{"id":35175,"date":"2018-09-05T01:00:00","date_gmt":"2018-09-17T05:50:35","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e5%8c%bb%e8%8d%af%e8%b6%a3%e9%97%bb-gmp%e7%9a%84%e6%9d%a5%e6%ba%90%e4%b8%8e%e5%8f%91%e5%b1%95%e5%8f%b2\/"},"modified":"2018-09-17T13:50:36","modified_gmt":"2018-09-17T05:50:36","slug":"%e5%8c%bb%e8%8d%af%e8%b6%a3%e9%97%bb-gmp%e7%9a%84%e6%9d%a5%e6%ba%90%e4%b8%8e%e5%8f%91%e5%b1%95%e5%8f%b2","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/35175\/","title":{"rendered":"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section  style=\"margin-right: auto;margin-left: auto;border-width: 2px;border-style: solid;border-color: rgb(200, 233, 252);border-radius: 25px;background: rgb(247, 252, 254);box-sizing: border-box;\">\n<section style=\"margin: 5px auto;width: 60%;overflow: hidden;\" ><img class=\"\"     style=\"display: block;margin-right: auto;margin-left: auto;width: 100% !important;height: auto !important;visibility: visible !important;\"  src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/8-1537163436.png\" alt=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\" title=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\"  \/><\/section>\n<section class=\"\" style=\"font-size: 14px;text-align: justify;letter-spacing: 1.5px;line-height: 1.75em;color: rgb(63, 62, 63);padding: 1em;margin-top: -15px;box-sizing: border-box;\">\n<p><span style=\"font-size: 16px;\"><strong><span style=\"color: rgb(247, 150, 70);\">GMP<\/span><\/strong>\u662f\u82f1\u6587\u540dGood Manufacturing Practices for Drugs\u6216\u8005Good Practice in the Manufacturing and Quality Control of Drugs\u7684\u7f29\u5199\u3002GMP\u53ef\u4ee5\u76f4\u8bd1\u4e3a\u201c<strong><span style=\"color: rgb(247, 150, 70);\">\u4f18\u826f\u7684\u751f\u4ea7\u5b9e\u8df5<\/span><\/strong>\u201d\uff1b\u5f53\u7136\u8fd9\u91cc\u6211\u4eec\u4e3b\u8981\u6307\u7684\u662f\u836f\u54c1\u7684\u751f\u4ea7\u3002\u98df\u54c1\u3001\u5316\u5986\u54c1\u7b49\u4e5f\u5e94\u53c2\u7167GMP\u8fdb\u884c\u751f\u4ea7\uff0c\u90a3\u5c31\u662f\u201cfor Food\u201d\u3001\u201cfor Cosmetic\u201d\u3002\u7531\u4e8e\u201cGMP\u201d\u5df2\u50cf\u201cTV\u201d\u7b49\u5916\u6765\u8bcd\u7f29\u5199\u4e60\u60ef\u5e94\u7528\uff0e\u9664\u5b98\u65b9\u6587\u4ef6\u5916\uff0c\u5927\u5bb6\u5df2\u7ea6\u5b9a\u4fd7\u6210\uff0c\u6210\u4e3a\u56fd\u9645\u95f4\u901a\u7528\u8bcd\u6c47\u3002<br  \/><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><strong><span style=\"max-width: 100%;color: rgb(247, 150, 70);\">\u6211\u56fd\u7684GMP\u5168\u79f0\u4e3a\u201c\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u201d\u3002<\/span><\/strong><span style=\"max-width: 