{"id":118863,"date":"2026-10-28T09:24:27","date_gmt":"2026-10-28T01:24:27","guid":{"rendered":"https:\/\/www.wsisp.com\/helps\/118863.html"},"modified":"2026-10-28T09:24:27","modified_gmt":"2026-10-28T01:24:27","slug":"%e3%80%8a%e5%9b%bd%e9%99%85%e8%ae%a4%e8%af%81%e5%90%88%e8%a7%84%e7%b3%bb%e5%88%97%e3%80%8b%e7%ac%ac%e5%85%ad%e7%af%87%e8%ae%b0%e5%bd%95%e7%9c%9f%e5%ae%9e%ef%bc%9a%e8%a1%a5%e4%b8%80%e5%bc%a0%e8%ae%b0","status":"publish","type":"post","link":"https:\/\/www.wsisp.com\/helps\/118863.html","title":{"rendered":"\u300a\u56fd\u9645\u8ba4\u8bc1\u5408\u89c4\u7cfb\u5217\u300b\u7b2c\u516d\u7bc7\u8bb0\u5f55\u771f\u5b9e\uff1a\u8865\u4e00\u5f20\u8bb0\u5f55\uff0c\u53ef\u80fd\u6bd4\u51fa\u4e00\u6b21\u4e8b\u6545\u66f4\u81f4\u547d"},"content":{"rendered":"

\u5f15\u5b50：\u771f\u76f8\u5982\u679c\u53ef\u4ee5\u88ab\u300c\u8a8a\u4e00\u904d\u300d，\u6240\u6709\u7684\u5408\u89c4\u5c31\u90fd\u6210\u4e86\u6446\u8bbe<\/span><\/span><\/h2>\n

\u00a0 \u00a0 \u00a0 \u5728\u5236\u836f\u5236\u9020\u7684\u4f17\u591a\u98ce\u9669\u91cc，\u6709\u4e00\u79cd\u98ce\u9669\u662f\u6700\u7279\u6b8a\u7684，\u56e0\u4e3a\u5b83\u4f24\u5bb3\u7684\u4e0d\u662f\u67d0\u4e00\u6279\u4ea7\u54c1，\u800c\u662f\u6574\u5957\u4f53\u7cfb\u7684\u516c\u4fe1\u529b\u2014\u2014\u90a3\u5c31\u662f\u8bb0\u5f55\u771f\u5b9e\u3002\u5de5\u827a\u53ef\u4ee5\u4f18\u5316\u3001\u8bbe\u5907\u53ef\u4ee5\u66f4\u6362\u3001\u504f\u5dee\u53ef\u4ee5\u6574\u6539，\u4f46\u4e00\u65e6\u300c\u8bb0\u5f55\u9020\u5047\u300d\u6210\u4e3a\u4e8b\u5b9e，\u76d1\u7ba1\u5bf9\u6574\u4e2a\u4f01\u4e1a\u7684\u4fe1\u4efb\u5c31\u4f1a\u964d\u5230\u51b0\u70b9\u3002\u56e0\u4e3a\u5728\u76d1\u7ba1\u770b\u6765：\u8fde\u6700\u57fa\u672c\u7684\u4e8b\u5b9e\u90fd\u4e0d\u613f\u610f\u5982\u5b9e\u8bb0\u5f55\u7684\u4f01\u4e1a，\u5176\u4f59\u6240\u6709\u5408\u89c4\u627f\u8bfa\u90fd\u503c\u5f97\u6000\u7591\u3002<\/p>\n

\u00a0 \u00a0 \u00a0\u5f88\u591a\u4f01\u4e1a\u5728\u73b0\u573a\u88ab\u6293\u5230\u7684，\u5f80\u5f80\u4e0d\u662f\u300c\u505a\u9519\u4e86\u300d，\u800c\u662f\u300c\u8bb0\u5f55\u662f\u540e\u6765\u8865\u7684\u300d\u3002\u68c0\u67e5\u5458\u5728\u7535\u5b50\u7cfb\u7edf\u7684\u65f6\u95f4\u6233\u3001\u7eb8\u8d28\u8bb0\u5f55\u7684\u5b57\u8ff9\u4e0e\u58a8\u8ff9\u3001\u6279\u8bb0\u5f55\u7684\u8fde\u8d2f\u6027\u91cc，\u4e00\u70b9\u70b9\u62fc\u51fa\u300c\u539f\u59cb\u8bb0\u5f55\u88ab\u8a8a\u6284\/\u7be1\u6539\u300d\u7684\u5168\u8c8c\u3002\u4e00\u65e6\u5750\u5b9e，\u8f7b\u5219\u8b66\u544a\u4fe1，\u91cd\u5219\u540a\u9500\u4e0a\u5e02\u8bb8\u53ef\u3001\u5168\u7403\u9000\u5e02\u3002\u672c\u7bc7\u6587\u7ae0\u628a\u300c\u8bb0\u5f55\u771f\u5b9e\u300d\u8bb2\u900f：\u4e3a\u4ec0\u4e48\u5b83\u662f\u6570\u636e\u5b8c\u6574\u6027\u7684\u6838\u5fc3\u3001\u7eb8\u8d28\u8bb0\u5f55\u600e\u4e48\u4f1a\u88ab\u89c6\u4e3a\u4e0d\u53ef\u4fe1\u3001\u5341\u5e74\u6cd5\u89c4\u600e\u4e48\u56f4\u5835\u9020\u5047\u3001\u4ee5\u53ca\u4f01\u4e1a\u5982\u4f55\u7528\u5236\u5ea6\u4e0e\u6587\u5316\u5b88\u4f4f\u300c\u8bb0\u5f55\u5373\u771f\u5b9e\u300d\u8fd9\u6761\u5e95\u7ebf\u3002\u5bf9\u4efb\u4f55\u51c6\u5907\u51fa\u6d77\u7684\u836f\u4f01，\u8bb0\u5f55\u771f\u5b9e\u90fd\u4e0d\u662f\u300c\u9526\u4e0a\u6dfb\u82b1\u300d，\u800c\u662f\u300c\u4e00\u7968\u5426\u51b3\u300d\u9879\u2014\u2014\u5b83\u4e00\u65e6\u51fa\u95ee\u9898，\u524d\u9762\u6240\u6709\u7684\u5de5\u827a\u3001\u8bbe\u5907\u3001\u6e05\u6d01\u3001\u8d28\u91cf\u4f53\u7cfb\u5efa\u8bbe\u90fd\u53ef\u80fd\u77ac\u95f4\u5f52\u96f6\u3002<\/p>\n

\u4e00\u3001\u8bb0\u5f55\u771f\u5b9e：\u6570\u636e\u5b8c\u6574\u6027\u7684\u300c\u6700\u5e95\u5c42\u300d<\/span><\/span><\/p>\n

