{"id":49727,"date":"2018-09-18T01:00:00","date_gmt":"2018-09-26T02:01:05","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/26\/gmp%e9%a3%9e%e6%a3%80%e8%a6%81%e7%82%b9\/"},"modified":"2018-09-26T10:01:05","modified_gmt":"2018-09-26T02:01:05","slug":"gmp%e9%a3%9e%e6%a3%80%e8%a6%81%e7%82%b9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/49727\/","title":{"rendered":"GMP\u98de\u68c0\u8981\u70b9"},"content":{"rendered":"
\n

\"GMP\u98de\u68c0\u8981\u70b9\"<\/span><\/a><\/p>\n

GMP\u98de\u884c\u68c0\u67e5\u91cd\u70b9\u4f01\u4e1a\u7c7b\u578b<\/strong><\/span><\/strong><\/section>\n

<\/strong><\/span><\/strong><\/section>\n

<\/span><\/strong>\u836f\u76d1\u5c40\u4ea7\u54c1\u62bd\u68c0\u4e0d\u5408\u683c\u7684\u4f01\u4e1a<\/span>
\u88ab\u53d1\u653e\u544a\u8beb\u4fe1\u7684\u4f01\u4e1a<\/span>
\u6ce8\u518c\u73b0\u573a\u68c0\u67e5\u6216GMP\u8ba4\u8bc1\u68c0\u67e5\u53d1\u73b0\u7f3a\u9677\u8f83\u591a\u7684\u4f01\u4e1a<\/span>
\u56fd\u5916\u68c0\u67e5\u673a\u6784\u68c0\u67e5\u53d1\u73b0\u8f83\u4e25\u91cd\u7f3a\u9677\u7684\u4f01\u4e1a<\/span><\/span><\/strong><\/p>\n


<\/p>\n


<\/p>\n

\u98de\u884c\u68c0\u67e5\u4e94\u5927\u7279\u70b9<\/strong><\/span><\/section>\n


<\/p>\n

\u7279\u70b9\u4e00\uff1a\u884c\u52a8\u7684\u9690\u5bc6\u6027\u3002
\u3000\u3000\u98de\u884c\u68c0\u67e5\u5b89\u6392\u5373\u4f7f\u5728\u7ec4\u7ec7\u5b9e\u65bd\u90e8\u95e8\u5185\u4e5f\u662f\u76f8\u5bf9\u9690\u5bc6\u7684\uff0c\u53ea\u6709\u8be5\u9879\u5de5\u4f5c\u7684\u4e3b\u7ba1\u9886\u5bfc\u548c\u5177\u4f53\u8d1f\u8d23\u7684\u540c\u5fd7\u638c\u63e1\u60c5\u51b5\u3002\u4f01\u4e1a\u6240\u5728\u5730\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u4e5f\u662f\u5728\u6700\u540e\u65f6\u9650\u624d\u5f97\u5230\u901a\u77e5\uff0c\u4f01\u4e1a\u66f4\u4e0d\u53ef\u80fd\u5f97\u5230\u901a\u77e5\u3002\u539f\u6765\u4ee5\u4e3a\u7684\u5f53\u5730\u4fdd\u62a4\uff0c\u73b0\u5728\u53ef\u4e0d\u80fd\u6709\u8fd9\u6837\u7684\u60f3\u6cd5\u4e86\uff0c\u4f01\u4e1a\u662f\u836f\u54c1\u8d28\u91cf\u7684\u4e3b\u4f53\u3002

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

\u7279\u70b9\u4e8c\uff1a\u68c0\u67e5\u7684\u7a81\u7136\u6027\u3002
\u3000\u3000\u7531\u4e8e\u98de\u884c\u68c0\u67e5\u7684\u9690\u5bc6\u6027\uff0c\u6240\u4ee5\uff0c\u88ab\u68c0\u67e5\u4f01\u4e1a\u4e8b\u5148\u4e0d\u53ef\u80fd\u505a\u4efb\u4f55\u51c6\u5907\u5de5\u4f5c\uff0c\u68c0\u67e5\u7ec4\u73b0\u573a\u6240\u770b\u5230\u7684\u5c31\u662f\u4f01\u4e1a\u65e5\u5e38\u751f\u4ea7\u7ba1\u7406\u7684\u771f\u5b9e\u72b6\u51b5\u3002<\/span><\/p>\n


\u7279\u70b9\u4e09\uff1a\u63a5\u5f85\u7684\u7edd\u7f18\u6027\u3002
\u3000\u3000\u98de\u884c\u68c0\u67e5\u7ec4\u8981\u505a\u5230\u4e0d\u5403\u4f01\u4e1a\u996d\u3001\u4e0d\u4f4f\u4f01\u4e1a\u5e97\u3001\u4e0d\u7528\u4f01\u4e1a\u8f66\uff0c\u8d39\u7528\u5168\u90e8\u7531\u836f\u54c1\u8ba4\u8bc1\u7ba1\u7406\u4e2d\u5fc3\u652f\u4ed8\u3002<\/span><\/p>\n


\u7279\u70b9\u56db\uff1a\u73b0\u573a\u7684\u7075\u6d3b\u6027\u3002
\u3000\u3000\u836f\u54c1\u8ba4\u8bc1\u7ba1\u7406\u4e2d\u5fc3\u5236\u5b9a\u68c0\u67e5\u9884\u6848\uff0c\u4e3b\u8981\u786e\u5b9a\u73b0\u573a\u68c0\u67e5\u91cd\u70b9\u3002\u68c0\u67e5\u7ec4\u73b0\u573a\u68c0\u67e5\u7684\u5177\u4f53\u65f6\u95f4\u53ca\u6b65\u9aa4\u7531\u68c0\u67e5\u7ec4\u6839\u636e\u68c0\u67e5\u9700\u8981\u786e\u5b9a\uff0c\u786e\u4fdd\u68c0\u67e5\u8d28\u91cf\u3002<\/span><\/p>\n


\u7279\u70b9\u4e94\uff1a\u8bb0\u5f55\u7684\u5373\u65f6\u6027\u3002
\u3000\u3000\u68c0\u67e5\u5458\u8981\u5728\u73b0\u573a\u68c0\u67e5\u8fc7\u7a0b\u4e2d\u5373\u65f6\u586b\u5199\u98de\u884c\u68c0\u67e5\u5de5\u4f5c\u8bb0\u5f55\u3002\u8fdb\u5165\u6bcf\u4e00\u5de5\u4f5c\u73b0\u573a\uff0c\u5747\u8981\u6839\u636e\u5177\u4f53\u60c5\u51b5\u586b\u5199\u597d\u68c0\u67e5\u5185\u5bb9\u3001\u63a5\u89e6\u4eba\u5458\u3001\u60c5\u51b5\u8bb0\u5f55\u7b49\u9879\u5185\u5bb9\u3002<\/span>
<\/p>\n

\u98de\u68c0\u7684\u8303\u56f4\uff1a<\/strong><\/span><\/section>\n


<\/p>\n

\u3000\u3000
<\/span>      1\u3001\u68c0\u67e5\u7684\u8303\u56f4\u5305\u62ec\uff1a\u533b\u7597\u5668\u68b0\u7814\u5236\u3001\u751f\u4ea7\u3001\u7ecf\u8425\u548c\u4f7f\u7528\u7684\u5168\u8fc7\u7a0b\u3002
\u3000\u30002\u3001\u68c0\u67e5\u7684\u5bf9\u8c61\u5305\u62ec\uff1a
\u3000\u30001)\u6295\u8bc9\u4e3e\u62a5\u6216\u8005\u5176\u4ed6\u6765\u6e90\u7684\u7ebf\u7d22\u8868\u660e\u53ef\u80fd\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684(\u5bf9\u4e8e\u9ad8\u98ce\u9669\u7a0b\u5ea6\u4ea7\u54c1\uff0c\u5fc5\u5c06\u6210\u4e3a\u68c0\u67e5\u7684\u91cd\u70b9);
\u3000\u30002)\u68c0\u9a8c\u53d1\u73b0\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684(\u5982\uff1a\u7701\u7ea7\u4ee5\u4e0a\u5355\u4f4d\u7684\u76d1\u7763\u62bd\u67e5);
\u3000\u30003)\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u63d0\u793a\u53ef\u80fd\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684;
\u3000\u30004)\u5bf9\u7533\u62a5\u8d44\u6599\u771f\u5b9e\u6027\u6709\u7591\u95ee\u7684(\u5982\uff1a\u6ce8\u518c\u7533\u62a5\u3001\u751f\u4ea7\u8bb8\u53ef\u7b49);
\u3000\u30005)\u6d89\u5acc\u4e25\u91cd\u8fdd\u53cd\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u8981\u6c42\u7684(\u8fdd\u53cd\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u88ab\u76d1\u7ba1\u5355\u4f4d\u53d1\u73b0\u7684);
\u3000\u30006)\u4f01\u4e1a\u6709\u4e25\u91cd\u4e0d\u5b88\u4fe1\u8bb0\u5f55\u7684(\u90e8\u5206\u7701\u5e02\u5df2\u5efa\u7acb\u4e86\u8bda\u4fe1\u6863\u6848\uff0c\u6709\u4e0d\u826f\u8bb0\u5f55\u7684\uff0c\u5c06\u662f\u98de\u68c0\u7684\u91cd\u70b9);
\u3000\u30007)\u5176\u4ed6\u9700\u8981\u5f00\u5c55\u98de\u884c\u68c0\u67e5\u7684\u60c5\u5f62\u3002<\/span><\/p>\n

\u3000\u30002\u3001\u68c0\u67e5\u7684\u5bf9\u8c61\u5305\u62ec\uff1a
\u3000\u30001)\u6295\u8bc9\u4e3e\u62a5\u6216\u8005\u5176\u4ed6\u6765\u6e90\u7684\u7ebf\u7d22\u8868\u660e\u53ef\u80fd\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684(\u5bf9\u4e8e\u9ad8\u98ce\u9669\u7a0b\u5ea6\u4ea7\u54c1\uff0c\u5fc5\u5c06\u6210\u4e3a\u68c0\u67e5\u7684\u91cd\u70b9);
\u3000\u30002)\u68c0\u9a8c\u53d1\u73b0\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684(\u5982\uff1a\u7701\u7ea7\u4ee5\u4e0a\u5355\u4f4d\u7684\u76d1\u7763\u62bd\u67e5);
\u3000\u30003)\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u63d0\u793a\u53ef\u80fd\u5b58\u5728\u8d28\u91cf\u5b89\u5168\u98ce\u9669\u7684;
\u3000\u30004)\u5bf9\u7533\u62a5\u8d44\u6599\u771f\u5b9e\u6027\u6709\u7591\u95ee\u7684(\u5982\uff1a\u6ce8\u518c\u7533\u62a5\u3001\u751f\u4ea7\u8bb8\u53ef\u7b49);
\u3000\u30005)\u6d89\u5acc\u4e25\u91cd\u8fdd\u53cd\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u8981\u6c42\u7684(\u8fdd\u53cd\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u88ab\u76d1\u7ba1\u5355\u4f4d\u53d1\u73b0\u7684);
\u3000\u30006)\u4f01\u4e1a\u6709\u4e25\u91cd\u4e0d\u5b88\u4fe1\u8bb0\u5f55\u7684(\u90e8\u5206\u7701\u5e02\u5df2\u5efa\u7acb\u4e86\u8bda\u4fe1\u6863\u6848\uff0c\u6709\u4e0d\u826f\u8bb0\u5f55\u7684\uff0c\u5c06\u662f\u98de\u68c0\u7684\u91cd\u70b9);
\u3000\u30007)\u5176\u4ed6\u9700\u8981\u5f00\u5c55\u98de\u884c\u68c0\u67e5\u7684\u60c5\u5f62\u3002<\/span>

<\/p>\n

\u98de\u884c\u68c0\u67e5\u7c7b\u578b\uff1a<\/strong><\/span><\/section>\n


<\/p>\n

\u3000\u3000
<\/span>      1\u3001\u68c0\u67e5\u4eba\u5458\u7ec4\u6210\uff1a\u901a\u5e38\u75312\u540d\u4ee5\u4e0a\u68c0\u67e5\u4eba\u5458\u7ec4\u6210\uff0c\u68c0\u67e5\u7ec4\u5b9e\u884c\u7ec4\u957f\u8d1f\u8d23\u5236\uff0c\u5e76\u7531\u5f53\u5730\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u6d3e\u51fa\u76f8\u5173\u9886\u57df\u4e13\u5bb6\u53c2\u52a0\u68c0\u67e5\u5de5\u4f5c;
\u3000\u30002\u3001\u68c0\u67e5\u5f62\u5f0f\uff1a\u7a81\u51fb\u68c0\u67e5\u3001\u53d7\u68c0\u5355\u4f4d\u53ca\u68c0\u67e5\u5185\u5bb9\u53ca\u65f6\u95f4\u4fdd\u5bc6\u3001\u68c0\u67e5\u8fdb\u5c55\u4fdd\u5bc6\u3001**\u8bc1\u636e\u8fc5\u901f\u3001\u76f4\u63a5;
\u3000\u30003\u3001\u68c0\u67e5\u65b9\u5f0f\uff1a\u4f01\u4e1a\u76f8\u5173\u573a\u6240\u65e0\u6761\u4ef6\u5411\u68c0\u67e5\u7ec4\u5f00\u653e\uff0c\u6838\u5bf9\u4f01\u4e1a\u73b0\u573a\u5b9e\u7269\uff0c\u786e\u8ba4\u4ea7\u54c1\u8d28\u91cf\uff0c\u76f4\u63a5\u73b0\u573a\u8c03\u67e5\u53d6\u8bc1\u5e76\u8bb0\u5f55\u3001\u5fc5\u8981\u65f6\u62bd\u6837\u9001\u68c0\u9a8c\u90e8\u95e8;\u5bf9\u5b58\u5728\u7591\u95ee\u6216\u5f02\u5e38\u7684\u8d27\u7269\u8fdb\u884c\u5c01\u5b58;<\/span><\/p>\n

