{"id":160,"date":"2026-08-04T13:39:58","date_gmt":"2026-08-04T05:39:58","guid":{"rendered":"https:\/\/www.renewyou.cn\/?p=160"},"modified":"2026-08-04T13:39:59","modified_gmt":"2026-08-04T05:39:59","slug":"%e5%86%85%e9%83%a8%e5%ae%a1%e6%a0%b8%e4%b8%8e%e8%b4%a8%e9%87%8f%e7%ae%a1%e7%90%86%e4%bd%93%e7%b3%bb%e8%87%aa%e6%9f%a5%e7%a8%8b%e5%ba%8f","status":"publish","type":"post","link":"https:\/\/www.renewyou.cn\/?p=160","title":{"rendered":"\u5185\u90e8\u5ba1\u6838\u4e0e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u7a0b\u5e8f"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u53d7\u63a7\u6587\u4ef6&nbsp; \u672a\u7ecf\u6279\u51c6\u4e0d\u5f97\u590d\u5236\u6216\u64c5\u81ea\u4fee\u6539<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u82ae\u599e\u4f18\uff08\u4e0a\u6d77\uff09\u533b\u7597\u79d1\u6280\u6709\u9650\u516c\u53f8<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u53d7\u63a7\u6587\u4ef6<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>QP-0400<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5185\u90e8\u5ba1\u6838\u4e0e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u7a0b\u5e8f<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u6587\u4ef6\u7f16\u53f7<\/strong><\/td><td>QP-0400<\/td><td><strong>\u7248\u672c\/\u7248\u6b21<\/strong><\/td><td>A0<\/td><\/tr><tr><td><strong>\u6587\u4ef6\u5c5e\u6027<\/strong><\/td><td>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7a0b\u5e8f\u6587\u4ef6<\/td><td><strong>\u53d7\u63a7\u72b6\u6001<\/strong><\/td><td>\u53d7\u63a7<\/td><\/tr><tr><td><strong>\u66ff\u4ee3\u6587\u4ef6<\/strong><\/td><td>\u65b0\u5236\u5b9a<\/td><td><strong>\u5206\u53d1\u8303\u56f4<\/strong><\/td><td>\u6309\u53d7\u63a7\u6587\u4ef6\u6e05\u5355<\/td><\/tr><tr><td><strong>\u7f16\u5236<\/strong><\/td><td>________________<\/td><td><strong>\u65e5\u671f<\/strong><\/td><td>____\u5e74__\u6708__\u65e5<\/td><\/tr><tr><td><strong>\u5ba1\u6838\uff08\u8d28\u91cf\u8d1f\u8d23\u4eba\uff09<\/strong><\/td><td>________________<\/td><td><strong>\u65e5\u671f<\/strong><\/td><td>____\u5e74__\u6708__\u65e5<\/td><\/tr><tr><td><strong>\u6279\u51c6\uff08\u7ba1\u7406\u8005\u4ee3\u8868\uff09<\/strong><\/td><td>________________<\/td><td><strong>\u751f\u6548\u65e5\u671f<\/strong><\/td><td>____\u5e74__\u6708__\u65e5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u63a7\u5236\u58f0\u660e<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>\u672c\u6587\u4ef6\u7684\u6709\u6548\u7248\u672c\u4ee5\u53d7\u63a7\u6587\u4ef6\u6e05\u5355\u6216\u7ecf\u6388\u6743\u7684\u7535\u5b50\u6587\u4ef6\u5e93\u4e3a\u51c6\u3002\u6253\u5370\u4ef6\u672a\u52a0\u53d7\u63a7\u6807\u8bc6\u65f6\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u5f97\u7528\u4e8e\u751f\u4ea7\u3001\u68c0\u9a8c\u6216\u4ea7\u54c1\u653e\u884c\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6587\u4ef6\u4fee\u8ba2\u8bb0\u5f55<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u5e8f\u53f7<\/strong><\/td><td><strong>\u7248\u672c<\/strong><\/td><td><strong>\u751f\u6548\u65e5\u671f<\/strong><\/td><td><strong>\u4fee\u8ba2\u5185\u5bb9<\/strong><\/td><td><strong>\u7f16\u5236<\/strong><\/td><td><strong>\u6279\u51c6<\/strong><\/td><\/tr><\/thead><tbody><tr><td>1<\/td><td>A0<\/td><td>____\u5e74__\u6708__\u65e5<\/td><td>\u9996\u6b21\u5236\u5b9a\u3002\u5efa\u7acb\u9002\u7528\u4e8e\u5c0f\u578b\u65e0\u83cc\u533b\u7597\u5668\u68b0\u751f\u4ea7\u4f01\u4e1a\u7684\u5185\u90e8\u5ba1\u6838\u4e0e\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u4e00\u4f53\u5316\u3001\u98ce\u9669\u5bfc\u5411\u548c\u5355\u8868\u95ed\u73af\u63a7\u5236\u3002<\/td><td>\u2014<\/td><td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6587\u4ef6\u4f7f\u7528\u8bf4\u660e<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u6cd5\u89c4\u72b6\u6001\u63d0\u793a\uff1a<\/strong>\u56fd\u5bb6\u836f\u76d1\u5c402025\u5e74\u7b2c107\u53f7\u516c\u544a\u53d1\u5e03\u7684\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u81ea2026\u5e7411\u67081\u65e5\u8d77\u65bd\u884c\u3002\u672c\u7a0b\u5e8f\u6309\u5176\u76ee\u6807\u8981\u6c42\u7f16\u5236\uff1b\u5728\u65bd\u884c\u524d\u4f7f\u7528\u65f6\uff0c\u540c\u65f6\u6ee1\u8db3\u5c4a\u65f6\u73b0\u884c\u6709\u6548\u7684\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\u3001\u65e0\u83cc\u533b\u7597\u5668\u68b0\u9644\u5f55\u53ca\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u76d1\u7763\u7ba1\u7406\u529e\u6cd5\u300b\u7b49\u8981\u6c42\u3002\u51fa\u73b0\u5dee\u5f02\u65f6\uff0c\u7531\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u7ec4\u7ec7\u8bc4\u4f30\uff0c\u5e76\u6309\u5c4a\u65f6\u6709\u6548\u6cd5\u89c4\u548c\u7ecf\u6279\u51c6\u7684\u8f83\u4e25\u683c\u5185\u90e8\u8981\u6c42\u6267\u884c\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u7a0b\u5e8f\u5c06GB\/T 42061-2022\u89c4\u5b9a\u7684\u5185\u90e8\u5ba1\u6838\u4e0e\u6cd5\u89c4\u8981\u6c42\u7684\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u7edf\u7b79\u7ba1\u7406\u3002\u5bf9\u4e8e\u7ea620\u4eba\u7684\u7ec4\u7ec7\uff0c\u53ef\u5728\u540c\u4e00\u6b21\u5e74\u5ea6\u6d3b\u52a8\u4e2d\u5b8c\u6210\uff0c\u4f46\u5ba1\u6838\u8303\u56f4\u3001\u72ec\u7acb\u6027\u3001\u8bc1\u636e\u3001\u62a5\u544a\u548c\u5e74\u5ea6\u81ea\u67e5\u62a5\u9001\u8981\u6c42\u5747\u987b\u6ee1\u8db3\uff0c\u4e0d\u5f97\u4ee5\u201c\u5408\u5e76\u201d\u4e3a\u7531\u51cf\u5c11\u5ba1\u6838\u6df1\u5ea6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5e74\u5ea6\u5ba1\u6838\u539f\u5219\u4e0a\u8986\u76d6\u5168\u90e8\u9002\u7528\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8fc7\u7a0b\u3001\u751f\u4ea7\u573a\u6240\u548c\u65e0\u83cc\u4fdd\u8bc1\u76f8\u5173\u63a7\u5236\uff1b\u9ad8\u98ce\u9669\u8fc7\u7a0b\u6839\u636e\u98ce\u9669\u4fe1\u53f7\u589e\u52a0\u4e13\u9879\u5ba1\u6838\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u4eba\u5458\u4e0d\u5f97\u5ba1\u6838\u672c\u4eba\u76f4\u63a5\u8d1f\u8d23\u6216\u5b9e\u65bd\u7684\u5de5\u4f5c\u3002\u4eba\u5458\u6709\u9650\u65f6\uff0c\u53ef\u91c7\u7528\u4ea4\u53c9\u5ba1\u6838\u3001\u7ba1\u7406\u8005\u4ee3\u8868\u6307\u5b9a\u72ec\u7acb\u590d\u6838\u4eba\u6216\u8058\u7528\u5408\u683c\u5916\u90e8\u5ba1\u6838\u5458\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u4e00\u9879\u4e0d\u7b26\u5408\u539f\u5219\u4e0a\u4f7f\u7528\u4e00\u5f20\u300a\u5ba1\u6838\u68c0\u67e5\u8bb0\u5f55\u53ca\u4e0d\u7b26\u5408\u9879\u95ed\u73af\u5355\u300b\u5b8c\u6210\u8bc1\u636e\u8bb0\u5f55\u3001\u98ce\u9669\u8bc4\u4ef7\u3001\u7ea0\u6b63\/CAPA\u3001\u6709\u6548\u6027\u9a8c\u8bc1\u548c\u5173\u95ed\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u5bf9\u5ba1\u6838\u7ed3\u8bba\u3001\u98ce\u9669\u7b49\u7ea7\u3001\u6574\u6539\u8bc1\u636e\u548c\u5173\u95ed\u7ed3\u8bba\u62e5\u6709\u72ec\u7acb\u5ba1\u6838\u53ca\u5426\u51b3\u6743\uff1b\u5b58\u5728\u4ea7\u54c1\u98ce\u9669\u65f6\u6709\u6743\u8981\u6c42\u6682\u505c\u76f8\u5173\u6d3b\u52a8\u3001\u9694\u79bb\u4ea7\u54c1\u6216\u6682\u505c\u653e\u884c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1&nbsp; \u76ee\u7684<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5efa\u7acb\u72ec\u7acb\u3001\u5ba2\u89c2\u3001\u98ce\u9669\u5bfc\u5411\u4e14\u9002\u5408\u672c\u4f01\u4e1a\u89c4\u6a21\u7684\u5185\u90e8\u5ba1\u6838\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u65b9\u6cd5\uff0c\u8bc4\u4ef7\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5bf9\u9002\u7528\u6cd5\u89c4\u3001\u6807\u51c6\u3001\u6ce8\u518c\/\u5907\u6848\u8981\u6c42\u53ca\u4f01\u4e1a\u6587\u4ef6\u7684\u7b26\u5408\u6027\u548c\u8fd0\u884c\u6709\u6548\u6027\uff