\u00a0 \u00a0 \u00a0\u6570\u636e\u5b8c\u6574\u6027（Data Integrity）\u524d\u4e00\u7bc7\u5df2\u5c55\u5f00，\u5176\u6838\u5fc3\u662f ALCOA+ \u539f\u5219\u2014\u2014\u53ef\u8ffd\u6eaf\u3001\u6e05\u6670\u3001\u540c\u6b65\u3001\u539f\u59cb\u3001\u51c6\u786e，\u518d\u53e0\u52a0\u5b8c\u6574\u3001\u4e00\u81f4\u3001\u6301\u4e45\u3001\u53ef\u5f97\u3002\u800c\u300c\u8bb0\u5f55\u771f\u5b9e\u300d\u6b63\u662f ALCOA+ \u91cc\u6700\u786c\u3001\u4e5f\u6700\u96be\u9020\u5047\u7684\u300c\u539f\u59cb（Original）\u300d\u300c\u540c\u6b65（Contemporary）\u300d\u300c\u51c6\u786e（Accurate）\u300d\u4e09\u8005\u7684\u843d\u5730\u3002\u5b83\u56de\u7b54\u4e00\u4e2a\u6700\u57fa\u672c\u7684\u95ee\u9898：\u8fd9\u4efd\u8bb0\u5f55，\u5230\u5e95\u662f\u4e0d\u662f\u300c\u5f53\u65f6\u3001\u5f53\u573a\u3001\u5982\u5b9e\u300d\u5199\u4e0b\u7684？<\/p>\n

\u00a0 \u00a0 \u8bb0\u5f55\u771f\u5b9e\u8986\u76d6\u4e24\u5c42：\u7eb8\u8d28\u8bb0\u5f55\u4e0e\u7535\u5b50\u8bb0\u5f55\u3002\u7535\u5b50\u8bb0\u5f55\u6709\u5ba1\u8ba1\u8ffd\u8e2a\u53ef\u4ee5\u8ffd\u6eaf，\u7eb8\u8d28\u8bb0\u5f55\u5219\u5b8c\u5168\u4f9d\u8d56\u64cd\u4f5c\u8005\u7684\u5982\u5b9e\u4e66\u5199\u548c\u5236\u5ea6\u7684\u7ea6\u675f\u4e0d\u653e\u4efb\u3002\u6070\u6070\u662f\u65e0\u5f62\u7684\u7eb8\u8d28\u8bb0\u5f55，\u6700\u5bb9\u6613\u5728\u300c\u8d76\u8fdb\u5ea6\u3001\u6015\u9ebb\u70e6\u3001\u6015\u62c5\u8d23\u300d\u7684\u5fc3\u6001\u4e0b\u88ab\u8a8a\u6284\u3001\u88ab\u8865\u8bb0\u2014\u2014\u800c\u5b83\u4e00\u65e6\u88ab\u505a\u5047，\u6574\u5957\u8d28\u91cf\u4f53\u7cfb\u7684\u8bc1\u636e\u94fe\u5c31\u65ad\u4e86\u3002<\/p>\n

1.1 \u7eb8\u8d28 vs \u7535\u5b50\u8bb0\u5f55\u7684\u771f\u5b9e\u6027\u8981\u70b9\u5bf9\u7167<\/h3>\n\n\n\n\n\n\n\n\n
\n

\u8981\u70b9<\/span><\/span><\/p>\n<\/td>\n

\n

\u7eb8\u8d28\u8bb0\u5f55<\/span><\/span><\/p>\n<\/td>\n

\n

\u7535\u5b50\u8bb0\u5f55<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u539f\u59cb\u6027<\/span><\/span><\/p>\n<\/td>\n

\n

\u73b0\u573a\u540c\u6b65\u586b\u5199，\u53d7\u63a7\u53d1\u653e<\/span><\/span><\/p>\n<\/td>\n

\n

\u7cfb\u7edf\u6355\u83b7，\u5ba1\u8ba1\u8ffd\u8e2a\u8bb0\u5f55\u6765\u6e90<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u540c\u6b65\u6027<\/span><\/span><\/p>\n<\/td>\n

\n

\u5f53\u65f6\u3001\u5f53\u573a\u3001\u5373\u65f6，\u4e0d\u5f97\u4e8b\u540e\u8865\u6284<\/span><\/span><\/p>\n<\/td>\n

\n

\u6570\u636e\u4ea7\u751f\u65f6\u95f4\u7531\u7cfb\u7edf\u65f6\u95f4\u6233\u56fa\u5316<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4fee\u6539<\/span><\/span><\/p>\n<\/td>\n

\n

\u5212\u6539\u2014\u7b7e\u540d\u2014\u65e5\u671f\u2014\u539f\u56e0，\u7981\u6b62\u6d82\u6539<\/span><\/span><\/p>\n<\/td>\n

\n

\u5ba1\u8ba1\u8ffd\u8e2a\u8bb0\u5f55\u8c01\u6539\u3001\u4f55\u65f6\u6539\u3001\u6539\u4e86\u5565<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u8ffd\u6eaf<\/span><\/span><\/p>\n<\/td>\n

\n

\u5b57\u8ff9\u3001\u58a8\u8ff9\u3001\u7b7e\u540d\u3001\u8d23\u4efb\u4eba<\/span><\/span><\/p>\n<\/td>\n

\n

\u7528\u6237\u6743\u9650\u3001\u8d26\u53f7\u3001\u64cd\u4f5c\u65e5\u5fd7\u4e00\u4e00\u5bf9\u5e94<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u98ce\u9669\u4fa7\u91cd<\/span><\/span><\/p>\n<\/td>\n

\n

\u8a8a\u6284\u3001\u4ee3\u7b7e\u3001\u65e0\u75d5\u5220\u6539<\/span><\/span><\/p>\n<\/td>\n

\n

\u8d26\u53f7\u5171\u4eab\u3001\u8ffd\u6d4b\u5173\u95ed\u3001\u65f6\u95f4\u6233\u53ef\u6539<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u5bf9\u7167\u53ef\u89c1，\u4e24\u79cd\u8f7d\u4f53\u5404\u6709\u6613\u5931\u624b\u5904，\u4f46 ALCOA+ \u7684\u5e95\u7ebf\u76f8\u540c：\u539f\u59cb\u3001\u540c\u6b65\u3001\u51c6\u786e\u3001\u53ef\u8ffd\u6eaf\u3002\u65e0\u8bba\u7eb8\u8fd8\u662f\u7535\u5b50，\u8131\u79bb\u8fd9\u56db\u6761，\u5c31\u4e0d\u518d\u662f\u300c\u771f\u5b9e\u8bb0\u5f55\u300d\u3002<\/p>\n

1.2 ALCOA+ \u4e5d\u9879\u539f\u5219\u5728\u300c\u8bb0\u5f55\u771f\u5b9e\u300d\u7684\u843d\u5730<\/h3>\n

\u8bb0\u5f55\u771f\u5b9e\u4e0d\u662f\u7b3c\u7edf\u7684\u300c\u8981\u8bda\u5b9e\u300d，\u800c\u662f\u53ef\u62c6\u6210\u4e5d\u6761\u53ef\u6267\u884c\u3001\u53ef\u6838\u67e5\u7684\u5e95\u7ebf，\u6b63\u597d\u5bf9\u5e94 ALCOA+：<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u539f\u5219<\/span><\/span><\/p>\n<\/td>\n

\n

\u8bb0\u5f55\u5c42\u9762\u7684\u6267\u884c\u8981\u4e49<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53ef\u6eaf\u6e90<\/span><\/span><\/p>\n<\/td>\n

\n

\u8c01\u4ea7\u751f\u7684\u8bb0\u5f55\u80fd\u8ffd\u5230\u4eba，\u7b7e\u540d\/\u8d26\u53f7\u4e0e\u771f\u5b9e\u6267\u884c\u8005\u5bf9\u5e94<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6e05\u6670<\/span><\/span><\/p>\n<\/td>\n

