{"id":22583,"date":"2018-08-06T01:00:00","date_gmt":"2018-08-09T03:15:17","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/%e4%b8%89%e9%98%b6%e6%ae%b5%e5%b7%a5%e8%89%ba%e9%aa%8c%e8%af%81%e7%9a%84%e5%ae%9e%e4%be%8b\/"},"modified":"2018-08-09T11:15:19","modified_gmt":"2018-08-09T03:15:19","slug":"%e4%b8%89%e9%98%b6%e6%ae%b5%e5%b7%a5%e8%89%ba%e9%aa%8c%e8%af%81%e7%9a%84%e5%ae%9e%e4%be%8b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/22583\/","title":{"rendered":"\u4e09\u9636\u6bb5\u5de5\u827a\u9a8c\u8bc1\u7684\u5b9e\u4f8b"},"content":{"rendered":"
\n

PDA TR60  7.2 <\/span><\/span><\/strong>\u5c0f\u5206\u5b50\u836f\u7269\u7684\u4f8b\u5b50\uff08\u6ce8\u5c04\u7528\u836f\u7269\uff09<\/span><\/p>\n

\u88687.2-1\uff08\u9636\u6bb51\uff09\u3001\u88687.2-2\uff08\u9636\u6bb52\uff09\u548c\u88687.2-3\uff08\u9636\u6bb53\uff09\u63d0\u4f9b\u4e86\u4e00\u4e2a\u6709\u673a\u7684\u6ce8\u5c04\u5242\u7684\u5de5\u827a\u9a8c\u8bc1\u4e09\u4e2a\u9636\u6bb5\u7684\u793a\u4f8b\u3002<\/span><\/p>\n

\u8868 7.2-1<\/span><\/strong>\u9636\u6bb5 1\uff1a\u5de5\u827a\u8bbe\u8ba1<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u7c7b\u522b<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6d3b\u52a8<\/span><\/strong><\/p>\n<\/td>\n

\n

\u8f93\u51fa\/\u4ea4\u4ed8\u7269<\/span><\/strong><\/p>\n<\/td>\n

\n

\u539f\u7406\/\u793a\u4f8b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u5f00\u53d1<\/span><\/p>\n<\/td>\n

\n

\u5efa\u7acb\u76ee\u6807\u4ea7\u54c1\u6982\u51b5TPP\u548c\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5QTPP<\/span><\/p>\n<\/td>\n

\n

\u6db2\u4f53\u6ce8\u5c04\u5242\uff1a 3\u4e2a\u89c4\u683c\u7684\u65e0\u83cc\u5904\u65b9\uff0c\u5e94\u7b26\u5408USP\u5bf9\u6ce8\u5c04\u5242\u7684\u8981\u6c42\u3002\u76ee\u6807\u6709\u6548\u671f\u81f3\u5c11\u4e3a24\u4e2a\u6708\uff0825\u00b0C\uff09<\/span><\/p>\n<\/td>\n

\n

\u4ea7\u54c1\u5f00\u53d1\u8fc7\u7a0b\u672a\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff1b\u6cbb\u7597\u89c4\u683c\u4f9d\u636e\u751f\u7269\u7b49\u6548\u6027\u786e\u5b9a\u3002\u56e0\u6b64\u540c\u65b0\u5316\u5b66\u4f53\u76f8\u6bd4\uff0c\u4e34\u5e8a\u751f\u4ea7\u7ecf\u9a8c\u5f88\u5c11\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u8bc6\u522b\u5173\u952e\u8d28\u91cf\u5c5e\u6027<\/span><\/p>\n<\/td>\n

\n

\u7814\u53d1\u3001\u5de5\u827a\u5f00\u53d1\u3001\u5904\u65b9\u7814\u7a76\u4eba\u5458\u548c\u5206\u6790\u79d1\u5b66\u5bb6\u79ef\u6781\u534f\u4f5c\uff0c\u8bc6\u522b\u6f5c\u5728\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u53ca\u5176\u68c0\u6d4b\u65b9\u6cd5\u3002 \u4ee5\u5f80\u6db2\u4f53\u5236\u5242\u751f\u4ea7\u7ecf\u9a8c\u5728\u8bc6\u522b\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u65f6\u7684\u4f5c\u7528\u91cd\u5927\u3002<\/span><\/p>\n

\u5728\u9636\u6bb51\u5efa\u7acb\u5e76\u786e\u8ba4\u653e\u884c\u5236\u5242\u4ea7\u54c1\u7684\u542b\u91cf\u6d4b\u5b9a\u548c\u653e\u884c\u539f\u6599\u836f\u7684\u6d4b\u8bd5\u65b9\u6cd5\uff0c\u4ee5\u4fbf\u5bf9\u5176\u8fdb\u884c\u9a8c\u8bc1\uff0c\u5e76\u8f6c\u79fb\u81f3\u751f\u4ea7\u5de5\u5382\uff0c\u4e3a\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u63d0\u4f9b\u652f\u6301<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

\u786e\u5b9a\u751f\u4ea7\u5de5\u827a<\/span><\/p>\n<\/td>\n

\n

\u5de5\u827a\u5f00\u53d1\u662f\u57fa\u4e8e\u516c\u53f8\u5f53\u524d\u7684\u751f\u4ea7\u573a\u5730\u4ee5\u524d\u548c\u73b0\u6709\u5de5\u827a\u3001\u8f85\u6599\u3001\u751f\u4ea7\u80fd\u529b\u7684\u76f8\u5173\u7ecf\u9a8c\u3002\u91c7\u7528\u5b8c\u5168\u76f8\u540c\u7684\u5185\u5305\u88c5\u6750\u6599\u751f\u4ea7\u5b9e\u9a8c\u5ba4\u89c4\u6a21\u7684\u4ea7\u54c1\u3002\u6240\u6709\u539f\u6599\u5e94\u7b26\u5408\u516c\u53f8GMP\u8981\u6c42\u3002<\/span><\/p>\n

\u8fdb\u884c\u8bd5\u9a8c\u8bbe\u8ba1\uff08DOE\uff09\uff0c\u56e0\u4e3a\u5236\u5242\u5bf9\u70ed\u654f\u611f\uff0c\u6240\u4ee5\u91c7\u7528\u65e0\u83cc\u5de5\u827a\u751f\u4ea7\u800c\u4e0d\u662f\u6700\u7ec8\u706d\u83cc\u3002\u5728\u5b9e\u9a8c\u5ba4\u89c4\u6a21\u7684\u53ef\u884c\u6027\/\u5904\u65b9\u6478\u7d22\u6279\u751f\u4ea7\u540e\uff0c\u5728\u7814\u53d1\u4e2d\u8bd5\u5382\u623f\u5236\u5907\u4e2d\u8bd5\u89c4\u6a21\u7684\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6279\uff08\u81f3\u5c11\u5e94\u67093\u4e2a\u4e0d\u540cpH\u6c34\u5e73\uff09\u3002\u5efa\u7acb\u4e86\u914d\u6599\u3001\u8fc7\u6ee4\u3001\u704c\u88c5\u6700\u5927\u6e29\u5ea6\u5bf9\u6eb6\u6db2\u7a33\u5b9a\u6027\u7684\u6570\u636e\uff0c\u5bf9\u5236\u5242\u964d\u89e3\u901f\u5ea6\u548c\u6742\u8d28\u5206\u5e03\u7684\u5f71\u54cd\u3002<\/span><\/p>\n

\u81f3\u5c11\u5e94\u8003\u86512\u4e2a\u539f\u6599\u836f\u4f9b\u5e94\u5546\u6279\u6b21\u3002\u76ee\u7684\u662f\u91c7\u7528\u6807\u51c6\u5316\u548c\u7c7b\u4f3c\u7684\u5355\u5143\u64cd\u4f5c\uff0c\u5e76\u5c06\u5de5\u827a\u5f00\u53d1\u5468\u671f\u964d\u81f3\u6700\u4f4e\u3002\u4e2d\u8bd5\uff08\u81f3\u5c11\u4e3a\u5546\u4e1a\u6279\u91cf\u768410%\uff09\u65f6\u5904\u65b9\u7814\u7a76\u7684\u8fc7\u7a0b\u63d0\u9ad8\u4e86\u5bf9\u5de5\u827a\u53d8\u91cf\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u4ee5\u53ca\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08CQA\uff09\u7684\u8ba4\u8bc6\u3002\u53ef\u901a\u8fc7\u4e2d\u8bd5\u6279\u751f\u4ea7\u5efa\u7acb\u5de5\u827a\u653e\u5927\u53c2\u6570\u3001\u751f\u4ea7\u6807\u51c6\u3001\u5206\u6790\u65b9\u6cd5\u4ee5\u53ca\u751f\u7269\u5b66\u6307\u6807\u3002<\/span><\/p>\n<\/td>\n