\u3000\u30002\u3001\u68c0\u67e5\u5f62\u5f0f\uff1a\u7a81\u51fb\u68c0\u67e5\u3001\u53d7\u68c0\u5355\u4f4d\u53ca\u68c0\u67e5\u5185\u5bb9\u53ca\u65f6\u95f4\u4fdd\u5bc6\u3001\u68c0\u67e5\u8fdb\u5c55\u4fdd\u5bc6\u3001**\u8bc1\u636e\u8fc5\u901f\u3001\u76f4\u63a5;
\u3000\u30003\u3001\u68c0\u67e5\u65b9\u5f0f\uff1a\u4f01\u4e1a\u76f8\u5173\u573a\u6240\u65e0\u6761\u4ef6\u5411\u68c0\u67e5\u7ec4\u5f00\u653e\uff0c\u6838\u5bf9\u4f01\u4e1a\u73b0\u573a\u5b9e\u7269\uff0c\u786e\u8ba4\u4ea7\u54c1\u8d28\u91cf\uff0c\u76f4\u63a5\u73b0\u573a\u8c03\u67e5\u53d6\u8bc1\u5e76\u8bb0\u5f55\u3001\u5fc5\u8981\u65f6\u62bd\u6837\u9001\u68c0\u9a8c\u90e8\u95e8;\u5bf9\u5b58\u5728\u7591\u95ee\u6216\u5f02\u5e38\u7684\u8d27\u7269\u8fdb\u884c\u5c01\u5b58;<\/span><\/p>\n


<\/p>\n

\u5982\u4f55\u5e94\u5bf9\u98de\u68c0<\/strong><\/span><\/section>\n


<\/p>\n

\u3000\u3000<\/span>\u4ece\u8fd1\u671f\u4e24\u6b21\u98de\u68c0\u5f53\u4e2d\u66b4\u9732\u51fa\u7684\u4e25\u91cd\u95ee\u9898\u70b9\uff0c\u4e3b\u8981\u4f53\u73b0\u57288\u4e2a\u65b9\u9762\uff1a
<\/span><\/p>\n

\u3000\u30001\u3001\u4eba\u5458\u57f9\u8bad\u4e0d\u5230\u4f4d\uff1a\u672a\u5bf9\u5173\u952e\u53ca\u7279\u6b8a\u5c97\u4f4d\u8fdb\u884c\u76f8\u5e94\u7684\u57f9\u8bad;
\u3000\u30002\u3001\u751f\u4ea7\u7ba1\u7406\u4e0d\u5230\u4f4d\uff1a\u672a\u5236\u5b9a\u53d7\u63a7\u7684\u5173\u952e\u548c\u7279\u6b8a\u8fc7\u7a0b\u7684\u4f5c\u4e1a\u6307\u5bfc\u4e66;\u672a\u5bf9\u5173\u952e\u548c\u7279\u6b8a\u8fc7\u7a0b\u7684\u91cd\u8981\u53c2\u6570\u8fdb\u884c\u9a8c\u8bc1\u6216\u786e\u8ba4\u3002
\u3000\u30003\u3001\u8d28\u91cf\u63a7\u5236\u4e0d\u5230\u4f4d\uff1a\u68c0\u9a8c\u65b9\u6cd5\u53ca\u5224\u5b9a\u89c4\u5219\u4e0d\u660e\u786e\u3001\u51fa\u5382\u68c0\u9a8c\u672a\u6309\u8981\u6c42\u8fdb\u884c\u3001\u73b0\u573a\u672a\u505a\u68c0\u9a8c\u6807\u8bc6;
\u3000\u30004\u3001\u672a\u5bf9\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u8fd0\u884c\u8fdb\u884c\u8bc4\u4ef7\u548c\u5ba1\u6838\uff1a\u672a\u6309\u8981\u6c42\u8fdb\u884c\u5185\u5ba1\u3001\u5b9a\u671f\u53ec\u5f00\u7ba1\u7406\u8bc4\u5ba1;
\u3000\u30005\u3001\u5382\u623f\u8bbe\u65bd\u4e0d\u6ee1\u8db3\u751f\u4ea7\u6761\u4ef6\u4e0d\u7b26\u5408\u8981\u6c42\uff1a\u4ed3\u5e93\u8d2e\u5b58\u6761\u4ef6\u53ca\u8bbe\u65bd\u4e0d\u7b26\u5408\uff0c\u751f\u4ea7\u5de5\u827a\u4e0d\u5b8c\u5584\uff0c\u751f\u4ea7\u6761\u4ef6\u4e0d\u7b26\u5408\u8981\u6c42;
\u3000\u30006\u3001\u8bbe\u8ba1\u5f00\u53d1\u7ba1\u7406\u4e0d\u5230\u4f4d\uff1a\u672a\u5efa\u7acb\u5168\u5957\u5b8c\u6574\u7684\u8bbe\u8ba1\u5f00\u53d1\u6587\u6863\uff0c\u4fdd\u6301\u8bbe\u8ba1\u66f4\u6539\u8bb0\u5f55;
\u3000\u30007\u3001\u8d28\u91cf\u4f53\u7cfb\u6587\u4ef6\u7ba1\u63a7\u4e0d\u5230\u4f4d\uff1a\u68c0\u9a8c\u89c4\u7a0b\u4e0e\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u89c4\u5b9a\u4e0d\u4e00\u81f4\u3001\u672a\u5236\u8ba2\u653e\u884c\u7a0b\u5e8f\u3001\u672a\u6309\u68c0\u9a8c\u65b9\u6cd5\u68c0\u9a8c;
\u3000\u30008\u3001\u4e0d\u5408\u683c\u54c1\u63a7\u5236\u4e0d\u5230\u4f4d\uff1a\u4e0d\u5408\u683c\u54c1\u672a\u6309\u8981\u6c42\u8fdb\u884c\u6807\u8bc6\u3001\u8bb0\u5f55\u3001\u9694\u79bb\u3001\u8bc4\u5ba1;
\u3000\u3000\u4f5c\u4e3a\u68b0\u4f01\uff0c\u5e94\u53ca\u65f6\u5173\u6ce8\u98de\u68c0\u68c0\u67e5\u60c5\u51b5\uff0c\u4ece\u5b83\u4eba\u8eab\u4e0a\u53cd\u601d\u81ea\u5df2\uff0c\u4e0d\u65ad\u6539\u8fdb\u3002<\/span>

<\/p>\n

\u719f\u77e5\u73b0\u573a\u68c0\u67e5\u7ec6\u5219\uff1a<\/strong><\/span><\/section>\n


<\/p>\n

\u3000\u3000
<\/span>      \u56e0\u6bcf\u4e2a\u4f01\u4e1a\u4ea7\u54c1\u4e0d\u540c\uff0c\u73b0\u573a\u68c0\u67e5\u6807\u51c6\u4e5f\u4e0d\u540c\u3002\u4f46\u5bf9\u4e8eGMP\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u6709\u5982\u4e0b\u516d\u4e2a\u91cd\u70b9\uff1a
\u3000\u3000\u7b2c\u4e00\uff1a\u67e5\u770b\u73b0\u573a\u5b9e\u7269\uff0c\u8c03\u67e5\u53d6\u8bc1\u5e76\u68c0\u67e5\u5b9e\u7269\u8d28\u91cf\u72b6\u51b5
\u3000\u3000\u6839\u636e\u53cc\u65b9\u786e\u5b9a\u7684\u8def\u7ebf\u548c\u6b65\u9aa4\uff0c\u9996\u5148\u53bb\u4ed3\u5e93\u3001\u8f66\u95f4\u73b0\u573a\u8c03\u67e5\u53d6\u8bc1\uff0c\u67e5\u770b\u4ed3\u5e93\u4e3b\u8981\u836f\u6750(\u996e\u7247)\u4f9b\u5e94\u5546\u540d\u79f0\u3001\u5e93\u5b58\u5b9e\u7269\u6570\u91cf\u3001\u6279\u53f7\u3001\u8d28\u91cf\u60c5\u51b5(\u91cd\u70b9\u662f\u771f\u4f2a\u3001\u6709\u65e0\u63ba\u5047)\u3001\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u53ca\u4f01\u4e1a\u8d28\u91cf\u90e8\u53d6\u6837\u8bc1\u660e\u8d44\u6599\u3001\u68c0\u9a8c\u5408\u683c\u62a5\u544a\u53ca\u8f66\u95f4\u751f\u4ea7\u4ea7\u54c1\u540d\u79f0\u3001\u6240\u7528\u7269\u6599\u7684\u540d\u79f0\u3001\u6279\u53f7;<\/span><\/p>\n

\u3000\u3000\u7b2c\u4e00\uff1a\u67e5\u770b\u73b0\u573a\u5b9e\u7269\uff0c\u8c03\u67e5\u53d6\u8bc1\u5e76\u68c0\u67e5\u5b9e\u7269\u8d28\u91cf\u72b6\u51b5
\u3000\u3000\u6839\u636e\u53cc\u65b9\u786e\u5b9a\u7684\u8def\u7ebf\u548c\u6b65\u9aa4\uff0c\u9996\u5148\u53bb\u4ed3\u5e93\u3001\u8f66\u95f4\u73b0\u573a\u8c03\u67e5\u53d6\u8bc1\uff0c\u67e5\u770b\u4ed3\u5e93\u4e3b\u8981\u836f\u6750(\u996e\u7247)\u4f9b\u5e94\u5546\u540d\u79f0\u3001\u5e93\u5b58\u5b9e\u7269\u6570\u91cf\u3001\u6279\u53f7\u3001\u8d28\u91cf\u60c5\u51b5(\u91cd\u70b9\u662f\u771f\u4f2a\u3001\u6709\u65e0\u63ba\u5047)\u3001\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u53ca\u4f01\u4e1a\u8d28\u91cf\u90e8\u53d6\u6837\u8bc1\u660e\u8d44\u6599\u3001\u68c0\u9a8c\u5408\u683c\u62a5\u544a\u53ca\u8f66\u95f4\u751f\u4ea7\u4ea7\u54c1\u540d\u79f0\u3001\u6240\u7528\u7269\u6599\u7684\u540d\u79f0\u3001\u6279\u53f7;<\/span><\/p>\n

\u3000\u3000\u7b2c\u4e8c\uff1a\u68c0\u67e5\u6838\u5bf9\u4e3b\u8981\u4f9b\u5e94\u5546\u7684\u6863\u6848\u8d44\u6599\u3001\u8d44\u8d28\uff1a
\u3000\u3000\u786e\u8ba4\u4f9b\u5e94\u5546\u662f\u5426\u5408\u683c\uff0c\u4f9b\u5e94\u8303\u56f4\u548c\u73b0\u573a\u5b9e\u7269\u8bb0\u5f55\u662f\u5426\u4e00\u81f4\uff0c\u5c24\u5176\u662f\u4e00\u4e9b\u8fdb\u53e3\u836f\u6750\u5e94\u6709\u8fdb\u53e3\u6279\u4ef6\u53ca\u53e3\u5cb8\u6240\u68c0\u9a8c\u62a5\u544a\u590d\u5370\u4ef6(\u52a0\u76d6\u4f9b\u8d27\u5355\u4f4d\u8d28\u91cf\u7ae0);<\/span><\/p>\n

\u3000\u3000\u7b2c\u4e09\uff1a\u68c0\u67e5\u7269\u6599\u5e73\u8861
\u3000\u3000\u4f9d\u636e\u91c7\u8d2d\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u3001\u5e93\u5b58\u8d27\u4f4d\u5361\u3001\u68c0\u67e5\u9636\u6bb5\u6027\u524d\u5904\u7406\u53ca\u63d0\u53d6\u3001\u5236\u5242\u751f\u4ea7\u8bb0\u5f55\uff0c\u6838\u67e5\u4e3b\u8981\u836f\u6750(\u996e\u7247)\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u7684\u5165\u5e93\u65f6\u95f4\u3001\u6279\u53f7\u3001\u6570\u91cf\uff0c\u5e76\u4e0e\u751f\u4ea7\u8bb0\u5f55\u3001\u5e93\u5b58\u5b9e\u7269\u3001\u5e93\u5b58\u8d27\u4f4d\u5361\u3001\u5206\u7c7b\u8d26\u6838\u5bf9\uff0c\u8fdb\u884c\u6295\u5165\u3001\u4ea7\u51fa\u7269\u6599\u5e73\u8861\u6838\u5bf9\u548c\u5206\u6790\uff0c\u6838\u5bf9\u836f\u6750(\u996e\u7247)\u8d27\u4f4d\u5361\u8fdb\u51fa\u8bb0\u5f55\u6570\u91cf\u3001\u65f6\u95f4\u4e0e\u524d\u5904\u7406\u53ca\u63d0\u53d6\u8bb0\u5f55\u3001\u51fa\u5165\u5e93\u7968\u636e\u7684\u4e00\u81f4\u6027\uff0c\u91cd\u70b9\u6838\u5bf9\u4e2d\u836f\u6750(\u996e\u7247)\u996e\u7247\u524d\u5904\u7406\u53ca\u63d0\u53d6\u751f\u4ea7\u7684\u4e2d\u95f4\u4f53\u53ca\u5236\u5242\u6240\u751f\u4ea7\u7684\u6210\u54c1\u7684\u7269\u6599\u5e73\u8861\u662f\u5426\u7b26\u5408\u89c4\u5b9a(\u4f9d\u636e\u4ea7\u54c1\u8d28\u91cf\u6807\u51c6\u548c\u4ea7\u54c1\u5de5\u827a\u89c4\u7a0b\uff0c\u636e\u6709\u5173\u6d88\u606f\uff0c\u73b0\u5728\u6709\u98de\u884c\u68c0\u67e5\u4f9d\u636e\u6ce8\u518c\u5de5\u827a\u6838\u5bf9\u5de5\u827a\u7684\u7b26\u5408\u6027);<\/span><\/p>\n