\n

\u5b57\u8ff9\u53ef\u8bfb\u3001\u5185\u5bb9\u6e05\u695a，\u4e0d\u56e0\u6f66\u8349\u800c\u65e0\u6cd5\u6838\u67e5<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u540c\u6b65<\/span><\/span><\/p>\n<\/td>\n

\n

\u73b0\u573a\u3001\u5373\u65f6\u586b\u5199，\u4e0d\u5f97\u4e8b\u540e\u8865\u6284<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u539f\u59cb<\/span><\/span><\/p>\n<\/td>\n

\n

\u4fdd\u7559\u539f\u59cb\u8bb0\u5f55，\u4e0d\u4ee5\u8a8a\u6284\u4ef6\u4ee3\u66ff<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u51c6\u786e<\/span><\/span><\/p>\n<\/td>\n

\n

\u8bb0\u5f55\u53cd\u6620\u771f\u5b9e\u53d1\u751f，\u65e0\u865a\u6784\u3001\u65e0\u7be1\u6539<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5b8c\u6574<\/span><\/span><\/p>\n<\/td>\n

\n

\u6240\u6709\u6570\u636e\u53ca\u5143\u6570\u636e\u9f50\u5168，\u4e0d\u5220\u51cf\u3001\u4e0d\u9057\u6f0f<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e00\u81f4<\/span><\/span><\/p>\n<\/td>\n

\n

\u5404\u73af\u8282\u8bb0\u5f55\u903b\u8f91\u81ea\u6d3d，\u65f6\u95f4\u7ebf\/\u6279\u53f7\u5bf9\u5f97\u4e0a<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6301\u4e45<\/span><\/span><\/p>\n<\/td>\n

\n

\u7eb8\u8d28\u53d7\u63a7\u4fdd\u5b58\u3001\u7535\u5b50\u53ef\u957f\u671f\u8bfb\u53d6，\u9632\u7be1\u6539\u5b58\u50a8<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53ef\u5f97<\/span><\/span><\/p>\n<\/td>\n

\n

\u9700\u8981\u65f6\u80fd\u53ca\u65f6\u8c03\u53d6，\u4f9b\u5ba1\u8ba1\u6838\u67e5<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u8fd9\u4e5d\u6761，\u662f\u4f01\u4e1a\u81ea\u67e5\u8bb0\u5f55\u771f\u5b9e\u6027\u6700\u73b0\u6210\u7684\u300c\u5c3a\u5b50\u300d\u2014\u2014\u9010\u6761\u8fc7\u4e00\u904d，\u54ea\u91cc\u5bf9\u4e0d\u4e0a，\u54ea\u91cc\u5c31\u662f\u98ce\u9669\u6240\u5728\u3002\u5efa\u8bae\u628a\u5b83\u4eec\u5370\u5728\u8f66\u95f4\u4e0e\u68c0\u9a8c\u533a\u57df\u7684\u89c4\u8303\u91cc，\u8ba9\u6267\u884c\u8005\u968f\u65f6\u5bf9\u7167\u3002<\/p>\n

\u4e8c\u3001\u5341\u5e74\u6f14\u53d8：\u4ece\u300c\u6280\u672f\u9632\u63a7\u300d\u5230\u300c\u6587\u5316\u9632\u63a7\u300d<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5e74\u4efd\/\u6587\u4ef6<\/span><\/span><\/p>\n<\/td>\n

\n

\u5173\u952e\u70b9<\/span><\/span><\/p>\n<\/td>\n

\n

\u610f\u4e49<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

1997 \/ 21 CFR Part 11<\/span><\/span><\/p>\n<\/td>\n

\n

\u7535\u5b50\u8bb0\u5f55\u4e0e\u7535\u5b50\u7b7e\u540d\u89c4\u5219<\/span><\/span><\/p>\n<\/td>\n

\n

\u7535\u5b50\u6570\u636e\u7684\u539f\u59cb\u6027\/\u771f\u5b9e\u6027\u6210\u4e3a\u5408\u89c4\u8981\u6c42<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2010+<\/span><\/span><\/p>\n<\/td>\n

\n

\u591a\u8d77\u8bb0\u5f55\u9020\u5047\u6848\u66dd\u5149\u540e，\u76d1\u7ba1\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u4e13\u9879\u4e25\u67e5<\/span><\/span><\/p>\n<\/td>\n

\n

\u8bb0\u5f55\u771f\u5b9e\u6027\u4ece\u300c\u6280\u672f\u95ee\u9898\u300d\u4e0a\u5347\u4e3a\u300c\u76d1\u7ba1\u9ad8\u538b\u533a\u300d<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2016\u20132021<\/span><\/span><\/p>\n<\/td>\n

\n

FDA\u3001PIC\/S\u3001WHO \u76f8\u7ee7\u53d1\u5e03\u6570\u636e\u5b8c\u6574\u6027\u6307\u5357<\/span><\/span><\/p>\n<\/td>\n

\n

ALCOA+\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u6570\u636e\u7ba1\u7406\u8d23\u4efb\u6210\u4e3a\u7edf\u4e00\u8bed\u8a00<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2021 \u751f\u6548 PI 041-1<\/span><\/span><\/p>\n<\/td>\n

\n

Good Practices for Data Management and Integrity<\/span><\/span><\/p>\n<\/td>\n

\n

\u628a\u6570\u636e\/\u8bb0\u5f55\u7684\u7ba1\u7406\u8d23\u4efb\u660e\u786e\u5230\u7ec4\u7ec7\u4e0e\u4eba\u5458<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

2020s<\/span><\/span><\/p>\n<\/td>\n

\n

\u76d1\u7ba1\u4ece\u300c\u67e5\u7535\u5b50\u7cfb\u7edf\u300d\u6269\u5c55\u5230\u300c\u67e5\u8bb0\u5f55\u6587\u5316\u548c\u9020\u5047\u52a8\u673a\u300d<\/span><\/span><\/p>\n<\/td>\n

\n

\u8bb0\u5f55\u771f\u5b9e\u7684\u6210\u8d25\u6700\u540e\u843d\u5728\u300c\u4eba\u7684\u884c\u4e3a\u300d\u4e0e\u300c\u7ec4\u7ec7\u6587\u5316\u300d<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00a0 \u00a0 \u00a0 \u8fd9\u6761\u6f14\u53d8\u7ebf\u63ed\u793a\u4e00\u4e2a\u91cd\u8981\u4e8b\u5b9e：\u76d1\u7ba1\u5bf9\u8bb0\u5f55\u9020\u5047\u7684\u6001\u5ea6，\u5df2\u7ecf\u4ece\u300c\u67e5\u4f60\u6709\u6ca1\u6709\u5ba1\u8ba1\u8ffd\u8e2a\u300d\u5347\u7ea7\u5230\u300c\u67e5\u4f60\u4eec\u516c\u53f8\u6709\u6ca1\u6709\u9020\u5047\u7684\u571f\u58e4\u300d\u3002\u6570\u636e\u7f3a\u5931\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u5173\u95ed\u3001\u5171\u4eab\u8d26\u53f7\u3001\u4e8b\u540e\u8865\u8bb0\u3001\u8a8a\u6284\u53f0\u8d26\u2014\u2014\u8fd9\u4e9b\u4e0d\u53ea\u662f\u300c\u8bb0\u5f55\u7ba1\u7406\u95ee\u9898\u300d，\u800c\u662f\u88ab\u76f4\u63a5\u5f53\u4f5c\u300c\u6570\u636e\u5b8c\u6574\u6027\u7f3a\u9677\u300d\u5b9a\u6027\u3002\u6280\u672f\u624b\u6bb5\u9632\u5f97\u4f4f\u4e00\u90e8\u5206，\u800c\u6839\u5b50\u5728\u4eba\u7684\u884c\u4e3a\u4e0e\u6587\u5316\u3002<\/p>\n

