679c\u672a\u80fd\u53ca\u65f6\u8c03\u67e5\uff0c\u6216\u8005\u8c03\u67e5\u4e0d\u6df1\u5165\u3001\u4e0d\u5168\u9762\uff0c\u672a\u80fd\u5bf9\u4ea7\u751f\u7684\u6839\u672c\u539f\u56e0\u8fdb\u884c\u5145\u5206\u8c03\u67e5\u3002\u7279\u522b\u662f\u5f53\u53d1\u73b0\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6570\u636e\u504f\u79bb\u8d8b\u52bf\u7684\u5f02\u5e38\u6570\u636e\uff0c\u672a\u80fd\u5f15\u8d77\u8db3\u591f\u91cd\u89c6\uff0c\u672a\u53ca\u65f6\u5f00\u5c55\u8c03\u67e5\uff0c\u540e\u671f\u518d\u67e5\u627e\u539f\u56e0\u53d8\u5f97\u5341\u5206\u56f0\u96be\u3002<\/span><\/p>\n

\n

\uff08\u4e09\uff09\u5de5\u827a\u9a8c\u8bc1\u4e0d\u79d1\u5b66\u3001\u4e0d\u5145\u5206<\/span><\/p>\n

\n

\u90e8\u5206\u4f01\u4e1a\u5bf9\u4ea7\u54c1\u548c\u5de5\u827a\u524d\u671f\u7814\u7a76\u4e0d\u8db3\uff0c\u5bf9\u5de5\u827a\u7406\u89e3\u4e0d\u591f\uff0c\u836f\u54c1\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u8bbe\u8ba1\u4e0d\u79d1\u5b66\u3002\u5de5\u827a\u9a8c\u8bc1\u51fa\u73b0\u504f\u5dee\u4e0d\u80fd\u6309\u7167\u836f\u54c1GMP\u8981\u6c42\u8fdb\u884c\u8bb0\u5f55\u3001\u5206\u6790\uff0c\u4e0d\u80fd\u627e\u5230\u6839\u672c\u539f\u56e0\u5e76\u5236\u5b9a\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u3002\u4e2a\u522b\u4f01\u4e1a\u751a\u81f3\u628a\u8fde\u7eed\u751f\u4ea73\u6279\u5408\u683c\u4ea7\u54c1\u4f5c\u4e3a\u5224\u5b9a\u5de5\u827a\u9a8c\u8bc1\u5408\u683c\u7684\u6807\u51c6\u3002<\/span><\/p>\n


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

\n

<\/span><\/span><\/strong>\u65b0\u653f\u4e0b<\/span><\/span><\/strong>\u836f\u54c1\u7814\u53d1\u9879\u76ee\u89c4\u5212\u7ba1\u7406<\/span><\/span><\/strong>\u53ca<\/span><\/span><\/strong>\u7533\u62a5\u8d44\u6599<\/span><\/span><\/strong>\u5408\u89c4\u7ba1\u7406<\/span><\/span><\/strong>\u7814\u8ba8\u73ed<\/span><\/span><\/strong><\/span><\/span><\/strong><\/p>\n

\n
\n
\n
\n
\n
\n
\n
\n
\n

\u6ce8\u518c\u5931\u8d25\u4e0d\u662f\u6e90\u4e8e\u6280\u672f\uff0c\u800c\u662f\u7f3a\u5931\u6cd5\u89c4\u5bf9\u8fc7\u7a0b\u63a7\u5236\u8981\u6c42<\/span><\/span><\/strong><\/p>\n

\u6211\u4eec\u9700\u8981\u53cd\u601d\u7684\u8fc7\u53bb<\/span>—\u836f\u54c1\u7814\u53d1\u4e4b\u6b87<\/span><\/strong><\/p>\n

1\u7f3a\u5931\u4e4b\u6b87–\u7f3a\u5931\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e0e\u836f\u54c1\u6ce8\u518c\u5173\u7cfb\u7814\u7a76<\/span><\/p>\n

2\u6025\u529f\u8fd1\u5229\u4e4b\u6b87–\u8d28\u91cf\u4f53\u7cfb\u7f3a\u9677\u9020\u6210\u4e34\u5e8a\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u95ee\u9898<\/span><\/p>\n

\u4e34\u5e8a\u524d\u7814\u7a76\u4e2d\u8bd5\u9636\u6bb5\uff0c\u4e34\u5e8a\u6837\u54c1\u751f\u4ea7\u524d\uff0c\u4f60\u6700\u6025\u9700\u7684\u4e0d\u662f\u5de5\u827a\uff0c\u800c\u662f<\/span>GMP\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u662f\u5426\u771f\u5b9e\u5efa\u7acb\u8d77\u6765\uff0c\u4e0d\u8981\u6307\u671b\u540e\u671f\u7684\u9884\u671f\uff0c\u56e0\u4e3a\u4f60\u7684\u56e2\u961f\u5df2\u7ecf\u88ab\u8fd9\u4e2a\u9884\u671f\u6467\u6bc1<\/span><\/strong><\/p>\n