\u3000\u3000\u7b2c\u56db\uff1a\u68c0\u67e5\u6838\u5bf9\u53d6\u6837\u7559\u6837\u548c\u5168\u68c0\u60c5\u51b5
\u3000\u3000\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u548c\u8d27\u4f4d\u5361\u8d44\u6599\uff0c\u68c0\u67e5\u8d28\u91cf\u90e8\u53d6\u6837\u8bb0\u5f55\u3001\u68c0\u67e5\u6838\u5bf9\u6bcf\u6279\u836f\u6750(\u996e\u7247)\u7559\u6837\u8bb0\u5f55\u53ca\u7559\u6837\u5b9e\u7269\uff0c\u68c0\u67e5\u6838\u5bf9\u68c0\u9a8c\u539f\u59cb\u8bb0\u5f55\u3001\u68c0\u9a8c\u62a5\u544a\uff0c\u5bf9\u9ad8\u6548\u6db2\u76f8\u3001\u539f\u5b50\u5438\u6536\u3001\u6c14\u76f8\u8272\u8c31\u7b49\u56fe\u8c31\u6253\u5f00\u7535\u8111\u6838\u5bf9\u68c0\uff0c\u5c24\u5176\u662f\u4ece\u5165\u5e93\u9a8c\u6536\u65f6\u95f4\u3001\u53d6\u6837\u65f6\u95f4\u3001\u68c0\u9a8c\u65f6\u95f4\u3001\u51fa\u62a5\u544a\u65f6\u95f4\u3001\u8bbe\u5907\u4eea\u5668\u4f7f\u7528\u8bb0\u5f55\u4e2d\u5bf9\u5e94\u7684\u65f6\u95f4\u6765\u8fdb\u884c\u771f\u5b9e\u6027\u548c\u5b8c\u6574\u6027;<\/span><\/p>\n

\u3000\u3000\u9488\u5bf9\u5173\u952e\u836f\u6750(\u996e\u7247)\u91c7\u8d2d\u5165\u5e93\u6b21\u6570\u548c\u6279\u53f7\uff0c\u6838\u5bf9\u5173\u952e\u5bf9\u7167\u54c1\u7684\u8d2d\u8fdb\u3001\u4f7f\u7528\u8bb0\u5f55\uff0c\u4ee5\u786e\u8ba4\u68c0\u9a8c\u6b21\u6570\u4e0e\u5bf9\u7167\u54c1\u91c7\u8d2d\u91cf\u3001\u4f7f\u7528\u91cf\u7684\u5e73\u8861\u3002<\/span><\/p>\n

\u3000\u3000\u7b2c\u4e94\uff1a\u62bd\u67e5\u6210\u54c1\u7559\u6837\u53ca\u68c0\u67e5\u6838\u5bf9\u9500\u552e\u8bb0\u5f55
\u3000\u3000\u4f9d\u636e\u6210\u54c1\u5e93\u5b58\u8d27\u4f4d\u5361\u8bb0\u5f55\u53ca\u6279\u751f\u4ea7\u539f\u59cb\u8bb0\u5f55\uff0c\u968f\u673a\u62bd\u67e5\u6838\u5bf9\u8d28\u91cf\u90e8\u6210\u54c1\u6210\u54c1\u7559\u6837\u53d6\u6837\u8bb0\u5f55\u548c\u7559\u6837\u5b9e\u7269\uff0c\u5e76\u4f9d\u636e\u751f\u4ea7\u539f\u59cb\u8bb0\u5f55\u4e2d\u6210\u54c1\u5165\u5e93\u6570\u91cf\u6838\u5bf9\u9500\u552e\u8bb0\u5f55\u3001\u67e5\u770b\u9500\u552e\u53d1\u7968;<\/span><\/p>\n

\u3000\u3000\u7b2c\u516d\uff1a\u6838\u539f\u8f85\u6599\u8d2d\u8fdb\u53d1\u7968\uff0c\u5e76\u4e0e\u5165\u5e93\u9a8c\u6536\u8bb0\u5f55\u3001\u751f\u4ea7\u4f7f\u7528\u8bb0\u5f55\u6838\u5bf9\u8d2d\u8fdb\u65e5\u671f\u3001\u8d2d\u8fdb\u6570\u91cf\u3001\u6838\u67e5\u7269\u6599\u5e73\u8861\u60c5\u51b5\u3002
\u3000\u3000\u73b0\u5728\u68c0\u67e5\u90fd\u4f1a\u67e5\u5230\u53d1\u7968\uff0c\u6240\u4ee5\u53d1\u7968\u6570\u91cf\u3001\u91c7\u8d2d\u5408\u540c\u3001\u8d28\u91cf\u68c0\u9a8c\u3001\u5165\u5e93\u6570\u91cf\u3001\u8d2d\u8fdb\u65f6\u95f4\u90fd\u8981\u5bf9\u5e94\u4e00\u81f4\u3002\u5982\u6709\u4e0d\u4e00\u81f4\uff0c\u8fd8\u53ef\u80fd\u4f1a\u8fdb\u884c\u8ffd\u6eaf\u6027\u5bf9\u4e0a\u6e38\u4f01\u4e1a\u8fdb\u884c\u6838\u67e5\u3002
\u3000\u3000\u5176\u5b9e\u8bf4\u91cd\u70b9\u4e5f\u597d\uff0c\u53ea\u662f\u5176\u4e2d\u7684\u4e00\u65b9\u9762\u800c\u5df2\uff0c\u76f8\u4fe1\u6bcf\u6b21\u6839\u636e\u68c0\u67e5\u9488\u5bf9\u6027\u7684\u4e0d\u540c\uff0c\u80af\u5b9a\u8fd8\u6709\u5176\u4ed6\u65b9\u9762\u7684\u91cd\u70b9\u5185\u5bb9\uff0c\u5e0c\u671b\u5927\u5bb6\u8fdb\u884c\u5b8c\u5584\uff0c\u8865\u5145\u3002\u7531\u4e8e\u98de\u884c\u68c0\u67e5\u4e0e\u4ee5\u5f80 GMP<\/span> <\/span>\u8ddf\u8e2a\u68c0\u67e5\u4ece\u5f62\u5f0f\u4e0a\u5230\u5b9e\u8d28\u4e0a\u90fd\u53d1\u751f\u4e86\u53d8\u5316\uff0c\u800c\u4e14\u5728\u56fd\u5bb6\u5c40\u5173\u4e8e\u98de\u884c\u68c0\u67e5\u7684\u76f8\u5173\u6587\u4ef6\u4e2d\u4e5f\u5bf9\u98de\u884c\u68c0\u67e5\u8fdb\u884c\u4e86\u8bf4\u660e\uff0c\u5176\u7a81\u51fa\u7684\u7279\u70b9\u6709\u4e94\u65b9\u9762\u3002<\/span><\/p>\n


\u3000\u3000<\/span><\/p>\n

\u6784\u5efa\u7b26\u5408GMP\u8981\u6c42\u7684\u4f53\u7cfb\uff1a
\u3000\u30001\u3001CMP\u6838\u67e5\u7684\u91cd\u70b9\u5728\u4e8e\u4f01\u4e1a\u662f\u5426\u6709\u5efa\u7acb\u76f8\u5e94\u7684GMP\u4f53\u7cfb\uff0c\u65e5\u5e38\u7ecf\u8425\u7ba1\u7406\u662f\u5426\u6709\u6309GMP\u4f53\u7cfb\u6267\u884c\uff0c\u5efa\u7acb\u4e00\u5957\u7b26\u5408\u8981\u6c42\u7684GMP\u4f53\u7cfb\uff0c\u5e76\u6301\u7eed\u8fd0\u884c\uff0c\u663e\u5f97\u5c24\u4e3a\u91cd\u8981;
\u3000\u30002\u3001\u65b0\u7684GMP\u8f83\u4e4b\u524d\u7684\u6cd5\u89c4\uff0c\u5728\u8bf8\u591a\u65b9\u9762\u53d1\u751f\u4e86\u53d8\u5316\u3002\u4f5c\u4e3a\u5df2\u6210\u7acb\u8f83\u4e45\u7684\u4f01\u4e1a\uff0c\u539fGMP\u8981\u6c42\u5efa\u7acb\u7684\u4f53\u7cfb\uff0c\u5728\u76f8\u5f53\u4e00\u90e8\u5206\u6761\u6b3e\u4e0a\u90fd\u65e0\u6cd5\u6ee1\u8db3\u6700\u65b0GMP\u7684\u8981\u6c42\uff0c\u4f01\u4e1a\u5e94\u5bf9\u6574\u4e2a\u4f53\u7cfb\u6587\u4ef6\u8fdb\u884c\u68b3\u7406\u786e\u8ba4\uff0c\u7ed3\u5408\u81ea\u8eab\u4ea7\u54c1\u7279\u70b9\uff0c\u6765\u8bc6\u522bGMP\u6761\u6b3e\u7684\u9002\u7528\u6027\uff0c\u8865\u5145\u53ca\u4f18\u5316\u73b0\u6709\u4f53\u7cfb(\u53ef\u80fd\u4f1a\u6d89\u53ca\u5230\u4ece\u4eba\u5458\u3001\u5382\u623f\u8bbe\u65bd\u3001\u751f\u4ea7\u5de5\u827a\u3001\u68c0\u9a8c\u6761\u4ef6\u7b49\u65b9\u9762\u7684\u91cd\u65b0\u8c03\u6574)\u3002\u65b0\u7684GMP\u5c06\u4e8e2018\u5e7401\u670801\u65e5\u5168\u9762\u5b9e\u65bd\uff0c\u79bb\u5168\u9762\u6267\u884c\u65f6\u95f4\u5df2\u4e0d\u8db3\u4e24\u5e74\u7684\u8fc7\u6e21\u671f\u3002\u5982\u4ecd\u6309GMP\u8981\u6c42\u6267\u884c\u4f01\u4e1a\uff0c\u5e94\u53ca\u65f6\u505a\u597d\u51c6\u5907;
\u3000\u30003\u3001\u5bf9\u4e8e\u4ea7\u54c1\u6d89\u53ca\u5230\u5f3a\u5236\u6027\u6807\u51c6\u7684\u60c5\u51b5\uff0c\u5fc5\u987b\u6309\u5f3a\u5236\u6027\u6807\u51c6\u4ee5\u53ca\u7ecf\u6ce8\u518c\u6216\u8005\u5907\u6848\u7684\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u5236\u5b9a\u4ea7\u54c1\u7684\u68c0\u9a8c\u89c4\u7a0b\uff0c\u4e14\u4e0d\u80fd\u968f\u610f\u66f4\u6539\uff0c\u786e\u4fdd\u51fa\u5382\u68c0\u9a8c\u9879\u76ee\u7b26\u5408\u8981\u6c42;
\u3000\u30004\u3001\u4f9d\u636eGMP\u53ca\u8d28\u91cf\u4f53\u7cfb\u6587\u4ef6\u5efa\u7acb\u76f8\u5e94\u7684\u6279\u8bb0\u5f55(\u5305\u62ec\uff1a\u8bbe\u8ba1\u7814\u53d1\u3001\u6279\u751f\u4ea7\u8bb0\u5f55\u3001\u6279\u68c0\u9a8c\u8bb0\u5f55\u3001\u91c7\u8d2d\u3001\u4ed3\u5e93\u3001\u6279\u9500\u552e\u8bb0\u5f55\u3001\u4eba\u5458\u57f9\u8bad\u3001\u7ba1\u5185\u5ba1\u3001\u6587\u4ef6\u7ba1\u63a7\u7b49)\u3002<\/span>
\u3000\u3000<\/span><\/p>\n

\u5b9a\u671f\u5c55\u5f00GMP\u81ea\u67e5\uff1a<\/strong><\/span><\/section>\n


\u3000\u3000<\/span><\/p>\n

1\u3001\u6b64\u524d\u56fd\u5bb6\u603b\u5c40\u53d1\u5e03\u4e86\u300a\u5173\u4e8e\u53d1\u5e03\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u7f16\u5199\u6307\u5357\u7684\u901a\u544a\u300b(2016\u5e74\u7b2c76\u53f7)\uff0c\u5bf9\u751f\u4ea7\u4f01\u4e1a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u505a\u51fa\u4e86\u89c4\u5b9a;\u53ef\u89c1\u8d28\u91cf\u4f53\u7cfb\u81ea\u67e5\u7684\u91cd\u8981\u6027\uff0c\u8fd9\u4e0d\u4ec5\u5bf9\u5916\u5f62\u5f0f\u7684\u4e0a\u62a5\u81ea\u67e5\uff0c\u66f4\u5e94\u8be5\u5728\u5e73\u65f6\u5c55\u5f00\u5185\u90e8\u7684\u68c0\u67e5\uff0c\u53ca\u65f6\u53d1\u73b0\u95ee\u9898\u5e76\u6539\u8fdb\uff0c\u4e0d\u8981\u6577\u884d\u53ca\u56de\u907f\u4efb\u4f55\u7684\u95ee\u9898\uff0c\u53ea\u6709\u5bf9\u81ea\u5df1\u8d1f\u8d23\uff0c\u8fd9\u6837\u624d\u80fd\u5e94\u5bf9\u4efb\u4f55\u65f6\u5019\u3001\u4efb\u4f55\u60c5\u51b5\u4e0b\u7684\u5916\u90e8\u68c0\u67e5;<\/span>
<\/p>\n