\n

\u5bf9\u4e2d\u8bd5\u6279\u91cf400L\u8fdb\u884c\u53d6\u6837\u3001\u5206\u6790\uff0c\u57fa\u4e8e\u4e00\u81f4\u6027\u548c\u7a33\u5b9a\u6027\u7b5b\u9009\u5904\u65b9\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u5149\u654f\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u6c27\u7075\u654f\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u5904\u65b9\u7684pH<\/span><\/p>\n

\u2022 <\/span><\/span>\u5bb9\u5668\u6750\u8d28\u7684\u4e0d\u76f8\u5bb9\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u751f\u4ea7\u7269\u6599\u7684\u4e0d\u76f8\u5bb9\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u70ed\u7a33\u5b9a\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u6210\u8272<\/span><\/p>\n

\u2022 <\/span><\/span>\u4efb\u4f55\u9884\u671f\u7684\u5f71\u54cd\u7a33\u5b9a\u6027\u7684\u56e0\u7d20<\/span><\/p>\n

\u5728\u6df7\u5408\u3001\u704c\u88c5\u65f6\u6eb6\u6db2\u6e29\u5ea6\u7684\u63a7\u5236\uff0c\u50a8\u5b58\u4e5f\u5e94\u8fdb\u884c\u63a7\u5236<\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n
<\/td>\n		\n

\u2022 <\/span><\/span>\u5f00\u53d1\u5404\u5de5\u5e8f\u7684\u653e\u5927\u6a21\u578b\u3002\u901a\u8fc7\u8bbe\u8ba1\u548c\u9636\u6bb5\u6027\u5ba1\u6838\u8fc7\u7a0b\uff0c\u7814\u53d1\u4eba\u5458\u63d0\u4f9b\u6a21\u578b\u5efa\u7acb\u4f9d\u636e\u5e76\u8bb0\u5f55\u5404\u79cd\u8fb9\u754c\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u5728\u653e\u5927\u751f\u4ea7\u7684GMP\u5382\u623f\u91c7\u7528\u62ec\u5f27\u6cd5\u751f\u4ea7\u7a33\u5b9a\u6027\u8bd5\u9a8c\u6279\u524d\u542f\u52a8\u5de5\u827a\u8bc4\u4ef7\uff08PE\uff09\u7814\u7a76\u3002\u603b\u5171\u751f\u4ea72\u6279\u6700\u9ad8\u6d53\u5ea6\u7684\u653e\u5927\u6279\u6b21\uff0c\u5e76\u91c7\u75282\u4e2a\u4e0d\u540c\u4f9b\u5e94\u5546\u7684\u539f\u6599\u836f\u3002\u4e3a\u4e86\u5efa\u7acb\u5e76\u7406\u89e3\u6240\u6709\u5173\u952e\u5de5\u827a\u53c2\u6570\u548c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c 2\u6279\u4ea7\u54c1\u7684\u751f\u4ea7\u5e94\u91c7\u7528\u6700\u5927\u6279\u91cf\u3002\u7814\u7a76\u65b9\u6848\u7684\u8bbe\u8ba1\u5e94\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\uff0c\u65b9\u6848\u4e2d\u786e\u5b9a\u7684\u4e00\u4e2a\u6269\u5927\u7684\u4e2d\u95f4\u63a7\u5236\u8ba1\u5212\uff0c\u4ee5\u53ca\u7279\u5b9a\u4ea7\u54c1\/\u6279\u6b21\u7684\u53d6\u6837\u8ba1\u5212\u3002\u8fd9\u4e9b\u7814\u7a76\u5efa\u7acb\u4e86\uff1a<\/span><\/p>\n

o<\/span>\u836f\u7269\u6eb6\u89e3\u6982\u51b5<\/span><\/p>\n

o<\/span>\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u964d\u89e3<\/span><\/p>\n

o<\/span>\u6eb6\u6db2\u6ee4\u5668\u76f8\u5bb9\u6027<\/span><\/p>\n

o<\/span>\u6eb6\u6db2\u6682\u5b58\u65f6\u95f4<\/span><\/p>\n

o<\/span>\u6eb6\u6db2\u5bc6\u5c01\u4ef6\/\u5bb9\u5668\u7684\u76f8\u5bb9\u6027<\/span><\/p>\n

\u2022<\/span>\u8fdb\u884c\u5168\u9762\u53d6\u6837\u548c\u6807\u51c6\u8bc4\u4ef7\u3002\u5b8c\u6210\u4e86\u539f\u6599\u836f\u548c\u5236\u5242\u751f\u4ea7\u6279\u6b21\u7684\u8868\u5f81\u548c\u6bd4\u8f83\u3002\u6570\u636e\u663e\u793a\u5f53\u91c7\u7528\u6700\u5dee\u6761\u4ef6\u751f\u4ea7\u65f6\uff0c\u5236\u5242\u80fd\u591f\u7b26\u5408\u6210\u54c1\u8d28\u91cf\u6807\u51c6\u3002<\/span><\/p>\n

\u2022<\/span>\u7814\u53d1\u4eba\u5458\u662f\u8fd9\u4e9b\u6279\u6b21\u7684\u7b2c\u4e00\u8d1f\u8d23\u4eba\uff0c\u4f46\u751f\u4ea7\u4eba\u5458\u4e5f\u5e94\u53c2\u4e0e\u3002<\/span><\/p>\n<\/td>\n

\n

\u8d28\u91cf\u5c5e\u6027\u7684\u6d4b\u8bd5\u5305\u62ec\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u5916\u89c2\u548c\u9274\u522b<\/span><\/p>\n

\u2022 <\/span><\/span>\u7eaf\u5ea6\u6d4b\u8bd5<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u6db2pH<\/span><\/p>\n

\u2022 <\/span><\/span>\u6e17\u900f\u538b\u6d53\u5ea6<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u89e3\u6982\u51b5<\/span><\/p>\n

\u2022 <\/span><\/span>\u5de5\u827a\u6742\u8d28<\/span><\/p>\n

\u2022 <\/span><\/span>\u9897\u7c92\u7269<\/span><\/p>\n

\u2022 <\/span><\/span>\u5fae\u751f\u7269\u5c5e\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73
 \u8fd9\u4e9b\u7814\u7a76\u5efa\u7acb\u4e86\u5173\u952e\u5de5\u827a\u53c2\u6570\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u8f6c\u901f<\/span><\/p>\n

\u2022 <\/span><\/span>\u6e29\u5ea6<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u89e3\u6c27<\/span><\/p>\n

\u2022 <\/span><\/span>\u6df7\u5408\u65f6\u95f4<\/span><\/p>\n

\u57282800L\u7684\u704c\u88c5\u8fc7\u7a0b\u5de5\u827a\u8bc4\u4ef7\u6279\u6b21\u4e2d\uff0c\u670910\u4e2a\u53d6\u6837\u70b9\u3002\u5305\u62ec\u751f\u4ea7\u8fc7\u7a0b\u5f00\u59cb\u3001\u4e2d\u95f4\u548c\u7ed3\u675f\u7684\u591a\u4e2a\u6837\u54c1\uff08\u5982\u4e00\u5f0f\u4e09\u4efd\u6837\u54c1\uff09\u3002\u8fd9\u79cd\u65b9\u6cd5\u662f\u6839\u636e\u5176\u4ed6\u975e\u5747\u4e00\u7cfb\u7edf\u53d6\u6837\u64cd\u4f5c\uff08\u5982FDA\u7c89\u672b\u6df7\u5408\u53d6\u6837\u8ba1\u5212\uff09\u5efa\u7acb\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n		\n

\u8d28\u91cf\u98ce\u9669\u8bc4\u4f30<\/span><\/p>\n<\/td>\n

\n

\u5728\u5de5\u827a\u5f00\u53d1\u65f6\u8fdb\u884c\u4e86\u6b63\u5f0f\u7684\u98ce\u9669\u8bc4\u4f30\u3002\u8bc4\u4f30\u8303\u56f4\u9650\u5b9a\u5728\u4ea7\u54c1\u548c\u5de5\u827a\u7684\u751f\u4ea7\u98ce\u9669\u4e0a\u3002\u8be5\u6587\u4ef6\u7684\u6279\u51c6\u8868\u660e\u5de5\u827a\u5f00\u53d1\u8bd5\u9a8c\u8bbe\u8ba1\u6d3b\u52a8\u7684\u6b8b\u7559\u98ce\u9669\u548c\u76f8\u5173\u7684\u98ce\u9669\u8bc4\u5206\u662f\u5bf9\u4e8e\u8fdb\u5165\u7a33\u5b9a\u6027\u8bbe\u8ba1\u9636\u6bb5\u7684\u5de5\u827a\u662f\u53ef\u63a5\u53d7\u7684\u3002  \u8fdc\u8fdc\u6ede\u540e\u4e8e\u9636\u6bb52\uff0c\u5728\u9636\u6bb53\u4ee5\u53ca\u6f2b\u957f\u800c\u6210\u529f\u7684\u5546\u4e1a\u5316\u751f\u4ea7\u9636\u6bb5\u4e2d\u8fdb\u884c\u5176\u4ed6\u6b63\u5f0f\u98ce\u9669\u8bc4\u4f30\u3002\u8fd9\u5305\u62ec\u5c06\u6700\u5dee\u6761\u4ef6\u4e0e\u5404\u64cd\u4f5c\u76f8\u5173\u8054\uff0c\u8fd9\u6709\u52a9\u4e8e\u5efa\u7acb\u8bbe\u8ba1\u7a7a\u95f4\u3002<\/span><\/p>\n<\/td>\n