100%;\">\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c401999\u5e746\u670818\u65e5\u9881\u5e03\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303(1998\u5e74\u4fee\u8ba2)\u300b\u3002GMP\u662f\u4eba\u7c7b\u793e\u4f1a\u79d1\u5b66\u6280\u672f\u8fdb\u6b65\u548c\u7ba1\u7406\u79d1\u5b66\u53d1\u5c55\u7684\u5fc5\u7136\u4ea7\u7269\uff0c\u5b83\u662f\u9002\u5e94\u4fdd\u8bc1\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u7684\u9700\u8981\u800c\u4ea7\u751f\u7684\u3002GMP\u8d77\u6e90\u4e8e\u56fd\u5916\uff0c\u5b83\u662f\u7531\u91cd\u5927\u7684\u836f\u7269\u707e\u96be\u4f5c\u4e3a\u50ac\u751f\u5242\u800c\u8bde\u751f\u7684\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<section class=\"\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section style=\"width: 100%;\" >\n<section style=\"display: flex;justify-content: space-around;padding-right: 25px;padding-left: 25px;margin-bottom: -28px;box-sizing: border-box;\">\n<section style=\"width: 50px;\"><img class=\"\"     style=\"display: block;width: 100% !important;height: auto !important;visibility: visible !important;\"  src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/9-1537163436.png\" alt=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\" title=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\"  \/><\/section>\n<section style=\"width: 50px;\"><img class=\"\"     style=\"display: block;width: 100% !important;height: auto !important;visibility: visible !important;\"  src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/10-1537163436.png\" alt=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\" title=\"\u533b\u836f\u8da3\u95fb | GMP\u7684\u6765\u6e90\u4e0e\u53d1\u5c55\u53f2\"  \/><\/section>\n<section style=\"width: 50px;\"><\/section>\n<\/section>\n<section style=\"width: 100%;height: 6px;background: #1a2868;\" ><\/section>\n<section style=\"padding-right: 20px;padding-left: 20px;box-sizing: border-box;\">\n<section style=\"padding: 3em 2em 1em;box-shadow: rgb(234, 237, 246) 2px 2px 5px, rgb(234, 237, 246) -2px 2px 5px;color: rgb(26, 40, 104);box-sizing: border-box;\">\n<p style=\"line-height: 1.75em;text-indent: 2em;\">\u56de\u987e20\u4e16\u7eaa\u533b\u836f\u65b9\u9762\u7684\u91cd\u5927\u53d1\u660e\uff0c\u6709\u963f\u53f8\u5339\u6797\u3001\u78fa\u9170\u80fa\u3001\u9752\u9709\u7d20\u3001\u80f0\u5c9b\u7d20\u3001\u907f\u5b55\u836f\u7b49\u4ee3\u8868\u836f\u7269\u5177\u6709\u5212\u65f6\u4ee3\u7684\u610f\u4e49\uff0c\u5b83\u4eec\u5728\u4eba\u7c7b\u533b\u7597\u4fdd\u5065\u65b9\u9762\u53d1\u6325\u4e86\u91cd\u5927\u4f5c\u7528\uff1a\u53ef\u662f\u4eba\u4eec\u5728\u8ba4\u8bc6\u836f\u7269\u7684\u4e0d\u826f\u53cd\u5e94\u65b9\u9762\u4e5f\u4ed8\u51fa\u4e86\u91cd\u5927\u7684\u4ee3\u4ef7\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><strong><span style=\"max-width: 100%;color: rgb(247, 150, 70);\">\u78fa\u9170\u80fa(SN)\u662f\u7b2c\u4e00\u4e2a\u73b0\u4ee3\u5316\u5b66\u7597\u6cd5\u5316\u5408\u7269<\/span><\/strong><span style=\"max-width: 