\u4e00\u3001<\/span>CFDA\u8fd1\u671f\u6cd5\u89c4\u53d8\u5316\u5bf9\u836f\u54c1\u7814\u53d1\u5f71\u54cd<\/span><\/strong><\/p>\n

1.MAH\u5236\u5ea6\u8bd5\u70b9\u76f8\u5173\u653f\u7b56\u8ba8\u8bba        2.\u4e00\u81f4\u6027\u8bc4\u4ef7\u76f8\u5173\u653f\u7b56\u8ba8\u8bba<\/span><\/p>\n

3.\u5173\u8054\u5ba1\u8bc4\u5ba1\u6279\u76f8\u5173\u653f\u7b56\u8ba8\u8bba       4.\u672a\u6765\u6cd5\u89c4\u5411ICH\u7684\u53d8\u5316\u8d8b\u52bf<\/span><\/p>\n

\u4e8c\u3001<\/span><\/span>GMP\u6846\u67b6\u4e0b\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u4e0e\u6ce8\u518c\u7533\u62a5\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/strong><\/p>\n

1 \u7533\u62a5\u8d44\u6599\u5173\u952e\u8981\u7d20\u4e0eGMP\u7ba1\u7406\u4f53\u7cfb\u7684\u6838\u5fc3\u5bf9\u63a5\u8981\u6c42<\/span><\/p>\n

2 \u98ce\u9669\u7ba1\u7406\u4e0e\u7533\u62a5\u8d44\u6599–\u751f\u547d\u5468\u671f\u4e0d\u540c\u9636\u6bb5\u7684\u7533\u62a5\u8981\u7d20\u7684\u98ce\u9669\u8bc4\u4ef7<\/span><\/p>\n

3 \u9a8c\u8bc1\u7ba1\u7406\u4e0e\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/p>\n

4 \u7a33\u5b9a\u6027\u8bd5\u9a8c\u9a8c\u8bc1\u4e0e\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7684\u5173\u7cfb\u89e3\u6790<\/span><\/p>\n

5\u4e00\u4e9bGMP\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6587\u4ef6\u7ecf\u5178\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

\u4e09\u3001\u836f\u54c1<\/span><\/span><\/strong>\u7814\u53d1\u5168\u751f\u547d\u5468\u671f\u6587\u4ef6\u7ba1\u7406<\/span><\/span><\/strong><\/p>\n

1\u6784\u5efa\u7533\u62a5\u6587\u4ef6\u7ba1\u7406\u4f53\u7cfb<\/span><\/strong><\/p>\n

1\uff09<\/span>\u5efa\u7acb\u516c\u53f8\u5185\u90e8\u836f\u653f\u7ba1\u7406<\/span>SOP\/Best Practices<\/span><\/p>\n

2\uff09<\/span>\u5efa\u7acb\u7533\u62a5\u6d3b\u52a8\u8bb0\u5f55\u8ddf\u8e2a\u7cfb\u7edf<\/span>   3\uff09\u5efa\u7acb\u7f3a\u9677\u8bb0\u5f55\u8ddf\u8e2a\u7cfb\u7edf<\/span><\/p>\n

2<\/span><\/strong>\u7814\u53d1\u4ea7\u751f\u7684\u6587\u4ef6\u4f53\u7cfb\u7684\u7ba1\u7406<\/span><\/span><\/strong><\/p>\n

1\uff09<\/span>\u7814\u53d1\u65b9\u6848\u548c<\/span><\/span>SOP 2\uff09<\/span>\u7814\u53d1\u539f\u59cb\u6570\u636e\u548c\u62a5\u544a<\/span> <\/span>3)<\/span>\u7533\u62a5\u8981\u6c42\u7684\u65b9\u6848\u3001\u62a5\u544a\u6a21\u677f<\/span><\/span><\/p>\n

3<\/span><\/strong>\u7814\u53d1\u8d28\u91cf\u4f53\u7cfb\u6709\u6548\u5b9e\u65bd\u7684<\/span><\/span><\/strong>SOP<\/span><\/strong>\u6587\u4ef6\u6e05\u5355<\/span><\/span><\/strong><\/p>\n

4<\/span><\/strong>\u6570\u636e\u53ef\u9760\u6027\u76f8\u5173\u6587\u4ef6<\/span><\/span><\/strong><\/p>\n

\u56db<\/span><\/span><\/strong>\u3001\u4e0d\u540c\u7533\u62a5\u9636\u6bb5\u7684\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u9879\u76ee\u7684\u89c4\u5212\u548c\u7ba1\u7406\u8981\u70b9\u89e3\u6790<\/span><\/span><\/strong><\/p>\n

1.\u57fa\u4e8eGMP\u4f53\u7cfb\u7684\u7533\u62a5\u57fa\u7840\u4f53\u7cfb\u6784\u5efa\u53ca\u56e2\u961f\u8981\u6c42\u6848\u4f8b\u89e3\u6790<\/span><\/strong><\/p>\n