0c\u8bc6\u522b\u4f53\u7cfb\u8584\u5f31\u73af\u8282\uff0c\u63a8\u52a8\u7ea0\u6b63\u9884\u9632\u548c\u6301\u7eed\u6539\u8fdb\uff0c\u5e76\u786e\u4fdd\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u771f\u5b9e\u3001\u5b8c\u6574\u3001\u53ef\u8ffd\u6eaf\u548c\u6309\u89c4\u5b9a\u63d0\u4ea4\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2&nbsp; \u9002\u7528\u8303\u56f4<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9002\u7528\u4e8e\u516c\u53f8\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5168\u90e8\u9002\u7528\u8fc7\u7a0b\u3001\u90e8\u95e8\u3001\u573a\u6240\u3001\u4ea7\u54c1\u53ca\u5916\u5305\u63a5\u53e3\u7684\u5185\u90e8\u5ba1\u6838\u3001\u4e13\u9879\u5ba1\u6838\u3001\u8ddf\u8e2a\u5ba1\u6838\u548c\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\uff0c\u5305\u62ec\u8bbe\u8ba1\u5f00\u53d1\u3001\u91c7\u8d2d\u4e0e\u4f9b\u5e94\u5546\u3001\u539f\u6750\u6599\u548c\u4ed3\u50a8\u3001\u5382\u623f\u8bbe\u65bd\u4e0e\u6d01\u51c0\u73af\u5883\u3001\u751f\u4ea7\u8fc7\u7a0b\u3001\u65e0\u83cc\u5c4f\u969c\u4e0e\u706d\u83cc\u3001\u9a8c\u8bc1\u786e\u8ba4\u3001\u8d28\u91cf\u63a7\u5236\u4e0e\u4ea7\u54c1\u653e\u884c\u3001\u9500\u552e\u4e0e\u552e\u540e\u3001\u6295\u8bc9\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u3001\u6570\u636e\u5206\u6790\u3001CAPA\u4ee5\u53ca\u59d4\u6258\u706d\u83cc\u3001\u5916\u534f\u52a0\u5de5\u548c\u59d4\u6258\u68c0\u9a8c\u7b49\u6d3b\u52a8\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0d\u9002\u7528\u6761\u6b3e\u6216\u6d3b\u52a8\u4ec5\u5728\u6709\u5ba2\u89c2\u4f9d\u636e\u5e76\u8bb0\u5f55\u5408\u7406\u6027\u7684\u60c5\u51b5\u4e0b\u5224\u5b9a\uff1b\u5916\u5305\u6d3b\u52a8\u4e0d\u7b49\u540c\u4e8e\u4f01\u4e1a\u8d23\u4efb\u4e0d\u9002\u7528\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3&nbsp; \u4f9d\u636e\u6587\u4ef6<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. <\/strong>\u56fd\u5bb6\u836f\u76d1\u5c402025\u5e74\u7b2c107\u53f7\u516c\u544a\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u300b\uff0c\u91cd\u70b9\u627f\u63a5\u7b2c\u5341\u4e00\u6761\u3001\u7b2c\u5341\u4e94\u6761\u3001\u7b2c\u5341\u4e5d\u6761\u3001\u7b2c\u4e00\u767e\u4e8c\u5341\u516b\u6761\u3001\u7b2c\u4e00\u767e\u4e09\u5341\u6761\u53ca\u76f8\u5173\u8981\u6c42\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. <\/strong>\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u76d1\u7763\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u56fd\u5bb6\u5e02\u573a\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u4ee4\u7b2c53\u53f7\uff09\uff0c\u91cd\u70b9\u627f\u63a5\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u548c\u81ea\u67e5\u62a5\u544a\u63d0\u4ea4\u8981\u6c42\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. <\/strong>\u56fd\u5bb6\u836f\u76d1\u5c40\u901a\u544a2022\u5e74\u7b2c13\u53f7\u300a\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u7f16\u5199\u6307\u5357\u300b\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. <\/strong>GB\/T 42061-2022\u300a\u533b\u7597\u5668\u68b0&nbsp; \u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb&nbsp; \u7528\u4e8e\u6cd5\u89c4\u7684\u8981\u6c42\u300b\uff0c8.2.4\u5185\u90e8\u5ba1\u6838\u53ca\u76f8\u5173\u6761\u6b3e\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. <\/strong>\u73b0\u884c\u300a\u533b\u7597\u5668\u68b0\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u5f55&nbsp; \u65e0\u83cc\u533b\u7597\u5668\u68b0\u300b\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. <\/strong>\u4f01\u4e1a\u9002\u7528\u7684\u533b\u7597\u5668\u68b0\u6cd5\u5f8b\u3001\u6cd5\u89c4\u3001\u89c4\u7ae0\u3001\u5f3a\u5236\u6027\u6807\u51c6\u3001\u4ea7\u54c1\u6ce8\u518c\/\u5907\u6848\u8d44\u6599\u3001\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3001\u98ce\u9669\u7ba1\u7406\u6587\u4ef6\u53ca\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u6587\u4ef6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4&nbsp; \u672f\u8bed\u548c\u5b9a\u4e49<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u672f\u8bed<\/strong><\/td><td><strong>\u5b9a\u4e49<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u5185\u90e8\u5ba1\u6838<\/td><td>\u4e3a\u83b7\u5f97\u5ba2\u89c2\u8bc1\u636e\u5e76\u5bf9\u5176\u8fdb\u884c\u5ba2\u89c2\u8bc4\u4ef7\uff0c\u4ee5\u786e\u5b9a\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8981\u6c42\u6ee1\u8db3\u7a0b\u5ea6\u6240\u5b9e\u65bd\u7684\u7cfb\u7edf\u3001\u72ec\u7acb\u5e76\u5f62\u6210\u6587\u4ef6\u7684\u8fc7\u7a0b\u3002<\/td><\/tr><tr><td>\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5<\/td><td>\u4f01\u4e1a\u5bf9\u4e00\u4e2a\u5e74\u5ea6\u5185\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8fd0\u884c\u3001\u91cd\u8981\u53d8\u66f4\u3001\u751f\u4ea7\u8d28\u91cf\u6d3b\u52a8\u548c\u6cd5\u89c4\u5c65\u884c\u60c5\u51b5\u8fdb\u884c\u5168\u9762\u68c0\u67e5\u3001\u6c47\u603b\u8bc4\u4ef7\u5e76\u5f62\u6210\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u7684\u6d3b\u52a8\u3002<\/td><\/tr><tr><td>\u5ba1\u6838\u51c6\u5219<\/td><td>\u7528\u4e8e\u4e0e\u5ba1\u6838\u8bc1\u636e\u8fdb\u884c\u6bd4\u8f83\u7684\u4e00\u7ec4\u8981\u6c42\uff0c\u5305\u62ec\u9002\u7528\u6cd5\u89c4\u3001\u6807\u51c6\u3001\u6ce8\u518c\/\u5907\u6848\u8981\u6c42\u3001\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3001\u98ce\u9669\u63a7\u5236\u548c\u4f01\u4e1a\u53d7\u63a7\u6587\u4ef6\u3002<\/td><\/tr><tr><td>\u5ba2\u89c2\u8bc1\u636e<\/td><td>\u652f\u6301\u4e8b\u5b9e\u5b58\u5728\u6216\u771f\u5b9e\u6027\u7684\u6570\u636e\uff0c\u5305\u62ec\u6587\u4ef6\u3001\u8bb0\u5f55\u3001\u89c2\u5bdf\u3001\u8bbf\u8c08\u3001\u5b9e\u7269\u72b6\u6001\u3001\u7535\u5b50\u6570\u636e\u548c\u53ef\u8ffd\u6eaf\u6837\u672c\u3002<\/td><\/tr><tr><td>\u4e0d\u7b26\u5408<\/td><td>\u672a\u6ee1\u8db3\u5ba1\u6838\u51c6\u5219\u7684\u8981\u6c42\u3002\u6309\u672c\u7a0b\u5e8f\u5206\u4e3a\u91cd\u5927\u4e0d\u7b26\u5408\u548c\u4e00\u822c\u4e0d\u7b26\u5408\uff1b\u53e6\u53ef\u8bb0\u5f55\u89c2\u5bdf\u9879\/\u6539\u8fdb\u5efa\u8bae\u3002<\/td><\/tr><tr><td>\u4e13\u9879\u5ba1\u6838<\/td><td>\u56e0\u98ce\u9669\u4e8b\u4ef6\u3001\u91cd\u5927\u53d8\u66f4\u3001\u76d1\u7ba1\u8981\u6c42\u6216\u4f53\u7cfb\u5f02\u5e38\uff0c\u5bf9\u7279\u5b9a\u8fc7\u7a0b\u3001\u4ea7\u54c1\u3001\u573a\u6240\u6216\u95ee\u9898\u5f00\u5c55\u7684\u805a\u7126\u5ba1\u6838\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5&nbsp; \u804c\u8d23<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u8d23\u4efb\u5c97\u4f4d<\/strong><\/td><td><strong>\u6838\u5fc3\u804c\u8d23<\/strong><\/td><td><strong>\u6743\u9650\u4e0e\u63a5\u53e3<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u4e3b\u8981\u8d1f\u8d23\u4eba\/\u6cd5\u5b9a\u4ee3\u8868\u4eba<\/td><td>\u4fdd\u969c\u5ba1\u6838\u72ec\u7acb\u6027\u548c\u8d44\u6e90\uff1b\u6279\u51c6\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u53ca\u9700\u5347\u7ea7\u7684\u91cd\u5927\u98ce\u9669\u5904\u7f6e\uff1b\u786e\u4fdd\u5ba1\u6838\u4eba\u5458\u4e0d\u53d7\u4e0d\u5f53\u5e72\u9884\u3002<\/td><td>\u5bf9\u9690\u7792\u4e8b\u5b9e\u3001\u963b\u788d\u5ba1\u6838\u3001\u53ef\u80fd\u5f71\u54cd\u5df2\u4e0a\u5e02\u4ea7\u54c1\u6216\u9700\u76d1\u7ba1\u62a5\u544a\u7684\u91cd\u5927\u4e8b\u9879\u4f5c\u6700\u7ec8\u7ba1\u7406\u51b3\u5b9a\u3002<\/td><\/tr><tr><td>\u7ba1\u7406\u8005\u4ee3\u8868<\/td><td>\u7ec4\u7ec7\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\uff1b\u6279\u51c6\u5e74\u5ea6\u5185\u5ba1\u8ba1\u5212\uff0c\u4efb\u547d\u5ba1\u6838\u7ec4\u957f\/\u5ba1\u6838\u5458\uff1b\u8bc4\u5ba1\u5ba1\u6838\u62a5\u544a\u548c\u4f53\u7cfb\u6539\u8