100%;\">\u30021935\u5e74\u751f\u7269\u5b66\u5bb6\u683c\u54c8\u7279\uff0e\u591a\u9a6c\u514b\u53d1\u89c2\u4e86\u5176\u6291\u83cc\u7279\u6027\u3002\u7ea2\u8272\u767e\u6d6a\u591a\u606f\u4f5c\u4e3a\u78fa\u9170\u80fa\u7684\u524d\u4f53\u7269\u4e5f\u66fe\u5e94\u7528\u4e8e\u4e34\u5e8a10\u591a\u5e74.1937\u5e74\u5728\u7f8e\u56fd\u7530\u7eb3\u897f\u5dde\u6709\u4f4d\u836f\u5242\u5e08\u914d\u5236\u4e86\u78fa\u80fa\u914f\u5242\uff0c\u7ed3\u679c\u5f15\u8d77300\u591a\u4eba\u6025\u6027\u80be\u529f\u80fd\u8870\u7aed\uff0c107\u4eba\u6b7b\u4ea1\u3002\u7a76\u5176\u539f\u56e0\u7cfb\u751c\u5473\u5242\u4e8c\u7518\u9187\u5728\u4f53\u5185\u6c27\u5316\u4e3a\u8349\u9178\u4e2d\u6bd2\u6240\u81f4\uff0c\u7f8e\u56fd\u4e3a\u6b64\u4e8e1938\u5e74\u4fee\u6539\u4e86\u300a\u8054\u90a6\u98df\u54c1\u836f\u54c1\u5316\u5986\u54c1\u6cd5\u300b\uff08Federal  Food\uff0cDrug\uff0cCosmetic Act\uff09\u3002\u518d\u6b21\u4fee\u6539\u6b64\u6cd5\u662f1962\u5e74\uff0c\u90a3\u662f\u56e0\u4e3a\u5728\u4e16\u754c\u4e0a\u53d1\u751f\u4e8620\u4e16\u7eaa\u6700\u5927\u7684\u836f\u7269\u707e\u96be\u2014\u2014\u201c<strong><span style=\"max-width: 100%;color: rgb(247, 150, 70);\">\u53cd\u5e94\u505c\u201d\u4e8b\u4ef6\u3002<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">20\u4e16\u7eaa50\u5e74\u4ee3\u540e\u671f\u539f\u8054\u90a6\u5fb7\u56fd\u683c\u4ed1\u5357\u82cf\u5236\u836f\u5382\u751f\u4ea7\u4e86\u4e00\u79cd\u58f0\u79f0<span style=\"max-width: 100%;color: rgb(247, 150, 70);\">\u6cbb\u7597\u598a\u5a20\u53cd\u5e94\u7684\u9547\u9759\u836fThalidomide<\/span>(\u53c8\u79f0<span style=\"max-width: 100%;color: rgb(247, 150, 70);\">\u53cd\u5e94\u505c<\/span>\u3001\u6c99\u5229\u5ea6\u80fa\u3001\u80bd\u54aa\u54cc\u5576\u916e)\u3002\u5b9e\u9645\u8fd9\u662f\u4e00\u79cd100%\u7684\u81f4\u7578\u80ce\u836f\u3002\u8be5\u836f\u51fa\u552e\u540e\u76846\u5e74\u95f4\uff0c\u5148\u540e\u5728\u539f\u8054\u90a6\u5fb7\u56fd\u3001\u6fb3\u5927\u5229\u4e9a\u3001\u52a0\u62ff\u5927\u3001\u65e5\u672c\u4ee5\u53ca\u62c9\u4e01\u7f8e\u6d32\u3001\u975e\u6d32\u7684\u517128\u4e2a\u56fd\u5bb6\uff0c\u53d1\u73b0\u7578\u5f62\u80ce\u513f12000\u4f59\u4f8b\u3002\u60a3\u513f\u65e0\u80a2\u3001\u77ed\u80a2\u3001\u80a2\u95f4\u6709\u8e7c\u3001\u5fc3\u810f\u7578\u5f62\u7b49\u5148\u5929\u6027\u5f02\u5e38\uff0c\u5448\u6d77\u8c79\u80a2\u7578\u5f62\u3002\u76ee\u524d\u5c1a\u6709\u6570\u5343\u4eba\u5b58\u6d3b\uff0c\u7ed9\u793e\u4f1a\u9020\u6210\u5f88\u5927\u7684\u8d1f\u62c5\u3002\u53cd\u5e94\u505c\u7684\u53e6\u4e00\u526f\u4f5c\u7528\u662f\u53ef\u5f15\u8d77\u591a\u53d1\u6027\u795e\u7ecf\u708e\uff0c\u7ea6\u67091300\u4f8b\u3002\u9020\u6210\u8fd9\u573a\u836f\u7269\u707e\u96be\u7684\u539f\u56e0\uff0c\u4e00\u662f\u201c\u53cd\u5e94\u505c\u201d\u672a\u7ecf\u8fc7\u4e25\u683c\u7684\u4e34\u5e8a\u524d\u836f\u7406\u5b9e\u9a8c\uff0c\u4e8c\u662f\u751f\u4ea7\u8be5\u836f\u7684\u683c\u4ed1\u5357\u82cf\u5236\u836f\u5382\u867d\u5df2\u6536\u5230\u6709\u5173\u53cd\u5e94\u505c\u6bd2\u6027\u