\n

\u91c7\u7528\u98ce\u9669\u6392\u5e8f\u548c\u8fc7\u6ee4\uff0c\u5305\u62ec\u4e25\u91cd\u6027\u548c\u53ef\u80fd\u6027\u3002\u8fd9\u662f\u4e2a\u66f4\u6613\u7406\u89e3\u7684\u5de5\u5177\uff1b\u5b83\u5173\u6ce8\u4e8e\u6700\u91cd\u8981\u7684\u56e0\u5b50\u3002\u5176\u4ed6\u5de5\u5177\u5305\u62ec\u6545\u969c\u6a21\u5f0f\u548c\u5f71\u54cd\u5206\u6790\u3001\u56e0\u679c\u56fe\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u8868\u5f81<\/span><\/p>\n<\/td>\n


<\/td>\n		\n

\u4f18\u5316\u5355\u5143\u64cd\u4f5c\u4ee5\u63d0\u9ad8\u6548\u7387\u548c\u8010\u53d7\u6027\u3002\u91c7\u7528\u8bd5\u9a8c\u548c\u653e\u5927\u7814\u7a76\uff0c\u79d1\u5b66\u5bb6\u80fd\u591f\u5efa\u7acb\u653e\u5927\u5de5\u827a\u53c2\u6570\uff0c\u5e76\u5728\u7a33\u5b9a\u6027\u6279\u6b21\u751f\u4ea7\u524d\u8fdb\u884c\u8bc4\u4ef7\u3002<\/span><\/p>\n

\u5de5\u827a\u7684\u6539\u8fdb\u5305\u62ec\u4f18\u5316\u6eb6\u6db2\u6df7\u5408\u5de5\u827a\u3001\u7f50\u5185\u6eb6\u6db2pH\u548c\u6eb6\u89e3\u6c27\u76d1\u63a7\u7cfb\u7edf\u6765\u4fc3\u8fdb\u5feb\u901f\u6eb6\u89e3\u3002\u91c7\u7528\u5b9e\u9a8c\u8bbe\u8ba1\u65b9\u6cd5\u8fdb\u884c\u5de5\u827a\u8868\u5f81\u6216\u8bc4\u4ef7\u7814\u7a76\u7684\u8bbe\u8ba1\uff0c\u4ee5\u51cf\u5c11\u8bd5\u9a8c\u91cf\u3002\u8fde\u540c\u786e\u8ba4\u548c\u5de5\u827a\u7406\u89e3\u62a5\u544a\u4e00\u8d77\u6709\u5f88\u591a\u7814\u7a76\u548c\u653e\u5927\/\u8f6c\u79fb\u62a5\u544a\u3002\u91c7\u7528\u6b63\u5e38\u6279\u91cf\u5236\u5242\u751f\u4ea7\u5bf9\u6765\u81ea\u4e0d\u540c\u4f9b\u5e94\u5546\u7684\u6700\u5173\u952e\u8f85\u6599\u8fdb\u884c\u786e\u8ba4\u3002<\/span><\/p>\n<\/td>\n

\n

\u9700\u786e\u8ba4\u7684\u8f85\u6599\u4e3a\u90a3\u4e9b\u5f71\u54cd\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff0c \u5982\u63a7\u5236pH\u548c\u6e17\u900f\u538b\u6d53\u5ea6\u7684\u7269\u6599\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n		\n

\u5b9a\u7a3f\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u548c\u5173\u952e\u5de5\u827a\u53c2\u6570<\/span><\/p>\n<\/td>\n

\n

\u2022 <\/span><\/span>\u5728\u5de5\u827a\u5f00\u53d1\u548c\u653e\u5927\u8fc7\u7a0b\u4e2d\uff0c\u7531\u4e8e\u539f\u6599\u7c92\u5f84\u7684\u53d8\u5316\uff0c\u5bfc\u81f4\u4e86\u539f\u6599\u836f\u6eb6\u51fa\u95ee\u9898\u3002\u901a\u8fc7\u6a21\u578b\u8ba1\u7b97\uff0c\u5bf9\u653e\u5927\u5de5\u827a\u6405\u62cc\u548c\u6eb6\u6db2\u6e29\u5ea6\u7684\u5de5\u827a\u53c2\u6570\u8fdb\u884c\u4e86\u8c03\u6574\u548c\u8bc4\u4ef7\u3002\u5bf9\u751f\u4ea7\u5de5\u827a\u8fdb\u884c\u4e86\u4fee\u8ba2\u548c\u8bc4\u4ef7\uff0c\u8fdb\u4e00\u6b65\u786e\u8ba4\u6210\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u6db2\u4f53\u4ea7\u54c1\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5728\u5f00\u53d1\u9636\u6bb5\u5df2\u8fdb\u884c\u4e86\u8bc6\u522b\uff0c\u5728\u9636\u6bb51\u8fdb\u884c\u4e86\u6539\u8fdb\uff0c\u5e76\u4f5c\u4e3a\u751f\u4ea7\u7a0b\u5e8f\u4e2d\u6700\u7ec8\u6807\u51c6\u6267\u884c\u3002\u8fd9\u4e9b\u5206\u5b50\u548c\u5904\u65b9\u7684\u5185\u5728\u5c5e\u6027\u63d0\u4f9b\u4e86\u9884\u671f\u7684\u6d3b\u6027\u3001\u7eaf\u5ea6\u548c\u5b89\u5168\u6027\u3002\u7531\u6307\u5b9a\u56e2\u961f\u8fdb\u884c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u5ba1\u6838\u548c\u6279\u51c6\uff0c\u5e76\u6709\u6b63\u5f0f\u62a5\u544a\u3002\u5728\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u4e2d\u5bf9\u5f71\u54cd\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u5de5\u827a\u53c2\u6570\u8fdb\u884c\u4e86\u8bc6\u522b\uff0c\u5e76\u6839\u636e\u5de5\u827a\u9a8c\u8bc1\u7814\u7a76\u7ed3\u679c\u786e\u5b9a\u4e86\u5176\u5173\u952e\u7a0b\u5ea6\u3002<\/span><\/p>\n<\/td>\n

\n

\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u662f\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u6db2 pH<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u89e3\u6c27<\/span><\/p>\n

\u2022 <\/span><\/span>\u836f\u7269\u6eb6\u51fa\u548c\u5747\u4e00\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u5de5\u827a\u6742\u8d28<\/span><\/p>\n

\u2022 <\/span><\/span>\u836f\u7269\u6d53\u5ea6\uff08\u6548\u4ef7\uff09<\/span><\/p>\n

\u2022 <\/span><\/span>\u6e17\u900f\u538b\u6d53\u5ea6<\/span><\/p>\n

\u2022 <\/span><\/span>\u5fae\u751f\u7269\u5c5e\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u65e0\u83cc\u4fdd\u8bc1\u6c34\u5e73<\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n		\n

\u6587\u4ef6\u5316\u5de5\u827a\u8bbe\u8ba1<\/span><\/p>\n<\/td>\n

\n

\u2022 <\/span><\/span>\u5bf9\u4e8e\u5de5\u827a\u8bc4\u4ef7\/\u8bd5\u4ea7\u6279\uff0c\u4e0d\u8fdb\u884c\u5206\u6790\u65b9\u6cd5\u7684\u9a8c\u8bc1\uff1b\u4f46\u662f\u5728\u7a33\u5b9a\u6027\u6279\u6b21\u751f\u4ea7\u524d\u5e94\u8fdb\u884c\u9a8c\u8bc1\u5e76\u4ece\u7814\u53d1\u8f6c\u79fb\u81f3\u751f\u4ea7\u5382\u3002\u5185\u5bb9\u5305\u62ec\u4e13\u5c5e\u6027\u3001\u5f3a\u5236\u964d\u89e3\u3001\u7cbe\u5bc6\u5ea6\u3001\u7ebf\u6027\u3001\u68c0\u6d4b\u9650\/\u5b9a\u91cf\u9650\u3001\u51c6\u786e\u5ea6\u548c\u8010\u53d7\u6027\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u9f13\u52b1\u79d1\u5b66\u5bb6\u8d77\u8349\u6280\u672f\u62a5\u544a\uff0c\u603b\u7ed3\u5de5\u827a\u7684\u4e0d\u540c\u65b9\u9762\u3002\u901a\u5e38\u4ed6\u4eec\u4e13\u6ce8\u4e8e\u5355\u4e2a\u4e00\u4e2a\u5de5\u5e8f\uff0c\u5bf9\u53d8\u66f4\u548c\u6539\u8fdb\u8fdb\u884c\u63cf\u8ff0\u3002\u8fd8\u5e94\u8d77\u8349\u6280\u672f\u8bc4\u5ba1\u7684\u53c2\u8003\u6587\u4ef6\u3002\u5b83\u603b\u7ed3\u4e86\u6240\u6709\u5f00\u53d1\u62a5\u544a\uff0c\u6db5\u76d6\u6574\u4e2a\u5de5\u827a\u7684\u65b9\u6cd5\u3001\u8303\u56f4\u3001\u6761\u4ef6\u548c\u77e5\u8bc6\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u6bcf\u6b21\u53d1\u751f\u91cd\u5927\u5de5\u827a\u53d8\u66f4\u65f6\uff0c\u5e94\u5bf9\u6587\u4ef6\u8fdb\u884c\u66f4\u65b0\u3002\u6280\u672f\u8bc4\u5ba1\u53c2\u8003\u6587\u4ef6\u3001\u76f8\u5173\u8d28\u91cf\u6807\u51c6\u548c\u7a0b\u5e8f\u96c6\u4e2d\u5f52\u6863\uff0c\u5e76\u7528\u4e8e\u6279\u751f\u4ea7\u8bb0\u5f55\u7684\u5236\u8ba2\u3002<\/span><\/p>\n<\/td>\n

