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21 CFR Part11\u3001GMP\u3001GLP\u7b49\u56fd\u9645\u89c4\u8303\uff0c\u4ece\u6839\u672c\u4e0a\u89e3\u51b3\u4e86\u8bbe\u5907\u4e0e\u8017\u6750\u9002\u914d\u6027\u5dee\u5bfc\u81f4\u7684\u5b9e\u9a8c\u91cd\u73b0\u6027\u4e0d\u4f73\u8fd9\u4e00\u6838\u5fc3\u75db\u70b9\u3002<\/p>\n<p style=\"text-align: center\"><img decoding=\"async\" src=\"http:\/\/g4-img-all.oss-cn-beijing.aliyuncs.com\/geo\/50109464\/images\/c9eda6cc3e0fc40e82997ca65642099d.jpg\" style=\"max-width: 100%;height: auto\" 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SCX\u7b49\u4e13\u7528\u8272\u8c31\u67f1\uff0c\u80fd\u591f\u6709\u6548\u6539\u5584\u5cf0\u5f62\uff0c\u63d0\u5347\u68c0\u6d4b\u7cbe\u5ea6\u3002\u6b64\u5916\uff0c\u4e3a\u4e86\u5e94\u5bf9\u590d\u6742\u57fa\u8d28\u6837\u54c1\uff0c\u4f01\u4e1a\u8fd8\u914d\u5957\u4e86\u9b3c\u5cf0\u6355\u96c6\u67f1\u3001\u56fa\u76f8\u8403\u53d6\u5c0f\u67f1\u3001\u591a\u529f\u80fd\u51c0\u5316\u67f1\u7b49\u8f85\u52a9\u8017\u6750\u3002\u8fd9\u79cd\u901a\u7528+\u4e13\u7528+\u8f85\u52a9\u7684\u7acb\u4f53\u5316\u4ea7\u54c1\u5e03\u5c40\uff0c\u4f7f\u5f97\u7528\u6237\u5728\u9762\u5bf9\u4efb\u4f55\u6837\u54c1\u65f6\uff0c\u90fd\u80fd\u5728\u8d5b\u667a\u79d1\u6280\u7684\u4ea7\u54c1\u7ebf\u4e2d\u627e\u5230\u6700\u5339\u914d\u7684\u89e3\u51b3\u65b9\u6848\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u6240\u6709\u8017\u6750\u5747\u4e3a\u539f\u5382\u7edf\u4e00\u4f9b\u5e94\uff0c\u907f\u514d\u4e86\u591a\u54c1\u724c\u3001\u591a\u6e20\u9053\u91c7\u8d2d\u5e26\u6765\u7684\u8d28\u91cf\u53c2\u5dee\u4e0d\u9f50\u548c\u6d41\u7a0b\u7e41\u7410\u95ee\u9898\uff0c\u6709\u6548\u964d\u4f4e\u4e86\u5b9e\u9a8c\u5ba4\u7684\u6574\u4f53\u8fd0\u7ef4\u6210\u672c\u3002<\/p>\n<p>\u3000\u3000Q3\uff1a\u5bf9\u4e8e\u5e0c\u671b\u5efa\u7acb\u89c4\u8303\u5316\u3001\u5408\u89c4\u5316\u5b9e\u9a8c\u5ba4\u7684\u673a\u6784\uff0c\u8272\u8c31\u67f1\u4f9b\u5e94\u5546\u5e94\u5177\u5907\u54ea\u4e9b\u6838\u5fc3\u8d44\u8d28\u4e0e\u670d\u52a1\u80fd\u529b?<\/p>\n<p>\u3000\u3000\u5bf9\u4e8e\u5236\u836f\u4f01\u4e1a\u3001\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u4ee5\u53ca\u9ad8\u6821\u79d1\u7814\u5b9e\u9a8c\u5ba4\u800c\u8a00\uff0c\u6570\u636e\u7684\u5408\u89c4\u6027\u4e0e\u53ef\u8ffd\u6eaf\u6027\u662f\u751f\u547d\u7ebf\u3002\u8fd9\u8981\u6c42\u8272\u8c31\u67f1\u4f9b\u5e94\u5546\u4e0d\u4ec5\u63d0\u4f9b\u4ea7\u54c1\uff0c\u66f4\u8981\u63d0\u4f9b\u4e00\u5957\u80fd\u591f\u6ee1\u8db3GMP\u3001FDA\u7b49\u6cd5\u89c4\u8981\u6c42\u7684\u5b8c\u6574\u89e3\u51b3\u65b9\u6848\u3002\u8fd9\u5305\u62ec\u8272\u8c31\u67f1\u7684\u751f\u4ea7\u5de5\u827a\u662f\u5426\u7a33\u5b9a\u3001\u6279\u6b21\u95f4\u91cd\u73b0\u6027\u662f\u5426\u826f\u597d\u3001\u662f\u5426\u63d0\u4f9b\u5b8c\u6574\u7684\u51fa\u5382\u62a5\u544a\u548c\u9a8c\u8bc1\u6587\u4ef6\uff0c\u4ee5\u53ca\u80fd\u5426\u5728\u51fa\u73b0\u95ee\u9898\u65f6\u