53cd\u5e94\u7684100\u591a\u4f8b\u62a5\u544a\uff0c\u4f46\u90fd\u88ab\u4ed6\u4eec\u9690\u7792\u4e0b\u6765\u3002\u572817\u4e2a\u56fd\u5bb6\u91cc\uff0c\u53cd\u5e94\u505c\u7ecf\u8fc7\u6539\u5934\u6362\u9762\u9690\u853d\u4e0b\u6765\uff0c\u7ee7\u7eed\u9020\u6210\u5371\u5bb3\u3002\u4f8b\u5982\u65e5\u672c\u76f4\u52301963\u5e74\u624d\u505c\u7528\u53cd\u5e94\u505c\uff0c\u9020\u6210\u5f88\u5927\u7684\u707e\u5bb3\u3002\u8fd9\u6b21\u7578\u80ce\u4e8b\u4ef6\u5f15\u8d77\u516c\u6124\uff0c\u60a3\u513f\u7236\u6bcd\u8054\u5408\u5411\u6cd5\u9662\u63d0\u51fa\u63a7\u544a\u3002\u88ab\u79f0\u4e3a\u201c20\u4e16\u7eaa\u6700\u5927\u7684\u836f\u7269\u707e\u96be\u201d\u3002\u5382\u5bb6\u539f\u5148\u5938\u5f20\u6027\u7684\u5ba3\u4f20\uff0c\u906d\u5230\u8206\u8bba\u7684\u62a8\u51fb\uff0c\u8feb\u4f7f\u4e00\u4e9b\u56fd\u5bb6\u7684\u653f\u5e9c\u90e8\u95e8\u4e0d\u5f97\u4e0d\u52a0\u5f3a\u5bf9\u4e0a\u5e02\u836f\u54c1\u7684\u7ba1\u7406\u3002\u8fd9\u5bb6\u836f\u5382\u4e5f\u56e0\u53cd\u5e94\u505c\u4e8b\u4ef6\u800c\u58f0\u540d\u72fc\u85c9\u4e0d\u5f97\u4e0d\u5173\u95ed\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">\u7f8e\u56fd\u3001\u6cd5\u56fd\u3001\u6377\u514b\u65af\u6d1b\u4f10\u514b\u7b49\u5c11\u6570\u56fd\u5bb6\u5e78\u514d\u6b64\u707e\u96be.\u7f8e\u56fd\u5438\u53d6\u4e861938\u5e74\u78fa\u80fa\u9191\u5242\u4e8b\u4ef6\u7684\u6559\u8bad\uff0c\u6ca1\u6709\u6279\u51c6\u8fdb\u53e3\u201c\u53cd\u5e94\u505c\u201d\u3002\u5f53\u65f6\u7684FDA(\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff0cFood  and Drug  Administration)\u5b98\u5458\u5728\u5ba1\u67e5\u8be5\u836f\u65f6\u53d1\u73b0\u7f3a\u4e4f\u8db3\u591f\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u800c\u62d2\u7edd\u8fdb\u53e3\uff0c\u4ece\u800c\u907f\u514d\u4e86\u6b64\u6b21\u707e\u96be\u3002\u4f46\u6b64\u6b21\u4e8b\u4ef6\u7684\u4e25\u91cd\u540e\u679c\u5728\u7f8e\u56fd\u5f15\u8d77\u4e86\u4e0d\u5b89\uff0c\u6fc0\u8d77\u516c\u4f17\u5bf9\u836f\u54c1\u76d1\u7763\u548c\u836f\u54c1\u6cd5\u89c4\u7684\u666e\u904d\u5174\u8da3\uff0c\u5e76\u6700\u7ec8\u5bfc\u81f4\u4e86\u56fd\u4f1a\u5bf9<strong><span style=\"max-width: 100%;color: rgb(192, 80, 77);\">\u300a\u98df\u54c1\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b<\/span><\/strong>\u7684\u91cd\u5927\u4fee\u6539\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">1962\u5e74\u7684\u4fee\u6b63\u6848\u660e\u663e\u52a0\u5f3a\u836f\u54c1\u6cd5\u7684\u4f5c\u7528\uff0c\u5177\u4f53\u6709\u4ee5\u4e0b\u4e09\u4e2a\u65b9\u9762\uff1a<\/span><\/p>\n<section class=\"\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section style=\"width: 100%;\" >\n<section style=\"padding-right: 15px;padding-left: 15px;box-sizing: border-box;\">\n<section   style=\"border-top: 6px solid rgb(112, 89, 65);border-right: 6px solid rgb(112, 89, 65);border-left: 6px solid rgb(112, 89, 65);border-bottom: none;box-sizing: border-box;\">\n<section