\n

\u5206\u6790\u65b9\u6cd5\u662f\u53ef\u9760\u7684\uff0c\u4f46\u6ca1\u6709\u8fdb\u884c\u6700\u521d\u9a8c\u8bc1\uff0c\u56e0\u4e3a\uff1a
 \u2022 \u5728\u751f\u547d\u5468\u671f\u7684\u65e9\u671f\u5df2\u5b8c\u6210\u8bd5\u9a8c\u6279\u7684\u77e5\u8bc6\u6536\u96c6<\/span><\/p>\n

\u2022 <\/span><\/span>\u91c7\u7528\u8349\u6848\u6807\u51c6\uff0c\u53d8\u66f4\u5728\u8303\u56f4\u5185  <\/span><\/p>\n

\u2022 <\/span><\/span>\u8282\u7701\u4e86\u5728\u8be5\u9636\u6bb5\u65b9\u6cd5\u9a8c\u8bc1\u7684\u65f6\u95f4<\/span><\/p>\n

\u5728\u65b9\u6cd5\u8f6c\u79fb\u65f6\uff0c\u5b9e\u9a8c\u5ba4\u5316\u9a8c\u5458\u9700\u6309\u7167\u5185\u90e8SOP\u8fdb\u884c\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u3002\u4e5f\u5e94\u8be5\u7b26\u5408ICH Q2\u3001USP\u6216\u5176\u4ed6\u6cd5\u89c4\/\u6216\u836f\u5178\u6807\u51c6<\/span><\/p>\n<\/td>\n<\/tr>\n


<\/td>\n		\n

\u5de5\u827a\u9a8c\u8bc1\u4e3b\u8ba1\u5212<\/span><\/p>\n<\/td>\n

\n

\u5efa\u7acb\u8be6\u7ec6\u7684\u9a8c\u8bc1\u4e3b\u8ba1\u5212\uff0c\u8bc6\u522b\u9700\u8fdb\u884c\u7684\u7279\u5b9a\u9a8c\u8bc1\u6d3b\u52a8\u3002\u5404\u4ea7\u54c1\u5747\u8d77\u8349\u76f8\u5e94\u7684\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u3002\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u5e94\u521a\u597d\u5728\u9884\u671f\u7684\u65b0\u836fNDA\u6279\u51c6\u4e4b\u524d\u5b8c\u6210\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u9664\u4e86\u65b0\u5de5\u827a\u7684\u9a8c\u8bc1\u8bd5\u9a8c\uff0c\u4e3b\u8ba1\u5212\u8fd8\u786e\u5b9a\u4e86\u5176\u4ed6\u9879\u76ee\u5df2\u91c7\u7528\u7684\u7814\u7a76\u548c\u9002\u5f53\u53c2\u8003\uff0c\u4f46\u80fd\u5bf9\u8fd9\u4e00\u4ea7\u54c1\u63d0\u4f9b\u652f\u6301\u3002<\/span><\/p>\n<\/td>\n

\n

\u5de5\u827a\u9a8c\u8bc1\u8ba1\u5212\u5e94\u5728\u9636\u6bb52\u524d\u8d77\u8349\uff0c\u786e\u5b9a\u6240\u9700\u7684\u6765\u81ea\u9636\u6bb51\u7684\u652f\u6301\u6027\u4fe1\u606f\u3002\u4f46\u6b63\u5f0f\u7684\u9a8c\u8bc1\u4e3b\u8ba1\u5212\u5728\u9636\u6bb52\u786e\u5b9a\uff0c\u8fd9\u65f6\u5df2\u7ecf\u77e5\u9053\u4e86\u6240\u6709\u5c5e\u6027\u3001\u53c2\u6570\u548c\u7cfb\u7edf\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


<\/span>\u8868 7.2-2 <\/span><\/span><\/strong>\u9636\u6bb5 2\uff1a\u5de5\u827a\u786e\u8ba4<\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u7c7b\u522b<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6d3b\u52a8<\/span><\/strong><\/p>\n<\/td>\n

\n

\u8f93\u51fa\/\u4ea4\u4ed8\u7269<\/span><\/strong><\/p>\n<\/td>\n

\n

\u539f\u7406\/\u793a\u4f8b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u786e\u8ba4<\/span><\/p>\n<\/td>\n

\n

\u8bbe\u5907\u3001\u8bbe\u65bd\u548c\u5382\u623f\u786e\u8ba4<\/span><\/p>\n<\/td>\n

\n

\u8bbe\u5907\u786e\u8ba4\u548c\u786e\u8bc1\u7684\u8303\u56f4\u5e94\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u3002\u5173\u952e\u8981\u7d20\uff08\u5982\u5173\u952e\u529f\u80fd\u3001\u63a7\u5236\u548c\u7279\u6027\uff09\u548c\u5176\u4ed6\u7cfb\u7edf\u7ec4\u4ef6\u6216\u529f\u80fd\u7ecf\u8bc1\u5b9e\u7b26\u5408\u9884\u5b9a\u7528\u9014\u3002\u8bbe\u5907\u548c\u8bbe\u65bd\u5e94\u5904\u4e8e\u786e\u8ba4\u72b6\u6001\u3002\u8fd9\u5e94\u6839\u636e\u5de5\u5382\u7684\u7a0b\u5e8f\u8fdb\u884c\uff0c\u4ee5\u4fdd\u6301\u53d7\u63a7\u72b6\u6001\u3002<\/span><\/p>\n

\u5bf9\u786e\u8ba4\u6d3b\u52a8\u548c\u6821\u51c6\u8fdb\u884c\u786e\u8ba4\u3002\u5bf9\u4e8e\u901a\u8fc7\u65e5\u5e38\u6821\u51c6\u548c\/\u6216\u9884\u9632\u7ef4\u62a4\u8ba1\u5212\u786e\u4fdd\u6b63\u5e38\u8fd0\u884c\u7684\u4efb\u4f55\u7cfb\u7edf\uff0c\u53ef\u80fd\u4e0d\u9700\u8981\u8fdb\u884c\u6b63\u5f0f\u786e\u8ba4\u3002<\/span><\/p>\n<\/td>\n

\n

\u5bf9\u4ee5\u4e0b\u8fdb\u884c\u786e\u8ba4\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u6405\u62cc\u6df7\u5408\u901f\u5ea6<\/span><\/p>\n

\u2022 <\/span><\/span>\u4f20\u611f\u5668\u5982\u6db2\u4f4d\u3001\u4f53\u79ef\u548c\u6e29\u5ea6\u6d4b\u91cf<\/span><\/p>\n

\u2022 <\/span><\/span>\u7f50\u5185pH\u6d4b\u91cf<\/span><\/p>\n

\u2022 <\/span><\/span>\u6c27\u6d4b\u91cf<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u6db2\u704c\u88c5\u7cfb\u7edf<\/span><\/p>\n

\u2022 <\/span><\/span>\u51b7\u51bb\u50a8\u5b58\u7bb1<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4<\/span><\/p>\n<\/td>\n

\n

\u6280\u672f\u8f6c\u79fb\u548c\u8bd5\u751f\u4ea7<\/span><\/p>\n<\/td>\n

\n

\u2022 <\/span><\/span>\u6839\u636e\u5de5\u827a\u8bc4\u4ef7\u6279\u7ed3\u679c\uff0c\u5c06\u751f\u4ea7\u3001\u5206\u6790\u548c\u751f\u7269\u7a0b\u5e8f\u8f6c\u79fb\u81f3\u751f\u4ea7\u5382  <\/span><\/p>\n

\u2022 <\/span><\/span>\u4ee510-15%\u5546\u4e1a\u6279\u91cf\u751f\u4ea73\u6279\u7a33\u5b9a\u6027\u5236\u5242<\/span><\/p>\n