\u00a0 \u00a0 \u8fd9\u79cd\u300c\u6587\u5316\u9632\u63a7\u300d\u7684\u601d\u8def，\u4e5f\u89e3\u91ca\u4e86\u4e3a\u4ec0\u4e48\u76d1\u7ba1\u90e8\u95e8\u8fd1\u5e74\u53cd\u590d\u5f3a\u8c03\u6570\u636e\u5b8c\u6574\u6027\u4e0d\u53ea\u662f IT \u6216\u5b9e\u9a8c\u5ba4\u7684\u4e8b，\u800c\u662f\u300c\u4f01\u4e1a\u6cbb\u7406\u4e0e\u8d28\u91cf\u6587\u5316\u300d\u7684\u4f53\u73b0\u3002\u5b83\u8981\u6c42\u4f01\u4e1a\u628a\u300c\u4e0d\u9020\u5047\u300d\u5f53\u6210\u4e00\u9879\u6cbb\u7406\u539f\u5219，\u800c\u4e0d\u53ea\u662f\u4e00\u5957\u9632\u4f5c\u5f0a\u5de5\u5177；\u4e00\u65e6\u88ab\u8ba4\u5b9a\u300c\u9020\u5047\u571f\u58e4\u5b58\u5728\u300d，\u76d1\u7ba1\u5f80\u5f80\u8981\u6c42\u4f01\u4e1a\u5bf9\u5168\u5382\u6570\u636e\u5f00\u5c55\u4e13\u9879\u6838\u67e5\u4e0e\u6574\u6539，\u6210\u672c\u8fdc\u9ad8\u4e8e\u65e5\u5e38\u5982\u5b9e\u8bb0\u5f55\u3002<\/p>\n

\u4e09\u3001\u6848\u4f8b：\u8bb0\u5f55\u9020\u5047，\u600e\u4e48\u628a\u4e00\u4e2a\u4f01\u4e1a\u62d6\u8fdb\u6df1\u6e0a<\/span><\/span><\/p>\n

3.1 \u5170\u4f2f\u897f（Ranbaxy）：\u4ece\u300c\u5168\u7403\u5de8\u5934\u300d\u5230\u300c\u6570\u636e\u5b8c\u6574\u6027\u8b66\u793a\u300d<\/p>\n

\u00a0 \u00a0 \u00a0 \u5370\u5ea6\u5170\u4f2f\u897f（Ranbaxy）\u662f\u6570\u636e\u5b8c\u6574\u6027\u5386\u53f2\u4e0a\u6700\u5178\u578b\u7684\u6848\u4f8b\u4e4b\u4e00\u30022011 \u5e74\u81f3 2013 \u5e74，\u7f8e\u56fd FDA \u5bf9\u5176\u5370\u5ea6\u5de5\u5382\u5148\u540e\u91c7\u53d6\u884c\u52a8，\u6700\u7ec8\u4e8e 2013 \u5e74\u53d1\u5e03\u6c38\u4e45\u6027\u7981\u4ee4（Consent Decree），\u6838\u5fc3\u6307\u63a7\u5c31\u5305\u62ec\u6570\u636e\u5b8c\u6574\u6027\u2014\u2014\u672a\u5982\u5b9e\u8bb0\u5f55\u3001\u7be1\u6539\u6570\u636e\u3001\u4f2a\u9020\u68c0\u6d4b\u7ed3\u679c\u7b49\u3002\u8fd9\u5bb6\u66fe\u4f4d\u5217\u5168\u7403\u4eff\u5236\u836f\u5de8\u5934\u7684\u4f01\u4e1a，\u56e0\u6570\u636e\u9020\u5047\u95ee\u9898\u4ed8\u51fa\u4e86\u5de8\u989d\u7f5a\u6b3e\u3001\u5de5\u5382\u505c\u4ea7\u6574\u6539\u3001\u4e0a\u5e02\u8bb8\u53ef\u53d7\u5f71\u54cd\u7b49\u4e00\u7cfb\u5217\u4ee3\u4ef7，\u5176\u5174\u8870\u88ab\u4e1a\u5185\u89c6\u4e3a\u300c\u6570\u636e\u5b8c\u6574\u6027\u4e4b\u6b87\u300d\u7684\u6559\u79d1\u4e66（\u636e FDA \u516c\u544a\u4e0e\u591a\u6e90\u62a5\u9053，\u4e8c\u7ea7\/\u786e\u8bc1）\u3002<\/p>\n

3.2 \u4e3a\u4ec0\u4e48\u300c\u8865\u8bb0\u300d\u6bd4\u300c\u51fa\u9519\u300d\u66f4\u5371\u9669<\/p>\n

\u00a0 \u00a0 \u00a0\u6bd4\u8d77\u9020\u5047\u88ab\u76f4\u63a5\u6293\u5230\u7684\u6781\u7aef\u6848\u4f8b，\u66f4\u666e\u904d\u4e5f\u66f4\u9690\u853d\u7684\u662f\u300c\u4e8b\u540e\u8865\u8bb0\u300d\u3002\u539f\u56e0\u5f88\u5e38\u89c1：\u68c0\u9a8c\u6ca1\u6309\u8ba1\u5212\u505a\u3001\u6279\u6b21\u653e\u884c\u4e86\u8bb0\u5f55\u8fd8\u6ca1\u5199\u5b8c\u3001\u64cd\u4f5c\u5458\u6015\u6328\u7f5a\u5c31\u81ea\u884c\u8865\u586b\u3002\u4f46\u300c\u8865\u8bb0\u300d\u5728\u76d1\u7ba1\u773c\u91cc\u5f80\u5f80\u5c31\u662f\u300c\u9020\u5047\u300d\u2014\u2014\u56e0\u4e3a\u5b83\u8fdd\u80cc\u4e86\u540c\u6b65\u3001\u539f\u59cb\u7684\u539f\u5219\u3002\u66f4\u81f4\u547d\u7684\u662f，\u8865\u8bb0\u4e00\u65e6\u88ab\u8bc6\u7834，\u76d1\u7ba1\u5c31\u4f1a\u63a8\u800c\u5e7f\u4e4b\u5730\u6000\u7591\u4f01\u4e1a\u6240\u6709\u8bb0\u5f55\u7684\u53ef\u4fe1\u5ea6，\u8fdb\u800c\u8981\u6c42\u5168\u9762\u6570\u636e\u6838\u67e5，\u4ee3\u4ef7\u8fdc\u8d85\u539f\u59cb\u504f\u5dee\u672c\u8eab\u3002\u300c\u8865\u4e00\u5f20\u8bb0\u5f55，\u53ef\u80fd\u6bd4\u51fa\u4e00\u6b21\u4e8b\u6545\u66f4\u81f4\u547d\u300d，\u8fd9\u53e5\u8bdd\u4e0d\u662f\u5371\u8a00\u8038\u542c\u3002<\/p>\n

3.3 \u6559\u8bad\u5f52\u7eb3：\u8bb0\u5f55\u9020\u5047\u7684\u4e09\u4e2a\u9012\u8fdb\u540e\u679c<\/p>\n