fdb\u9700\u6c42\uff1b\u5411\u4e3b\u8981\u8d1f\u8d23\u4eba\u62a5\u544a\u3002<\/td><td>\u53ef\u51b3\u5b9a\u589e\u52a0\u4e13\u9879\u5ba1\u6838\u3001\u8c03\u6574\u5ba1\u6838\u8303\u56f4\u3001\u6682\u505c\u4e89\u8bae\u4e8b\u9879\u5e76\u5347\u7ea7\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><tr><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\/<br>\u8d28\u91cf\u8d1f\u8d23\u4eba<\/td><td>\u62df\u8ba2\u8ba1\u5212\u3001\u534f\u8c03\u5b9e\u65bd\u3001\u7ef4\u62a4\u5ba1\u6838\u8bb0\u5f55\uff1b\u72ec\u7acb\u786e\u8ba4\u4e0d\u7b26\u5408\u5206\u7ea7\u3001\u7ea0\u6b63\/CAPA\u5145\u5206\u6027\u548c\u6709\u6548\u6027\uff1b\u6c47\u603b\u5e74\u5ea6\u81ea\u67e5\u8d44\u6599\u3002<\/td><td>\u5bf9\u8bc1\u636e\u4e0d\u8db3\u3001\u98ce\u9669\u8bc4\u4ef7\u7f3a\u5931\u3001\u6574\u6539\u65e0\u6548\u6216\u8fdd\u89c4\u653e\u884c\u62e5\u6709\u5426\u51b3\u6743\uff1b\u5fc5\u8981\u65f6\u8981\u6c42\u505c\u5de5\u3001\u9694\u79bb\u3001\u6682\u505c\u653e\u884c\u6216\u542f\u52a8\u504f\u5dee\/CAPA\/\u53ec\u56de\u8bc4\u4f30\u3002<\/td><\/tr><tr><td>\u5ba1\u6838\u7ec4\u957f\/<br>\u5ba1\u6838\u5458<\/td><td>\u6309\u6279\u51c6\u8ba1\u5212\u5b9e\u65bd\u5ba1\u6838\uff0c\u83b7\u53d6\u5ba2\u89c2\u8bc1\u636e\uff0c\u5f62\u6210\u53d1\u73b0\u548c\u62a5\u544a\uff1b\u4fdd\u6301\u72ec\u7acb\u3001\u516c\u6b63\u548c\u4fdd\u5bc6\u3002<\/td><td>\u6709\u6743\u8bbf\u95ee\u5ba1\u6838\u8303\u56f4\u5185\u5fc5\u8981\u6587\u4ef6\u3001\u8bb0\u5f55\u3001\u573a\u6240\u548c\u4eba\u5458\uff1b\u4e0d\u5f97\u5ba1\u6838\u672c\u4eba\u76f4\u63a5\u8d1f\u8d23\u7684\u5de5\u4f5c\u3002<\/td><\/tr><tr><td>\u5404\u90e8\u95e8\/<br>\u8fc7\u7a0b\u8d1f\u8d23\u4eba<\/td><td>\u63d0\u4f9b\u771f\u5b9e\u8d44\u6599\u5e76\u914d\u5408\u5ba1\u6838\uff1b\u5bf9\u4e0d\u7b26\u5408\u5b9e\u65bd\u7acb\u5373\u7ea0\u6b63\u3001\u539f\u56e0\u5206\u6790\u3001CAPA\u548c\u8bc1\u636e\u63d0\u4ea4\u3002<\/td><td>\u4e0d\u5f97\u5220\u9664\u3001\u4fee\u6539\u3001\u9690\u533f\u5ba1\u6838\u8bc1\u636e\u6216\u4ee5\u751f\u4ea7\u7d27\u6025\u4e3a\u7531\u62d2\u7edd\u6574\u6539\u3002<\/td><\/tr><tr><td>\u5168\u4f53\u4eba\u5458<\/td><td>\u5982\u5b9e\u63a5\u53d7\u8bbf\u8c08\uff0c\u62a5\u544a\u5df2\u77e5\u95ee\u9898\uff0c\u6267\u884c\u7ecf\u6279\u51c6\u7684\u7ea0\u6b63\u548c\u6539\u8fdb\u63aa\u65bd\u3002<\/td><td>\u6709\u6743\u5411\u8d28\u91cf\u8d1f\u8d23\u4eba\u6216\u7ba1\u7406\u8005\u4ee3\u8868\u62a5\u544a\u5ba1\u6838\u72ec\u7acb\u6027\u53d7\u5e72\u6270\u6216\u91cd\u5927\u8d28\u91cf\u98ce\u9669\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>\u8d28\u91cf\u72ec\u7acb\u5ba1\u6838\u4e0e\u5426\u51b3\uff1a<\/strong>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u7684\u590d\u6838\u4e0d\u662f\u5f62\u5f0f\u4f1a\u7b7e\u3002\u51e1\u5ba1\u6838\u8bc1\u636e\u4e0d\u8db3\u3001\u91cd\u5927\u98ce\u9669\u672a\u53d7\u63a7\u3001CAPA\u7f3a\u5c11\u6839\u56e0\u6216\u6709\u6548\u6027\u9a8c\u8bc1\u3001\u5df2\u653e\u884c\u4ea7\u54c1\u5f71\u54cd\u672a\u8bc4\u4ef7\uff0c\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u5e94\u62d2\u7edd\u5173\u95ed\uff1b\u5fc5\u8981\u65f6\u6682\u505c\u76f8\u5173\u6d3b\u52a8\u6216\u4ea7\u54c1\u653e\u884c\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6&nbsp; \u5de5\u4f5c\u7a0b\u5e8f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.1&nbsp; \u57fa\u672c\u539f\u5219\u4e0e\u5ba1\u6838\u7c7b\u578b<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u4ee5\u98ce\u9669\u548c\u5ba2\u89c2\u8bc1\u636e\u4e3a\u57fa\u7840\uff0c\u8986\u76d6\u201c\u6587\u4ef6\u89c4\u5b9a\u662f\u5426\u5145\u5206\u3001\u5b9e\u9645\u6267\u884c\u662f\u5426\u7b26\u5408\u3001\u8fc7\u7a0b\u7ed3\u679c\u662f\u5426\u6709\u6548\u3001\u98ce\u9669\u63a7\u5236\u662f\u5426\u6301\u7eed\u6709\u6548\u201d\u56db\u4e2a\u5c42\u9762\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5e74\u5ea6\u5168\u4f53\u7cfb\u5ba1\u6838\/\u81ea\u67e5\uff1a\u6bcf\u4e2a\u81ea\u7136\u5e74\u5ea6\u5b8c\u6210\u4e00\u6b21\u8986\u76d6\u5168\u90e8\u9002\u7528\u8fc7\u7a0b\u7684\u7efc\u5408\u8bc4\u4ef7\uff1b\u53ef\u5206\u9636\u6bb5\u5b9e\u65bd\uff0c\u4f46\u5e74\u5ea6\u5185\u5e94\u5b9e\u73b0\u5b8c\u6574\u8986\u76d6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u4e13\u9879\u5ba1\u6838\uff1a\u5728\u91cd\u5927\u53d8\u5316\u3001\u98ce\u9669\u4e8b\u4ef6\u3001\u91cd\u590d\u4e0d\u7b26\u5408\u3001\u76d1\u7ba1\u68c0\u67e5\u8981\u6c42\u6216\u6570\u636e\u5f02\u5e38\u65f6\u5b9e\u65bd\uff0c\u53ef\u4e0d\u9884\u5148\u901a\u77e5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u8ddf\u8e2a\u5ba1\u6838\uff1a\u7528\u4e8e\u9a8c\u8bc1\u91cd\u5927\u4e0d\u7b26\u5408\u6216\u590d\u6742CAPA\u7684\u5b9e\u65bd\u548c\u6709\u6548\u6027\uff1b\u7b80\u5355\u95ee\u9898\u53ef\u901a\u8fc7\u8bb0\u5f55\u6838\u67e5\u3001\u73b0\u573a\u786e\u8ba4\u6216\u8d8b\u52bf\u6570\u636e\u5b8c\u6210\uff0c\u4e0d\u53e6\u884c\u7ec4\u7ec7\u4f1a\u8bae\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5e74\u5ea6\u5185\u90e8\u5ba1\u6838\u53ef\u4ee5\u4f5c\u4e3a\u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u7684\u91cd\u8981\u8bc1\u636e\uff0c\u4f46\u5e74\u5ea6\u81ea\u67e5\u8fd8\u5e94\u6c47\u603b\u751f\u4ea7\u6d3b\u52a8\u3001\u91cd\u8981\u53d8\u66f4\u3001\u4f53\u7cfb\u8fd0\u884c\u3001\u76d1\u7ba1\u68c0\u67e5\u3001\u5904\u7f5a\u3001\u6295\u8bc9\u3001\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u548c\u7ba1\u7406\u8bc4\u5ba1\u7b49\u5e74\u5ea6\u4fe1\u606f\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.2&nbsp; \u5ba1\u6838\u5468\u671f\u3001\u5e74\u5ea6\u8ba1\u5212\u4e0e\u98ce\u9669\u6392\u5e8f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u4f9d\u636e\u4e0a\u4e00\u5e74\u5ea6\u5ba1\u6838\u548c\u7ba1\u7406\u8bc4\u5ba1\u7ed3\u679c\u3001\u4ea7\u54c1\u548c\u8fc7\u7a0b\u98ce\u9669\u3001\u65e0\u83cc\u4fdd\u8bc1\u72b6\u6001\u3001\u8d28\u91cf\u6570\u636e\u8d8b\u52bf\u3001\u504f\u5dee\/CAPA\u3001\u6295\u8bc9\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u3001\u76d1\u7ba1\u68c0\u67e5\u3001\u91cd\u5927\u53d8\u66f4\u3001\u5916\u5305\u65b9\u7ee9\u6548\u548c\u4eba\u5458\u53d8\u5316\u7b49\u4fe1\u606f\u62df\u8ba2\u5e74\u5ea6\u8ba1\u5212\uff0c\u7531\u7ba1\u7406\u8005\u4ee3\u8868\u6279\u51c6\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u98ce\u9669\u5c42\u7ea7<\/strong><\/td><td><strong>\u5178\u578b\u8fc7\u7a0b<\/strong><\/td><td><strong>\u8ba1\u5212\u539f\u5219<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u9ad8\u98ce\u9669\u8fc7\u7a0b<\/td><td>\u65e0\u83cc\u4fdd\u8bc1\u3001\u706d\u83cc\u53ca\u518d\u786e\u8ba4\u3001\u6d01\u51c0\u73af\u5883\u548c\u5fae\u751f\u7269\u63a7\u5236\u3001\u65e0\u83cc\u5c4f\u969c\u5bc6\u5c01\u3001\u7279\u6b8a\u8fc7\u7a0b\u3001\u5173\u952e\u68c0\u9a8c\u4e0e\u4ea7\u54c1\u653e\u884c\u3001\u6570\u636e\u5b8c\u6574\u6027\u3001\u6295\u8bc9\/\u4e0d\u826f\u4e8b\u4ef6\/\u53ec\u56de\u3001\u91cd\u5927\u5916\u5305\u8fc7\u7a0b<\/td><td>\u5e74\u5ea6\u5168\u8986\u76d6\uff0c\u5e76\u5728\u51fa\u73b0\u98ce\u9669\u4fe1\u53f7\u65f6\u8ffd\u52a0\u4e13\u9879\u5ba1\u6838\uff1b\u5ba1\u6838\u6837\u672c\u548c\u4eba\u5458\u80fd\u529b\u5e94\u5f3a\u5316\u3002<\/td><\/tr><tr><td>\u4e2d\u98ce\u9669\u8fc7\u7a0b<\/td><td>\u91c7\u8d2d\u548c\u5173\u952e\u4f9b\u5e94\u5546\u3001\u4ed3\u50a8\u4e0e\u8ffd\u6eaf\u3001\u8bbe\u5907\u548c\u8ba1\u91cf\u3001\u9a8c\u8bc1\u786e\u8ba4\u3001\u8bbe\u8ba1\u53d8\u66f4\u3001\u751f\u4ea7\u8fc7\u7a0b\u3001\u57f9\u8bad<\/td><td>\u7eb3\u5165\u5e74\u5ea6\u8986\u76d6\uff1b\u6839\u636e\u53d8\u5316\u548c\u65e2\u5f80\u95ee\u9898\u8c03\u6574\u6df1\u5ea6\u3002<\/td><\/tr><tr><td>\u4f4e\u98ce\u9669\/\u652f\u6301\u8fc7\u7a0b<\/td><td>\u884