\u3000\u3000<\/span><\/p>\n

2\u3001\u81ea\u67e5\u524d\uff0c\u9996\u5148\u8981\u6e05\u695aGMP\u9a8c\u6536\u6807\u51c6\uff1a\u73b0\u884c\u7684GMP\u8f83\u4e4b\u524d\u7684\u6cd5\u89c4\uff0c\u5220\u9664\u4e86\u9a8c\u6536\u8bc4\u5224\u6807\u51c6\uff0c\u5220\u9664\u4e86\u901a\u8fc7\u68c0\u67e5\uff0c\u5141\u8bb8\u4ea7\u751f\u7684\u4e00\u5b9a\u6570\u91cf\u4e00\u822c\u4e0d\u7b26\u5408\u9879\u7684\u60c5\u5f62\u3002\u76ee\u524d\u836f\u76d1\u7ba1\u5355\u4f4d\u7684\u73b0\u573a\u9a8c\u6536\u62a5\u544a\u4e3a\u300a\u73b0\u573a\u68c0\u67e5\u7f3a\u9677\u8868\u300b\uff0c\u8fd9\u5c31\u610f\u5473\u7740\u73b0\u573a\u68c0\u67e5\u4e3b\u8981\u662f\u67e5\u95ee\u9898\u70b9\u7684\uff0c\u6700\u540e\u6240\u6709\u4e0d\u7b26\u5408\u9879\u5fc5\u987b\u5168\u90e8\u6574\u6539\u5408\u683c\uff0c\u5e76\u7ecf\u836f\u76d1\u90e8\u95e8\u590d\u67e5\u786e\u8ba4\u540e\uff0c\u65b9\u53ef\u901a\u8fc7\u3002\u5bf9\u4e8e\u5173\u952e\u9879*\u4e5f\u662f\u73b0\u573a\u68c0\u67e5\u4e2d\u7684\u9ad8\u538b\u7ebf\uff0c\u5343\u4e07\u4e0d\u80fd\u89e6\u78b0\uff0c\u4e00\u6761\u5c31\u81f4\u547d\uff0c\u8f7b\u5219\u9650\u671f\u6574\u6539\uff0c\u91cd\u5219\u64a4\u9500\u76f8\u5173\u8d44\u683c\u8ba4\u8bc1\u8ba4\u5b9a\u8bc1\u4e66\u3001\u534a\u5e74\u5185\u4e0d\u53d7\u7406\u6750\u6599\u7533\u62a5\u6216\u884c\u653f\u7f5a\u6b3e\u7b49\u5904\u7f5a\u63aa\u65bd;
\u3000\u3000<\/span><\/p>\n

3\u3001\u5982\u4ea7\u54c1\u5c5e\u4e8e\u9ad8\u98ce\u9669\u4ea7\u54c1\u6216\u56fd\u5bb6\u603b\u5c40\u3001\u7701\u5c40\u53d1\u5e03\u7684\u91cd\u70b9\u76d1\u63a7\u76ee\u5f55\u5185\u7684\u4ea7\u54c1\uff0c\u6bcf\u4e00\u6b3e\u8282\u90fd\u5e94\u4e25\u683c\u63a7\u5236;
\u3000\u3000<\/span><\/p>\n

4\u3001\u5b9a\u671f\u7ec4\u7ec7\u5404\u76f8\u5173\u90e8\u95e8\u53ca\u4eba\u5458\u5bf9\u7167\u76f8\u5e94\u7684GMP\u6761\u6b3e\u9010\u4e00\u8fdb\u884c\u81ea\u67e5\u53ca\u6574\u6539\uff0c\u4e0d\u8981\u9057\u6f0f\u4efb\u4f55\u6761\u6b3e\uff0c\u6b63\u786e\u8bc6\u522b\u5408\u7406\u4e0d\u9002\u7528\u7684\u6761\u6b3e;\u7279\u522b\u662f\u5f53\u4e2d\u5173\u952e\u9879*\u7684\u90e8\u5206\uff0c\u5fc5\u987b\u9ad8\u5ea6\u91cd\u89c6\u3002\u4f5c\u4e3a\u65b0\u5f00\u529e\u7684\u4f01\u4e1a\uff0c\u5982\u4ea7\u54c1\u8fd8\u672a\u9500\u552e\uff0c\u6d89\u53ca\u5230\u6761\u6b3e\u4e2d\u9500\u552e\u7684\u5185\u5bb9\u4e00\u822c\u662f\u7a7a\u767d\u7684\uff0c\u5bf9\u4e8e\u6b64\u6761\u6b3e\u53ea\u662f\u786e\u8ba4\u6587\u4ef6\u7684\u7b26\u5408\u6027;\u4f5c\u4e3a\u5df2\u83b7\u8bc1\u4f01\u4e1a\uff0c\u5e94\u6309\u6761\u6b3e\u7684\u8981\u6c42\u5efa\u7acb\u5168\u5957\u7684\u6279\u8d28\u91cf\u8bb0\u5f55;
\u3000\u3000<\/span><\/p>\n

5\u3001\u81ea\u67e5\u6709\u53ef\u6309\u7167\u4e00\u6761\u7ebf\u8def\u53ca\u65b9\u5f0f\u8fdb\u884c\u81ea\u67e5\uff0c\u5982\uff1a\u4ece\u9500\u552e\u8ba2\u5355\u8ffd\u67e5\u5230\u539f\u6750\u6599\u7684\u91c7\u8d2d\uff0c\u786e\u8ba4\u4e2d\u95f4\u6bcf\u4e00\u8fc7\u7a0b\u7684\u76f8\u5173\u6279\u8bb0\u5f55\u7684\u5b8c\u6574\u6027(\u5305\u62ec\uff1a\u9500\u552e\u6279\u8bb0\u5f55\u3001\u4ed3\u5e93\u51fa\u5165\u5e93\u7ba1\u7406\u3001\u751f\u4ea7\u6279\u8bb0\u5f55\u3001\u68c0\u9a8c\u6279\u8bb0\u5f55\u3001\u91c7\u8d2d\u8bb0\u5f55\u7b49);
\u3000\u3000<\/span><\/p>\n

6\u3001\u5728\u65b0\u89c4\u4e0b\uff0c\u56fd\u5bb6\u603b\u5c40\u7279\u522b\u5f3a\u8c03\u4ea7\u54c1\u8ffd\u6eaf\u4f53\u7cfb\uff0c\u8fd9\u4e5f\u662f\u73b0\u884c\u6838\u67e5\u7ebf\u7d22\u7684\u4e3b\u52a8\u8109\uff0c\u4f01\u4e1a\u5e94\u5728\u5efa\u7acb\u4f53\u7cfb\u65f6\u53ca\u6279\u8bb0\u5f55\u65f6\uff0c\u5fc5\u987b\u786e\u8ba4\u8ffd\u6eaf\u6d41\u7a0b\u662f\u5426\u5b8c\u6574\u3002<\/span><\/p>\n


<\/p>\n

\u81ea\u67e5\u5173\u952e\u70b9<\/strong><\/span><\/section>\n


<\/p>\n

\u4e00\u3001\u73b0\u573a\u51b3\u4e0d\u5141\u8bb8\u51fa\u73b0\u7684\u95ee\u9898 <\/span><\/strong><\/p>\n

1\u3001\u5404\u79cd\u73b0\u573a\u5b58\u653e\u7684\u7269\u6599\uff0c\u51fa\u73b0\u5e10\u3001\u5361\u3001\u7269\u4e0d\u7b26\u6216\u6ca1\u6709\u6807\u7b7e\u6216\u6ca1\u6709\u5b9a\u7f6e\u5b9a\u4f4d\uff1b <\/span><\/p>\n

2\u3001\u73b0\u573a\u6f14\u793a\u65e0\u6cd5\u64cd\u4f5c\u6216\u64cd\u4f5c\u4e0d\u5408\u89c4\u3001\u4e0d\u80fd\u8bf4\u6e05\u5982\u4f55\u5de5\u4f5c\uff1b <\/span><\/p>\n

3\u3001\u73b0\u573a\uff08\u5305\u62ec\u5783\u573e\u6876\u3001\u5783\u573e\u7ad9\uff09\u5b58\u5728\u5e9f\u65e7\u6587\u4ef6\uff08\u53d7\u63a7\u6216\u975e\u53d7\u63a7\uff09\uff0c\u6216\u6709\u6495\u6bc1\u8bb0\u5f55\uff0c\u968f\u610f\u6d82\u6539\u4ee5\u53ca\u63d0\u524d\u6216\u660e\u663e\u6ede\u540e\u586b\u5199\u73b0\u8c61\uff1b <\/span><\/p>\n

4\u3001\u4e13\u5bb6\u9762\u524d\u63a8\u5378\u8d23\u4efb\u3001\u4e89\u8fa9\u3001\u8bad\u65a5\u4e0b\u5c5e\u6216\u6709\u963b\u6320\u3001\u5e72\u6270\u68c0\u67e5\u5de5\u4f5c\u7684\u73b0\u8c61\uff1b <\/span><\/p>\n

5\u3001\u73af\u5883\u6e29\u6e7f\u5ea6\u3001\u538b\u5dee\u3001\u6d01\u51c0\u533a\u5bc6\u5c01\u7b49\u65b9\u9762\u5b58\u5728\u95ee\u9898\uff1b <\/span><\/p>\n

6\u3001\u7a7f\u7740\u6d01\u51c0\u670d\u884c\u8d70\u5728\u4e0d\u540c\u6d01\u51c0\u7ea7\u522b\u533a\u57df\u4e4b\u5185\uff1b <\/span><\/p>\n

7\u3001\u73b0\u573a\u8bbe\u5907\u8bbe\u65bd\u8868\u9762\u5b58\u5728\u660e\u663e\u7684\u9508\u8ff9\u3001\u6cb9\u6c61\u6216\u7c89\u5c18\u3002. <\/span><\/p>\n

8\u3001\u8f66\u95f4\u3001\u4ed3\u5e93\u5b58\u5728\u556e\u9f7f\u7c7b\u52a8\u7269\u5c38\u4f53\u3001\u7caa\u4fbf\u6216\u5176\u4ed6\u6d3b\u52a8\u75d5\u8ff9\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\u4e8c\u3001\u5404\u90e8\u95e8\u8f66\u95f4\u6307\u5b9a\u8d1f\u8d23\u56de\u7b54\u95ee\u9898\u7684\u4eba\u5458\u7d20\u8d28\u8981\u6c42<\/span><\/strong><\/p>\n

1\u3001\u6709\u80fd\u529b\u53ef\u80dc\u4efb\uff1b<\/span><\/p>\n

2\u3001\u6c89\u7a33\u81ea\u4fe1\uff1b <\/span><\/p>\n

3\u3001\u653e\u5fc3\u53ef\u9760\u3001\u80fd\u4fe1\u4efb\u7684\uff08\u4ee5\u9632\u6545\u610f\u6363\u4e71\uff09\uff1b <\/span><\/p>\n

4\u3001\u6709\u7ecf\u9a8c\u53ca\u4e13\u4e1a\u6709\u77e5\u8bc6\uff1b <\/span><\/p>\n

5\u3001\u4e0d\u8be5\u8bf4\u7684\u522b\u4e71\u8bf4\uff0c\u4ee5\u514d\u8282\u5916\u751f\u679d\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\u4e09\u3001\u5404\u90e8\u95e8\u5fc5\u987b\u6ce8\u610f\u7684\u95ee\u9898  <\/span><\/strong>
<\/p>\n

\uff08\u4e00\uff09\u8bbe\u5907\u8bbe\u65bd\u65b9\u9762\u5fc5\u987b\u907f\u514d\u51fa\u73b0\u7684\u95ee\u9898<\/span>
<\/p>\n

1\u3001\u4e0d\u5408\u7406\u5b89\u88c5\uff08\u8bbe\u8ba1\u7f3a\u9677\uff0c\u53ef\u80fd\u5f15\u8d77\u64cd\u4f5c\u4e0d\u4fbf\u53ca\u6e05\u6d01\u4e0d\u5f7b\u5e95\u60c5\u5f62\uff0c\u7ee7\u800c\u6000\u7591\u9a8c\u8bc1\u786e\u8ba4\u7684\u5408\u7406\u6027\uff09\uff1b <\/span><\/p>\n

2\u3001\u7ba1\u9053\u8fde\u63a5\u4e0d\u6b63\u786e\uff08\u5b58\u5728\u4ea4\u53c9\u6216\u8f83\u591a\u76f2\u7aef\u4ee5\u53ca\u6d41\u901a\u4e0d\u7545\u3001\u503e\u659c\u89d2\u5ea6\u4e0d\u5bf9\u7b49\uff09\uff1b <\/span><\/p>\n

3\u3001\u7f3a\u4e4f\u6e05\u6d01\uff08\u8bbe\u5907\u5185\u8868\u9762\u6709\u6b8b\u7559\uff0c\u6e05\u6d17SOP\u7684\u6709\u6548\u6027\uff09\uff1b<\/span><\/p>\n

4\u3001\u7f3a\u4e4f\u7ef4\u62a4\uff08\u73b0\u573a\u5b58\u5728\u8dd1\u5192\u6ef4\u6f0f\u7684\u75d5\u8ff9\u6216\u6b63\u5728\u8fdb\u884c\uff09\uff1b <\/span><\/p>\n

5\u3001\u6ca1\u6709\u4f7f\u7528\u6216\u8fd0\u884c\u8bb0\u5f55\uff1b <\/span><\/p>\n

6\u3001\u4f7f\u7528\u4e0d\u5408\u9002\u7684\u79f0\u91cf\u8bbe\u5907\u6216\u68c0\u6d4b\u8bbe\u5907\uff1b <\/span><\/p>\n

7\u3001\u8bbe\u5907\u3001\u7ba1\u9053\u65e0\u6807\u5fd7\uff0c\u672a\u6e05\u695a\u5730\u663e\u793a\u5185\u5bb9\u7269\u540d\u79f0\u548c\u6d41\u5411\uff1b <\/span><\/p>\n