\u2022 <\/span><\/span>\u6240\u6709\u7a33\u5b9a\u6027\u6279\u6b21\u9700\u91c7\u7528\u4e09\u6279\u6765\u81ea\u4e0d\u540c\u4f9b\u5e94\u5546\u7684\u539f\u6599\u836f\uff08\u77e9\u9635\u6cd5\uff09\u3002\u5176\u4e2d\u89c4\u683c\u6700\u9ad8\u7684\u4e00\u6279\u91c7\u7528\u6700\u5dee\u5de5\u827a\u6761\u4ef6\uff08\u5982\uff0c\u6eb6\u6db2\u6682\u5b58\u65f6\u95f4\uff09\u751f\u4ea7\u3002\u7a33\u5b9a\u6027\u7814\u7a76\u91c7\u7528\u914d\u6db2\u7f50\u653e\u884c\u3001\u4e2d\u95f4\u63a7\u5236\u6d4b\u8bd5\u548c\u6210\u54c1\u653e\u884c\u7684\u542b\u91cf\u6d4b\u5b9a\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u5bf9\u5206\u6790\u548c\u5fae\u751f\u7269\u65b9\u6cd5\u8fdb\u884c\u9a8c\u8bc1\u3002\u542b\u91cf\u6d4b\u5b9a\u7531\u4e13\u95e8\u7684\u7a33\u5b9a\u6027\u68c0\u6d4b\u5c0f\u7ec4\u5b8c\u6210\u3002\u4ee5\u4e0a\u6279\u6b21\u957f\u671f\u7a33\u5b9a\u6027\u8003\u5bdf\u6761\u4ef6\u4e3a  \u6e29\u5ea62-8\u00b0C\/\u76f8\u5bf9\u6e7f\u5ea660%\uff1b\u540c\u65f6\u8fdb\u884c\u6e29\u5ea630\u00b0 C\/\u76f8\u5bf9\u6e7f\u5ea665%\u548c\u6e29\u5ea640\u00b0C\/\u76f8\u5bf9\u6e7f\u5ea675%\u7684\u8bd5\u9a8c\u3002\u5404\u4ea7\u54c1\u7684\u6bcf\u4e00\u89c4\u683c\uff0c\u5e94\u8fdb\u884c\u4e00\u6279\u7a33\u5b9a\u6027\u8bd5\u9a8c\uff0c\u5e76\u5e94\u5c06\u7a33\u5b9a\u6027\u6837\u54c1\u5012\u7f6e\u5b58\u653e\u3002\u5728\u8fdb\u884c\u7a33\u5b9a\u6027\u751f\u4ea7\u524d\uff0c\u5236\u8ba2\u6b63\u5f0f\u7684\u7a33\u5b9a\u6027\u8ba1\u5212\uff0c\u5e76\u5728\u63d0\u4ea4\u7533\u62a5\u8d44\u6599\u524d\u53d1\u5e03\u3002\u5728\u7a33\u5b9a\u6027\u751f\u4ea7\u524d\uff0c\u53d1\u5e03\u6b63\u5f0f\u7684\u7a33\u5b9a\u6027\u8003\u5bdf\u65b9\u6848\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u5728\u6b63\u5e38\u5546\u4e1a\u6279\u91cf\u7684\u9884\u9a8c\u8bc1\u6279\u540e\uff0c\u5728\u751f\u4ea7\u5382\u8fdb\u884c\u591a\u6279\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u4e0a\u5e02\u4ea7\u54c1\u7684\u751f\u4ea7\u3002<\/span><\/p>\n<\/td>\n

\n

\u9a8c\u8bc1\u6279\u5e94\u786e\u8ba4\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u6eb6\u6db2\u6df7\u5408\u5de5\u827a<\/span><\/p>\n

\u2022 <\/span><\/span>\u704c\u88c5\u5de5\u827a<\/span><\/p>\n

\u2022 <\/span><\/span>\u706d\u83cc\u5de5\u827a\uff08\u9002\u5f53\u65f6\uff09<\/span><\/p>\n

\u2022 <\/span><\/span>\u5305\u88c5\u5e76\u786e\u8ba4\u6210\u54c1\u7b26\u5408\u6700\u7ec8\u8d28\u91cf\u6807\u51c6<\/span><\/p>\n

\u6ce8\u518c\u65f6\uff0c\u91c7\u7528\u77e9\u9635\u6cd5\u8003\u5bdf\u4e0d\u540c\u4f9b\u5e94\u5546\u7684\u5f71\u54cd\uff0c\u5176\u4ed6\u5747\u4fdd\u6301\u4e0d\u53d8\u3002<\/span><\/p>\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u5bf9\u793a\u8303\u6279\uff08\u9884\u9a8c\u8bc1\u6279\uff09\u4e2d\u76f8\u540c\u5de5\u827a\u53c2\u6570\u548c\u8d28\u91cf\u5c5e\u6027\u8fdb\u884c\u4e86\u786e\u8ba4\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u51c6\u5907\u60c5\u51b5\u8bc4\u4f30<\/span><\/p>\n<\/td>\n

\n

\u2022 <\/span><\/span>\u5728\u9636\u6bb51\u786e\u5b9a\u5546\u4e1a\u751f\u4ea7\u573a\u5730\u3002\u5e76\u5728\u201c\u9636\u6bb5\u603b\u7ed3\u201d\u4f1a\u8bae\u4e0a\u786e\u8ba4\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u7684\u51c6\u5907\u60c5\u51b5\u3002<\/span><\/p>\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u5728\u5e38\u89c4\u6761\u4ef6\u4e0b\u751f\u4ea7\u3002<\/span><\/p>\n<\/td>\n

\n

\u6700\u7ec8\u786e\u5b9a\uff1a<\/span><\/p>\n

\u2022 <\/span><\/span>\u8d28\u91cf\u6807\u51c6<\/span><\/p>\n

\u2022 <\/span><\/span>\u4ee5\u5f80\u62a5\u544a\uff08\u5982\u5904\u65b9\u3001\u5de5\u827a\u8bc4\u4ef7\uff09<\/span><\/p>\n

\u2022 <\/span><\/span>\u8bbe\u5907\u548c\u5382\u623f\u786e\u8ba4<\/span><\/p>\n

\u2022 <\/span><\/span>\u6700\u5dee\u6761\u4ef6\u751f\u4ea7\u7684\u4ee5\u524d\u6279\u6b21<\/span><\/p>\n

\u2022 <\/span><\/span>\u5176\u4ed6\u4e8b\u9879\uff08\u5982\u8d34\u7b7e\uff09\u7684\u51c6\u5907\u60c5\u51b5\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u751f\u4ea7\u6279<\/span><\/p>\n<\/td>\n

\n

\u5546\u4e1a\u751f\u4ea7\u7528\u7269\u6599\u7684\u8981\u6c42\u51b3\u5b9a\u4e86\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u7684\u6279\u6b21\u3002\u5236\u5242\u7684\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u5171\u67095\u6279\uff0c\u5305\u62ec\u6700\u9ad8\u89c4\u683c\u76843\u6279\u3001\u4e2d\u95f4\u89c4\u683c\u76841\u6279\uff0c\u4ee5\u53ca\u6700\u5c0f\u89c4\u683c\u7684\u4e00\u6279\uff0c\u5747\u91c7\u7528\u5546\u4e1a\u751f\u4ea7\u6279\u91cf\u3002\u6240\u6709\u6279\u6b21\u90fd\u8fdb\u884c\u4e86\u989d\u5916\u53d6\u6837\u3002\u6240\u6709\u7b26\u5408\u653e\u884c\u8981\u6c42\u7684\u6279\u6b21\u90fd\u53ef\u4e0a\u5e02\u4f9b\u5e94\u3002\u6240\u6709\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u6b21\u90fd\u5728\u6b63\u5e38\u6761\u4ef6\u4e0b\u751f\u4ea7\u3002<\/span><\/p>\n

\u2022 <\/span><\/span>\u7528\u89c4\u683c\u6700\u5927\u76841\u6279\u8fdb\u884c\u6682\u5b58\u65f6\u95f4\u7814\u7a76\uff0c\u4ee5\u5efa\u7acb\u5e76\u9a8c\u8bc1\u6eb6\u6db2\u6df7\u5408\u3001\u704c\u88c5\u548c\u706d\u83cc\u524d\u5b58\u653e\u7684\u65f6\u95f4\u95f4\u9694\uff08\u9002\u5f53\u65f6\uff09<\/span><\/p>\n

\u2022 <\/span><\/span>\u5bf9\u8f93\u51fa\u53d8\u91cf\u8fdb\u884c\u521d\u6b65\u5206\u6790\u7684\u6570\u636e\u62a5\u544a\uff0c\u5982\u9636\u6bb51\u548c2\u4e2d\u8d28\u91cf\u548c\u6027\u80fd\u7279\u6027<\/span><\/p>\n

\u2022 <\/span><\/span>\u7279\u5b9a\u65b0\u5de5\u827a\u7684\u6e05\u6d01\u9a8c\u8bc1\u4e0e\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u540c\u6b65\u8fdb\u884c\u3002<\/span><\/p>\n<\/td>\n