style=\"background: rgb(12, 42, 41);padding: 1em;text-align: center;color: rgb(255, 255, 255);font-size: 14px;letter-spacing: 1.5px;line-height: 1.75em;box-sizing: border-box;\">\n<p style=\"font-size: 16px;line-height: 1.5em;text-align: left;\">(1)\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u4e0d\u4ec5\u8981\u8bc1\u660e\u836f\u54c1\u662f\u6709\u6548\u7684\uff0c\u800c\u4e14\u8981\u8bc1\u660e\u836f\u54c1\u662f\u5b89\u5168\u7684<\/p>\n<p style=\"font-size: 16px;line-height: 1.5em;text-align: left;\"><br  \/><\/p>\n<p style=\"line-height: 1.5em;text-align: left;\"><span style=\"font-size: 16px;\">(2)\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u8981\u5411FDA\u62a5\u544a\u836f\u54c1\u7684\u4e0d\u826f\u53cd\u5e94\u3002<\/span><\/p>\n<p style=\"line-height: 1.5em;text-align: left;\"><br  \/><\/p>\n<p style=\"line-height: 1.5em;text-align: left;\"><span style=\"font-size: 16px;\">(3)\u8981\u6c42\u5236\u836f\u4f01\u4e1a\u5b9e\u65bd\u836f\u54c1\u751f\u4ea7\u548c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section   style=\"border-top:6px solid #705941;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">\u6309\u7167\u4fee\u6b63\u6848\u7684\u8981\u6c42\uff0c\u7f8e\u56fd\u56fd\u4f1a\u4e8e1963\u5e74\u9881\u5e03\u4e86\u4e16\u754c\u4e0a\u7b2c\u4e00\u90e8GMP\uff0c\u662f\u7531\u7f8e\u56fd\u5766\u666e\u5c14\u5927\u5b666\u540d\u6559\u6388\u7f16\u5199\u5236\u5b9a\u7684\uff0c\u7ecfFDA\u5b98\u5458\u591a\u6b21\u8ba8\u8bba\u4fee\u6539\uff0c\u7ecf\u8fc7\u51e0\u5e74\u5b9e\u65bd\uff0c\u786e\u5b9e\u6536\u5230\u5b9e\u6548\u30021967\u5e74\u4e16\u754c\u536b\u751f\u7ec4\u7ec7(the  World Health  Organization\uff0cWHO)\u5728\u51fa\u7248\u7684\u300a\u56fd\u9645\u836f\u5178\u300b(1967\u5e74\u7248)\u9644\u5f55\u4e2d\u8fdb\u884c\u4e86\u6536\u8f7d\uff0c1969\u5e74\u7b2c22\u5c4a\u4e16\u754c\u536b\u751f\u5927\u4f1aWHO\u5efa\u8bae\u5404\u6210\u5458\u56fd\u7684\u836f\u54c1\u751f\u4ea7\u91c7\u7528GMP\u5236\u5ea6\uff0c\u4ee5\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u548c\u53c2\u52a0\u201c\u56fd\u9645\u8d38\u6613\u836f\u54c1\u8d28\u91cf\u7b7e\u8bc1\u4f53\u5236\u201d  (Certificate\uff0dion Scheme On the Quality Of Pharmaceutical Products  Moving in International  Commerce\uff0c\u7b80\u79f0\u7b7e\u8bc1\u4f53\u5236)\u30021973\u5e74\u65e5\u672c\u5236\u836f\u5de5\u4e1a\u534f\u4f1a\u63d0\u51fa\u4e86\u81ea\u5df1\u7684GMP\uff0c1974\u5e74\u65e5\u672c\u653f\u5e9c\u9881\u5e03GMP\uff0c\u8fdb\u884c\u6307\u5bfc\u63a8\u884c\u30021975\u5e7411\u6708WHO\u6b63\u5f0f\u516c\u5e03GMP\uff0c1977\u5e74\u7b2c28\u5c4a\u4e16\u754c\u536b\u751f\u5927\u4f1a\u65f6WHO\u518d\u6b21\u5411\u6210\u5458\u56fd\u63a8\u8350GMP\uff0c\u5e76\u786e\u5b9a\u4e3aWHO\u7684\u6cd5\u89c4.GMP\u7ecf\u8fc7\u4fee\u8ba2\u540e\uff0c\u6536\u8f7d\u4e8e\u300a\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u6b63\u5f0f\u8bb0\u5f55\u300b\u7b2c226\u53f7\u9644\u4ef612\u4e2d.   