8\u3001\u6709\u6545\u969c\u548c\u95f2\u7f6e\u4e0d\u7528\u7684\u8bbe\u5907\u672a\u79fb\u8d70\u6216\u6807\u8bc6\u4e0d\u6e05\u695a\u3002 <\/span><\/p>\n

9\u3001\u538b\u5dee\u8868\u4e0d\u56de\u96f6\u6216\u6307\u793a\u4e0d\u51c6\u786e\u3002

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

\uff08\u4e8c\uff09\u751f\u4ea7\u73b0\u573a\u68c0\u67e5\u65f6\u907f\u514d\u51fa\u73b0\u7684\u95ee\u9898\u6216\u5173\u6ce8\u70b9 
<\/span><\/p>\n

1\u3001\u4eba\u6d41\u3001\u7269\u6d41\u3001\u5899\u58c1\u3001\u5730\u9762\u3001\u4ea4\u53c9\u6c61\u67d3\uff1b <\/span><\/p>\n

2\u3001\u6bcf\u4e2a\u533a\u57df\uff0c\u6bcf\u6b21\u53ea\u80fd\u751f\u4ea7\u4e00\u4e2a\u4ea7\u54c1\uff0c\u6216\u8005\u5fc5\u987b\u6ca1\u6709\u6df7\u6dc6\u3001\u4ea4\u53c9\u6c61\u67d3\u7684\u5371\u9669\uff1b <\/span><\/p>\n

3\u3001\u540c\u4e00\u6279\u7269\u6599\u6216\u4e0d\u540c\u6279\u53f7\u662f\u5426\u653e\u5728\u4e00\u8d77\uff0c\u76f8\u5173\u7ba1\u7406\u63aa\u65bd\uff1b <\/span><\/p>\n

3\u3001\u5728\u5f00\u59cb\u751f\u4ea7\u4e4b\u524d\uff0c\u5bf9\u751f\u4ea7\u533a\u548c\u8bbe\u5907\u7684\u536b\u751f\u8fdb\u884c\u68c0\u67e5\uff1b <\/span><\/p>\n

4\u3001\u4ea7\u54c1\u548c\u7269\u6599\u8981\u6709\u9632\u6b62\u5fae\u751f\u7269\u548c\u5176\u5b83\u6c61\u67d3\u6e90\u6c61\u67d3\u7684\u63aa\u65bd\uff1b <\/span><\/p>\n

5\u3001\u8fdb\u5165\u751f\u4ea7\u533a\u4eba\u6570\u53d7\u63a7\u3001\u90e8\u5206\u4f7f\u7528\u7269\u54c1\u53d7\u63a7\uff0c\u504f\u5dee\u53d7\u63a7\u5236\uff0c\u4e2d\u95f4\u8fc7\u7a0b\u53d7\u63a7\u5236\uff1b <\/span><\/p>\n

6\u3001\u8ba1\u7b97\u4ea7\u91cf\u548c\u6536\u7387\uff0c\u4e0d\u4e00\u81f4\u7684\u5730\u65b9\u5219\u8981\u8c03\u67e5\u5e76\u89e3\u91ca\uff1b <\/span><\/p>\n

7\u3001\u7b7e\u5b57\u786e\u8ba4\u5173\u952e\u6b65\u9aa4\uff1b <\/span><\/p>\n

8\u3001\u5305\u88c5\u7269\u6216\u8bbe\u5907\u8fdb\u5165\u751f\u4ea7\u533a\u4e4b\u524d\uff0c\u6e05\u9664\u5176\u4e0a\u4e0d\u9002\u5f53\u7684\u6807\u7b7e\uff1b <\/span><\/p>\n

9\u3001\u73af\u5883\u68c0\u6d4b\uff1b <\/span><\/p>\n

10\u3001\u907f\u514d\u4ea4\u53c9\u6c61\u67d3\uff0c\u5b9a\u671f\u6709\u6548\u7684\u68c0\u67e5\uff0cSOP\u53ca\u76f8\u5173\u8bb0\u5f55\uff1b <\/span><\/p>\n

11\u3001\u907f\u514d\u7070\u5c18\u4ea7\u751f\u548c\u4f20\u64ad\uff0c\u901a\u98ce\u6216\u51c0\u5316\u63aa\u65bd\u7684\u5904\u7406\uff1b <\/span><\/p>\n

12\u3001\u751f\u4ea7\u524d\u8981\u7ecf\u8fc7\u6279\u51c6\uff08\u6709\u751f\u4ea7\u6307\u4ee4\uff09\uff1b <\/span><\/p>\n

13\u3001\u4e2d\u95f4\u4ea7\u54c1\u548c\u5f85\u5305\u88c5\u54c1\uff1a\u50a8\u5b58\u6761\u4ef6\u7b26\u5408\uff0c\u6807\u8bc6\u548c\u6807\u7b7e\u9f50\u5168\uff1b <\/span><\/p>\n

14\u3001\u91cd\u52a0\u5de5\u7684SOP\uff0c\u6267\u884c\u60c5\u51b5\uff1b <\/span><\/p>\n

15\u3001\u5728\u751f\u4ea7\u533a\u57df\u5185\u4e0d\u5f97\u6709\uff1a\u5403\u4e1c\u897f\u3001\u559d\u6c34\u3001\u5403\u96f6\u98df\u3001\u62bd\u70df\u6216\u5b58\u6709\u98df\u7269\u3001\u996e\u6599\uff0c\u79c1\u4eba\u836f\u54c1\u7b49\u79c1\u4eba\u7269\u54c1\uff1b <\/span><\/p>\n

16\u3001\u64cd\u4f5c\u8005\u4e0d\u5f97\u88f8\u624b\u76f4\u63a5\u63a5\u89e6\u539f\u6599\u3001\u4e2d\u95f4\u4ea7\u54c1\u548c\u672a\u5305\u88c5\u7684\u6210\u54c1\uff1b <\/span><\/p>\n

17\u3001GMP\u68c0\u67e5\u5458\u7684\u6d01\u51c0\u670d\u6309\u7537\u5973\u5907\u8db3\u5408\u4f53\uff1b <\/span><\/p>\n

18\u3001\u64cd\u4f5c\u5de5\u719f\u6089\u672c\u5c97\u4f4d\u64cd\u4f5c\u3001\u6e05\u6d01SOP\uff1b <\/span><\/p>\n

19\u3001\u8bbe\u5907\u5728\u6e05\u6d01\u3001\u5e72\u71e5\u7684\u73af\u5883\u4e2d\u8fdb\u884c\u50a8\u85cf\uff1b <\/span><\/p>\n

20\u3001\u5b8c\u6574\u7684\u6e05\u6d01\u8bb0\u5f55\uff0c\u663e\u793a\u4e0a\u4e00\u6279\u4ea7\u54c1\uff1b <\/span><\/p>\n

21\u3001\u8bb0\u5f55\u586b\u5199\u6e05\u6670\u7b26\u5408\u89c4\u8303\uff0c\u590d\u6838\u4eba\u7b7e\u5b57\uff0c\u6ca1\u6709\u6d82\u6539\uff0c\u7528\u58a8\u6c34\u6216\u5176\u5b83\u4e0d\u80fd\u64e6\u6389\u7684\u7b14\u586b\u5199\uff1b <\/span><\/p>\n

22\u3001\u8bb0\u5f55\u53ca\u65f6\u548c\u64cd\u4f5c\u540c\u6b65\uff0c\u6309\u53ca\u65f6\u3001\u51c6\u786e\u3001\u6e05\u6670\u3001\u5b8c\u6574\u516b\u5b57\u65b9\u9488\u6267\u884c\uff1b <\/span><\/p>\n

23\u3001\u8bb0\u5f55\u9519\u8bef\u4fee\u6539\uff1a\u539f\u6765\u7684\u5b57\u8ff9\u7559\u5b58\uff0c\u4fee\u6539\u8005\u7b7e\u540d\u548c\u4fee\u6539\u65e5\u671f\uff0c\u6ce8\u660e\u4fee\u6539\u7684\u539f\u56e0\uff0c\u4e0d\u5f97\u6d82\u6539\uff1b <\/span><\/p>\n

24\u3001\u5305\u88c5\u533a\u57df\u5458\u5de5\u719f\u6089\u4f5c\u5e9f\u7684\u5370\u5237\u5305\u6750\u7684\u9500\u6bc1SOP\uff0c\u800c\u4e14\u6709\u8bb0\u5f55\uff1b <\/span><\/p>\n

25\u3001\u5305\u88c5\u7ebf\u5f88\u597d\u5730\u5206\u5f00\uff0c\u6216\u7528\u7269\u7406\u6805\u680f\u9694\u79bb\uff0c\u9632\u6b62\u6df7\u6dc6\uff0c\u5916\u5305\u533a\u4e0e\u6d01\u51c0\u7f13\u51b2\u533a\u8fdb\u884c\u5f88\u597d\u7ba1\u7406\uff0c\u9632\u6b62\u64cd\u4f5c\u53ca\u4eba\u5458\u7684\u4ea4\u53c9\uff1b <\/span><\/p>\n

26\u3001\u5728\u5305\u88c5\u573a\u6240\u6216\u5305\u88c5\u7ebf\u4e0a\u6302\u4e0a\u5305\u88c5\u7684\u54c1\u540d\u548c\u6279\u53f7\uff1b <\/span><\/p>\n

27\u3001\u5bf9\u8fdb\u5165\u5305\u88c5\u90e8\u95e8\u7684\u7269\u6599\u8981\u6838\u5bf9\uff0c\u54c1\u540d\uff0c\u4e0e\u5305\u88c5\u6307\u4ee4\u4e00\u81f4\uff1b <\/span><\/p>\n

28\u3001\u6253\u5370\uff08\u5982\u6279\u53f7\u548c\u6709\u6548\u671f\uff09\u64cd\u4f5c\u8981\u590d\u6838\u5e76\u8bb0\u5f55\uff1b <\/span><\/p>\n

29\u3001\u624b\u5de5\u5305\u88c5\u8981\u52a0\u5f3a\u8b66\u60d5\uff0c\u9632\u6b62\u4e0d\u7ecf\u610f\u7684\u6df7\u6dc6\uff0c\u9632\u6b62\u5934\u53d1\u53ca\u5176\u4ed6\u968f\u8eab\u7269\u54c1\u8131\u843d\u81f3\u5305\u88c5\u888b\u4e2d\u3002 <\/span><\/p>\n

30\u3001\u5173\u952e\u8bbe\u5907\u786e\u8ba4\u72b6\u6001\u7684\u6807\u7b7e\uff0c\u5982\u65e0\u83cc\u6ce8\u5c04\u5242\u7684\u706f\u68c0\u673a <\/span><\/p>\n


<\/p>\n

\uff08\u4e09\uff09\u5316\u9a8c\u5ba4\u73b0\u573a\u68c0\u67e5\u65f6\u7684\u5173\u6ce8\u70b9 <\/span><\/p>\n

1\u3001\u6e05\u6d01\uff1a\u5730\u677f\u3001\u5899\u3001\u5929\u82b1\u677f\uff0c\u96c6\u5c18\u3001\u901a\u98ce\uff0c\u5149\u7167\uff0c\u7ba1\u9053\uff0c\u8bb0\u5f55\u3001\u8bb0\u5f55\u672c\u7b49\u73b0\u573a\u6574\u6d01\u6709\u5e8f\uff1b <\/span><\/p>\n

2\u3001\u6587\u4ef6\u548c\u8bb0\u5f55\uff1a\u53d6\u6837\u548c\u7559\u6837SOP\u53ca\u6837\u54c1\u548c\u8bb0\u5f55\u7684\u4fdd\u5b58\uff0c\u7a33\u5b9a\u6027\u8bd5\u9a8c\uff0c\u4e0e\u8d28\u91cf\u6709\u5173\u7684\u6295\u8bc9\u7684\u8c03\u67e5\uff0c\u6240\u6709\u7269\u6599\u548c\u4ea7\u54c1\u7684\u68c0\u9a8c\uff0c\u68c0\u9a8c\u7684\u7ba1\u7406\uff0c\u8d28\u91cf\u6807\u51c6\uff0c\u76f8\u5173GMP\u6587\u4ef6\uff0c\u8bb0\u5f55\u672c\uff0c\u68c0\u9a8c\u7ed3\u679c\uff0c\u68c0\u9a8c\u62a5\u544a\u5355\uff0c\u6807\u7b7e\uff0c\u8d8b\u52bf\u5206\u6790\uff0c\u5f52\u6863\uff1b <\/span><\/p>\n

3\u3001\u8bd5\u5242\u3001\u6ef4\u5b9a\u6db2\u3001\u6bd2\u54c1\u548c\u5371\u9669\u54c1\u3001\u6807\u51c6\u54c1\u914d\u5236\u3001\u6807\u7b7e\u3001\u8bb0\u5f55\u3001\u5b58\u653e\u7b49\uff1b <\/span><\/p>\n

4\u3001\u73bb\u7483\u5668\u76bf\uff1a\u5b89\u5168\u4f7f\u7528\uff08\u88c2\u7eb9\u3001\u788e\u88c2\u3001\u6253\u7834\u3001\u672a\u6821\u8005\u4e0d\u5f97\u51fa\u73b0\u5728\u73b0\u573a\uff09\uff1b <\/span><\/p>\n

5\u3001\u4eea\u5668\u6821\u51c6\uff1a\u5468\u671f\u3001\u76f8\u5173\u8bb0\u5f55\u3001\u5408\u683c\u8bc1\u7b49\uff1b <\/span><\/p>\n

6\u3001PH\u8ba1\uff1a\u64cd\u4f5c\u3001\u6e05\u6d01\u3001\u6821\u51c6\u7b49SOP\uff0c\u7f13\u51b2\u6db2\u914d\u5236\uff0c\u6807\u7b7e\uff0c\u8bb0\u5f55\uff1b<\/span><\/p>\n