c\u653f\u652f\u6301\u3001\u4e00\u822c\u6587\u4ef6\u7ba1\u7406\u3001\u4f4e\u98ce\u9669\u8f85\u52a9\u6d3b\u52a8<\/td><td>\u7eb3\u5165\u5e74\u5ea6\u4f53\u7cfb\u8986\u76d6\uff0c\u53ef\u4e0e\u76f8\u5173\u8fc7\u7a0b\u5408\u5e76\u5ba1\u6838\u5e76\u9002\u5f53\u62bd\u6837\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5e74\u5ea6\u81ea\u67e5\u7edf\u8ba1\u5468\u671f\u4e3a\u5f53\u5e74\u5ea61\u67081\u65e5\u81f312\u670831\u65e5\u3002\u516c\u53f8\u6309\u5c4a\u65f6\u6709\u6548\u6cd5\u89c4\u89c4\u5b9a\uff0c\u5728\u6b21\u5e743\u670831\u65e5\u524d\u5411\u6240\u5728\u5730\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u90e8\u95e8\u63d0\u4ea4\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\uff1b\u63d0\u4ea4\u65b9\u5f0f\u548c\u683c\u5f0f\u6309\u76d1\u7ba1\u90e8\u95e8\u53ca\u56fd\u5bb6\u836f\u76d1\u5c40\u73b0\u884c\u6307\u5357\u6267\u884c\u3002<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.3&nbsp; \u5ba1\u6838\u4eba\u5458\u80fd\u529b\u4e0e\u72ec\u7acb\u6027<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u5458\u5e94\u63a5\u53d7\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u3001GB\/T 42061\u3001\u5185\u90e8\u5ba1\u6838\u65b9\u6cd5\u4ee5\u53ca\u4e0e\u5ba1\u6838\u8303\u56f4\u76f8\u9002\u5e94\u7684\u65e0\u83cc\u533b\u7597\u5668\u68b0\u4e13\u4e1a\u77e5\u8bc6\u57f9\u8bad\uff0c\u5e76\u7ecf\u7ba1\u7406\u8005\u4ee3\u8868\u786e\u8ba4\u5177\u5907\u80fd\u529b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u7ec4\u957f\u5e94\u80fd\u591f\u5236\u5b9a\u8ba1\u5212\u3001\u7ec4\u7ec7\u53d6\u8bc1\u3001\u5224\u5b9a\u4e0d\u7b26\u5408\u3001\u4e3b\u6301\u6c9f\u901a\u548c\u5f62\u6210\u62a5\u544a\uff1b\u6d89\u53ca\u706d\u83cc\u3001\u5fae\u751f\u7269\u3001\u6d01\u51c0\u73af\u5883\u3001\u7279\u6b8a\u8fc7\u7a0b\u6216\u8f6f\u4ef6\/\u6570\u636e\u5b8c\u6574\u6027\u65f6\uff0c\u5e94\u5b89\u6392\u76f8\u5e94\u4e13\u4e1a\u4eba\u5458\u53c2\u52a0\u6216\u63d0\u4f9b\u6280\u672f\u652f\u6301\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u5458\u4e0d\u5f97\u5ba1\u6838\u672c\u4eba\u7f16\u5236\u5e76\u76f4\u63a5\u6267\u884c\u7684\u5de5\u4f5c\u6216\u5bf9\u672c\u4eba\u5de5\u4f5c\u4f5c\u6700\u7ec8\u7ed3\u8bba\u3002\u5c0f\u578b\u4f01\u4e1a\u65e0\u6cd5\u5b8c\u5168\u56de\u907f\u65f6\uff0c\u5e94\u7531\u53e6\u4e00\u540d\u72ec\u7acb\u4e14\u5177\u5907\u80fd\u529b\u7684\u4eba\u5458\u590d\u6838\u8bc1\u636e\u548c\u7ed3\u8bba\uff1b\u5fc5\u8981\u65f6\u8058\u7528\u5408\u683c\u5916\u90e8\u5ba1\u6838\u5458\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5916\u90e8\u5ba1\u6838\u5458\u5e94\u7b7e\u7f72\u4fdd\u5bc6\u8981\u6c42\u5e76\u58f0\u660e\u5229\u76ca\u51b2\u7a81\uff1b\u4f01\u4e1a\u4ecd\u5bf9\u5ba1\u6838\u8303\u56f4\u3001\u7ed3\u8bba\u3001\u6574\u6539\u548c\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u627f\u62c5\u8d23\u4efb\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.4&nbsp; \u5ba1\u6838\u8303\u56f4\u4e0e\u51c6\u5219<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u5ba1\u6838\u677f\u5757<\/strong><\/td><td><strong>\u6700\u4f4e\u8986\u76d6\u5185\u5bb9<\/strong><\/td><td><strong>\u4e3b\u8981\u51c6\u5219\/\u8bc1\u636e<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u6cbb\u7406\u4e0e\u4f53\u7cfb<\/td><td>\u8d28\u91cf\u65b9\u9488\/\u76ee\u6807\u3001\u7ec4\u7ec7\u804c\u8d23\u3001\u7ba1\u7406\u8005\u4ee3\u8868\u5c65\u804c\u3001\u7ba1\u7406\u8bc4\u5ba1\u3001\u6587\u4ef6\u8bb0\u5f55\u3001\u57f9\u8bad\u3001\u98ce\u9669\u7ba1\u7406\u3001\u6570\u636e\u5b8c\u6574\u6027\u3001\u5185\u5ba1\/CAPA\u3002<\/td><td>\u9002\u7528\u6cd5\u89c4\u3001GB\/T 42061\u3001\u4f01\u4e1a\u7a0b\u5e8f\u548c\u5e74\u5ea6\u76ee\u6807\u3002<\/td><\/tr><tr><td>\u8bbe\u8ba1\u4e0e\u6280\u672f<\/td><td>\u8bbe\u8ba1\u5f00\u53d1\u3001\u98ce\u9669\u7ba1\u7406\u3001\u8bbe\u8ba1\u8f6c\u6362\u3001\u6ce8\u518c\u4e00\u81f4\u6027\u3001\u6280\u672f\u6587\u4ef6\u3001\u53d8\u66f4\u3001\u9a8c\u8bc1\u786e\u8ba4\u3002<\/td><td>\u6ce8\u518c\/\u5907\u6848\u8d44\u6599\u3001\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3001\u8bbe\u8ba1\u8f93\u51fa\u548c\u98ce\u9669\u6587\u4ef6\u3002<\/td><\/tr><tr><td>\u4f9b\u5e94\u94fe\u4e0e\u5916\u5305<\/td><td>\u4f9b\u5e94\u5546\u3001\u91c7\u8d2d\u3001\u8fdb\u8d27\u9a8c\u6536\u3001\u4ed3\u50a8\u3001\u59d4\u6258\u706d\u83cc\u3001\u5916\u534f\u52a0\u5de5\u3001\u59d4\u6258\u68c0\u9a8c\u53ca\u8d28\u91cf\u534f\u8bae\u3002<\/td><td>\u91c7\u8d2d\u8981\u6c42\u3001\u534f\u8bae\u3001\u9a8c\u6536\u51c6\u5219\u3001\u4f9b\u5e94\u5546\u7ee9\u6548\u548c\u53d8\u66f4\u3002<\/td><\/tr><tr><td>\u751f\u4ea7\u4e0e\u65e0\u83cc\u4fdd\u8bc1<\/td><td>\u5382\u623f\u8bbe\u65bd\u3001\u516c\u7528\u7cfb\u7edf\u3001\u6d01\u51c0\u533a\u3001\u4eba\u5458\u4e0e\u7269\u6599\u6d41\u3001\u6e05\u6d01\u6d88\u6bd2\u3001\u73af\u5883\u76d1\u6d4b\u3001\u521d\u59cb\u6c61\u67d3\u83cc\u3001\u65e0\u83cc\u5c4f\u969c\u3001\u706d\u83cc\u3001\u5de5\u827a\u63a7\u5236\u3001\u6807\u8bc6\u8ffd\u6eaf\u3002<\/td><td>\u65e0\u83cc\u9644\u5f55\u3001\u7ecf\u9a8c\u8bc1\u72b6\u6001\u3001\u5de5\u827a\u89c4\u7a0b\u3001\u73af\u5883\/\u5fae\u751f\u7269\u9650\u5ea6\u548c\u6279\u8bb0\u5f55\u3002<\/td><\/tr><tr><td>\u8d28\u91cf\u63a7\u5236\u4e0e\u653e\u884c<\/td><td>\u53d6\u6837\u3001\u68c0\u9a8c\u65b9\u6cd5\u3001\u5b9e\u9a8c\u5ba4\u3001\u68c0\u9a8c\u8bbe\u5907\u3001\u5fae\u751f\u7269\u68c0\u9a8c\u3001\u4e0d\u5408\u683c\u54c1\u3001\u8fd4\u5de5\u8fd4\u4fee\u3001\u6279\u8bb0\u5f55\u5ba1\u6838\u548c\u4ea7\u54c1\u653e\u884c\u3002<\/td><td>\u4ea7\u54c1\u6280\u672f\u8981\u6c42\u3001\u68c0\u9a8c\u89c4\u7a0b\u3001\u653e\u884c\u6761\u4ef6\u548c\u6388\u6743\u3002<\/td><\/tr><tr><td>\u4e0a\u5e02\u540e\u4e0e\u6539\u8fdb<\/td><td>\u9500\u552e\u8ffd\u6eaf\u3001\u987e\u5ba2\u53cd\u9988\u3001\u6295\u8bc9\u3001\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u3001\u5e74\u5ea6\u8d28\u91cf\u56de\u987e\u3001\u8d8b\u52bf\u5206\u6790\u3001\u7ea0\u6b63\u9884\u9632\u63aa\u65bd\u3002<\/td><td>\u4e0a\u5e02\u540e\u6cd5\u89c4\u8981\u6c42\u3001\u98ce\u9669\u7ba1\u7406\u548c\u4f01\u4e1a\u7a0b\u5e8f\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.5&nbsp; \u6d3b\u52a8\u63a7\u5236\u4e0e\u8f93\u51fa<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u6d3b\u52a8<\/strong><\/td><td><strong>\u8d23\u4efb\u5c97\u4f4d<\/strong><\/td><td><strong>\u8f93\u5165<\/strong><\/td><td><strong>\u4e3b\u8981\u6b65\u9aa4<\/strong><\/td><td><strong>\u8f93\u51fa<\/strong><\/td><td><strong>\u8bb0\u5f55<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u5e74\u5ea6\u7b56\u5212<\/td><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8<\/td><td>\u6cd5\u89c4\/\u6807\u51c6\u3001\u8fc7\u7a0b\u6e05\u5355\u3001\u98ce\u9669\u4e0e\u8d28\u91cf\u6570\u636e<\/td><td>\u786e\u5b9a\u5e74\u5ea6\u8303\u56f4\u3001\u9891\u6b21\u3001\u65f6\u95f4\u3001\u5ba1\u6838\u7ec4\u548c\u91cd\u70b9\uff1b\u7ba1\u7406\u8005\u4ee3\u8868\u6279\u51c6\u3002<\/td><td>\u6279\u51c6\u7684\u5e74\u5ea6\u8ba1\u5212<\/td><td>FR-0400-001<\/td><\/tr><tr><td>\u5ba1\u6838\u51c6\u5907<\/td><td>\u5ba1\u6838\u7ec4\u957f<\/td><td>\u5e74\u5ea6\u8ba1\u5212\u3001\u9002\u7528\u51c6\u5219\u3001\u524d\u6b21\u95ee\u9898\u3001\u8fc7\u7a0b\u8d44\u6599<\/td><td>\u660e\u786e\u5177\u4f53\u8303\u56f4\u548c\u6837\u672c\u7b56\u7565\uff1b\u51c6\u5907\u68c0\u67e5\u8981\u70b9\uff1b\u786e\u8ba4\u72ec\u7acb\u6027\u548c\u4e13\u4e1a\u652f\u6301\u3002<\/td><td>\u5ba1\u6838\u5b9e\u65bd\u5b89\u6392<\/td><td>FR-0400-001<\/td><\/tr><tr><td>\u5b9e\u65bd\u53d6\u8bc1<\/td><td>\u5ba1\u6838\u7ec4<\/td><td>\u6587\u4ef6\u8bb0\u5f55\u3001\u73b0\u573a\u3001\u4eba\u5458\u3001\u7535\u5