\n

\u2022<\/span>\u6eb6\u6db2\u6df7\u5408\u6b65\u9aa4\uff1a\u65f6\u95f4\u3001\u6e29\u5ea6\u3001\u6eb6\u89e3\u6c27\u3001\u6405\u62cc\u901f\u5ea6\u3001\u901a\u8fc7\u542b\u91cf\u6d4b\u5b9a\u786e\u5b9a\u7684\u6eb6\u6db2\u5747\u4e00\u6027\uff0c\u4ee5\u53capH-\u6df7\u5408\u9a8c\u8bc1<\/span><\/p>\n

\u2022 <\/span><\/span>\u65e0\u83cc\u704c\u88c5\u6216\u6700\u7ec8\u706d\u83cc\u4ea7\u54c1\u7684\u6d4b\u8bd5\uff1a\u6210\u54c1\u542b\u91cf\u68c0\u67e5\u3001\u964d\u89e3\u548c\u6742\u8d28\u3001 pH\u3001\u7c92\u5b50\u3001\u5fae\u751f\u7269\u548c\u65e0\u83cc\u6d4b\u8bd5<\/span><\/p>\n

\u6574\u4e2a\u9636\u6bb51\u548c\u9636\u6bb52\u9a8c\u8bc1\u6279\u6b21\u6570\u91cf\uff1a<\/span><\/p>\n

\u2022 3-6<\/span>\u6279\u6478\u7d22\u6279<\/span><\/p>\n

\u2022 3-6<\/span>\u6279\u5904\u65b9\u7b5b\u9009\u6279<\/span><\/p>\n

\u2022 1-2<\/span>\u6279\u5de5\u827a\u8bc4\u4ef7\u6279<\/span><\/p>\n

\u2022 3<\/span>\u6279\u7a33\u5b9a\u6027\u6279<\/span><\/p>\n

\u2022 5<\/span>\u6279\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279<\/span><\/p>\n

\u5bf92\u4e2a\u9636\u6bb5\u7684\u6570\u636e\u8fdb\u884c\u5206\u6790\u3002<\/span><\/p>\n

\u6839\u636e\u4ea7\u54c1\u89c4\u683c\u3001\u5904\u65b9\u548c\u5de5\u827a\u590d\u6742\u7a0b\u5ea6\u4ee5\u53ca\u5de5\u827a\u8bc4\u4ef7\u548c\u7a33\u5b9a\u6027\u6279\u7684\u7ed3\u679c\uff0c\u5f00\u53d1\u548c\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u6b21\u6570\u53ef\u7565\u505a\u53d8\u52a8\u3002<\/span><\/p>\n

5<\/span>\u6279\u4e2d\u67093\u6279\u4e3a\u9ad8\u6d53\u5ea6\uff08\u6700\u5dee\u6761\u4ef6\uff09\u3002\u4f4e\u6d53\u5ea6\u5de5\u827a\u91c7\u75282\u4e2a\u6279\u6b21\u8fdb\u884c\u786e\u8ba4\u3002<\/span><\/p>\n

\u5728\u9884\u8ba1\u65b0\u836f\u7533\u8bf7\u63d0\u4ea4\u65e5\u524d\u505a\u597d\u5de5\u827a\u6027\u80fd \u786e\u8ba4\u6279\u7684\u751f\u4ea7\u8ba1\u5212\uff0c\u786e\u4fdd\u7533\u62a5\u4e2d\u5305\u542b\u65e9\u671f \u6570\u636e\u3002\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u6709\u4e861\u4e2a\u6708\u7684\u957f\u671f\u548c \u52a0\u901f\u6570\u636e\u3002\u8fd9\u6837\u53ef\u4ee5\u5728\u9884\u671f\u6279\u51c6\u65e5\u524d12\u548c 9\u4e2a\u6708\u5206\u522b\u5f00\u59cb\u539f\u6599\u836f\u548c\u5236\u5242\u7684\u5de5\u827a\u6027\u80fd \u786e\u8ba4\u6279\u751f\u4ea7\u3002\u8fd9\u6837\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6279\u5c31\u53ef\u4ee5\u4e0a\u5e02\u9500\u552e\u4e86\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7a33\u5b9a\u6027<\/span><\/p>\n<\/td>\n

\n

\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u7684\u6240\u6709\u5236\u5242\u6279\u6b21\u5747\u8fdb\u884c\u7a33\u5b9a\u6027\u8003\u5bdf\u3002\u9664\u4e86\u957f\u671f\u6d4b\u8bd5\u548c\u6307\u5b9a\u50a8\u5b58\u6e29\u5ea6\u5916\uff0c\u8fd8\u8981\u6309\u7167ICH\u6307\u5357\u8fdb\u884c\u52a0\u901f\u6761\u4ef6\u8bd5\u9a8c\u3002\u9664\u4e86\u9636\u6bb51\u83b7\u5f97\u7684\u57fa\u672c\u7a33\u5b9a\u6027\u6570\u636e\uff0c\u9700\u8981\u65f6\uff0c\u5728\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u4e2d\u83b7\u5f97\u7684\u652f\u6301\u6027\u7a33\u5b9a\u6027\u6570\u636e\u4e5f\u7528\u4e8e\u7533\u62a5\u8d44\u6599\u4e2d\u3002<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/strong><\/p>\n

\u88687.2-3 <\/span><\/span><\/strong>\u9636\u6bb5 3\uff1a\u6301\u7eed\u5de5\u827a\u786e\u8bc1<\/span><\/p>\n\n\n\n\n\n\n
\n

\u7c7b\u522b<\/span><\/strong><\/p>\n<\/td>\n

\n

\u6d3b\u52a8<\/span><\/strong><\/p>\n<\/td>\n

\n

\u8f93\u51fa\/\u4ea4\u4ed8\u7269<\/span><\/strong><\/p>\n<\/td>\n

\n

\u539f\u7406\/\u793a\u4f8b<\/span><\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

\u6301\u7eed\u5de5\u827a\u786e\u8bc1<\/span><\/p>\n<\/td>\n

\n

\u5de5\u827a\u76d1\u63a7<\/span><\/p>\n<\/td>\n

\n

\u5728\u5546\u4e1a\u751f\u4ea7\u9636\u6bb5\uff0c\u5efa\u7acb\u5de5\u827a\u76d1\u63a7\u8ba1\u5212\u5e76\u8fdb\u884c\u8d8b\u52bf\u5206\u6790\u3002\u76d1\u63a7\u8ba1\u5212\u7528\u4e8e\u65e5\u5e38\u751f\u4ea7\u4e2d\u786e\u4fdd\u5de5\u827a\u5904\u4e8e\u63a7\u5236\u72b6\u6001\u3002\u8fc7\u7a0b\u80fd\u529b\u6307\u6807\u548c\u8d8b\u52bf\u5206\u6790\u7ed3\u679c\u826f\u597d\u3002<\/span><\/p>\n<\/td>\n

\n

\u2022 <\/span><\/span>\u5728\u5546\u4e1a\u751f\u4ea7\u9636\u6bb5\u8fdb\u884c\u76d1\u63a7\u6027\u80fd\u6307\u6807\uff08\u5982\u6536\u7387\u3001\u6295\u8bc9\u548c\u504f\u5dee\uff09<\/span><\/p>\n

\u2022 <\/span><\/span>\u5f53\u6570\u636e\u91cf\u5c11\u65f6\uff08\u5982\u4f4e\u4e8e20-25\uff09\uff0c\u91c7\u7528\u5de5\u827a\u8010\u53d7\u7b49\u9ad8\u7ebf\u56fe\u3002\u5f53\u6570\u636e\u91cf\u4e0d\u4f4e\u4e8e25\u65f6\uff0c\u91c7\u7528\u5de5\u827a\u6027\u80fd\u80fd\u529b\u6307\u6807\uff0c\u4f8b\u5982\u8fc7\u7a0b\u6027\u80fd\u6307\u6570\u548c\/\u6216\u8fc7\u7a0b\u80fd\u529b\u6307\u6570\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4ea7\u54c1\u6280\u672f\u56e2\u961f<\/span><\/p>\n<\/td>\n

\n

\u6bcf\u4e00\u4ea7\u54c1\u6709\u4ea7\u54c1\u6280\u672f\u56e2\u961f\uff0c\u534f\u52a9\u5bf9\u5269\u4f59\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u8fdb\u884c\u76d1\u7ba1\u3002<\/span><\/p>\n