7\u3001\u5929\u5e73\uff1a\u9632\u9707\uff0c\u6821\u6b63\u3001\u7ef4\u62a4\uff1b <\/span><\/p>\n

8\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\uff08\u836f\u5178\u6216\u975e\u836f\u5178\uff09\uff1b <\/span><\/p>\n

9\u3001\u7a33\u5b9a\u6027\u5b9e\u9a8c\uff08\u52a0\u901f\u3001\u957f\u671f\uff09\uff1b <\/span><\/p>\n

10\u3001\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\uff08\u65e0\u83cc\u3001\u5fae\u751f\u7269\u9650\u5ea6\u3001\u9633\u6027\u68c0\u67e5\uff09\uff1b <\/span><\/p>\n

11\u3001\u5404\u64cd\u4f5c\u5ba4\u6216\u64cd\u4f5c\u53f0\u6d01\u51c0\u5ea6\u68c0\u6d4b\u7ed3\u679c\u3001\u8bb0\u5f55\u7b49\u3002 <\/span><\/p>\n

12\u3001\u5de5\u4f5c\u7ad9\u6570\u636e\u9700\u8981\u5c55\u793a\u7684\u5185\u5bb9\uff0c\u63d0\u524d\u6f14\u7ec3\u548c\u9884\u6848\u3002 <\/span><\/p>\n

13\u3001\u5404\u7c7b\u5b9e\u9a8c\u6570\u636e\u7684\u5b8c\u6574\u6027\uff08\u662f\u5426\u5b58\u5728\u89c4\u7a0b\u63cf\u8ff0\u7684\u7f16\u53f7\u3001\u5220\u9664\u3001\u4fee\u6539\u3001\u4fdd\u5b58\u3001\u5907\u4efd\u53ca\u9a8c\u8bc1\u7684\u4e0d\u5f53\u7ba1\u7406\u53ca\u5904\u7f6e\uff09 <\/span><\/p>\n

14\u3001\u6db2\u76f8\u3001\u6c14\u76f8\u7b49\u5de5\u4f5c\u7ad9\u6216CDS\u7684\u7535\u8111\u5728\u4e0d\u4f7f\u7528\u65f6\u9700\u8981\u9501\u5c4f\uff0c\u53ef\u4ee5\u8bbe\u7f6e\u81ea\u52a8\u9501\u5c4f\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\uff08\u56db\uff09\u8d28\u91cf\u7ba1\u7406\u90e8\u73b0\u573a\u68c0\u67e5\u65f6\u7684\u5173\u6ce8\u70b9 <\/span><\/p>\n

1\u3001\u4ea7\u54c1\u5e74\u5ea6\u56de\u987e\u53ca\u65f6\u5b8c\u6574\u3001\u603b\u7ed3\u5177\u6709\u6761\u7406\u6027\uff0c\u5bf9\u4e0d\u826f\u8d8b\u52bf\u8fdb\u884c\u8bba\u8ff0\uff1b <\/span><\/p>\n

2\u3001\u5ba1\u8ba1\uff1aGMP\u81ea\u68c0\uff0c\u5bf9\u4f9b\u5e94\u5546\u7684\u5ba1\u8ba1\u548c\u836f\u653f\u90e8\u95e8\u6309\u89c4\u5b9a\u68c0\u67e5\u7684\u8d44\u6599\u53ca\u6574\u6539\u62a5\u544a\uff1b <\/span><\/p>\n

2\u3001\u53d8\u66f4\u63a7\u5236\uff1b <\/span><\/p>\n

3\u3001\u6295\u8bc9\uff1a\u5305\u62ec\u4ea7\u54c1\u8d28\u91cf\u6295\u8bc9\u3001\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u62a5\u544a\u548c\u7591\u4f3c\u865a\u5047\u836f\u54c1\u7684\u6295\u8bc9\uff1b <\/span><\/p>\n

4\u3001\u504f\u5dee\u7ba1\u7406\uff1b <\/span><\/p>\n

5\u3001\u4ea7\u54c1\u653e\u884c\uff1b <\/span><\/p>\n

6\u3001\u8fd4\u5de5\u3001\u518d\u52a0\u5de5\u7ba1\u7406\uff1b <\/span><\/p>\n

7\u3001SOP \u7ba1\u7406\uff1b <\/span><\/p>\n

8\u3001\u5404\u7ea7\u4eba\u5458\u8d44\u8d28\u3001\u57f9\u8bad\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\uff08\u4e94\uff09\u5404\u90e8\u95e8\u529e\u516c\u533a\u57df\u573a\u6240<\/span><\/p>\n

1\u3001\u4e25\u7981\u6742\u4e71\u7684\u8bb0\u5f55\u3001\u6587\u4ef6\u6563\u653e\u4e8e\u684c\u9762\uff1b <\/span><\/p>\n

2\u3001\u975e\u53d7\u63a7\u53ca\u5176\u4ed6\u4e0d\u53ef\u51fa\u793a\u8bb0\u5f55\u6216\u6587\u4ef6\u9700\u6e05\u7406\uff0c\u53d7\u63a7\u6587\u4ef6\u9700\u4e3a\u73b0\u884c\u7248\u5e76\u6709\u76ee\u5f55\uff0c\u7ecf\u6574\u7406\u540e\u53ef\u5b58\u653e\u81f3\u6587\u4ef6\u5939\u5f52\u6863\uff1b <\/span><\/p>\n

3\u3001\u5df2\u5f00\u542f\u7684\u7535\u8111\u684c\u9762\u9700\u8fdb\u884c\u6e05\u7406\uff0c\u90e8\u5206\u6587\u4ef6\u53ef\u5907\u4efd\u81f3U\u76d8\u540e\u6e05\u9664\uff1b <\/span><\/p>\n

4\u3001\u6574\u7406\u4e2a\u4eba\u7535\u8111\u684c\u9762\u7684\u79c1\u4eba\u90ae\u7bb1\u6216\u5de5\u4f5c\u90ae\u7bb1\uff0c\u4e0d\u5f97\u5448\u5f00\u542f\u72b6\u6001\uff0c\u9700\u52a0\u5bc6\u540e\u5173\u95ed\uff1b <\/span><\/p>\n

5\u3001\u529e\u516c\u62bd\u5c49\u5c3d\u91cf\u51cf\u5c11\u6216\u4e0d\u5b58\u653e\u4e0e\u5de5\u4f5c\u65e0\u5173\u7684\u79c1\u4eba\u7269\u54c1\u3002 <\/span><\/p>\n

6\u3001\u4fdd\u6301\u529e\u516c\u5899\u9762\u6574\u6d01\uff0c\u4ec5\u53ef\u60ac\u6302\u65e5\u5386\u7b49\u4e0e\u5de5\u4f5c\u65e0\u76f4\u63a5\u5173\u8054\u7684\u7269\u54c1\u3002<\/span><\/p>\n


<\/p>\n

\u56db\u3001\u73b0\u573a\u68c0\u67e5\u65f6\u5fc5\u987b\u505a\u5230  <\/span><\/strong>
<\/p>\n

\uff08\u4e00\uff09\u6587\u4ef6\u548c\u8bb0\u5f55\u65b9\u9762\uff08\u5373\u5982\u4f55\u5411\u5ba1\u8ba1\u5b98\u63d0\u4f9b\u6587\u4ef6\uff09<\/span><\/p>\n

1\u3001\u4ec5\u63d0\u4f9b\u68c0\u67e5\u5458\u8981\u770b\u7684\u6587\u4ef6\u8d44\u6599\uff1b <\/span><\/p>\n

2\u3001\u6240\u6709\u9012\u4ea4\u7ed9\u68c0\u67e5\u4eba\u5458\u7684\u6587\u4ef6\uff0c\u4e8b\u5148\u4e00\u5b9a\u8981\u5c3d\u53ef\u80fd\u7ecf\u90e8\u95e8\u8d1f\u8d23\u4eba\u5feb\u901f\u68c0\u67e5\u4e00\u904d\uff08\u4ee5\u514d\u6709\u7eb8\u6761\u5939\u5e26\u6216\u5176\u4ed6\u9519\u8bef\u5982\u6f0f\u7b7e\u540d\u7b49\u73b0\u8c61\uff09\uff1b <\/span><\/p>\n

3\u3001\u614e\u91cd\u56de\u7b54\u68c0\u67e5\u5458\u5bf9\u539f\u59cb\u6570\u636e\u548c\u5404\u79cd\u8bb0\u5f55\u6240\u63d0\u51fa\u7684\u95ee\u9898\uff08\u4ee5\u514d\u4f7f\u68c0\u67e5\u5458\u4ea7\u751f\u6709\u201c\u9020\u5047\u201d\u7684\u9519\u89c9\uff09\u3002<\/span> <\/span><\/p>\n

\uff08\u4e8c\uff09\u4eba\u5458\u65b9\u9762\uff1a <\/span><\/p>\n

1\u3001\u5728GMP\u68c0\u67e5\u4eba\u5458\u5230\u6765\u4e4b\u524d\uff0c\u6240\u6709\u76f8\u5173\u4eba\u5458\u5fc5\u987b\u63d0\u524d\u5c31\u4f4d\uff1b <\/span><\/p>\n

2\u3001\u7531\u516c\u53f8\u6307\u5b9a\u4eba\u5458\u8d1f\u8d23\u4f1a\u8bae\u5b89\u6392\u548c\u8fce\u63a5\u68c0\u67e5\u5458\uff1b <\/span><\/p>\n

3\u3001\u7531\u516c\u53f8\u6307\u5b9a\u9886\u5bfc\u5411\u68c0\u67e5\u5458\u4ecb\u7ecd\u6240\u6709\u76f8\u5173\u4eba\u5458\uff1b <\/span><\/p>\n

4\u3001\u7531\u516c\u53f8\u6307\u5b9a\u4eba\u5458\u966a\u4f34\u68c0\u67e5\u5458\u8fdb\u884c\u73b0\u573a\uff0c\u8981\u4fdd\u6301\u966a\u540c\u4eba\u5458\u6700\u5c11\uff0c\u4ee5\u514d\u51fa\u73b0\u6709\u963b\u788d\u68c0\u67e5\u9519\u89c9\u3002<\/span><\/p>\n

5\u3001GMP\u8ba4\u8bc1\u68c0\u67e5\u671f\u95f4\uff0c\u5404\u90e8\u95e8\u8d1f\u8d23\u4eba\u5fc5\u987b\u5c06\u68c0\u67e5\u8fc7\u7684\u5185\u5bb9\u3001\u68c0\u67e5\u5458\u8d28\u7591\u7684\u95ee\u9898\u3001\u68c0\u67e5\u65f6\u88ab\u53d1\u73b0\u7684\u6307\u51fa\u7684\u95ee\u9898\u4e8e\u5f53\u5929\u4e0b\u73ed\u524d\u6c47\u603b\u5230\u8d28\u91cf\u90e8\u7b80\u77ed\u603b\u7ed3\uff0c\u5e76\u63d0\u9192\u5230\u5404\u90e8\u95e8\u63a5\u4e0b\u6765\u9700\u6ce8\u610f\uff1b <\/span><\/p>\n

6\u3001\u68c0\u67e5\u8fc7\u7a0b\u9700\u6709\u4e00\u540d\u7ecf\u9a8c\u4e30\u5bcc\u7684\u9886\u5bfc\u4eba\u5458\uff0c\u7edf\u7b79\u6307\u6325\u3001\u5c3d\u53ef\u80fd\u7075\u6d3b\u5f15\u5bfc\u73b0\u573a\u68c0\u67e5\uff0c\u505a\u51fa\u9884\u6d4b\u51b3\u7b56\uff0c\u626c\u957f\u907f\u77ed\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\u4e94\u3001\u68c0\u67e5\u5458\u63d0\u95ee\u95ee\u9898\u65f6\u5fc5\u987b\u6ce8\u610f <\/span><\/strong><\/section>\n

1\u3001\u672a\u5728SOP\u4e2d\u89c4\u5b9a\u800c\u8fdb\u884c\u64cd\u4f5c\u548c\u7ba1\u7406\u7684\u5185\u5bb9\uff0c\u5c3d\u91cf\u4e0d\u8981\u548c\u68c0\u67e5\u5458\u4ea4\u8c08\uff1b <\/span>
<\/p>\n

2\u3001\u95ee\u5565\u7b54\u5565\uff0c\u7981\u6b62\u4e34\u65f6\u53d1\u6325\uff0c\u4e0d\u8981\u5c55\u5f00\u6216\u6f14\u7ece\u89e3\u91ca\u8fc7\u591a\u95ee\u9898\uff08\u68c0\u67e5\u4eba\u5458\u5927\u591a\u65f6\u5019\u4f1a\u5728\u4e0d\u540c\u7684\u5730\u70b9\u3001\u65f6\u95f4\uff0c\u5411\u4e0d\u540c\u7684\u4eba\u5458\u63d0\u51fa\u540c\u6837\u7684\u95ee\u9898\u3002\u5982\u679c\u7b54\u6848\u662f\u4e0d\u4e00\u81f4\u7684\uff0c\u4ed6\u4eec\u4f1a\u4ea7\u751f\u7591\u95ee\uff0c\u4e3a\u4ec0\u4e48\u4f1a\u8fd9\u6837\uff1f\uff09  <\/span><\/p>\n

3\u3001 \u5bf9\u68c0\u67e5\u5458\u63d0\u95ee\u8fdb\u884c\u56de\u7b54\u65f6 <\/span><\/p>\n

\uff081\uff09\u4e0d\u80fd\u62d2\u7edd\uff1b <\/span><\/p>\n

\uff082\uff09\u76f4\u63a5\u56de\u7b54\uff0c\u4e0d\u80fd\u542b\u7cca\u4e0d\u6e05\uff1b <\/span><\/p>\n

\uff083\uff09\u7edd\u4e0d\u80fd\u51fa\u73b0\u76f8\u4e92\u77db\u76fe\u7684\u56de\u7b54\uff1b <\/span><\/p>\n