    \n
  • \u00a0\u5355\u4e2a\u4e8b\u4ef6\u88ab\u5750\u5b9e：\u4e00\u6b21\u8865\u8bb0\/\u7be1\u6539\u88ab\u8bc6\u7834，\u4f01\u4e1a\u5c31\u8981\u5bf9\u8be5\u8bb0\u5f55\u6d89\u53ca\u7684\u6279\u6b21\u91cd\u65b0\u8bc4\u4f30，\u751a\u81f3\u542f\u52a8\u4ea7\u54c1\u5904\u7f6e\u3002<\/li>\n
  • \u4fe1\u4efb\u88ab\u6574\u4f53\u4fb5\u8680：\u76d1\u7ba1\u4ece\u4e2a\u6848\u63a8\u65ad\u300c\u53ef\u80fd\u8fd8\u6709\u66f4\u591a\u300d，\u542f\u52a8\u5bf9\u5168\u5382\u8bb0\u5f55\u4e0e\u7cfb\u7edf\u7684\u6df1\u5ea6\u6570\u636e\u6838\u67e5\u3002<\/li>\n
  • \u51c6\u5165\u4e0e\u5546\u8a89\u53d7\u635f：\u8b66\u544a\u4fe1\u3001\u8fdb\u53e3\u8b66\u793a\u3001\u4e0a\u5e02\u8bb8\u53ef\u53d7\u5f71\u54cd，\u5ba2\u6237\u4e0e\u76d1\u7ba1\u7684\u4fe1\u4efb\u77ed\u671f\u96be\u4ee5\u91cd\u5efa\u3002<\/li>\n<\/ul>\n

    \u00a0 \u00a0 \u00a0\u6240\u4ee5\u8bb0\u5f55\u771f\u5b9e\u7684\u4ee3\u4ef7\u66f2\u7ebf\u662f\u300c\u975e\u7ebf\u6027\u300d\u7684：\u7b2c\u4e00\u6b21\u88ab\u53d1\u73b0\u5f80\u5f80\u5c31\u5e26\u6765\u8fdc\u8d85\u539f\u59cb\u95ee\u9898\u7684\u8fde\u9501\u53cd\u5e94\u3002\u8fd9\u4e5f\u662f\u4e3a\u4ec0\u4e48\u300c\u5b81\u53ef\u5982\u5b9e\u62a5\u9519\u3001\u4e5f\u4e0d\u53ef\u8865\u8bb0\u300d\u5e94\u8be5\u6210\u4e3a\u5168\u5458\u7684\u94c1\u5f8b\u3002<\/p>\n

    \u56db\u3001\u7eb8\u8d28\u8bb0\u5f55\u7684\u4e94\u5927\u5931\u4fe1\u5f62\u6001（\u57f9\u8bad\u4e0e\u5ba1\u6838\u90fd\u8981\u76ef）<\/span><\/span><\/p>\n

      \n
    • \u4e8b\u540e\u8a8a\u6284：\u6279\u8bb0\u5f55\u3001\u68c0\u9a8c\u8bb0\u5f55\u4e0d\u662f\u73b0\u573a\u540c\u6b65\u586b\u5199，\u800c\u662f\u4e8b\u540e\u8865\u6284，\u7f3a\u5931\u300c\u539f\u59cb\u300d\u300c\u540c\u6b65\u300d\u3002<\/li>\n
    • \u94c5\u7b14\u5148\u884c\/\u6539\u7b14\u4e0d\u8bb0\u5f55：\u64cd\u4f5c\u5148\u7528\u94c5\u7b14\u3001\u540e\u9762\u518d\u8a8a，\u6216\u4fee\u6539\u6570\u636e\u4e0d\u6807\u6ce8\u65e5\u671f\/\u539f\u56e0\/\u7b7e\u540d\u3002<\/li>\n
    • \u5220\u6539\u65e0\u75d5：\u7528\u6d82\u6539\u6db2\u3001\u8d34\u7eb8\u3001\u5212\u6389\u4e0d\u7b7e\u540d，\u62b9\u6389\u4fee\u6539\u75d5\u8ff9，\u5931\u53bb\u300c\u51c6\u786e\u300d\u4e0e\u300c\u53ef\u8ffd\u6eaf\u300d\u3002<\/li>\n
    • \u4ee3\u7b7e\/\u5171\u4eab\u8d26\u53f7：\u64cd\u4f5c\u4eba\u4e0e\u8bb0\u5f55\u7b7e\u540d\u4e0d\u7b26，\u6216\u591a\u4eba\u5171\u7528\u4e00\u4e2a\u8d26\u53f7，\u65e0\u6cd5\u8ffd\u6eaf\u5230\u771f\u5b9e\u6267\u884c\u8005\u3002<\/li>\n
    • \u8bb0\u5f55\u4e0e\u4e8b\u4ef6\u8131\u8282：\u65f6\u95f4\u7ebf\u6df7\u4e71\u3001\u6279\u53f7\/\u65e5\u671f\/\u8bbe\u5907\u5bf9\u4e0d\u4e0a，\u903b\u8f91\u4e0d\u81ea\u6d3d，\u66b4\u9732\u300c\u62fc\u51d1\u300d\u3002<\/li>\n<\/ul>\n

      \u00a0 \u00a0 \u00a0\u8fd9\u4e94\u7c7b\u5f62\u6001，\u662f\u68c0\u67e5\u5458\u4e0e\u5185\u5ba1\u5728\u7eb8\u8d28\u8bb0\u5f55\u4e0a\u6700\u5e38\u6293\u7684\u70b9\u3002\u5b83\u4eec\u5728 21 CFR Part 11 \u4e0e PI 041-1 \u7684\u6846\u67b6\u4e0b\u90fd\u5c5e\u4e8e\u6570\u636e\u5b8c\u6574\u6027\u7f3a\u9677，\u800c\u4e00\u65e6\u5b9a\u6027，\u5f80\u5f80\u8fde\u5e26\u6574\u5382\u8bb0\u5f55\u88ab\u8981\u6c42\u5168\u9762\u6838\u67e5\u3002<\/p>\n

      \u5bf9\u4f01\u4e1a\u800c\u8a00，\u4e0e\u5176\u7b49\u88ab\u67e5\u51fa\u6765\u518d\u5168\u9762\u6838\u67e5，\u4e0d\u5982\u4e3b\u52a8\u628a\u300c\u4e94\u5927\u5931\u4fe1\u5f62\u6001\u300d\u4f5c\u4e3a\u5185\u5ba1\u6e05\u5355，\u5b9a\u671f\u5bf9\u8f66\u95f4\u4e0e\u5b9e\u9a8c\u5ba4\u7684\u7eb8\u8d28\u8bb0\u5f55\u505a\u62bd\u6837\u4f53\u68c0\u2014\u2014\u4e3b\u52a8\u53d1\u73b0\u5e76\u6574\u6539，\u8fdc\u6bd4\u88ab\u52a8\u66b4\u9732\u6765\u5f97\u4e3b\u52a8\u3002<\/p>\n

      \u4e94\u3001\u5b88\u4f4f\u300c\u8bb0\u5f55\u5373\u771f\u5b9e\u300d：\u9760\u5236\u5ea6，\u66f4\u9760\u6587\u5316<\/span><\/span><\/p>\n