\u4ea7\u54c1\u6280\u672f\u56e2\u961f\u7531\u591a\u90e8\u95e8\u7ec4\u6210\uff0c\u5305\u62ec\u751f\u4ea7\u5de5\u827a\u5f00\u53d1\u3001\u5206\u6790\u3001\u8d28\u91cf\u548c\u7edf\u8ba1\u90e8\u95e8\u7684\u4ee3\u8868\u3002\u8be5\u56e2\u961f\u8d1f\u8d23\u5ba1\u6838\u5546\u4e1a\u751f\u4ea7\u6536\u96c6\u7684\u5de5\u827a\u6570\u636e\u3002\u5bf9\u5de5\u827a\u53d8\u66f4\u63d0\u51fa\u5efa\u8bae\uff0c\u786e\u4fdd\u6301\u7eed\u6539\u8fdb\u3002\u4ea7\u54c1\u6280\u672f\u56e2\u961f\u4e5f\u8d1f\u8d23\u5ba1\u6838\u4e0d\u540c\u751f\u4ea7\u573a\u5730\u7684\u6570\u636e\uff0c\u786e\u4fdd\u4e00\u81f4\u7684\u5de5\u827a\u6027\u80fd\u548c\u4ea7\u54c1\u8d28\u91cf\u3002<\/span><\/p>\n<\/td>\n

\n

\u5728\u9636\u6bb53\u8fdb\u884c\u5176\u4ed6\u7814\u7a76\uff0c\u5305\u62ec\u8fc7\u7a0b\u5206\u6790\u6280\u672f\u3001\u8bd5\u9a8c\u8bbe\u8ba1\u3001\u6301\u7eed\u5de5\u827a\u8bd5\u9a8c\u548c\u4e34\u5e8a\u7814\u7a76\uff0c\u4ee5\u6539\u8fdb\u751f\u4ea7\u7ebf\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6807\u51c6\u6587\u4ef6\/\u65b0\u836fNDA\u8865\u5145\u7533\u8bf7<\/span><\/p>\n<\/td>\n

\n

\u589e\u52a0\u65b0\u7684\u751f\u4ea7\u548c\u68c0\u9a8c\u8bbe\u65bd\uff0c\u5bf9\u6ce8\u518c\u6587\u4ef6\u505a\u4e86\u591a\u6b21\u8865\u5145\u3002\u5728\u9636\u6bb53\u5b8c\u6210\u5de5\u827a\u8f6c\u79fb\u548c\u5de5\u827a\u9a8c\u8bc1\u3002\u6839\u636e\u76f8\u5173\u5b9e\u9a8c\uff0c\u5b9a\u671f\u66f4\u65b0\u5f00\u53d1\u65f6\u4ea7\u751f\u7684\u751f\u4ea7\u77e5\u8bc6\u6587\u4ef6\u3002<\/span><\/p>\n

\u5f00\u53d1\u548c\u8d28\u91cf\u90e8\u95e8\u4e00\u8d77\u786e\u5b9a\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u548c\u53c2\u6570\u3002\u5728\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\u5185\uff0c\u5bf9\u5de5\u827a\u7406\u89e3\u6587\u4ef6\u8fdb\u884c\u7ef4\u62a4\u3001\u66f4\u65b0\uff0c\u4ee5\u6db5\u76d6\u4efb\u4f55\u5de5\u827a\u548c\/\u6216\u6807\u51c6\u53d8\u66f4\u3002<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u8f6c\u53d1\u6b64\u6587\u4ec5\u4e3a\u5b66\u4e60\u4ea4\u6d41\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/p>\n


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    \u5728\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e2d\u5927\u5bb6\u9047\u5230\u7684\u95ee\u9898\uff0c\u8fd9\u91cc\u5c0f\u7f16\u4e3a\u5927\u5bb6\u63a8\u8350\u4e00\u4e2a\u4f1a\u8bae\uff0c\u80fd\u591f\u89e3\u51b3\u60a8\u7684\u7591\u95ee\uff01\uff01\uff01<\/span><\/p>\n<\/h2>\n

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2018\u5e748\u670824\u65e5(\u661f\u671f\u4e94)<\/span><\/strong>9:00-12:00  <\/span><\/strong>1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-1<\/span><\/strong>6<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0<\/span><\/strong>
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2018\u5e748\u670825\u65e5<\/span><\/strong>(\u661f\u671f\u516d)<\/span><\/strong>9:00-12:00  <\/span><\/strong>1<\/span><\/strong>3<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0-1<\/span><\/strong>6<\/span><\/strong>:<\/span><\/strong>3<\/span><\/strong>0<\/span><\/strong><\/span><\/p>\n

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

\u4e00\u3001\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u57fa\u672c\u8981\u6c42\u4e0e\u6848\u4f8b\u89e3\u6790<\/span><\/strong><\/p>\n

1FDA\/EMA\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7684\u89c4\u8303\u8981\u6c42\u4e0e\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

2\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7684\u4f53\u7cfb\u6784\u5efa\u4e0e\u5173\u952e\u8282\u70b9\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

3\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u76d1\u63a7\u548c\u53d7\u63a7\u7684\u57fa\u672c\u539f\u5219\u53ca\u6848\u4f8b<\/span><\/p>\n

4\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u8303\u56f4\u548c\u9891\u7387\u8981\u6c42\u89e3\u6790\u53ca\u6848\u4f8b<\/span><\/p>\n

5\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u98ce\u9669\u4e0e\u98ce\u9669\u8bc4\u4f30\u5de5\u5177\u7684\u5408\u7406\u4f7f\u7528\u6848\u4f8b\u89e3\u6790<\/span><\/p>\n

\u4e8c\u3001\u65b0\u7248GMP\u9644\u5f55\u4e2d\u201c\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u201d\u65b9\u6cd5\u63a2\u6790<\/span><\/strong><\/p>\n

1\u57fa\u4e8e\u98ce\u9669\u8bc4\u4ef7\u7684\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6982\u5ff5\u7406\u89e3\u63a2\u6790<\/span><\/strong><\/p>\n

2\u6709\u6548\u7684\u6570\u636e\u6536\u96c6\u4f53\u7cfb\u7684\u5efa\u7acb\u4e0e\u6570\u636e\u5b8c\u6574\u6027\u8981\u6c42<\/span><\/strong><\/p>\n

1)\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u6570\u636e\u7684\u8003\u5bdf\u8981\u6c42<\/span><\/p>\n

2)\u5173\u952e\u5de5\u827a\u53c2\u6570\u6570\u636e\u5b8c\u6574\u6027\u8981\u6c42<\/span><\/p>\n

3)\u5404\u5de5\u5e8f\u6210\u54c1\u7387\u53ca\u5e9f\u54c1\u7387\u53ca\u4e0d\u5408\u683c\u54c1\u63a7\u5236\u5173\u7cfb<\/span><\/p>\n

4)\u539f\u8f85\u6599\u6570\u636e\u4e0e\u5173\u8054\u8bc4\u5ba1\u8981\u6c42<\/span>    <\/span><\/p>\n

5)\u65e5\u5e38\u76d1\u6d4b\u6570\u636e\u7684\u5b8c\u6574\u6027\u8981\u6c42<\/span><\/p>\n

6)\u504f\u5dee\u53ca\u504f\u5dee\u8c03\u67e5\u7ba1\u7406\u5728\u5de5\u827a\u751f\u4ea7\u751f\u547d\u5468\u671f\u7684\u4f5c\u7528<\/span><\/p>\n

7)\u53d8\u66f4\u5206\u7c7b\u7ba1\u7406\u5728\u5de5\u827a\u751f\u4ea7\u751f\u547d\u5468\u671f\u7684\u4f5c\u7528<\/span><\/p>\n

8)\u8bbe\u5907\u9a8c\u8bc1\u72b6\u6001\u4fdd\u6301\u5728\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u91cd\u8981\u6027\u89e3\u6790<\/span><\/p>\n

3\u57fa\u4e8e\u7a33\u5b9a\u6027\u8003\u5bdf\u6570\u636e\u5efa\u7acb\u4ea7\u54c1\u8d28\u91cf\u8d8b\u52bf\u5206\u6790\u7684\u63a7\u5236\u7b56\u7565<\/span><\/strong><\/p>\n

1\uff09\u7a33\u5b9a\u6027\u7814\u7a76\u5728\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u5b9e\u65bd\u7edf\u8ba1\u8fc7\u7a0b\u63a7\u5236\u7ba1\u7406\u4f5c\u7528<\/span><\/p>\n

2\uff09\u5bf9\u54c1\u79cd\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u8fdb\u884c\u8fde\u7eed\u76d1\u63a7\u7684\u7edf\u8ba1\u5b66\u539f\u7406<\/span><\/p>\n

3\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u62a5\u544a\u4e0e\u8d28\u91cf\u56de\u987e<\/span><\/p>\n

\u4e09\u3001\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u53ca\u4e0d\u540c\u90e8\u95e8\u5982\u4f55\u914d\u5408\u6301\u7eed\u5de5\u827a\u786e\u8ba4<\/span><\/strong><\/p>\n

1.\u6d45\u6790\u5de5\u827a\u9a8c\u8bc1\u4e2d\u7684\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6267\u884c\u7b56\u7565<\/span><\/strong><\/p>\n

1\uff09\u5de5\u827a\u9a8c\u8bc1\u751f\u547d\u5468\u671f\u6d3b\u52a8\u6848\u4f8b\u8bb2\u89e3<\/span><\/strong><\/p>\n