\uff084\uff09\u786e\u5b9e\u4e0d\u4f1a\u56de\u7b54\u65f6\uff0c\u5766\u8bda\u627f\u8ba4\u5e76\u63d0\u51fa\u8ba9\u66f4\u4e86\u89e3\u7684\u4eba\u56de\u7b54\uff1b <\/span><\/p>\n

\uff085\uff09\u5728\u56de\u7b54\u95ee\u9898\u65f6\u7279\u522b\u6ce8\u610f\uff1a\u8981\u81ea\u4fe1\u5730\u56de\u7b54\u95ee\u9898\uff0c\u786e\u4fdd\u4f60\u7684\u56de\u7b54\u662f\u51c6\u786e\u7684\uff0c\u5982\u679c\u4f60\u4e0d\u77e5\u9053\uff0c\u53ef\u653e\u5f03\u56de\u7b54\u5e76\u63d0\u51fa\u8ba9\u66f4\u4e86\u89e3\u7684\u4eba\u56de\u7b54\uff1b\u5982\u679c\u95ee\u9898\u7684\u56de\u7b54\u9700\u8981\u4ece\u4e13\u5bb6\u7684\u89d2\u5ea6\u56de\u7b54\uff0c\u8bf7\u4e13\u5bb6\u56de\u7b54\uff1b <\/span><\/p>\n

\u5982\u679c\u4f60\u627f\u8bfa\u4e86\u4e00\u4e2a\u95ee\u9898\uff0c\u4e00\u5b9a\u8981\u5b8c\u6210\u5b83\uff0c\u5207\u8bb0\u4e0d\u8981\u8bf4\u8c0e\u3002  <\/span><\/p>\n

\uff086\uff09\u56de\u7b54\u95ee\u9898\u65f6\u907f\u514d\u51fa\u73b0\u7684\u8bdd\u8bed <\/span><\/p>\n

\u2460\u6211\u60f3\u8fd9\u53ef\u80fd\u662f\u2026 <\/span><\/p>\n

\u8fd9\u610f\u5473\u7740\u4f60\u4e0d\u77e5\u9053\u4e0d\u4e86\u89e3\uff0c\u5982\u679c\u662f\u4f60\u8d1f\u8d23\u4eba\uff0c\u8fd9\u662f\u4e0d\u53ef\u4ee5\u63a5\u53d7\u7684—\u4f60\u5e94\u8be5\u77e5\u9053\uff1b\u4e0d\u8981\u8bd5\u56fe\u6b3a\u9a97\uff0c\u4e0d\u8981\u8bf4\u4f60\u4e0d\u77e5\u8fd9\u4e00\u72b6\u51b5\uff1b\u505c\u6b62\u4f60\u7684\u9519\u8bef\uff0c\u8ba9\u9002\u5408\u7684\u4eba\u5458\u63d0\u4f9b\u6b63\u786e\u7684\u56de\u7b54\u3002<\/span><\/p>\n

\u2461 \u662f\u7684\uff0c\u901a\u5e38\u662f\u2026 <\/span><\/p>\n

\u7acb\u5373\u4f1a\u5f15\u8d77\u68c0\u67e5\u4eba\u5458\u95ee\u4e0d\u6b63\u5e38\u60c5\u51b5\uff1b \u5e94\u8be5\u907f\u514d\uff0c\u9664\u975e\u4f60\u6709\u6587\u4ef6\uff0c\u9a8c\u8bc1\u7b49\u652f\u6301\u4e0d\u6b63\u5e38\u7684\u60c5\u51b5\uff1b\u5207\u8bb0-\u56de\u7b54\u4ec5\u56de\u7b54\u88ab\u95ee\u7684\u95ee\u9898\uff0c\u4e0d\u8981\u8bd5\u56fe\u731c\u6d4b\u68c0\u67e5\u4eba\u5458\u7684\u4e0b\u4e00\u4e2a\u95ee\u9898\u3002 <\/span><\/p>\n

\u2462\u90a3\u4e0d\u662f\u6211\u7684\u95ee\u9898\u2026 <\/span><\/p>\n

\u5f15\u51fa\u4e00\u4e2a\u975e\u5e38\u8d1f\u9762\u7684\u53cd\u5e94\uff0c\u4e0d\u8981\u628a\u4f60\u8d23\u4efb\u8303\u56f4\u5e94\u8d1f\u8d23\u7684\u95ee\u9898\u63a8\u7ed9\u5176\u5b83\u90e8\u95e8\uff0c\u4e00\u5b9a\u4f1a\u5f15\u53d1\u8c03\u67e5\u5c31\u8fd9\u4e00\u95ee\u9898\u6240\u76f8\u5173\u7684\u6240\u6709\u65b9\u9762\u7684\u95ee\u9898\uff0c\u610f\u5473\u7740\u90e8\u95e8\u95f4\u7684\u4e0d\u548c\u8c10\uff0c\u68c0\u67e5\u4eba\u5458\u4e00\u5b9a\u4f1a\u4ece\u5047\u60f3\u7684\u8fd9\u91cc\u4e00\u5b9a\u6709\u76f8\u5173\u7684\u95ee\u9898\u800c\u5f00\u59cb\u8c03\u67e5\u3002<\/span><\/p>\n

\u2463 \u90a3\u592a\u8d35\u4e86\u2026 <\/span><\/p>\n

\u6240\u6709\u8d1f\u9762\u7684\u56de\u5e94\uff0c\u90fd\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\uff1b\u63d0\u51fa\u53ef\u4f9b\u9009\u62e9\u7684\u65b9\u6848\uff0c\u5f53\u68c0\u67e5\u4eba\u5458\u8ba4\u4e3a\u90a3\u662f\u5fc5\u9700\u91c7\u53d6\u7684\u63aa\u65bd\uff0c\u4ef7\u683c\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\u539f\u56e0\uff0c\u901a\u5e38\u4f1a\u8bf4\u660eSOP\u6ca1\u6709\u88ab\u5f88\u597d\u7684\u6267\u884c\uff1b\u5bf9\u53d8\u66f4\u5bf9\u4ea7\u54c1\u8d28\u91cf\u7684\u5f71\u54cd\uff0c\u6ca1\u6709\u53ef\u9760\u7684\u4fdd\u8bc1\uff0c\u8fd9\u6837\u9a6c\u4e0a\u5c31\u663e\u793a\u51fa\u53d8\u66f4\u7f3a\u4e4f\u63a7\u5236\u7ba1\u7406\u3002 <\/span><\/p>\n

\u2464\u8bf4\u5b9e\u8bdd \u2026 <\/span><\/p>\n

\u7ed9\u4e86\u4e00\u4e2a\u5370\u8c61\uff0c\u4ee5\u4e0a\u7684\u56de\u7b54\u90fd\u4e0d\u662f\u5b9e\u60c5\uff0c\u6210\u529f\u7684\u68c0\u67e5\u662f\u5efa\u7acb\u5728\u8bda\u4fe1\u7684\u57fa\u7840\u4e0a\u7684\uff0c\u4e0d\u8981\u8ba9\u7c97\u5fc3\u548c\u65e0\u610f\u6e10\u6e10\u5730\u6bc1\u4e86\u8bda\u4fe1\u3002 <\/span><\/p>\n

\u2465\u6211\u4eec\u4e00\u76f4\u5c31\u662f\u8fd9\u6837\u2026 <\/span><\/p>\n

\u9996\u5148\u8868\u660e\u4f60\u6ca1\u6709\u6539\u6b63\u7684\u610f\u5411\uff1b\u770b\u8d77\u6765\u662f\u4e0d\u60f3\u542c\u53d6\u68c0\u67e5\u5458\u7684\u610f\u89c1\uff1b\u4f60\u7684\u77e5\u8bc6\u6c34\u5e73\u592a\u5dee\u4e86\uff0c\u6b20\u7f3a\u57f9\u8bad\u3002

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

\u516d\u3001GMP\u8ba4\u8bc1\u68c0\u67e5\u4e2d\u5404\u90e8\u95e8\u987b\u9075\u5b88\u7684\u201c\u5341\u8981\u201d\u548c\u201c\u5341\u4e0d\u8981\u201d <\/span><\/strong><\/section>\n

\uff08\u4e00\uff09\u5341\u8981 <\/span><\/p>\n

1\u3001\u8981\u5c06\u4f60\u6240\u63d0\u4f9b\u7684\u56de\u5e94\uff0c\u5168\u90e8\u6574\u7406\u5f52\u7eb3\uff1b <\/span><\/p>\n

2\u3001\u8981\u505a\u4f60\u6216\u90e8\u95e8\u9700\u4f5c\u7684\u4e8b\uff0c\u8bb2\u4f60\u6216\u90e8\u95e8\u6240\u9700\u8bb2\u7684\uff1b <\/span><\/p>\n

3\u3001\u8981\u786e\u4fdd\u6240\u63d0\u4f9b\u7684\u8d44\u6599\u6216\u6570\u636e\uff0c\u5728\u51fa\u793a\u4e4b\u524d\u5df2\u88ab\u5ba1\u6838\u786e\u8ba4\u8fc7\uff1b <\/span><\/p>\n

4\u3001\u8981\u53ca\u65f6\u5730\u7ed9\u51fa\u6b63\u786e\u7684\u8d44\u6599\u6216\u4fe1\u606f\uff1b <\/span><\/p>\n

5\u3001\u8981\u786e\u4fdd\u4f60\u53ca\u90e8\u95e8\u7684\u533a\u57df\u5e72\u51c0\u6574\u6d01\uff1b <\/span><\/p>\n

6\u3001\u8981\u53ca\u65f6\u89e3\u51b3\u548c\u5904\u7406\u7ec6\u5c0f\u7684\u95ee\u9898\uff0c\u5728\u68c0\u67e5\u5458\u77e5\u9053\u4e4b\u524d\uff1b <\/span><\/p>\n

7\u3001\u5982\u679c\u4f60\u6ca1\u542c\u61c2\u6240\u95ee\u7684\u95ee\u9898\uff0c\u9996\u5148\u8981\u5f04\u6e05\u695a\u95ee\u9898\u518d\u56de\u7b54\uff1b <\/span><\/p>\n

8\u3001\u4ec5\u5c31\u95ee\u9898\u800c\u7b54\uff0c\u53ea\u8981\u62ff\u6240\u9700\u8d44\u6599\uff1b <\/span><\/p>\n

9\u3001\u8981\u975e\u5e38\u719f\u6089\u4f60\u7684\u73b0\u573a\u548c\u6863\u6848\u8d44\u6599\uff1b <\/span><\/p>\n

10. \u8981\u5feb\u901f\u63d0\u4f9b\u5173\u952e\u7684\u6587\u4ef6\u6863\u6848\u3002<\/span><\/p>\n

  <\/span><\/p>\n

\uff08\u4e8c\uff09\u5341\u4e0d\u8981 <\/span><\/p>\n

1\u3001\u4e0d\u8981\u731c\u6d4b\u3002\u5982\u679c\u4f60\u4e0d\u662f\u6700\u9002\u5408\u7684\u4eba\u9009\uff0c\u4f60\u5c31\u4e0d\u8981\u56de\u7b54\uff1b <\/span><\/p>\n

2\u3001\u4e0d\u8981\u80e1\u804a\u3002\u786e\u4fdd\u4f60\u7684\u56de\u7b54\u7b80\u660e\u800c\u6b63\u786e\uff1b <\/span><\/p>\n

3\u3001\u4e0d\u8981\u88ab\u68c0\u67e5\u4eba\u5458\u5e72\u6270\uff0c\u4fdd\u6301\u5e73\u9759\u548c\u6709\u5e8f\u7684\u5fc3\u6001\u5b8c\u6210\uff1b <\/span><\/p>\n

4\u3001\u4e0d\u8981\u663e\u5f97\u6ca1\u6709\u4fe1\u5fc3\uff0c\u541e\u541e\u5410\u5410\uff1b <\/span><\/p>\n

5\u3001\u4e0d\u8981\u8bf4\u8c0e\u6216\u56de\u907f\uff1b <\/span><\/p>\n

6\u3001\u4e0d\u8981\u7ed9\u51fa\u4e0d\u53ef\u80fd\u83b7\u5f97\u652f\u6301\u7684\u627f\u8bfa\uff1b <\/span><\/p>\n

7\u3001\u4e0d\u8981\u9996\u5148\u7533\u8fa9\u800c\u540e\u56de\u5e94\uff1b <\/span><\/p>\n

8\u3001\u4e0d\u8981\u63d0\u4f9b\u865a\u5047\u7684\u6570\u636e\u6216\u4fe1\u606f\uff1b <\/span><\/p>\n

9\u3001\u4e0d\u8981\u8fdd\u53cdSOP\uff0c \u540c\u65f6\u4e5f\u4e0d\u8bb8\u68c0\u67e5\u4eba\u5458\u8fdd\u53cd\uff1b <\/span><\/p>\n

10\u3001\u4e0d\u8981\u63d0\u4f9b\u4e0e\u672c\u6b21\u8ba4\u8bc1\u65e0\u5173\u7684\u540c\u7c7b\u8d44\u6599\u7ed9\u68c0\u67e5\u4eba\u5458\u3002  <\/span><\/p>\n