WHO\u63d0\u51fa\u7684GMP\u5236\u5ea6\u662f\u836f\u54c1\u751f\u4ea7\u5168\u9762\u8d28\u91cf\u7ba1\u7406\u7684\u4e00\u4e2a\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u662f\u4fdd\u8bc1\u836f\u54c1\u8d28\u91cf\uff0c\u5e76\u628a\u53d1\u751f\u5dee\u9519\u4e8b\u6545\u3001\u6df7\u836f\u3001\u5404\u7c7b\u6c61\u67d3\u7684\u53ef\u80fd\u6027\u964d\u5230\u6700\u4f4e\u7a0b\u5ea6\u6240\u89c4\u5b9a\u7684\u5fc5\u8981\u6761\u4ef6\u548c\u6700\u53ef\u9760\u7684\u529e\u6cd5\uff0c1978\u5e74\u7f8e\u56fd\u518d\u6b21\u9881\u884c\u7ecf\u4fee\u8ba2\u7684GMP\u30021980\u5e74\u65e5\u672c\u51b3\u5b9a\u6b63\u5f0f\u5b9e\u65bdGMP\u3002\u6b64\u540e\uff0c\u82f1\u56fd\u3001\u65e5\u672c\u53ca\u5927\u591a\u6570\u6b27\u6d32\u56fd\u5bb6\u5f00\u59cb\u5ba3\u4f20\u3001\u8ba4\u8bc6\u3001\u8d77\u8349\u672c\u56fd\u7684GMP\uff0c\u6b27\u6d32\u5171\u540c\u4f53\u59d4\u5458\u4f1a\u9881\u5e03\u4e86\u6b27\u5171\u4f53\u7684GMP\u3002\u52301980\u5e74\u670963\u4e2a\u56fd\u5bb6\u9881\u5e03\u4e86GMP\u3002\u76ee\u524d\uff0c\u5df2\u6709100\u591a\u4e2a\u56fd\u5bb6\u5b9e\u884c\u4e86GMP\u5236\u5ea6\u3002\u968f\u7740\u793e\u4f1a\u7684\u53d1\u5c55\uff0c\u79d1\u6280\u7684\u8fdb\u6b65\uff0c\u5404\u56fd\u5728\u6267\u884cGMP\u7684\u8fc7\u7a0b\u4e2d\u4e0d\u65ad\u5730\u5bf9\u5176\u8fdb\u884c\u4fee\u6539\u548c\u5b8c\u5584\uff0c\u5e76\u5236\u8ba2\u4e86\u5404\u9879\u8be6\u7ec6\u89c4\u5219\u548c\u5404\u79cd\u6307\u5bfc\u539f\u5219\uff0c1988\u5e74\u65e5\u672c\u653f\u5e9c\u5236\u5b9a\u4e86\u539f\u6599\u836fGMP\uff0c1990\u5e74\u6b63\u5f0f\u5b9e\u65bd\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><strong><span style=\"max-width: 100%;color: rgb(192, 80, 77);\">WHO\u57281990\u5e74\u5bf9GMP\u4fee\u8ba2\u540e\uff0c1992\u5e74\u518d\u6b21\u4fee\u8ba2\uff0c\u5176\u5305\u62ec\u4ee5\u4e0b\u56db\u65b9\u9762\u5185\u5bb9\uff1a<\/span><\/strong><\/p>\n<section class=\"\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section>\n<section style=\"border-top: 1px solid rgb(104, 201, 191);border-left: 1px solid rgb(104, 201, 191);width: 100px;height: 14px;box-sizing: border-box;\"><\/section>\n<section style=\"color: rgb(63, 63, 63);font-size: 14px;text-align: justify;padding: 0em 0.8em;letter-spacing: 1.5px;box-sizing: border-box;\">\n<section class=\"\">\n<p><span style=\"font-size: 16px;\">(1)\u5bfc\u8a00\u3001\u603b\u8bba\u548c\u672f\u8bed\u4ecb\u7ecd\u4e86GMP\u7684\u4ea7\u751f\u3001\u4f5c\u7528\u548cGMP\u4e2d\u6240\u4f7f\u7528\u7684\u672f\u8bed<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">(2)\u5236\u836f\u5de5\u4e1a\u4e2d\u7684\u8d28\u91cf\u7ba1\u7406 \u5b97\u65e8\u548c\u57fa\u672c\u8981\u7d20\u3002\u8fd9\u4e00\u90e8\u5206\u5305\u62ecQA\u3001GMP\u3001 QC\u3001\u73af\u5883\u548c\u536b\u751f\u3001\u9a8c\u8bc1\u3001\u7528\u6237\u6295\u8bc9\u3001\u4ea7\u54c1\u6536\u56de\u3001\u5408\u540c\u751f\u4ea7\u4e0e\u5408\u540c\u5206\u6790\u3001\u81ea\u68c0\u4e0e\u8d28\u91cf\u5ba1\u67e5\u3001\u4eba\u5458\u3001\u5382\u623f\u3001\u8bbe\u5907\u3001\u7269\u6599\u548c\u6587\u4ef6\u517114\u4e2a\u65b9\u9762\u3002<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">(3)\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236 \u8fd9\u90e8\u5206\u5305\u62ec\u751f\u4ea7\u3001\u8d28\u91cf\u63a7\u5236\u4e24\u9879\u5185\u5bb9.