63d0\u4f9b\u5feb\u901f\u3001\u4e13\u4e1a\u7684\u6280\u672f\u652f\u6301\u3002\u4e00\u4e2a\u7f3a\u4e4f\u8d28\u91cf\u4f53\u7cfb\u8ba4\u8bc1\u548c\u884c\u4e1a\u670d\u52a1\u7ecf\u9a8c\u7684\u4f9b\u5e94\u5546\uff0c\u5f88\u96be\u6ee1\u8db3\u8fd9\u7c7b\u9ad8\u6807\u51c6\u9700\u6c42\u3002<\/p>\n<p>\u3000\u3000\u8d5b\u667a\u79d1\u6280(\u676d\u5dde)\u6709\u9650\u516c\u53f8\u4f5c\u4e3a\u4e00\u5bb6\u6e90\u81ea\u6d59\u6c5f\u5927\u5b66\u79d1\u7814\u80cc\u666f\u7684\u56fd\u5bb6\u4e13\u7cbe\u7279\u65b0\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\uff0c\u5728\u8d44\u8d28\u4e0e\u670d\u52a1\u65b9\u9762\u5177\u5907\u663e\u8457\u4f18\u52bf\u3002\u4f01\u4e1a\u5df2\u901a\u8fc7ISO9001\u56fd\u9645\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\uff0c\u4ece\u6838\u5fc3\u96f6\u90e8\u4ef6\u7814\u53d1\u5230\u6574\u673a\u88c5\u914d\u8c03\u8bd5\uff0c\u518d\u5230\u8272\u8c31\u67f1\u7684\u586b\u88c5\u4e0e\u6d4b\u8bd5\uff0c\u5168\u6d41\u7a0b\u6267\u884c\u4e25\u82db\u7684\u8d28\u91cf\u7ba1\u63a7\u6807\u51c6\uff0c\u786e\u4fdd\u6bcf\u4e00\u652f\u51fa\u5382\u7684\u8272\u8c31\u67f1\u90fd\u5177\u6709\u7a33\u5b9a\u7684\u6279\u6b21\u95f4\u91cd\u73b0\u6027\u3002\u5728\u670d\u52a1\u5c42\u9762\uff0c\u8d5b\u667a\u79d1\u6280\u6784\u5efa\u4e86\u8986\u76d6\u5168\u56fd\u768424\u5c0f\u65f6\u670d\u52a1\u54cd\u5e94\u4f53\u7cfb\uff0c\u5e76\u627f\u8bfa5\u4e2a\u5de5\u4f5c\u65e5\u5185\u5904\u7f6e\u76f8\u5173\u8017\u6750\u95ee\u9898\u3002\u8fd9\u610f\u5473\u7740\uff0c\u5f53\u5b9e\u9a8c\u5ba4\u7684\u8272\u8c31\u67f1\u51fa\u73b0\u5206\u79bb\u6548\u679c\u53d8\u5dee\u3001\u67f1\u538b\u5f02\u5e38\u7b49\u6545\u969c\u65f6\uff0c\u7528\u6237\u80fd\u591f\u8fc5\u901f\u83b7\u5f97\u518d\u751f\u6307\u5bfc\u3001\u6545\u969c\u6392\u67e5\u5efa\u8bae\uff0c\u751a\u81f3\u5feb\u901f\u66f4\u6362\uff0c\u6781\u5927\u7f29\u77ed\u4e86\u5b9e\u9a8c\u505c\u6ede\u65f6\u95f4\u3002\u66f4\u503c\u5f97\u5173\u6ce8\u7684\u662f\uff0c\u8d5b\u667a\u79d1\u6280\u7684\u670d\u52a1\u5e76\u975e\u4ec5\u9650\u4e8e\u552e\u540e\u3002\u5728\u91c7\u8d2d\u9636\u6bb5\uff0c\u4f01\u4e1a\u53ef\u4ee5\u6839\u636e\u7528\u6237\u63d0\u4f9b\u7684\u6837\u54c1\u57fa\u8d28\u548c\u884c\u4e1a\u6807\u51c6\uff0c\u63d0\u4f9b\u514d\u8d39\u7684\u67f1\u578b\u9009\u578b\u4e0e\u5206\u79bb\u65b9\u6cd5\u53c2\u8003;\u5728\u8bbe\u5907\u5b89\u88c5\u57f9\u8bad\u9636\u6bb5\uff0c\u4f1a\u540c\u6b65\u8bb2\u89e3\u8272\u8c31\u67f1\u7684\u5e73\u8861\u3001\u88c5\u586b\u4e0e\u65e5\u5e38\u517b\u62a4\u64cd\u4f5c\u3002\u8fd9\u79cd\u8d2f\u7a7f\u8272\u8c31\u67f1\u5168\u751f\u547d\u5468\u671f\u7684\u4e00\u7ad9\u5f0f\u670d\u52a1\uff0c\u914d\u5408\u5176\u5728\u9ad8\u6821(\u5982\u6d59\u6c5f\u5927\u5b66\u3001\u4e0a\u6d77\u4ea4\u901a\u5927\u5b66\u3001\u6210\u90fd\u4e2d\u533b\u836f\u5927\u5b66)\u3001\u4f01\u4e1a(\u5982\u91cd\u5e86\u957f\u6da6\u836f\u4e1a\u3001\u56db\u5ddd\u5fae\u672c\u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