\u4f34\u968f\u5ba2\u6237\u53ca\u5b98\u65b9\u5bf9GMP\u836f\u4f01\u73b0\u573a\u5ba1\u8ba1\u8d8b\u4e8e\u5e38\u6001\uff0c\u836f\u4f01\u5fc5\u987b\u901a\u8fc7\u63d0\u9ad8\u8f6f\u4ef6\u53ca\u786c\u4ef6\u7ba1\u7406\u6c34\u5e73\u4e88\u4ee5\u5e73\u5e38\u5fc3\u9002\u5e94\u5bf9\u5f85\u3002\u5728\u5c3d\u91cf\u51cf\u5c11\u6216\u4e0d\u5f71\u54cd\u6216\u751f\u4ea7\u8fd0\u884c\u7684\u60c5\u51b5\u4e0b\uff0c\u5f3a\u5316\u5e76\u7ec6\u5316\u73b0\u573a\u7ba1\u7406\uff0c\u56e0\u4e3a\u7edd\u5927\u90e8\u5206\u95ee\u9898\u90fd\u662f\u4ece\u73b0\u573a\u5f15\u53d1\u7684\u3002\u9996\u5148\u4ece\u63d0\u9ad8\u4eba\u5458\u6267\u884c\u529b\u505a\u8d77\uff0c\u5236\u5b9a\u5404\u7c7b\u95ee\u9898\u7684\u6574\u6539\u76ee\u6807\u65b9\u6848\uff0c\u6bcf\u4e2a\u660e\u786e\u7684\u76ee\u6807\u5747\u8981\u4fdd\u969c\u6709\u5f3a\u529b\u7684PDCA\u5faa\u73af\uff0c\u5982\u6b64\u4e0d\u65ad\u6539\u5584\u63d0\u9ad8\u5e76\u5f62\u6210\u826f\u597d\u5faa\u73af\u3002<\/span><\/p>\n

\u6765\u6e90\uff1a\u51ef\u535a\u601d<\/span><\/strong><\/p>\n

\u514d\u8d23\u58f0\u660e\uff1a\u7f16\u8f91\u5bf9\u4e0a\u8ff0\u5185\u5bb9\uff0c\u5bf9\u6587\u4e2d\u9648\u8ff0\u3001\u89c2\u70b9\u5224\u65ad\u4fdd\u6301\u4e2d\u7acb\uff0c\u4e0d\u5bf9\u6240\u5305\u542b\u5185\u5bb9\u7684\u51c6\u786e\u6027\u3001\u53ef\u9760\u6027\u6216\u5b8c\u6574\u6027\u63d0\u4f9b\u4efb\u4f55\u660e\u793a\u6216\u6697\u793a\u7684\u4fdd\u8bc1\u3002\u4ec5\u4f5c\u53c2\u8003\uff0c\u5e76\u8bf7\u5404\u4f4d\u81ea\u884c\u627f\u62c5\u5168\u90e8\u8d23\u4efb\u3002<\/span><\/strong><\/p>\n


<\/p>\n


<\/p>\n

\u8fd1\u671f\u57f9\u8bad<\/span><\/p>\n

\n
\n
\n
\n

<\/p>
\u8fd1\u70ed\u95e8\u57f9\u8bad\u8bfe\u7a0b<\/strong><\/span>\u671f<\/strong>\u8bf7\u70b9\u51fb\u4e0b\u9762<\/strong><\/span><\/strong><\/span>\u84dd\u8272\u8bfe<\/strong><\/span><\/strong><\/span>\u9898\u94fe\u63a5<\/strong><\/span>\u9605\u8bfb<\/strong>\u6587

<\/strong><\/span><\/p>
\u676d\u5dde\u5e02-2018\u836f\u4f01OOS\/OOT\u8c03\u67e5\u8bef\u533a\u4e0e\u6539\u8fdb\u5b9e\u64cd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/a>10\u670825-27\u65e5<\/span><\/span><\/strong><\/p>
<\/span><\/strong><\/strong><\/span>
<\/p>
\u6b66\u6c49\u5e0210\u670819-21\u65e5-2018\u836f\u4f01\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u5b9e\u65bd\u4e0e\u6539\u8fdb\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5

<\/span><\/strong><\/span><\/p>
\u4e0a\u6d77\u5e02<\/span>10<\/span>\u6708<\/span>12-14<\/span>\u65e5<\/span>-\u7b2c\u4e8c\u671f\u201c\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836fGMP<\/span>\u5236\u5ea6\u8981\u70b9\u89e3\u6790\u53ca\u5e94\u7528\u5b9e\u65bd\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a>
<\/p><\/section>
\u4e0a\u6d77-2018\u836f\u4f01\u8d28\u91cf\u8c03\u67e5\u6280\u672f\u6307\u5bfc\u4e13\u9898\u57f9\u8bad\u73ed 10\u670826\u65e5\u81f328\u65e5<\/strong>\u201d\u7684\u901a\u77e5<\/span><\/span><\/a><\/p>

<\/p>
\u4e0a\u6d77-2018 QA\u4e13\u5458\u6280\u80fd\u5b8c\u5584\u3001\u63d0\u5347\u4e0e\u5b9e\u64cd\u4e13\u9898<\/a><\/span><\/span>
<\/p>
\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/h2>
\u4e0a\u6d7710\u670819-21\u65e5-\u5316\u5b66\u539f\u6599\u836f\u5236\u5907\u5de5\u827a<\/span><\/strong><\/span>\u5f00\u53d1\u5173\u952e\u70b9\u63a7\u5236\u4e0e\u8d28\u91cf\u7814\u7a76\u5b9e\u8df5\u201d\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a> \u4e13\u5bb6 \u5b89\u6c38\u5b8f \u4e01\u6069\u5cf0 \u5b59\u4e9a\u6d32<\/strong>
<\/p>
\u5357\u4eac<\/span><\/strong>
<\/p>
\u5357\u4eac-\u5236\u836f\u4f01\u4e1a\u5982\u4f55\u5b9e\u73b0GMP\u6709\u6548\u8fd0\u8425\u6c9f\u901a \u9ad8\u7ea7\u7814\u4fee\u73ed\u201d\u7684\u901a\u77e5<\/a>10\u670827-29\u65e5<\/span><\/span><\/p>

<\/span><\/strong><\/span><\/p>
\u5357\u4eac\u5e029\u670827---9\u670829\u65e5<\/strong>-\u65b0\u6cd5\u89c4\u73af\u5883\u4e0b\u836f\u54c1\u6280\u672f\u8f6c\u79fb\u7b56\u7565\u4e0e\u5b9e\u65bd\u64cd\u4f5c \u9ad8\u7ea7\u57f9\u8bad\u73ed\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a>

<\/p>
\u5357\u4eac\u5e02<\/span>-<\/span>10\u670825---27\u65e5<\/span>\u836f\u7269\u7814\u53d1\u8d28\u91cf\u7ba1\u7406\u8fd0\u884c\u96be\u70b9\u5b9e\u65bd\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u7528\u836f\u7269<\/span> GMP\u5b9e\u65bd\u5173\u952e\u70b9\u63a7\u5236\u201d\u9ad8\u7ea7\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/span><\/strong><\/span><\/a>

<\/p>
<\/span><\/strong><\/span><\/p>
\u676d\u5dde\u5e02-2018\u533b\u836f\u5316\u5de5\u5b89\u5168\u751f\u4ea7\u4e0e\u5de5\u827a\u5b89\u5168\u7ba1\u7406\u7814\u8ba8\u73ed\u201d\u7684\u901a\u77e5<\/a>11\u67081-3\u65e5<\/span><\/strong><\/span><\/p>

<\/p>
\u676d\u5dde\u5e0210\u670811-13\u65e5<\/span>-2018 cGMP\u6587\u4ef6\u7f16\u5236\u89c4\u8303\u201d\u4e13\u9898\u7814\u4fee\u73ed \u7684\u901a\u77e5<\/span><\/strong><\/a><\/p>
\uff08\u6210\u90fd9<\/span>\u6708<\/span>26-28<\/span>\u65e5<\/span>\uff09\u539f\u6599\u836f\u3001\u836f\u7528\u8f85\u6599\u548c\u836f\u5305\u6750\u5171\u540c\u5ba1\u8bc4\u5ba1\u6279\u89e3\u6790\u53ca\u5982\u4f55\u7f16\u5199\u7533\u62a5\u8d44\u6599\u4e13\u9898\u57f9\u8bad\u73ed\u201d\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a>

<\/p>
\u5317\u4eac10-\u670824-26\u6ee1\u8db3\u6b27\u7f8e\u6807\u51c6\u7684\u4eff\u5236\u836f\u7814\u53d1\u4f53\u7cfb\u642d\u5efa\u201d\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a>

<\/p>
\u9f50\u9f50\u54c8\u5c14-2018\u4e2d\u56fd\u5927\u5065\u5eb7\u80cc\u666f\u4e0b\u4e2d\u836f\u7c7b\u5065\u5eb7\u4ea7\u54c1\u5f00\u53d1\u4e0e\u521b\u65b0\u53ca\u4e2d\u836f\u8d44\u6e90\u7efc\u5408\u5229\u7528\u9ad8\u5cf0\u8bba\u575b\u201d\u7684\u901a\u77e5<\/a>9\u670827-29\u65e5<\/span><\/strong><\/span><\/p>
<\/span><\/strong><\/span>
<\/p>

<\/p>
\u676d\u5dde\u5e02<\/span>9\u670827\u65e5-29\u65e5<\/span><\/strong><\/span><\/strong><\/span>-\u5173\u4e8e\u53ec\u5f00\u7b2c\u4e09\u5c4a\u201c\u5168\u56fd\u5236\u836f\u5e9f\u6c34\u3001\u5e9f\u6c14\u3001\u5371\u5e9f\u5904\u7406\u65b0\u6280\u672f\u3001\u65b0\u6210\u679c\u4e0e\u65b0\u88c5\u5907\u5e94\u7528\u63a8\u5e7f\u4ea4\u6d41\u4f1a\u201d\u7684\u901a\u77e5<\/span><\/strong><\/span><\/a><\/p>
             <\/span><\/p>
\u91cd\u5e8611\u67081-3<\/span>\u65e5<\/span>-\u201c\u836f\u54c1\u5236\u5907\u5de5\u827a\u5f00\u53d1\u4e0e\u5de5\u827a\u9a8c\u8bc1<\/span>\/<\/span>\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7814\u7a76\u4e0e\u5b9e\u65bd<\/span>\u201d<\/span>\u7b2c\u4e94\u671f\u7814\u4fee\u73ed\u7684\u901a\u77e5<\/span><\/span><\/strong><\/span><\/a>
<\/p>
<\/strong><\/span>
<\/p>
\u5e7f\u5dde11<\/span>\u6708<\/span>09<\/span>\u65e5<\/span>-11<\/span>\u65e5<\/span><\/span>-<\/strong><\/span>2018\u4e2d\u56fd\u7279\u6b8a\u533b\u5b66\u7528\u9014\u914d\u65b9\u98df\u54c1\u6ce8\u518c\u7533\u62a5\u3001\u914d\u65b9\u8bbe\u8ba1\u53ca\u751f\u4ea7\u5de5\u827a\u3001\u73b0\u573a\u6838\u67e5\u4e0e\u8d28\u91cf\u68c0\u9a8c\u4ea4\u6d41\u4f1a\u7684\u901a\u77e5

<\/span><\/span><\/p>
\u676d\u5dde\u5e02-2018\u529f\u80fd\u98df\u54c1\u539f\u3001\u914d\u6599\u521b\u65b0\u4e0e\u6d3b\u6027\u6210\u5206\u5e94\u7528\u6280\u672f\u4e3b\u9898\u5cf0\u4f1a \u66a8\u65b0\u6280\u672f\u3001\u65b0\u4ea7\u54c1\u3001\u65b0\u88c5\u5907\u5c55\u793a\u4f1a\u201d\u7684\u901a\u77e5<\/a><\/span><\/span><\/strong><\/p><\/section><\/pre>\n<\/section>\n<\/section>\n
\u7ec4\u56e2\u62a5\u540d<\/span><\/strong>\u627e\u5c1a\u8001\u5e08\u4eab<\/span>\u4f18\u60e0\u66f4\u5927\u3002<\/span><\/span><\/strong><\/span><\/strong>
<\/p>\n<\/section>\n
\u57f9\u8bad\u4e2d\u5fc3\u8d1f\u8d23\u4eba\u5c1a\u4e3915652565785\uff08\u5fae\u4fe1\u540c\u53f7<\/strong><\/strong>\uff09<\/strong><\/span><\/p>
<\/span><\/h2>
QQ\u54a8\u8be2 2331466365<\/strong><\/span><\/p>
\u671b\u836f\u5c4a\u7684\u670b\u53cb\u5e2e\u5fd9\u8f6c\u53d1 \u8c22\u8c22\u5927\u5bb6<\/strong><\/strong><\/span><\/p>
<\/strong><\/span><\/p>
\u8bc6\u522b\u4e0b\u9762\u4e8c\u7ef4\u7801\u53ef\u586b\u5199\u62a5\u540d\u4fe1\u606f<\/strong><\/span><\/p>
<\/strong><\/span><\/p>
\"GMP\u98de\u68c0\u8981\u70b9\"<\/p>
\u8bc6\u522b\u4e8c\u7ef4\u7801\u6dfb\u52a0\u8d1f\u8d23\u4eba\u5fae\u4fe1<\/span><\/p>
\"GMP\u98de\u68c0\u8981\u70b9\"
<\/p>
<\/p><\/section><\/pre>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"
GMP\u98de\u884c\u68c0\u67e5\u91cd\u70b9\u4f01\u4e1a\u7c7b\u578b \u836f\u76d1\u5c40\u4ea7\u54c1\u62bd\u68c0\u4e0d\u5408\u683c\u7684\u4f01\u4e1a\u88ab\u53d1\u653e\u544a\u8beb\u4fe1\u7684\u4f01\u4e1a\u6ce8\u518c\u73b0\u573a\u68c0\u67e5\u6216GMP\u8ba4\u8bc1\u68c0\u67e5\u53d1\u73b0\u7f3a\u9677\u8f83 […]<\/p>\n","protected":false},"author":1,"featured_media":49728,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/49727"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=49727"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/49727\/revisions"}],"predecessor-version":[{"id":49732,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/49727\/revisions\/49732"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/49728"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=49727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=49727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=49727"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}