<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">(4)\u589e\u8865\u7684\u6307\u5bfc\u539f\u5219 \u5305\u62ec\u706d\u83cc\u836f\u54c1\u53ca\u6d3b\u6027\u836f\u7269\u7ec4\u5206(\u539f\u6599\u836f)\u7684GMP\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<section style=\"text-align:right;\">\n<section style=\"border-bottom: 1px solid rgb(104, 201, 191);border-right: 1px solid rgb(104, 201, 191);width: 100px;height: 14px;display: inline-block;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">GMP\u5728\u6211\u56fd\u662f20\u4e16\u7eaa70\u5e74\u4ee3\u672b\u968f\u7740\u5bf9\u5916\u5f00\u653e\u653f\u7b56\u548c\u51fa\u53e3\u836f\u54c1\u7684\u9700\u8981\u800c\u53d7\u5230\u5404\u65b9\u9762\u7684\u91cd\u89c6\uff0c\u5e76\u5728\u2014\u4e9b\u4f01\u4e1a\u548c\u67d0\u4e9b\u4ea7\u54c1\u751f\u4ea7\u4e2d\u5f97\u5230\u90e8\u5206\u7684\u5e94\u7528\u30021982\u5e74\u7531\u5f53\u65f6\u8d1f\u8d23\u884c\u4e1a\u7ba1\u7406\u7684\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u516c\u53f8\u5236\u8ba2\u4e86\u300a\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303(\u8bd5\u884c\u672c)\u300b\u30021985\u5e74\u7ecf\u4fee\u6539\uff0c\u7531\u539f\u56fd\u5bb6\u533b\u836f\u7ba1\u7406\u5c40\u4f5c\u4e3a\u300a\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u300b\u63a8\u884c\u672c\u9881\u53d1\uff1b\u7531\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u516c\u53f8\u7b49\u7f16\u5236\u4e86\u300a\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u5b9e\u65bd\u6307\u5357\u300b\uff081985\u5e74\u7248)\uff0c\u4e8e\u5f53\u5e7412\u6708\u9881\u53d1\u30021988\u5e74\u536b\u751f\u90e8\u9881\u5e03\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff0c\u4ee5\u540e\u53c8\u8fdb\u884c\u4fee\u8ba2\uff0c\u9881\u5e03\u4e861992\u5e74\u4fee\u8ba2\u7248\u3002<strong><span style=\"max-width: 100%;color: rgb(192, 80, 77);\">1992\u5e74\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u516c\u53f8\u7b49\u9881\u5e03\u4e86\u4fee\u8ba2\u7684\u300a\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u5b9e\u65bd\u6307\u5357\u300b\u3002<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">\u968f\u7740GMP\u7684\u53d1\u5c55\uff0c\u56fd\u9645\u95f4\u5b9e\u65bd\u4e86\u836f\u54c1GMP\u8ba4\u8bc1\u3002\u6211\u56fd\u536b\u751f\u90e8<span style=\"max-width: 100%;color: rgb(192, 80, 