b50\u6570\u636e\u548c\u6837\u672c<\/td><td>\u9996\u6b21\u6c9f\u901a\uff1b\u89c2\u5bdf\u3001\u8bbf\u8c08\u3001\u8ffd\u6eaf\u548c\u62bd\u6837\uff1b\u8bb0\u5f55\u8bc1\u636e\uff1b\u53ca\u65f6\u6c9f\u901a\u6f5c\u5728\u91cd\u5927\u98ce\u9669\u3002<\/td><td>\u5ba1\u6838\u8bc1\u636e\u548c\u53d1\u73b0<\/td><td>FR-0400-002<\/td><\/tr><tr><td>\u53d1\u73b0\u8bc4\u4ef7<\/td><td>\u5ba1\u6838\u7ec4\u957f\u3001\u8d28\u91cf\u8d1f\u8d23\u4eba<\/td><td>\u5ba2\u89c2\u8bc1\u636e\u3001\u98ce\u9669\u8d44\u6599<\/td><td>\u786e\u8ba4\u51c6\u5219\u3001\u4e8b\u5b9e\u548c\u5f71\u54cd\uff1b\u5206\u7c7b\u4e0d\u7b26\u5408\/\u89c2\u5bdf\u9879\uff1b\u5fc5\u8981\u65f6\u8981\u6c42\u7acb\u5373\u63a7\u5236\u3002<\/td><td>\u5df2\u786e\u8ba4\u53d1\u73b0\u53ca\u98ce\u9669\u7b49\u7ea7<\/td><td>FR-0400-002<\/td><\/tr><tr><td>\u62a5\u544a\u4e0e\u6279\u51c6<\/td><td>\u5ba1\u6838\u7ec4\u957f\u3001\u7ba1\u7406\u8005\u4ee3\u8868<\/td><td>\u5ba1\u6838\u8bb0\u5f55\u548c\u53d1\u73b0<\/td><td>\u6c47\u603b\u8303\u56f4\u3001\u7ed3\u8bba\u3001\u4f18\u70b9\u3001\u95ee\u9898\u3001\u6574\u6539\u8981\u6c42\u548c\u672a\u89e3\u51b3\u5206\u6b67\uff1b\u6279\u51c6\u5e76\u5206\u53d1\u3002<\/td><td>\u5ba1\u6838\u62a5\u544a<\/td><td>FR-0400-003<\/td><\/tr><tr><td>\u7ea0\u6b63\/CAPA<\/td><td>\u8d23\u4efb\u90e8\u95e8\u3001\u8d28\u91cf\u90e8<\/td><td>\u4e0d\u7b26\u5408\u548c\u98ce\u9669\u8bc4\u4ef7<\/td><td>\u7acb\u5373\u7ea0\u6b63\/\u904f\u5236\uff1b\u539f\u56e0\u5206\u6790\uff1b\u5236\u5b9a\u5e76\u5b9e\u65bdCAPA\uff1b\u6d89\u53ca\u590d\u6742\u6216\u7cfb\u7edf\u95ee\u9898\u65f6\u8f6cQP-0390\u3002<\/td><td>\u7ea0\u6b63\u53caCAPA\u8bc1\u636e<\/td><td>FR-0400-002\uff1b\u5fc5\u8981\u65f6CAPA\u8bb0\u5f55<\/td><\/tr><tr><td>\u6709\u6548\u6027\u9a8c\u8bc1\/\u5173\u95ed<\/td><td>\u8d28\u91cf\u8d1f\u8d23\u4eba\u6216\u72ec\u7acb\u5ba1\u6838\u5458<\/td><td>\u5b9e\u65bd\u8bc1\u636e\u3001\u9a8c\u8bc1\u6570\u636e\u3001\u8d8b\u52bf<\/td><td>\u6838\u67e5\u5b8c\u6210\u6027\u548c\u6709\u6548\u6027\uff1b\u5fc5\u8981\u65f6\u590d\u5ba1\u3001\u518d\u9a8c\u8bc1\/\u518d\u786e\u8ba4\uff1b\u65e0\u6548\u65f6\u91cd\u65b0\u5904\u7406\u3002<\/td><td>\u5173\u95ed\u6216\u91cd\u65b0\u5f00\u542f\u7ed3\u8bba<\/td><td>FR-0400-002<\/td><\/tr><tr><td>\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a<\/td><td>\u8d28\u91cf\u90e8\u3001\u7ba1\u7406\u8005\u4ee3\u8868\u3001\u4e3b\u8981\u8d1f\u8d23\u4eba<\/td><td>\u5e74\u5ea6\u5ba1\u6838\u53ca\u4f53\u7cfb\u8fd0\u884c\u6570\u636e<\/td><td>\u6309\u76d1\u7ba1\u6a21\u677f\u6c47\u603b\u3001\u590d\u6838\u3001\u7b7e\u7f72\u3001\u63d0\u4ea4\u5e76\u7559\u5b58\u56de\u6267\uff1b\u4f5c\u4e3a\u7ba1\u7406\u8bc4\u5ba1\u8f93\u5165\u3002<\/td><td>\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u53ca\u63d0\u4ea4\u8bc1\u636e<\/td><td>\u76d1\u7ba1\u6a21\u677f\uff1bFR-0400-003\u7d22\u5f15<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.6&nbsp; \u5ba1\u6838\u5b9e\u65bd\u4e0e\u8bc1\u636e\u8981\u6c42<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. <\/strong>\u5ba1\u6838\u5f00\u59cb\u65f6\uff0c\u5ba1\u6838\u7ec4\u957f\u5411\u53d7\u5ba1\u6838\u8d1f\u8d23\u4eba\u8bf4\u660e\u8303\u56f4\u3001\u51c6\u5219\u3001\u65b9\u6cd5\u3001\u6c9f\u901a\u8def\u5f84\u548c\u9884\u8ba1\u7ed3\u675f\u65f6\u95f4\u3002\u5c0f\u578b\u7ec4\u7ec7\u53ef\u5728FR-0400-001\u4e2d\u8bb0\u5f55\uff0c\u4e0d\u53e6\u8bbe\u4f1a\u8bae\u7eaa\u8981\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. <\/strong>\u5ba1\u6838\u65b9\u6cd5\u5305\u62ec\u8bb0\u5f55\u62bd\u6837\u3001\u73b0\u573a\u89c2\u5bdf\u3001\u4eba\u5458\u8bbf\u8c08\u3001\u6b63\u5411\/\u53cd\u5411\u8ffd\u6eaf\u3001\u6279\u6b21\u8ffd\u6eaf\u3001\u7535\u5b50\u6570\u636e\u6838\u5bf9\u548c\u8d8b\u52bf\u590d\u6838\u3002\u6837\u672c\u91cf\u7531\u5ba1\u6838\u5458\u6839\u636e\u98ce\u9669\u3001\u6279\u6b21\u6570\u91cf\u3001\u8fc7\u7a0b\u7a33\u5b9a\u6027\u548c\u65e2\u5f80\u95ee\u9898\u786e\u5b9a\uff0c\u4e0d\u91c7\u7528\u65e0\u4f9d\u636e\u7684\u56fa\u5b9a\u6bd4\u4f8b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. <\/strong>\u8bc1\u636e\u8bb0\u5f55\u5e94\u80fd\u5b9a\u4f4d\u5230\u5177\u4f53\u6587\u4ef6\u7f16\u53f7\/\u7248\u672c\u3001\u8bb0\u5f55\u540d\u79f0\u3001\u65e5\u671f\u3001\u6279\u53f7\/\u5e8f\u5217\u53f7\u3001\u8bbe\u5907\u6216\u533a\u57df\u7b49\uff1b\u4e0d\u5f97\u4ec5\u8bb0\u5f55\u201c\u7b26\u5408\u201d\u201c\u57fa\u672c\u7b26\u5408\u201d\u800c\u65e0\u8bc1\u636e\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. <\/strong>\u8bbf\u8c08\u4fe1\u606f\u5e94\u4e0e\u8bb0\u5f55\u6216\u73b0\u573a\u72b6\u6001\u4ea4\u53c9\u9a8c\u8bc1\u3002\u53d1\u73b0\u8bb0\u5f55\u53ef\u80fd\u88ab\u8865\u5199\u3001\u5220\u9664\u3001\u66ff\u6362\u6216\u6570\u636e\u5b8c\u6574\u6027\u5b58\u7591\u65f6\uff0c\u7acb\u5373\u4fdd\u5168\u8bc1\u636e\u5e76\u62a5\u544a\u8d28\u91cf\u8d1f\u8d23\u4eba\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. <\/strong>\u5ba1\u6838\u5458\u539f\u5219\u4e0a\u4e0d\u76f4\u63a5\u66ff\u4ee3\u53d7\u5ba1\u6838\u90e8\u95e8\u4f5c\u51b3\u5b9a\uff1b\u4f46\u53d1\u73b0\u53ef\u80fd\u7acb\u5373\u5f71\u54cd\u65e0\u83cc\u4fdd\u8bc1\u3001\u4ea7\u54c1\u8d28\u91cf\u6216\u4eba\u5458\u5b89\u5168\u7684\u60c5\u51b5\uff0c\u5e94\u8981\u6c42\u505c\u6b62\u76f8\u5173\u6d3b\u52a8\u5e76\u901a\u77e5\u8d28\u91cf\u8d1f\u8d23\u4eba\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.7&nbsp; \u5ba1\u6838\u53d1\u73b0\u5206\u7c7b\u4e0e\u6c9f\u901a<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u7c7b\u522b<\/strong><\/td><td><strong>\u5224\u5b9a\u539f\u5219<\/strong><\/td><td><strong>\u6700\u4f4e\u5904\u7406\u8981\u6c42<\/strong><\/td><td><strong>\u786e\u8ba4\u6743\u9650<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u91cd\u5927\u4e0d\u7b26\u5408<\/td><td>\u4f53\u7cfb\u8981\u6c42\u7f3a\u5931\u6216\u7cfb\u7edf\u6027\u5931\u6548\uff1b\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u4e0d\u7b26\u5408\u3001\u65e0\u83cc\u4fdd\u8bc1\u5931\u6548\u3001\u9519\u8bef\u653e\u884c\u3001\u8ffd\u6eaf\u4e2d\u65ad\u3001\u6570\u636e\u5931\u771f\uff1b\u91cd\u590d\u53d1\u751f\u7684\u4e00\u822c\u4e0d\u7b26\u5408\uff1b\u6545\u610f\u9690\u7792\u6216\u963b\u788d\u5ba1\u6838\u3002<\/td><td>\u7acb\u5373\u62a5\u544a\u8d28\u91cf\u8d1f\u8d23\u4eba\u548c\u7ba1\u7406\u8005\u4ee3\u8868\uff1b\u91c7\u53d6\u904f\u5236\/\u9694\u79bb\uff1b\u8bc4\u4ef7\u5728\u5236\u54c1\u53ca\u5df2\u653e\u884c\u4ea7\u54c1\uff1b\u542f\u52a8\u504f\u5dee\u3001\u4e0d\u5408\u683c\u54c1\u3001CAPA\u3001\u6295\u8bc9\/\u4e0d\u826f\u4e8b\u4ef6\u6216\u53ec\u56de\u8bc4\u4f30\u3002<\/td><td>\u8d28\u91cf\u90e8\u95e8\u786e\u8ba4\uff1b\u91cd\u5927\u4e89\u8bae\u5347\u7ea7\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><tr><td>\u4e00\u822c\u4e0d\u7b26\u5408<\/td><td>\u5355\u4e00\u6216\u5c40\u90e8\u672a\u6ee1\u8db3\u8981\u6c42\uff0c\u5c1a\u65e0\u8bc1\u636e\u8868\u660e\u9020\u6210\u91cd\u5927\u4ea7\u54c1\u6216\u4f53\u7cfb\u98ce\u9669\uff0c\u4f46\u9700\u8981\u7ea0\u6b63\u5e76\u9632\u6b62\u91cd\u590d\u3002<\/td><td>\u5728\u89c4\u5b9a\u671f\u9650\u5185\u7ea0\u6b63\u5e76\u8bc4\u4ef7\u662f\u5426\u9700\u8981CAPA\uff1b\u63d0\u4ea4\u5ba2\u89c2\u8bc1\u636e\u3002<\/td><td>\u5ba1\u6838\u7ec4\u957f\u63d0\u51fa\uff0c\u8d28\u91cf\u90e8\u95e8\u786e\u8ba4\u3002<\/td><\/tr><tr><td>\u89c2\u5bdf\u9879\/\u6539\u8fdb\u5efa\u8bae<\/td><td>\u5c1a\u672a\u6784\u6210\u4e0d\u7b26\u5408\uff0c\u4f46\u5b58\u5728\u8d8b\u52bf\u3001\u8584\u5f31\u73af\u8282\u6216\u6539\u8fdb\u673a\u4f1a\u3002<\/td><td>\u7531\u8fc7\u7a0b\u8d1f\u8d23\u4eba\u8bc4\u4f30\u662f\u5426\u7eb3\u5165\u6539\u8fdb\u8ba1\u5212\uff1b\u98ce\u9669\u