2.\u9879\u76ee\u89c4\u5212\u8981\u70b9\u53ca\u5e02\u573a\u9884\u671f\u8bf4\u660e<\/span><\/strong><\/p>\n

a\u7acb\u9879\u7684\u8c03\u7814\u8981\u7d20\u53ca\u6848\u4f8b\u89e3\u6790—–\u7b2c\u4e00\u96be\u9898       <\/span><\/p>\n

b\u57fa\u4e8e\u751f\u547d\u5468\u671f\u7684\u5904\u65b9\u5de5\u827a\u5f00\u53d1—\u53d8\u66f4\u7684\u827a\u672f<\/span><\/p>\n

c\u7814\u53d1\u7ed3\u679c\u3001\u8d44\u6599\u6574\u7406\u3001\u7814\u7a76\u7ed3\u679c\u5bf9\u6bd4\u5206\u6790\u6c47\u603b\u6848\u4f8b\u89e3\u6790–\u4e13\u5bb6\u4e4b\u95f4\u7684\u5bf9\u8bdd<\/span><\/p>\n

d\u57fa\u4e8e\u7269\u6599\u6807\u51c6\u53ca\u4e2d\u95f4\u8fc7\u7a0b\u63a7\u5236\u5b9e\u9a8c\u65b9\u6848\u7684\u5ba1\u6838\u8981\u70b9\u89e3\u6790–\u6ce8\u518c\u4e13\u5458\u7684\u5929\u804c<\/span><\/p>\n

e\u5de5\u827a\u9a8c\u8bc1\u7684\u7a33\u5b9a\u6027\u7814\u7a76\u7533\u62a5\u8d44\u6599\u7ec4\u7ec7\u53ca\u7a33\u5b9a\u6027\u7814\u7a76\u7ed3\u679c\u91cd\u8981\u6027\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

f\u4e0d\u540c\u4e34\u5e8a\u9636\u6bb5\u7814\u53d1\u53d8\u66f4\u89e6\u53d1\u7684\u7533\u62a5\u8d44\u6599\u53d8\u66f4\u6cd5\u89c4\u7b26\u5408\u6027\u8bf4\u660e\u53ca\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

3.\u6ce8\u518c\u7ba1\u7406<\/span><\/strong><\/p>\n

a\u4f53\u7cfb\u7814\u53d1\u7684\u91cd\u8981\u6027\u89e3\u6790(\u65f6\u95f4\u6548\u7387\u7684\u4fdd\u8bc1)<\/span><\/p>\n

b\u53d8\u66f4\u7ba1\u7406\u7684\u63d0\u524d\u9884\u5224\u4e0e\u540e\u7eed\u53d8\u66f4\u98ce\u9669\u5206\u6790\u53ca\u5bf9\u6bd4\u7814\u7a76\u6cd5\u5f8b\u8981\u6c42\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

c\u7edd\u4e0d\u80fd\u89e6\u53d1\u7684\u884c\u4e3a–\u201c\u4f5c\u5047\u201d\u548c\u201c\u5047\u4f5c\u201d<\/span><\/p>\n

dGMP\u7684\u98ce\u9669–\u539f\u8f85\u6599\u7684\u7b26\u5408\u6027\uff08\u968f\u65f6\u51c6\u5907\u8fdb\u884c\u7684\u539f\u6599\u836f\u53d8\u66f4\u7533\u62a5\u4e0e\u4e0d\u80fd\u505c\u6b62\u7684\u8f85\u6599\u63a2\u7a76\u5de5\u4f5c\uff09<\/span><\/p>\n

\u4e94<\/span><\/span><\/strong>\u3001\u7814\u53d1\u7533\u62a5\u89c4\u5212\u8981\u70b9\u53ca\u57fa\u4e8e\u4f53\u7cfb\u7ec4\u7ec7\u6846\u67b6\u5206\u5de5\u7684\u56e2\u961f\u8981\u6c42<\/span><\/span><\/strong><\/p>\n

a\u5982\u4f55\u6839\u636e\u6700\u65b0\u653f\u7b56\u8c03\u6574\u6ce8\u518c\u5de5\u4f5c<\/span><\/p>\n

b\u6ce8\u518c\u5de5\u4f5c\u5982\u4f55\u53ca\u65f6\u8ddf\u8e2a\u7814\u53d1\u8fdb\u5c55<\/span><\/p>\n

c\u5982\u4f55\u5b9e\u65f6\u8ddf\u8e2a\u8fdb\u5ea6\uff0c\u4ee5\u53ca\u57fa\u4e8e\u53d8\u66f4\u7ea0\u504f\u7ea0\u9519<\/span><\/p>\n

\u4e3b\u8bb2\u4eba\uff1a<\/p>\n

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\u65f6\u95f4\uff1a<\/span>2018\u5e74<\/span>12<\/span>\u6708<\/span><\/span>20<\/span>\u65e5<\/span>–<\/span>22<\/span>\u65e5\uff08<\/span><\/span>20<\/span>\u65e5\u5168\u5929\u62a5\u5230\uff09<\/span><\/span><\/p>\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<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

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