77);\">1995\u5e747\u670811\u65e5\u4e0b\u8fbe\u536b\u836f\u53d1(1995)\u7b2c53\u53f7\u6587\u4ef6\u201c\u5173\u4e8e\u5f00\u5c55\u836f\u54c1GMP\u8ba4\u8bc1\u5de5\u4f5c\u7684\u901a\u77e5\u201d\u3002<\/span>\u836f\u54c1GMP\u8ba4\u8bc1(certification)\u662f\u56fd\u5bb6\u4f9d\u6cd5\u5bf9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a(\u8f66\u95f4)\u548c\u836f\u54c1\u54c1\u79cd\u5b9e\u65bd\u836f\u54c1GMP\u76d1\u7763\u68c0\u67e5\u5e76\u53d6\u5f97\u8ba4\u53ef\u7684\u4e00\u79cd\u5236\u5ea6\uff0c\u662f\u56fd\u9645\u836f\u54c1\u8d38\u6613\u548c\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u7684\u91cd\u8981\u5185\u5bb9\uff0c\u4e5f\u662f\u786e\u4fdd\u836f\u54c1\u8d28\u91cf\u7a33\u5b9a\u6027\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u2014\u79cd\u79d1\u5b66\u7684\u3001\u5148\u8fdb\u7684\u7ba1\u7406\u624b\u6bb5\u3002\u540c\u5e74\uff0c\u6210\u7acb\u4e2d\u56fd\u836f\u54c1\u8ba4\u8bc1\u59d4\u5458\u4f1a(China  Certification Committee for Drugs\uff0c\u7f29\u5199\u4e3aCCCD)\u3002<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><span style=\"max-width: 100%;\">1998\u5e74\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6210\u7acb\u540e\uff0c\u5efa\u7acb\u4e86\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u8ba4\u8bc1\u7ba1\u7406\u4e2d\u5fc3\uff0c\u5e76\u4e8e<strong><span style=\"max-width: 100%;color: rgb(247, 150, 70);\">1999\u5e746\u670818\u65e5\u9881\u53d1\u4e86\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303(1998\u5e74\u4fee\u8ba2)\u300b\u3002<\/span><\/strong><\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><br  \/><\/p>\n<p style=\"max-width: 100%;min-height: 1em;text-indent: 2em;\"><strong><span style=\"max-width: 100%;color: rgb(192, 80, 77);text-shadow: rgb(216, 216, 216) 2px 2px 10px;\">\u7eb5\u89c2GMP\u53d1\u5c55\u7684\u5386\u53f2\uff0c\u53ef\u4ee5\u8bf4\u7ecf\u5386\u8fc7\u4e24\u4e2a\u53d1\u5c55\u9ad8\u5cf0\u3002\u4e00\u662f\u8ba4\u8bc6\u3001\u63a5\u53d7\u548c\u5b9e\u65bd\u8fd9\u4e00\u65b0\u7684\u79d1\u5b66\u7684\u7ba1\u7406\u5236\u5ea6\uff1b\u4e8c\u662f\u5728\u5df2\u7ecf\u5efa\u7acb\u8d77GMP\u5236\u5ea6\u7684\u57fa\u7840\u4e0a\uff0c\u5f15\u5165\u201c\u8bc1\u5b9e(verification)\u201d\u7684\u6982\u5ff5\u3002<\/span><\/strong><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>GMP\u662f\u82f1\u6587\u540dGood Manufacturing Practices for Drugs\u6216\u8005Good Pra [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":35176,"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\/35175"}],"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=35175"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/35175\/revisions"}],"predecessor-version":[{"id":35180,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/35175\/revisions\/35180"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/35176"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=35175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=35175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=35175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}