4e0a\u5347\u65f6\u8f6c\u4e3a\u4e0d\u7b26\u5408\u6216CAPA\u3002<\/td><td>\u4e0d\u4f5c\u4e3a\u4e0d\u7b26\u5408\u5173\u95ed\uff0c\u4f46\u5e94\u5728\u4e0b\u6b21\u5ba1\u6838\u5173\u6ce8\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u672b\u6b21\u6c9f\u901a\u65f6\u5e94\u786e\u8ba4\u4e8b\u5b9e\u548c\u8bc1\u636e\uff0c\u4f46\u53d7\u5ba1\u6838\u90e8\u95e8\u4e0d\u540c\u610f\u7ed3\u8bba\u4e0d\u5f71\u54cd\u5ba1\u6838\u7ec4\u8bb0\u5f55\u53d1\u73b0\u3002\u65e0\u6cd5\u8fbe\u6210\u4e00\u81f4\u65f6\uff0c\u5c06\u5206\u6b67\u3001\u53cc\u65b9\u4f9d\u636e\u548c\u4e34\u65f6\u98ce\u9669\u63a7\u5236\u8bb0\u5f55\u5728\u62a5\u544a\u4e2d\uff0c\u7531\u7ba1\u7406\u8005\u4ee3\u8868\u88c1\u51b3\uff1b\u6d89\u53ca\u6cd5\u89c4\u6216\u4ea7\u54c1\u8d28\u91cf\u5e95\u7ebf\u65f6\uff0c\u8d28\u91cf\u90e8\u95e8\u7684\u5426\u51b3\u51b3\u5b9a\u5728\u88c1\u51b3\u524d\u6301\u7eed\u6709\u6548\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.8&nbsp; \u7ea0\u6b63\u3001CAPA\u3001\u6709\u6548\u6027\u9a8c\u8bc1\u4e0e\u5173\u95ed<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u8d23\u4efb\u90e8\u95e8\u9996\u5148\u5b9e\u65bd\u7ea0\u6b63\u548c\u5fc5\u8981\u7684\u4e34\u65f6\u904f\u5236\uff0c\u9632\u6b62\u95ee\u9898\u6269\u5927\uff1b\u6d89\u53ca\u4ea7\u54c1\u65f6\u540c\u6b65\u8bc6\u522b\u53d7\u5f71\u54cd\u6279\u6b21\u3001\u5e93\u5b58\u3001\u5728\u5236\u54c1\u548c\u5df2\u9500\u552e\u4ea7\u54c1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5bf9\u91cd\u5927\u3001\u91cd\u590d\u3001\u7cfb\u7edf\u6027\u6216\u6f5c\u5728\u95ee\u9898\u5f00\u5c55\u6839\u56e0\u5206\u6790\u548cCAPA\uff1b\u7b80\u5355\u3001\u5b64\u7acb\u4e14\u5df2\u6d88\u9664\u539f\u56e0\u7684\u95ee\u9898\u53ef\u5728FR-0400-002\u4e2d\u5b8c\u6210\u5904\u7406\u5e76\u8bf4\u660e\u4e0d\u5355\u72ec\u7acb\u9879CAPA\u7684\u7406\u7531\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u6574\u6539\u5b8c\u6210\u671f\u9650\u7531\u5ba1\u6838\u62a5\u544a\u6839\u636e\u98ce\u9669\u3001\u63aa\u65bd\u590d\u6742\u7a0b\u5ea6\u548c\u8d44\u6e90\u786e\u5b9a\u3002\u91cd\u5927\u98ce\u9669\u4e0d\u5f97\u7b49\u5f85\u5e38\u89c4\u671f\u9650\uff0c\u5e94\u7acb\u5373\u63a7\u5236\u5e76\u6301\u7eed\u5411\u7ba1\u7406\u8005\u4ee3\u8868\u62a5\u544a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u6709\u6548\u6027\u9a8c\u8bc1\u7531\u8d28\u91cf\u8d1f\u8d23\u4eba\u6216\u672a\u53c2\u4e0e\u63aa\u65bd\u5b9e\u65bd\u7684\u5408\u683c\u4eba\u5458\u5b8c\u6210\uff0c\u53ef\u91c7\u7528\u73b0\u573a\u590d\u6838\u3001\u8bb0\u5f55\u62bd\u6837\u3001\u8d8b\u52bf\u6570\u636e\u3001\u518d\u5ba1\u6838\u3001\u8bd5\u8fd0\u884c\u6216\u9a8c\u8bc1\/\u518d\u786e\u8ba4\u3002\u4ec5\u6709\u6587\u4ef6\u4fee\u8ba2\u6216\u57f9\u8bad\u7b7e\u5230\u4e0d\u80fd\u81ea\u52a8\u8bc1\u660e\u63aa\u65bd\u6709\u6548\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u9a8c\u8bc1\u65e0\u6548\u3001\u903e\u671f\u672a\u5b8c\u6210\u3001\u540c\u7c7b\u95ee\u9898\u91cd\u590d\u53d1\u751f\u6216\u65b0\u8bc1\u636e\u663e\u793a\u98ce\u9669\u6269\u5927\u65f6\uff0c\u91cd\u65b0\u5f00\u542f\u4e0d\u7b26\u5408\u5e76\u5347\u7ea7CAPA\u548c\u7ba1\u7406\u8005\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.9&nbsp; \u9ad8\u98ce\u9669\u4e8b\u9879\u3001\u9a8c\u8bc1\u786e\u8ba4\u4e0e\u7ba1\u7406\u8005\u5347\u7ea7<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u89e6\u53d1\u7c7b\u522b<\/strong><\/td><td><strong>\u5178\u578b\u60c5\u5f62<\/strong><\/td><td><strong>\u5fc5\u987b\u91c7\u53d6\u7684\u63a7\u5236<\/strong><\/td><td><strong>\u5347\u7ea7\u6761\u4ef6<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u65e0\u83cc\u4fdd\u8bc1\/\u6c61\u67d3\u63a7\u5236<\/td><td>\u706d\u83cc\u53c2\u6570\u6216\u518d\u786e\u8ba4\u5931\u6548\u3001\u5305\u88c5\u5bc6\u5c01\u5f02\u5e38\u3001\u521d\u59cb\u6c61\u67d3\u83cc\/\u73af\u5883\u76d1\u6d4b\u5f02\u5e38\u3001\u6d01\u51c0\u533a\u5931\u63a7\u3001\u65e0\u83cc\u68c0\u9a8c\u6216\u5fae\u751f\u7269\u6570\u636e\u5f02\u5e38<\/td><td>\u7acb\u5373\u505c\u6b62\u76f8\u5173\u653e\u884c\u6216\u751f\u4ea7\uff0c\u9694\u79bb\u53d7\u5f71\u54cd\u4ea7\u54c1\uff1b\u5f00\u5c55\u98ce\u9669\u8bc4\u4ef7\uff1b\u5fc5\u8981\u65f6\u9a8c\u8bc1\/\u518d\u786e\u8ba4\u548c\u4ea7\u54c1\u5f71\u54cd\u8bc4\u4f30\u3002<\/td><td>\u8d28\u91cf\u8d1f\u8d23\u4eba+\u7ba1\u7406\u8005\u4ee3\u8868\uff1b\u53ef\u80fd\u5f71\u54cd\u5df2\u4e0a\u5e02\u4ea7\u54c1\u65f6\u5347\u7ea7\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><tr><td>\u5173\u952e\u8fc7\u7a0b\/\u68c0\u9a8c\/\u653e\u884c<\/td><td>\u7279\u6b8a\u8fc7\u7a0b\u672a\u786e\u8ba4\u3001\u5173\u952e\u8bbe\u5907\u5931\u6548\u3001\u68c0\u9a8c\u65b9\u6cd5\u6216\u63a5\u6536\u51c6\u5219\u9519\u8bef\u3001\u6279\u8bb0\u5f55\u7f3a\u5931\u3001\u65e0\u6388\u6743\u653e\u884c<\/td><td>\u6682\u505c\u8fc7\u7a0b\u6216\u653e\u884c\uff1b\u8ffd\u6eaf\u53d7\u5f71\u54cd\u6279\u6b21\uff1b\u9a8c\u8bc1\u65b9\u6cd5\/\u8bbe\u5907\/\u8fc7\u7a0b\u6062\u590d\u53d7\u63a7\u3002<\/td><td>\u8d28\u91cf\u90e8\u95e8\u5426\u51b3\u95e8\uff1b\u5fc5\u8981\u65f6\u4e3b\u8981\u8d1f\u8d23\u4eba\u51b3\u5b9a\u5e02\u573a\u63aa\u65bd\u3002<\/td><\/tr><tr><td>\u6570\u636e\u5b8c\u6574\u6027<\/td><td>\u8bb0\u5f55\u8865\u5199\u3001\u5220\u9664\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u5f02\u5e38\u3001\u5171\u4eab\u8d26\u53f7\u3001\u81ea\u52a8\u5224\u5b9a\u903b\u8f91\u672a\u7ecf\u786e\u8ba4\u3001\u539f\u59cb\u6570\u636e\u7f3a\u5931<\/td><td>\u4fdd\u5168\u6570\u636e\u548c\u6743\u9650\uff1b\u6682\u505c\u4f9d\u8d56\u8be5\u6570\u636e\u7684\u8d28\u91cf\u51b3\u5b9a\uff1b\u8bc4\u4ef7\u5386\u53f2\u6570\u636e\u548c\u7cfb\u7edf\u786e\u8ba4\u72b6\u6001\u3002<\/td><td>\u7ba1\u7406\u8005\u4ee3\u8868\uff1b\u6d89\u5acc\u6545\u610f\u884c\u4e3a\u6216\u5e7f\u6cdb\u5f71\u54cd\u65f6\u5347\u7ea7\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><tr><td>\u6cd5\u89c4\/\u6ce8\u518c\u4e00\u81f4\u6027<\/td><td>\u672a\u6309\u6ce8\u518c\u6280\u672f\u8981\u6c42\u751f\u4ea7\u3001\u91cd\u5927\u53d8\u66f4\u672a\u8bc4\u4ef7\u3001\u6807\u7b7e\u8bf4\u660e\u4e66\u6216UDI\u9519\u8bef\u3001\u76d1\u7ba1\u627f\u8bfa\u672a\u843d\u5b9e<\/td><td>\u505c\u6b62\u76f8\u5173\u5b9e\u65bd\u6216\u653e\u884c\uff1b\u5b8c\u6210\u6cd5\u89c4\u5f71\u54cd\u5224\u65ad\uff1b\u9700\u8981\u65f6\u6309\u89c4\u5b9a\u62a5\u544a\u6216\u529e\u7406\u53d8\u66f4\u3002<\/td><td>\u7ba1\u7406\u8005\u4ee3\u8868\u548c\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><tr><td>\u5df2\u653e\u884c\u4ea7\u54c1\u98ce\u9669<\/td><td>\u5ba1\u6838\u53d1\u73b0\u53ef\u80fd\u5f71\u54cd\u5df2\u9500\u552e\u4ea7\u54c1\u5b89\u5168\u3001\u6709\u6548\u6216\u65e0\u83cc\u72b6\u6001<\/td><td>\u542f\u52a8\u4e0a\u5e02\u540e\u98ce\u9669\u8bc4\u4f30\uff0c\u5fc5\u8981\u65f6\u6295\u8bc9\/\u4e0d\u826f\u4e8b\u4ef6\/\u53ec\u56de\u548c\u4fe1\u606f\u544a\u77e5\u7a0b\u5e8f\uff1b\u4e0d\u5f97\u7b49\u5f85\u5ba1\u6838\u5173\u95ed\u3002<\/td><td>\u7acb\u5373\u62a5\u544a\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.10&nbsp; \u5e74\u5ea6\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u4e0e\u62a5\u544a<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u4f9d\u636e\u56fd\u5bb6\u836f\u76d1\u5c40\u73b0\u884c\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u7f16\u5199\u6307\u5357\u6536\u96c6\u548c\u6838\u5bf9\u5e74\u5ea6\u6570\u636e\u3002\u5404\u8fc7\u7a0b\u8d1f\u8d23\u4eba\u5bf9\u6240\u63d0\u4f9b\u8d44\u6599\u7684\u771f\u5b9e\u6027\u3001\u5b8c\u6574\u6027\u548c\u53ef\u8ffd\u6eaf\u6027\u8d1f\u8d23\uff1b\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u8fdb\u884c\u4e00\u81f4\u6027\u590d\u6838\uff0c\u7ba1\u7406\u8005\u4ee3\u8