      \u8bb0\u5f55\u771f\u5b9e\u662f\u300c\u6280\u672f+\u5236\u5ea6+\u6587\u5316\u300d\u7684\u4e09\u5c42\u9632\u7ebf，\u7f3a\u4e00\u5c42，\u524d\u4e00\u5c42\u90fd\u53ef\u80fd\u88ab\u7ed5\u8fc7\u3002<\/p>\n

        \n
      • \u6280\u672f\u5c42：\u7eb8\u8d28\u8bb0\u5f55\u53d7\u63a7\u53d1\u653e\u3001\u7f16\u53f7\u7ba1\u7406\u3001\u540c\u6b65\u586b\u5199\u3001\u4fee\u6539\u7559\u75d5；\u7535\u5b50\u8bb0\u5f55\u5f00\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u6743\u9650\u5206\u7ea7\u3001\u65f6\u95f4\u6233\u771f\u5b9e\u3002<\/li>\n
      • \u5236\u5ea6\u5c42：\u660e\u786e\u300c\u8c01\u64cd\u4f5c\u8c01\u8bb0\u5f55\u3001\u8bb0\u5f55\u5fc5\u987b\u540c\u6b65\u3001\u4fee\u6539\u5fc5\u987b\u6709\u636e\u53ef\u67e5\u3001\u8865\u8bb0\u5373\u8fdd\u7eaa\u300d\u7684\u89c4\u5219，\u5e76\u8bbe\u60e9\u6212\u4e0e\u95ee\u8d23\u3002<\/li>\n
      • \u6587\u5316\u5c42：\u8ba9\u300c\u5982\u5b9e\u4e0a\u62a5\u4e0d\u8ffd\u8d23\u3001\u7792\u62a5\u9020\u5047\u5fc5\u91cd\u7f5a\u300d\u6210\u4e3a\u7ec4\u7ec7\u5171\u8bc6\u2014\u2014\u5458\u5de5\u4e0d\u6562\u9020\u5047\u3001\u4e0d\u5fc5\u9020\u5047\u3001\u4e0d\u613f\u9020\u5047\u3002<\/li>\n<\/ul>\n

        \u00a0 \u00a0 \u00a0 \u00a0 \u4e09\u5c42\u91cc\u6700\u96be\u4e5f\u6700\u5173\u952e\u7684\u662f\u6587\u5316\u3002\u4e00\u4e2a\u300c\u6015\u62c5\u8d23\u300d\u7684\u7ec4\u7ec7，\u4f1a\u4e0d\u81ea\u89c9\u5730\u7528\u8865\u8bb0\u6765\u300c\u4fdd\u5e73\u5b89\u300d；\u4e00\u4e2a\u300c\u5bb9\u9519\u300d\u7684\u7ec4\u7ec7，\u5219\u5141\u8bb8\u95ee\u9898\u66b4\u9732\u5e76\u5728\u521d\u59cb\u9636\u6bb5\u5c31\u88ab\u7ea0\u504f\u3002\u76d1\u7ba1\u8fd1\u5e74\u53cd\u590d\u5f3a\u8c03\u6570\u636e\u5b8c\u6574\u6027\u80cc\u540e\u7684\u300c\u8d28\u91cf\u6587\u5316\u300d，\u6b63\u662f\u8fd9\u4e2a\u9053\u7406\u3002<\/p>\n

        \u00a0 \u00a0 \u00a0 \u8fd9\u91cc\u8981\u6f84\u6e05\u4e00\u4e2a\u5e38\u89c1\u7684\u7406\u89e3\u504f\u5dee：\u300c\u5bb9\u9519\u300d\u4e0d\u7b49\u4e8e\u300c\u653e\u4efb\u300d\u3002\u5bb9\u9519\u6307\u7684\u662f\u300c\u5982\u5b9e\u4e0a\u62a5\u7684\u95ee\u9898\u4e0d\u56e0\u4e0a\u62a5\u672c\u8eab\u88ab\u8ffd\u8d23\u300d，\u800c\u4e0d\u662f\u300c\u51fa\u9519\u4e0d\u7ea0\u6b63\u3001\u9020\u5047\u4e0d\u5904\u7f5a\u300d\u3002\u6b63\u786e\u7684\u5bfc\u5411\u662f\u2014\u2014\u9519\u8bef\u53ef\u4ee5\u88ab\u66b4\u9732\u548c\u7ea0\u6b63，\u4f46\u9020\u5047\u4e0e\u9690\u7792\u5fc5\u987b\u4ed8\u51fa\u4ee3\u4ef7\u3002\u628a\u8fd9\u4e24\u8005\u7684\u8fb9\u754c\u5212\u6e05\u695a，\u5458\u5de5\u624d\u65e2\u6562\u8bf4\u5b9e\u8bdd，\u53c8\u4e0d\u6562\u9020\u5047\u3002<\/p>\n

        \u00a0 \u00a0 \u00a0\u843d\u5230\u505a\u6cd5\u4e0a，\u5efa\u8bae\u628a\u300c\u6570\u636e\u5b8c\u6574\u6027\u300d\u5199\u8fdb\u65b0\u5458\u5de5\u5165\u804c\u57f9\u8bad\u3001\u7eb3\u5165\u5e74\u5ea6\u518d\u57f9\u8bad，\u5e76\u5b9a\u671f\u7528\u771f\u5b9e\u6848\u4f8b\u505a\u8b66\u793a\u6559\u80b2\u2014\u2014\u8ba9\u6bcf\u4e2a\u5458\u5de5\u90fd\u628a\u300c\u8bb0\u5f55\u5373\u771f\u5b9e\u300d\u5185\u5316\u6210\u804c\u4e1a\u672c\u80fd，\u800c\u4e0d\u662f\u4e00\u6761\u4f1a\u88ab\u9057\u5fd8\u7684\u6761\u89c4\u3002\u6587\u5316\u4e0d\u662f\u9760\u4e00\u7eb8\u6587\u4ef6\u5efa\u7acb\u7684，\u662f\u9760\u65e5\u590d\u4e00\u65e5\u7684\u793a\u8303\u3001\u5956\u60e9\u4e0e\u6848\u4f8b\u91cd\u590d\u8bad\u7ec3\u6c89\u6dc0\u51fa\u6765\u7684\u3002<\/p>\n

        \u516d\u3001\u628a\u300c\u8bb0\u5f55\u5373\u771f\u5b9e\u300d\u505a\u6210\u786c\u5236\u5ea6\u7684\u516d\u6b65<\/span><\/span><\/p>\n