1.\u5de5\u827a\u8bbe\u8ba1<\/span><\/strong><\/p>\n

1)\u65b0\u836f\u5728\u5f00\u53d1\u53ca\u653e\u5927\u4e2d\u7684\u5de5\u827a\u77e5\u8bc6\u83b7\u53d6<\/span><\/p>\n

2)\u5982\u4f55\u4f7f\u7528\u98ce\u9669\u7ba1\u7406\u5de5\u5177\u8fdb\u884c\u5de5\u827a\u5206\u6790<\/span><\/p>\n

3)\u6848\u4f8b\u5206\u6790\uff1a\u5e94\u7528QbD\u539f\u5219\u786e\u8ba4\u5173\u952e\u8d28\u91cf\u5c5e\u6027CQA\u3001\u5173\u952e\u5de5\u827a\u53c2\u6570CPP\u3001\u5173\u952e\u7269\u6599\u5c5e\u6027CMA<\/span><\/p>\n

2. \u5de5\u827a\u6027\u80fd\u786e\u8ba4<\/span><\/strong><\/p>\n

1)\u5982\u4f55\u5bf9\u5de5\u827a\u8bbe\u5907\u9636\u6bb5\u8fdb\u884c\u91cf\u5316\u8bc4\u4f30 <\/span>   <\/span><\/p>\n

2)\u5546\u4e1a\u751f\u4ea7\u91cd\u590d\u80fd\u529b\u5173\u6ce8\u8981\u70b9<\/span><\/p>\n

3)\u5982\u4f55\u786e\u8ba4PPQ\u9636\u6bb5\u4e2d\u7684\u6279\u91cf\u3001\u6279\u6b21\u548c\u53d6\u6837\u8ba1\u5212<\/span><\/p>\n

4)\u6848\u4f8b\u5206\u6790\uff1a\u9488\u5bf9\u67d0\u5177\u4f53\u54c1\u79cd\u5b9e\u65bdPPQ\u53ca\u5173\u952e\u8981\u70b9\u89e3\u6790<\/span><\/p>\n

3. \u6301\u7eed\u5de5\u827a\u786e\u8ba4<\/span><\/strong><\/p>\n

1\uff09\u521d\u671f\u6279\u6b21\uff083A\u671f\uff09\u7684\u52a0\u5f3a\u76d1\u6d4b\u8ba1\u5212\u5236\u5b9a<\/span><\/p>\n

2\uff09\u65e5\u5e38\u6279\u6b21\uff083B\u671f\uff09\u751f\u4ea7\u76d1\u6d4b\u8ba1\u5212\u5236\u5b9a<\/span><\/p>\n

3\uff09\u5de5\u827a\u98d8\u79fb\u548c\u7edf\u8ba1\u8d8b\u52bf\u7684\u5173\u6ce8\u70b9<\/span><\/p>\n

4\uff09\u6848\u4f8b\u5206\u6790\uff1a\u67d0\u54c1\u79cd\u7684\u65e5\u5e38\u76d1\u6d4b\u65b9\u5f0f\u53ca\u7edf\u8ba1\u5de5\u5177<\/span><\/p>\n

\u56db\uff0e\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6267\u884c\u7b56\u7565<\/span><\/strong><\/p>\n

1\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6587\u4ef6\u8981\u7d20  <\/span>   <\/span><\/p>\n

2\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u6267\u884c\u5468\u671f<\/span><\/p>\n

\u4e94\uff0e\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u548c\u5176\u4ed6\u8d28\u91cf\u4f53\u7cfb\u8981\u7d20\u7684\u533a\u522b <\/span><\/strong><\/p>\n

1\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e0e\u518d\u9a8c\u8bc1\u7684\u533a\u522b <\/span><\/p>\n

2\uff09\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e0e\u4ea7\u54c1\u5e74\u5ea6\u8d28\u91cf\u56de\u987e\u7684\u533a\u522b<\/span><\/p>\n

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

\u5218\u53cc\u751f<\/span><\/span><\/strong>\u8001\u5e08\u8d44\u6df1<\/span>GMP\u57f9\u8bad\u4e13\u5bb6\uff0c\u66fe\u4efb\u804c\u4e8e\u5916\u8d44\u4f01\u4e1a\u9ad8\u7ba1\uff1b\u8fd120\u5e74\u836f\u7269\u5236\u5242\u3001\u751f\u7269\u75ab\u82d7\u3001\u751f\u7269\u86cb\u767d\u3001\u751f\u7269\u591a\u80bd\u7c7b\u836f\u7269\u7814\u53d1\u3001\u751f\u4ea7\u3001GMP\u7ba1\u7406\u7684\u4e30\u5bcc\u5b9e\u8df5\u7ecf\u9a8c\u3002\u4eb2\u81ea\u53c2\u52a0\u8fc7\u591a\u6b21FDA \u3001WHO\u3001TGA\u548cCEP\u8ba4\u8bc1\u53ca\u56fd\u5185\u7684\u68c0\u67e5\u3002\u5927\u91cf\u63a5\u89e6\u7b2c\u4e00\u7ebf\u7684\u5b9e\u9645\u95ee\u9898\uff0c\u5177\u6709\u4e30\u5bcc\u7684\u5206\u6790\u95ee\u9898\u548c\u89e3\u51b3\u95ee\u9898\u7684\u80fd\u529b\u548c\u7ecf\u9a8c\u3002<\/span><\/p>\n

SFDA\u9ad8\u7814\u9662\u7279\u8058\u8bb2\u5e08\u4ee5\u53ca\u591a\u5bb6\u534f\u4f1a\u7279\u8058\u4e13\u5bb6\uff0c\u66fe\u5bf9\u7f57\u6c0f\u3001\u6d77\u738b\u3001\u4e1c\u5317\u5236\u836f\u3001\u4ee5\u9886\u836f\u4e1a\u3001\u5317\u4eac\u5609\u6797\u3001\u5c71\u4e1c\u745e\u9633\u3001\u8475\u82b1\u836f\u4e1a\u8fdb\u884c\u4f53\u7cfb\u57f9\u8bad\u548c\u6784\u5efa\uff0c\u73b0\u4efb\u5eb7\u6cf0\u751f\u7269\u603b\u7ecf\u7406\u9ad8\u7ea7\u987e\u95ee\uff0c\u6784\u5efa\u751f\u7269\u7c7bGMP\u4f53\u7cfb\u3002<\/span><\/p>\n


<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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\u4e00\u3001\u4f1a\u8bae\u65f6\u95f4\u5730\u70b9\uff1a<\/span><\/strong> <\/span><\/span><\/p>\n

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\u65f6\u95f4\uff1a<\/span>2018\u5e748\u67082<\/span>3<\/span>\u65e5<\/span>-8\u67082<\/span>5<\/span>\u65e5\uff08<\/span>2<\/span>3<\/span>\u65e5\u5168\u5929\u62a5\u5230\uff09<\/span> <\/span><\/p>\n

\u5730\u70b9<\/span>: <\/span>\u82cf\u5dde<\/span><\/span>\u5e02<\/span> \uff08\u5730\u70b9\u786e\u5b9a\u76f4\u63a5\u901a\u77e5\u62a5\u540d\u8005\uff09<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

<\/section>\n<\/section>\n<\/section>\n
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\u4e8c\u3001\u53c2\u4f1a\u5bf9\u8c61<\/span><\/strong><\/span><\/p>\n

\u3000\u5236\u836f\u4f01\u4e1a\u548c\u7814\u53d1\u673a\u6784\u4ece\u4e8b\u836f\u54c1\u7814\u53d1\u3001\u5236\u5242\u7814\u53d1\u3001\u8d28\u91cf\u7814\u7a76\u3001<\/span>QA\u3001QC\u3001\u751f\u4ea7\u4eba\u5458\u3001\u5de5\u827a\u4eba\u5458\u548c\u5de5\u7a0b\u4eba\u5458\uff0c\u9662\u6821\u3001\u79d1\u7814\u9662\u6240\u76f8\u5173\u4eba\u5458\u3002<\/span> <\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u4e09\u3001\u4f1a\u8bae\u8d39\u7528<\/span><\/strong><\/span><\/p>\n

\u4f1a\u8bae\u8d39\uff1a<\/span>2200\u5143<\/span>\/<\/span>\u4eba\u3002\u4f1a\u8bae\u8d39\u5305\u62ec\uff1a\u4f1a\u8bae\u3001\u7814\u8ba8\u3001\u8d44\u6599\u53ca\u8bba\u6587\u96c6\u3002\u98df\u5bbf\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406\u3002<\/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


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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u4e00\u836f\u8054 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

PDA TR60  7.2 \u5c0f\u5206\u5b50\u836f\u7269\u7684\u4f8b\u5b50\uff08\u6ce8\u5c04\u7528\u836f\u7269\uff09 \u88687.2-1\uff08\u9636\u6bb51\uff09\u3001\u88687. […]<\/p>\n","protected":false},"author":1,"featured_media":22584,"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\/22583"}],"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=22583"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/22583\/revisions"}],"predecessor-version":[{"id":22589,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/22583\/revisions\/22589"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/22584"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=22583"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=22583"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=22583"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}