868\u5ba1\u67e5\uff0c\u6cd5\u5b9a\u4ee3\u8868\u4eba\u6216\u4e3b\u8981\u8d1f\u8d23\u4eba\u7b7e\u7f72\u627f\u8bfa\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u62a5\u544a\u6a21\u5757<\/strong><\/td><td><strong>\u6700\u4f4e\u5185\u5bb9<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u7efc\u8ff0<\/td><td>\u4f01\u4e1a\u3001\u751f\u4ea7\u8bb8\u53ef\/\u5907\u6848\u3001\u4ea7\u54c1\u6ce8\u518c\/\u5907\u6848\u548c\u751f\u4ea7\u6d3b\u52a8\uff1b\u59d4\u6258\/\u53d7\u6258\u751f\u4ea7\u53ca\u8d28\u91cf\u534f\u8bae\u5c65\u884c\u60c5\u51b5\u3002<\/td><\/tr><tr><td>\u5e74\u5ea6\u91cd\u8981\u53d8\u66f4<\/td><td>\u4ea7\u54c1\u8bbe\u8ba1\u4e0e\u6ce8\u518c\u53d8\u5316\uff1b\u751f\u4ea7\/\u68c0\u9a8c\u533a\u57df\u548c\u8bbe\u5907\uff1b\u5173\u952e\u5de5\u5e8f\/\u7279\u6b8a\u8fc7\u7a0b\uff1b\u5173\u952e\u539f\u6750\u6599\u548c\u91cd\u8981\u670d\u52a1\u4f9b\u5e94\u5546\u3002<\/td><\/tr><tr><td>\u4f53\u7cfb\u8fd0\u884c<\/td><td>\u7ec4\u7ec7\u4e0e\u4eba\u5458\u57f9\u8bad\uff1b\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\uff1b\u91c7\u8d2d\u4f9b\u5e94\u5546\uff1b\u6295\u8bc9\u9000\u8d27\uff1b\u4e0d\u5408\u683c\u54c1\/\u53ec\u56de\/\u62bd\u68c0\uff1b\u8ffd\u6eaf\u548cUDI\uff1b\u5185\u5ba1\u548c\u7ba1\u7406\u8bc4\u5ba1\uff1b\u4e0d\u826f\u4e8b\u4ef6\u4e0e\u518d\u8bc4\u4ef7\u3002<\/td><\/tr><tr><td>\u5176\u4ed6\u4e8b\u9879<\/td><td>\u76d1\u7ba1\u6216\u8ba4\u8bc1\u68c0\u67e5\u3001\u96c6\u4e2d\u5e26\u91cf\u91c7\u8d2d\u4e2d\u9009\u60c5\u51b5\u3001\u884c\u653f\u5904\u7f5a\u53ca\u6574\u6539\uff1b\u76d1\u7ba1\u6a21\u677f\u8981\u6c42\u7684\u5176\u4ed6\u5185\u5bb9\u3002<\/td><\/tr><tr><td>\u62a5\u544a\u4e0e\u7559\u5b58<\/td><td>\u6309\u76d1\u7ba1\u6a21\u677f\u586b\u62a5\uff0c\u9644\u4ef6\u8fde\u7eed\u7f16\u53f7\u5e76\u5f62\u6210\u6e05\u5355\uff1b\u4fdd\u7559\u7b7e\u7f72\u7248\u672c\u3001\u63d0\u4ea4\u56de\u6267\/\u7cfb\u7edf\u622a\u56fe\u548c\u652f\u6301\u6570\u636e\u3002\u5e74\u5ea6\u62a5\u544a\u4e0d\u80fd\u66ff\u4ee3\u5176\u4ed6\u5e94\u5f53\u53ca\u65f6\u62a5\u544a\u7684\u6cd5\u5b9a\u4e49\u52a1\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u5e74\u5ea6\u81ea\u67e5\u53d1\u73b0\u7684\u672a\u5173\u95ed\u95ee\u9898\u5e94\u5982\u5b9e\u53cd\u6620\uff0c\u4e0d\u5f97\u4e3a\u5f62\u6210\u201c\u65e0\u95ee\u9898\u201d\u7ed3\u8bba\u800c\u964d\u4f4e\u4e0d\u7b26\u5408\u7b49\u7ea7\u3001\u5220\u9664\u8bc1\u636e\u6216\u63a8\u8fdf\u7acb\u9879\u3002\u62a5\u544a\u63d0\u4ea4\u540e\u53d1\u73b0\u91cd\u5927\u9057\u6f0f\u6216\u9519\u8bef\u65f6\uff0c\u8d28\u91cf\u8d1f\u8d23\u4eba\u5e94\u7acb\u5373\u7ec4\u7ec7\u8bc4\u4f30\u5e76\u6309\u76d1\u7ba1\u90e8\u95e8\u8981\u6c42\u66f4\u6b63\u6216\u8865\u5145\u3002<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.11&nbsp; \u4e13\u9879\u5ba1\u6838\u89e6\u53d1\u4e0e\u5b9e\u65bd<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u51fa\u73b0\u4ee5\u4e0b\u4efb\u4e00\u60c5\u5f62\u65f6\uff0c\u7531\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u63d0\u51fa\u4e13\u9879\u5ba1\u6838\u5efa\u8bae\uff0c\u7ba1\u7406\u8005\u4ee3\u8868\u786e\u5b9a\u8303\u56f4\u548c\u65f6\u70b9\uff1b\u7d27\u6025\u98ce\u9669\u53ef\u5148\u91c7\u53d6\u63a7\u5236\u5e76\u540c\u6b65\u542f\u52a8\u5ba1\u6838\uff1a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u6cd5\u89c4\u3001\u5f3a\u5236\u6027\u6807\u51c6\u3001\u6ce8\u518c\/\u5907\u6848\u8981\u6c42\u6216\u65e0\u83cc\u9644\u5f55\u53d1\u751f\u91cd\u5927\u53d8\u5316\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u65b0\u4ea7\u54c1\/\u65b0\u573a\u5730\u6295\u4ea7\u3001\u5173\u952e\u8bbe\u5907\u6216\u5de5\u827a\u53d8\u5316\u3001\u706d\u83cc\u65b9\u5f0f\u6216\u53d7\u6258\u65b9\u53d8\u5316\u3001\u6d01\u51c0\u533a\u91cd\u5927\u6539\u9020\u3001\u505c\u4ea7\u540e\u6062\u590d\u751f\u4ea7\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u91cd\u5927\u504f\u5dee\u3001\u4e0d\u5408\u683c\u3001\u6295\u8bc9\u3001\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u3001\u62bd\u68c0\u4e0d\u5408\u683c\u3001\u6570\u636e\u5b8c\u6574\u6027\u4e8b\u4ef6\u6216\u8d28\u91cf\u8d8b\u52bf\u663e\u8457\u6076\u5316\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u76d1\u7ba1\u68c0\u67e5\u3001\u5ba2\u6237\u5ba1\u6838\u6216\u8ba4\u8bc1\u5ba1\u6838\u53d1\u73b0\u91cd\u5927\u95ee\u9898\uff1b\u540c\u7c7b\u4e0d\u7b26\u5408\u91cd\u590d\u53d1\u751f\u6216CAPA\u6709\u6548\u6027\u4e0d\u8db3\uff1b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u7ec4\u7ec7\u67b6\u6784\u3001\u5173\u952e\u5c97\u4f4d\u4eba\u5458\u6216\u8d28\u91cf\/\u751f\u4ea7\u8d1f\u8d23\u4eba\u53d1\u751f\u91cd\u5927\u53d8\u5316\uff0c\u53ef\u80fd\u5f71\u54cd\u4f53\u7cfb\u6709\u6548\u8fd0\u884c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e13\u9879\u5ba1\u6838\u6309\u672c\u7a0b\u5e8f\u6267\u884c\uff0c\u53ef\u7f29\u5c0f\u5230\u7279\u5b9a\u8fc7\u7a0b\u6216\u4ea7\u54c1\uff0c\u4f46\u4e0d\u5f97\u9057\u6f0f\u4e0e\u95ee\u9898\u76f8\u5173\u7684\u4e0a\u6e38\u3001\u4e0b\u6e38\u548c\u5df2\u653e\u884c\u4ea7\u54c1\u5f71\u54cd\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.12&nbsp; \u4e0d\u9002\u7528\u60c5\u5f62\u5224\u5b9a<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u60c5\u5f62<\/strong><\/td><td><strong>\u5224\u5b9a\u65b9\u6cd5<\/strong><\/td><td><strong>\u4ecd\u9700\u4fdd\u7559\u7684\u63a7\u5236<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u67d0\u6cd5\u89c4\u6761\u6b3e\/\u8fc7\u7a0b\u4e0e\u4ea7\u54c1\u65e0\u5173<\/td><td>\u7ed3\u5408\u4ea7\u54c1\u9884\u671f\u7528\u9014\u3001\u751f\u4ea7\u65b9\u5f0f\u3001\u6ce8\u518c\u8d44\u6599\u3001\u5de5\u827a\u6d41\u7a0b\u548c\u7ec4\u7ec7\u6d3b\u52a8\u9010\u9879\u5224\u65ad\uff0c\u8bb0\u5f55\u5ba2\u89c2\u7406\u7531\u548c\u8bc1\u636e\u3002<\/td><td>\u5728FR-0400-001\u6216\u5ba1\u6838\u62a5\u544a\u4e2d\u5217\u660e\uff1b\u4ea7\u54c1\u6216\u6d3b\u52a8\u53d8\u5316\u65f6\u91cd\u65b0\u8bc4\u4ef7\u3002<\/td><\/tr><tr><td>\u706d\u83cc\u3001\u68c0\u9a8c\u3001\u5916\u534f\u52a0\u5de5\u5df2\u5916\u5305<\/td><td>\u4f01\u4e1a\u5185\u90e8\u5177\u4f53\u64cd\u4f5c\u53ef\u4e0d\u9002\u7528\uff0c\u4f46\u4f9b\u5e94\u5546\u8bc4\u4ef7\u3001\u8d28\u91cf\u534f\u8bae\u3001\u6280\u672f\u8f6c\u79fb\u3001\u9a8c\u8bc1\/\u786e\u8ba4\u3001\u8bb0\u5f55\u5ba1\u6838\u3001\u653e\u884c\u548c\u53d8\u66f4\u76d1\u7763\u4ecd\u9002\u7528\u3002<\/td><td>\u4e0d\u5f97\u5c06\u4f01\u4e1a\u6cd5\u5b9a\u4e3b\u4f53\u8d23\u4efb\u5224\u5b9a\u4e3a\u4e0d\u9002\u7528\u3002<\/td><\/tr><tr><td>\u65e0\u5b89\u88c5\/\u7ef4\u4fee\u73b0\u573a\u670d\u52a1<\/td><td>\u4f9d\u636e\u8bf4\u660e\u4e66\u3001\u9884\u671f\u7528\u9014\u548c\u9500\u552e\u6a21\u5f0f\u786e\u8ba4\u3002<\/td><td>\u6295\u8bc9\u3001\u9000\u8d27\u3001\u98ce\u9669\u4fe1\u606f\u3001\u53ec\u56de\u3001\u4fe1\u606f\u544a\u77e5\u53ca\u5fc5\u8981\u6280\u672f\u652f\u6301\u4ecd\u9002\u7528\u3002<\/td><\/tr><tr><td>\u65e0\u59d4\u6258\u751f\u4ea7\/\u65e0\u5171\u7528\u7ebf\/\u65e0\u8fde\u7eed\u751f\u4ea7<\/td><td>\u4ee5\u5b9e\u9645\u5408\u540c\u3001\u573a\u5730\u5e03\u5c40\u3001\u8bbe\u5907\u6e05\u5355\u548c\u751f\u4ea7\u8ba1\u5212\u8bc1\u5b9e\u3002<\/td><td>\u4e00\u65e6\u4e1a\u52a1\u6216\u751f\u4ea7\u6a21\u5f0f\u53d8\u5316\uff0c\u89e6\u53d1\u91cd\u65b0\u8bc4\u4ef7\u548c\u5fc5\u8981\u4e13\u9879\u5ba1\u6838\u3002<\/td><\/tr><tr><td>\u5e74\u5ea6\u5185\u65e0\u751f\u4ea7\u6216\u67d0\u8fc7\u7a0b\u672a\u53d1\u751f<\/td><td>\u4e0d\u80fd\u636e\u6b64\u5220\u9664\u4f53\u7cfb\u8981\u6c42\uff1b\u5ba1\u6838\u5176\u7ef4\u6301\u80fd\u529b\u3001\u505c\u4ea7\u7ba1\u7406\u3001\u9a8c\u8bc1\u72b6\u6001\u3001\u4eba\u5458\u80fd\u529b\u53ca\u6062\u590d\u6761\u4ef6\u3002<\/td><