          \n
        • \u7b2c\u4e00\u6b65\u00b7\u8bb0\u5f55\u53d7\u63a7：\u6279\u8bb0\u5f55\u3001\u68c0\u9a8c\u8bb0\u5f55\u3001\u8bbe\u5907\u65e5\u5fd7\u7edf\u4e00\u53d7\u63a7\u53d1\u653e\u3001\u7f16\u53f7\u3001\u56de\u6536，\u675c\u7edd\u6563\u9875\u81ea\u7531\u586b\u5199\u3002<\/li>\n
        • \u7b2c\u4e8c\u6b65\u00b7\u540c\u6b65\u586b\u5199：\u660e\u786e\u5404\u73af\u8282\u300c\u73b0\u573a\u3001\u5373\u65f6\u3001\u5982\u5b9e\u300d\u586b\u5199\u7684\u8981\u6c42，\u628a\u540c\u6b65\u8bb0\u5f55\u5199\u8fdb SOP \u4e0e\u57f9\u8bad\u3002<\/li>\n
        • \u7b2c\u4e09\u6b65\u00b7\u4fee\u6539\u7559\u75d5：\u5efa\u7acb\u7edf\u4e00\u7684\u300c\u5212\u6539\u2014\u7b7e\u540d\u2014\u65e5\u671f\u2014\u539f\u56e0\u300d\u89c4\u8303，\u7981\u6b62\u6d82\u6539\u4e0d\u6807\u6ce8\u3002<\/li>\n
        • \u7b2c\u56db\u6b65\u00b7\u7535\u5b50\u5316\u8865\u5f3a：\u9010\u6b65\u5f15\u5165\u6709\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u7cfb\u7edf（\u5982 LIMS\u3001MES\u3001\u7535\u5b50\u6279\u8bb0\u5f55），\u7528\u6280\u672f\u51cf\u5c11\u4f5c\u5f0a\u7a7a\u95f4\u3002<\/li>\n
        • \u7b2c\u4e94\u6b65\u00b7\u95ee\u8d23\u5206\u660e：\u628a\u300c\u8865\u8bb0\/\u7be1\u6539\u300d\u4e0e\u300c\u5982\u5b9e\u4e0a\u62a5\u300d\u7684\u5956\u60e9\u5199\u8fdb\u5236\u5ea6，\u8ba9\u5b88\u771f\u8005\u53d7\u76ca\u3001\u9020\u5047\u8005\u5fc5\u7136\u4ed8\u51fa\u4ee3\u4ef7\u3002<\/li>\n
        • \u7b2c\u516d\u6b65\u00b7\u6587\u5316\u517b\u6210：\u7ba1\u7406\u5c42\u5e26\u5934\u9075\u5b88，\u5b9a\u671f\u5f00\u5c55\u6570\u636e\u5b8c\u6574\u6027\u57f9\u8bad\u4e0e\u6848\u4f8b\u8b66\u793a\u6559\u80b2，\u628a\u300c\u4e0d\u9020\u5047\u300d\u53d8\u6210\u4f01\u4e1a\u6587\u5316\u7684\u4e00\u90e8\u5206\u3002<\/li>\n<\/ul>\n

          \u516d\u6b65\u91cc，\u524d\u56db\u6b65\u662f\u300c\u9632\u300d，\u540e\u4e24\u6b65\u662f\u300c\u60e9\u4e0e\u80b2\u300d\u3002\u53ea\u6709\u9632\u6ca1\u6709\u60e9，\u5236\u5ea6\u5f62\u540c\u865a\u8bbe；\u53ea\u6709\u60e9\u6ca1\u6709\u80b2，\u9020\u5047\u53ea\u4f1a\u66f4\u9690\u853d\u3002<\/p>\n

          6.1 \u68c0\u67e5\u5458\u5982\u4f55\u8bc6\u522b\u9020\u5047<\/span><\/span><\/h2>\n
            \n
          • \u6bd4\u5bf9\u5b57\u8ff9\u4e0e\u58a8\u8ff9：\u540c\u4e00\u4efd\u8bb0\u5f55\u7684\u7b14\u8ff9\u662f\u5426\u524d\u540e\u4e00\u81f4\u3001\u662f\u5426\u4e3a\u540c\u4e00\u4eba\u5f53\u573a\u6240\u5199，\u58a8\u8272\u6df1\u5ea6\u662f\u5426\u7edf\u4e00\u3002<\/li>\n
          • \u6838\u5bf9\u65f6\u95f4\u7ebf：\u6279\u53f7\u3001\u65e5\u671f\u3001\u8bbe\u5907\u72b6\u6001\u3001\u68c0\u9a8c\u65f6\u957f\u662f\u5426\u81ea\u6d3d，\u662f\u5426\u5b58\u5728\u300c\u767d\u5929\u5b8c\u6210\u3001\u6df1\u591c\u7b7e\u5b57\u300d\u7b49\u903b\u8f91\u6f0f\u6d1e\u3002<\/li>\n
          • \u62bd\u67e5\u7535\u5b50\u65e5\u5fd7：\u7cfb\u7edf\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u767b\u5f55\u8bb0\u5f55\u3001\u6587\u4ef6\u4fee\u6539\u65f6\u95f4\u4e0e\u6279\u8bb0\u5f55\u662f\u5426\u5bf9\u5f97\u4e0a\u3002<\/li>\n
          • \u73b0\u573a\u95ee\u8be2\u64cd\u4f5c：\u8981\u6c42\u64cd\u4f5c\u5458\u590d\u8ff0\u8bb0\u5f55\u5185\u5bb9\u4e0e\u586b\u5199\u8fc7\u7a0b，\u89c2\u5bdf\u4e0e\u8bb0\u5f55\u7684\u662f\u5426\u4e00\u81f4\u3002<\/li>\n
          • \u8ffd\u67e5\u5f02\u5e38\u6279\u6b21：\u5bf9\u4e34\u754c\u68c0\u9a8c\u6570\u636e\u3001\u5f02\u5e38\u504f\u4f4e\/\u504f\u5dee\u6279\u6b21，\u5012\u67e5\u5176\u8bb0\u5f55\u4e0e\u5904\u7f6e\u662f\u5426\u771f\u5b9e\u5b8c\u6574\u3002<\/li>\n<\/ul>\n

            \u8bfb\u61c2\u68c0\u67e5\u5458\u300c\u600e\u4e48\u67e5\u300d，\u4f01\u4e1a\u624d\u77e5\u9053\u300c\u600e\u4e48\u9632\u300d\u3002\u53cd\u8fc7\u6765，\u4f01\u4e1a\u5185\u5ba1\u4e5f\u53ef\u4ee5\u501f\u7528\u540c\u4e00\u5957\u65b9\u6cd5\u505a\u81ea\u6211\u4f53\u68c0\u3002<\/p>\n

            6.2 \u7ba1\u7406\u8005\u7684\u7684\u4e09\u70b9\u8ba4\u77e5<\/span><\/span><\/h2>\n
              \n
            • \u8bb0\u5f55\u771f\u5b9e\u7684\u654c\u4eba\u662f\u300c\u6015\u62c5\u8d23\u300d\u7684\u6587\u5316\u3002\u60f3\u8ba9\u5458\u5de5\u5982\u5b9e\u8bb0\u5f55，\u5148\u7ed9\u300c\u5982\u5b9e\u4e0a\u62a5\u4e0d\u8ffd\u8d23\u300d\u5403\u5b9a\u5fc3\u4e38\u3002<\/li>\n
            • \u6280\u672f\u4e0d\u662f\u4e07\u80fd，\u4f46\u6ca1\u6709\u6280\u672f\u652f\u6491\u7684\u300c\u9760\u81ea\u89c9\u300d\u66f4\u5371\u9669\u3002\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u53d7\u63a7\u53d1\u653e\u3001\u6743\u9650\u5206\u7ea7\u662f\u515c\u5e95\u3002<\/li>\n
            • \u7ba1\u7406\u5c42\u7684\u6bcf\u4e00\u6b21\u300c\u59a5\u534f\u653e\u884c\u300d，\u90fd\u662f\u5728\u7ed9\u9020\u5047\u6587\u5316\u6d47\u6c34\u3002\u7ba1\u7406\u8005\u5148\u5b88\u5e95\u7ebf，\u5458\u5de5\u624d\u6709\u52c7\u6c14\u5b88\u771f\u76f8\u3002<\/li>\n<\/ul>\n