td>\u5e74\u5ea6\u81ea\u67e5\u6309\u76d1\u7ba1\u6307\u5357\u8bf4\u660e\u5b9e\u9645\u60c5\u51b5\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6.13&nbsp; \u5f02\u5e38\u3001\u4fdd\u5bc6\u548c\u8bb0\u5f55\u63a7\u5236<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u671f\u95f4\u53d1\u73b0\u8bc1\u636e\u53ef\u80fd\u88ab\u4fee\u6539\u3001\u5220\u9664\u6216\u8f6c\u79fb\u65f6\uff0c\u5e94\u7acb\u5373\u4fdd\u5168\u539f\u59cb\u8bb0\u5f55\u3001\u7535\u5b50\u6570\u636e\u548c\u8bbf\u95ee\u6743\u9650\uff0c\u5e76\u62a5\u544a\u8d28\u91cf\u8d1f\u8d23\u4eba\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u4efb\u4f55\u4eba\u5458\u4e0d\u5f97\u56e0\u5ba1\u6838\u53d1\u73b0\u3001\u5982\u5b9e\u9648\u8ff0\u6216\u63d0\u51fa\u8d28\u91cf\u95ee\u9898\u53d7\u5230\u4e0d\u5f53\u5904\u7406\uff1b\u5bf9\u5ba1\u6838\u72ec\u7acb\u6027\u7684\u5e72\u9884\u7531\u7ba1\u7406\u8005\u4ee3\u8868\u8c03\u67e5\u5e76\u62a5\u544a\u4e3b\u8981\u8d1f\u8d23\u4eba\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u8d44\u6599\u4ec5\u5411\u5c65\u804c\u6240\u9700\u4eba\u5458\u5f00\u653e\u3002\u6d89\u53ca\u4e2a\u4eba\u4fe1\u606f\u3001\u5546\u4e1a\u79d8\u5bc6\u3001\u6ce8\u518c\u8d44\u6599\u548c\u5916\u90e8\u673a\u6784\u8d44\u6599\u65f6\u6309\u6743\u9650\u4fdd\u5b58\u548c\u4f20\u9012\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u5ba1\u6838\u8bb0\u5f55\u3001\u62a5\u544a\u3001\u6574\u6539\u8bc1\u636e\u3001\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u53ca\u63d0\u4ea4\u8bc1\u660e\u6309\u300a\u8bb0\u5f55\u63a7\u5236\u7a0b\u5e8f\u300b\u89c4\u5b9a\u4fdd\u5b58\uff1b\u82e5\u6d89\u53ca\u6295\u8bc9\u3001\u4e0d\u826f\u4e8b\u4ef6\u3001\u53ec\u56de\u3001\u76d1\u7ba1\u8c03\u67e5\u6216\u8bc9\u8bbc\uff0c\u5e94\u6309\u8f83\u957f\u7684\u9002\u7528\u4fdd\u7559\u8981\u6c42\u6267\u884c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>7&nbsp; \u76f8\u5173\u6587\u4ef6<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0020\u300a\u7ba1\u7406\u8bc4\u5ba1\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0040\u300a\u6587\u4ef6\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u300a\u8bb0\u5f55\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u300a\u4eba\u5458\u57f9\u8bad\u4e0e\u80fd\u529b\u7ba1\u7406\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0120\u300a\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0310\u300a\u504f\u5dee\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0320\u300a\u4e0d\u5408\u683c\u54c1\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0350\u300a\u987e\u5ba2\u53cd\u9988\u4e0e\u6295\u8bc9\u5904\u7406\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0360\u300a\u4e0a\u5e02\u540e\u76d1\u7763\u4e0e\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0370\u300a\u53ec\u56de\u4e0e\u4ea7\u54c1\u4fe1\u606f\u544a\u77e5\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0380\u300a\u6570\u636e\u5206\u6790\u3001\u8fc7\u7a0b\u76d1\u89c6\u4e0e\u4ea7\u54c1\u8d28\u91cf\u5e74\u5ea6\u56de\u987e\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 QP-0390\u300a\u7ea0\u6b63\u63aa\u65bd\u4e0e\u9884\u9632\u63aa\u65bd\u63a7\u5236\u7a0b\u5e8f\u300b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 \u56fd\u5bb6\u836f\u76d1\u5c40\u73b0\u884c\u300a\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a\u7f16\u5199\u6307\u5357\u300b\u53ca\u76d1\u7ba1\u586b\u62a5\u6a21\u677f<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>8&nbsp; \u9644\u5f55\uff1a\u5185\u90e8\u5ba1\u6838\u4e0e\u4f53\u7cfb\u81ea\u67e5\u6d41\u7a0b\u7b80\u8868<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>1<\/strong><\/td><td><strong>2<\/strong><\/td><td><strong>3<\/strong><\/td><td><strong>4<\/strong><\/td><td><strong>5<\/strong><\/td><td><strong>6<\/strong><\/td><td><strong>7<\/strong><\/td><\/tr><\/thead><tbody><tr><td>\u98ce\u9669\u4e0e\u5e74\u5ea6\u7b56\u5212<br>\u8d28\u91cf\u90e8\/\u7ba1\u7406\u8005\u4ee3\u8868<\/td><td>\u4efb\u547d\u5ba1\u6838\u7ec4<br>\u786e\u8ba4\u72ec\u7acb\u6027\u4e0e\u80fd\u529b<\/td><td>\u51c6\u5907\u8303\u56f4\/\u51c6\u5219\/\u6837\u672c<br>FR-0400-001<\/td><td>\u73b0\u573a\u53d6\u8bc1\u4e0e\u8ffd\u6eaf<br>FR-0400-002<\/td><td>\u7ed3\u8bba\u548c\u62a5\u544a<br>FR-0400-003<\/td><td>\u7ea0\u6b63\/CAPA\u4e0e\u9a8c\u8bc1<br>\u5355\u8868\u95ed\u73af<\/td><td>\u5e74\u5ea6\u81ea\u67e5\u6c47\u603b\u3001\u7b7e\u7f72\u3001\u63d0\u4ea4<br>\u7ba1\u7406\u8bc4\u5ba1\u8f93\u5165<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>9&nbsp; \u8bb0\u5f55\u8868\u5355<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><td><strong>\u7f16\u53f7<\/strong><\/td><td><strong>\u540d\u79f0<\/strong><\/td><td><strong>\u7528\u9014\/\u6700\u5c11\u4fe1\u606f<\/strong><\/td><td><strong>\u4fdd\u7ba1\u8d23\u4efb<\/strong><\/td><\/tr><\/thead><tbody><tr><td>FR-0400-001<\/td><td>\u5e74\u5ea6\u5185\u90e8\u5ba1\u6838\u4e0e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u81ea\u67e5\u8ba1\u5212\/\u5b9e\u65bd\u8868<\/td><td>\u8bb0\u5f55\u5e74\u5ea6\u98ce\u9669\u8f93\u5165\u3001\u5ba1\u6838\u8303\u56f4\u3001\u51c6\u5219\u3001\u9891\u6b21\u3001\u4eba\u5458\u72ec\u7acb\u6027\u3001\u5b9e\u65bd\u5b89\u6392\u3001\u6279\u51c6\u548c\u5b8c\u6210\u72b6\u6001\uff1b\u540c\u4e00\u8868\u5b8c\u6210\u8ba1\u5212\u5230\u5b9e\u65bd\u786e\u8ba4\u3002<\/td><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8<\/td><\/tr><tr><td>FR-0400-002<\/td><td>\u5ba1\u6838\u68c0\u67e5\u8bb0\u5f55\u53ca\u4e0d\u7b26\u5408\u9879\u95ed\u73af\u5355<\/td><td>\u8bb0\u5f55\u5ba2\u89c2\u8bc1\u636e\u3001\u51c6\u5219\u3001\u53d1\u73b0\u3001\u5206\u7c7b\u3001\u98ce\u9669\u8bc4\u4ef7\u3001\u7acb\u5373\u7ea0\u6b63\u3001\u6839\u56e0\/CAPA\u3001\u8d23\u4efb\u548c\u5b8c\u6210\u65e5\u671f\u3001\u6709\u6548\u6027\u9a8c\u8bc1\u3001\u8d28\u91cf\u5173\u95ed\uff1b\u4e00\u9879\u4e0d\u7b26\u5408\u4e00\u5f20\u8868\u3002<\/td><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8<\/td><\/tr><tr><td>FR-0400-003<\/td><td>\u5185\u90e8\u5ba1\u6838\u4e0e\u4f53\u7cfb\u81ea\u67e5\u62a5\u544a<\/td><td>\u8bb0\u5f55\u5ba1\u6838\u76ee\u7684\u3001\u8303\u56f4\u3001\u51c6\u5219\u3001\u5ba1\u6838\u7ec4\u3001\u6982\u51b5\u3001\u53d1\u73b0\u6c47\u603b\u3001\u4f53\u7cfb\u6709\u6548\u6027\u7ed3\u8bba\u3001\u672a\u89e3\u51b3\u4e8b\u9879\u3001\u6539\u8fdb\u5efa\u8bae\u548c\u6279\u51c6\uff1b\u53ef\u4f5c\u4e3a\u5e74\u5ea6\u81ea\u67e5\u8d44\u6599\u7d22\u5f15\u3002<\/td><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8<\/td><\/tr><tr><td>\u5916\u6765\u76d1\u7ba1\u6a21\u677f\uff08\u4e0d\u7f16\u4f01\u4e1aFR\u53f7\uff09<\/td><td>\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u5e74\u5ea6\u81ea\u67e5\u62a5\u544a<\/td><td>\u6309\u56fd\u5bb6\u836f\u76d1\u5c40\u73b0\u884c\u6307\u5357\u548c\u76d1\u7ba1\u7cfb\u7edf\u6a21\u677f\u586b\u62a5\uff1b\u4fdd\u7559\u7b7e\u7f72\u7248\u3001\u9644\u4ef6\u6e05\u5355\u3001\u652f\u6301\u6570\u636e\u53ca\u63d0\u4ea4\u56de\u6267\u3002<\/td><td>\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u672c\u7a0b\u5e8f\u4e0d\u53e6\u8bbeWI\u3002\u5ba1\u6838\u68c0\u67e5\u8981\u70b9\u4f9d\u636e\u5f53\u6b21\u8303\u56f4\u3001\u98ce\u9669\u548c\u9002\u7528\u6cd5\u89c4\u5728FR-0400-001\/002\u4e2d\u5f62\u6210\u6216\u4f5c\u4e3a\u5176\u53d7\u63a7\u9644\u4ef6\uff1b\u6cd5\u89c4\u6a21\u677f\u53d1\u751f\u53d8\u5316\u65f6\uff0c\u76f4\u63a5\u91c7\u7528\u73b0\u884c\u76d1\u7ba1\u6a21\u677f\uff0c\u4e0d\u91cd\u590d\u8f6c\u5236\u4e3a\u4f01\u4e1a\u8868\u5355\u3002<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table 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