              \u4e03\u3001\u8bb0\u5f55\u771f\u5b9e\u00b710 \u95ee\u81ea\u68c0\u6e05\u5355<\/span><\/span><\/p>\n

              \u2460 \u6279\u8bb0\u5f55\/\u68c0\u9a8c\u8bb0\u5f55\u662f\u5426\u53d7\u63a7\u53d1\u653e\u3001\u7f16\u53f7\u3001\u56de\u6536，\u675c\u7edd\u6563\u9875\u81ea\u7531\u586b\u5199？<\/p>\n

              \u2461 \u5404\u73af\u8282\u662f\u5426\u505a\u5230\u300c\u73b0\u573a\u3001\u5373\u65f6\u3001\u5982\u5b9e\u300d\u586b\u5199？<\/p>\n

              \u2462 \u6570\u636e\u4fee\u6539\u662f\u5426\u7edf\u4e00\u300c\u5212\u6539\u2014\u7b7e\u540d\u2014\u65e5\u671f\u2014\u539f\u56e0\u300d，\u65e0\u6d82\u6539\u3001\u65e0\u5220\u6539\u65e0\u75d5？<\/p>\n

              \u2463 \u662f\u5426\u675c\u7edd\u94c5\u7b14\u5148\u884c\u3001\u4e8b\u540e\u8a8a\u6284？<\/p>\n

              \u2464 \u662f\u5426\u675c\u7edd\u4ee3\u7b7e\u3001\u5171\u4eab\u8d26\u53f7，\u64cd\u4f5c\u4e0e\u7b7e\u540d\u5bf9\u5e94\u771f\u5b9e\u6267\u884c\u8005？<\/p>\n

              \u2465 \u7535\u5b50\u7cfb\u7edf\u662f\u5426\u5f00\u542f\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u6743\u9650\u5206\u7ea7\u3001\u65f6\u95f4\u6233\u771f\u5b9e？<\/p>\n

              \u2466 \u65f6\u95f4\u7ebf\/\u6279\u53f7\/\u8bbe\u5907\u662f\u5426\u903b\u8f91\u81ea\u6d3d，\u65e0\u62fc\u51d1\u8ff9\u8c61？<\/p>\n

              \u2467 \u662f\u5426\u660e\u786e\u300c\u8865\u8bb0\/\u7be1\u6539\u2192\u60e9\u6212\u3001\u5982\u5b9e\u4e0a\u62a5\u2192\u4e0d\u8ffd\u8d23\u300d\u7684\u5956\u60e9\u5236\u5ea6？<\/p>\n

              \u2468 \u662f\u5426\u5f00\u5c55\u6570\u636e\u5b8c\u6574\u6027\u57f9\u8bad\u4e0e\u6848\u4f8b\u8b66\u793a\u6559\u80b2？<\/p>\n

              \u2469 \u7ba1\u7406\u5c42\u662f\u5426\u5e26\u5934\u9075\u5b88，\u5e76\u63a5\u53d7\u540c\u6837\u7684\u76d1\u7763？<\/p>\n

              \u00a0 \u00a0 \u00a0\u5341\u4e2a\u95ee\u9898\u91cc，\u53ea\u8981\u6709\u4e00\u4e2a\u56de\u7b54\u4e0d\u4e0a\u6765，\u5c31\u8bf4\u660e\u8bb0\u5f55\u771f\u5b9e\u6027\u8fd8\u6709\u88ab\u8d28\u7591\u7684\u7a7a\u95f4\u3002\u5efa\u8bae\u4ee5\u300c\u5047\u8bbe\u68c0\u67e5\u5458\u4f1a\u67e5\u6211\u7684\u6bcf\u4e00\u5f20\u8bb0\u5f55\u300d\u7684\u5fc3\u6001，\u5148\u81ea\u67e5\u4e00\u904d\u3002<\/p>\n

              \u516b\u3001\u4e24\u4e2a\u5e38\u88ab\u95ee\u7684\u95ee\u9898<\/span><\/span><\/p>\n

              8.1 \u51c6\u5907\u51fa\u6d77\u4f46\u5386\u53f2\u4e0a\u6709\u4e9b\u8bb0\u5f55\u4e0d\u5b8c\u5584，\u600e\u4e48\u529e？<\/h3>\n

              \u4e0d\u8981\u8bd5\u56fe\u300c\u53bb\u8865\u4e00\u5f20\u66f4\u65e9\u7684\u5b8c\u6574\u8bb0\u5f55\u300d\u2014\u2014\u90a3\u6b63\u662f\u8865\u8bb0，\u53cd\u800c\u5750\u5b9e\u9020\u5047\u3002\u6b63\u786e\u505a\u6cd5\u662f：\u5982\u5b9e\u8bc4\u4f30\u73b0\u6709\u8bb0\u5f55\u7684\u5b8c\u6574\u6027，\u8bc6\u522b\u5dee\u8ddd，\u628a\u4e0d\u5b8c\u5584\u7684\u8bb0\u5f55\u6309\u300c\u6570\u636e\u5b8c\u6574\u6027\u7f3a\u9677\u300d\u8d70\u504f\u5dee\u4e0e CAPA \u6d41\u7a0b\u2014\u2014\u8865\u7684\u662f\u300c\u7ea0\u6b63\u63aa\u65bd\u300d，\u800c\u4e0d\u662f\u8865\u300c\u8fc7\u53bb\u7684\u8bb0\u5f55\u300d\u3002\u76d1\u7ba1\u8ba4\u53ef\u7684\u662f\u300c\u73b0\u5728\u7684\u8bda\u5b9e\u300d，\u800c\u4e0d\u662f\u300c\u8fc7\u53bb\u7684\u7f8e\u5316\u300d\u3002<\/p>\n

              8.2 \u73b0\u573a\u786e\u5b9e\u6ca1\u8bb0\u3001\u4e8b\u540e\u8865\u4e00\u5f20，\u548c\u9020\u5047\u6709\u533a\u522b\u5417？<\/h3>\n

              \u5728\u76d1\u7ba1\u773c\u4e2d\u6ca1\u6709\u672c\u8d28\u533a\u522b，\u90fd\u8fdd\u80cc\u540c\u6b65\u4e0e\u539f\u59cb\u3002\u5982\u679c\u786e\u5b9e\u56e0\u5ba2\u89c2\u539f\u56e0\u672a\u80fd\u5373\u65f6\u8bb0\u5f55，\u5e94\u6309\u7a0b\u5e8f\u5982\u5b9e\u62a5\u544a\u3001\u8bf4\u660e\u539f\u56e0\u3001\u8d70\u504f\u5dee\u8bc4\u4f30，\u800c\u4e0d\u662f\u81ea\u884c\u8865\u586b\u3002\u8bda\u5b9e\u627f\u8ba4\u300c\u8fd9\u6761\u6ca1\u8bb0\u300d，\u8fdc\u6bd4\u300c\u8865\u6210\u8bb0\u4e86\u300d\u5b89\u5168\u3002\u8bb0\u4f4f：\u76d1\u7ba1\u6700\u6015\u7684\u4e0d\u662f\u300c\u6709\u8bb0\u5f55\u7f3a\u9677\u300d，\u800c\u662f\u300c\u88ab\u6b3a\u9a97\u300d\u3002<\/p>\n

              \u4e5d\u3001\u516d\u4e2a\u8bef\u533a<\/span><\/span><\/p>\n

                \n
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