{"id":17834,"date":"2026-08-30T00:52:13","date_gmt":"2026-08-30T00:52:13","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17834"},"modified":"2026-05-22T07:45:51","modified_gmt":"2026-05-22T07:45:51","slug":"sop-for-product-recall-in-pharmaceutical","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-product-recall-in-pharmaceutical\/","title":{"rendered":"\u533b\u85ac\u54c1\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"17834\" class=\"elementor elementor-17834\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u3002.<\/p><figure id=\"attachment_17886\" aria-describedby=\"caption-attachment-17886\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-17886\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical.jpg\" alt=\"\u533b\u85ac\u54c1\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\" width=\"1000\" height=\"895\" title=\"\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical-500x448.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical-300x269.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical-768x687.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Product-Recall-in-Pharmaceutical-13x12.jpg 13w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-17886\" class=\"wp-caption-text\"><em><strong>\u533b\u85ac\u54c1\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u3002.<\/strong><\/em><\/figcaption><\/figure><h2><strong>1.0 \u76ee\u7684:<\/strong><\/h2><p>\u6d41\u901a\u5f8c\u306b\u6b20\u9665\u3001\u5b89\u5168\u6027\u4e0a\u306e\u554f\u984c\u3001\u307e\u305f\u306f\u898f\u683c\u5916\u3067\u3042\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u305f\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u3001\u8fc5\u901f\u304b\u3064\u52b9\u679c\u7684\u306a\u56de\u53ce\u3092\u884c\u3046\u305f\u3081\u306e\u7ba1\u7406\u624b\u9806\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u3002.<\/p><h2><strong>2.0 \u7bc4\u56f2:<\/strong><\/h2><p>\u672c\u624b\u9806\u306f\u3001\u88fd\u9020\u62e0\u70b9\u3092\u96e2\u308c\u305f\u3059\u3079\u3066\u306e\u5b8c\u6210\u533b\u85ac\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u6d41\u901a\u30c1\u30a7\u30fc\u30f3\u4e0a\u306e\u88fd\u54c1\u3001\u5378\u58f2\u696d\u8005\u3001\u85ac\u5c40\u3001\u304a\u3088\u3073\u6700\u7d42\u30e6\u30fc\u30b6\u30fc\u306e\u624b\u5143\u306b\u3042\u308b\u88fd\u54c1\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><h2><strong>3.0 \u8cac\u4efb:<\/strong><\/h2><p>\u30ea\u30b3\u30fc\u30eb\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u3001\u54c1\u8cea\u4fdd\u8a3c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u304a\u3088\u3073\u898f\u5236\u5bfe\u5fdc\u62c5\u5f53\u8005<\/p><h2><strong>4.0 \u8aac\u660e\u8cac\u4efb:<\/strong><\/h2><p>\u4ee3\u8868\u53d6\u7de0\u5f79\u517c\u6709\u8cc7\u683c\u8005\uff08QP\uff09\u3002.<\/p><h2><strong>5.0 \u624b\u9806:<\/strong><\/h2><p>5.1 \u30ea\u30b3\u30fc\u30eb\u306f\u3001\u9867\u5ba2\u304b\u3089\u306e\u82e6\u60c5\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u306e\u7d50\u679c\u4e0d\u826f\u3001\u533b\u85ac\u54c1\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u6307\u6458\u3001\u307e\u305f\u306f\u4fdd\u7ba1\u30b5\u30f3\u30d7\u30eb\u306b\u304a\u3051\u308b\u6b20\u9665\u306e\u767a\u898b\u306b\u3088\u3063\u3066\u5f15\u304d\u8d77\u3053\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002.<\/p><p>5.2 \u88fd\u54c1\u306e\u6b20\u9665\u306e\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u793a\u5506\u3059\u308b\u60c5\u5831\u3092\u5165\u624b\u3057\u305f\u8005\u306f\u30011\u55b6\u696d\u6642\u9593\u4ee5\u5185\u306b\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.3 \u54c1\u8cea\u4fdd\u8a3c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001\u5831\u544a\u3092\u53d7\u3051\u53d6\u308a\u6b21\u7b2c\u3001\u30ea\u30b3\u30fc\u30eb\u8a55\u4fa1\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3002\u3053\u306e\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u3001\u88fd\u54c1\u540d\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u5831\u544a\u3055\u308c\u305f\u4e0d\u5177\u5408\u3001\u60c5\u5831\u6e90\u3001\u304a\u3088\u3073\u5831\u544a\u65e5\u304c\u8a18\u9332\u3055\u308c\u308b\u3002.<\/p><p>5.4 QA\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001\u8a55\u4fa1\u30d5\u30a1\u30a4\u30eb\u3092\u958b\u3044\u3066\u304b\u30894\u6642\u9593\u4ee5\u5185\u306b\u30ea\u30b3\u30fc\u30eb\u59d4\u54e1\u4f1a\u306b\u901a\u77e5\u3059\u308b\u3002\u59d4\u54e1\u4f1a\u304c\u4f1a\u5408\u3092\u958b\u304f\u307e\u3067\u306f\u3001\u516c\u5f0f\u58f0\u660e\u3084\u8ca9\u58f2\u696d\u8005\u3078\u306e\u901a\u77e5\u306f\u4e00\u5207\u884c\u308f\u306a\u3044\u3002.<\/p><p>5.4.1 \u307e\u305f\u3001QA\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3053\u306e\u6bb5\u968e\u3067\u30ea\u30b3\u30fc\u30eb\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u3092\u4efb\u547d\u3059\u308b\u3002\u30ea\u30b3\u30fc\u30eb\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u306b\u95a2\u3059\u308b\u65e5\u5e38\u7684\u306a\u7a93\u53e3\u3068\u306a\u308b\u3002\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u671f\u9593\u4e2d\u3001\u8fd4\u54c1\u72b6\u6cc1\u3092\u628a\u63e1\u3057\u3001\u9867\u5ba2\u3068\u306e\u9023\u7d61\u8abf\u6574\u3092\u884c\u3044\u3001\u5404\u90e8\u9580\u9593\u306e\u9023\u643a\u3092\u56f3\u308b\u3002.<\/p><h3><strong>5.5 \u30ea\u30b3\u30fc\u30eb\u306e\u5206\u985e\uff1a<\/strong><\/h3><p>5.5.1 \u5404\u30ea\u30b3\u30fc\u30eb\u306f\u3001\u6b20\u9665\u88fd\u54c1\u304c\u3082\u305f\u3089\u3059\u5065\u5eb7\u30ea\u30b9\u30af\u306e\u30ec\u30d9\u30eb\u306b\u57fa\u3065\u3044\u3066\u5206\u985e\u3055\u308c\u308b\u3002\u3053\u306e\u5206\u985e\u306b\u3088\u3063\u3066\u3001\u30ea\u30b3\u30fc\u30eb\u63aa\u7f6e\u306e\u8fc5\u901f\u3055\u3068\u5fb9\u5e95\u5ea6\u304c\u6c7a\u307e\u308b\u3002.<\/p><h4><strong>5.5.2 3\u3064\u306e\u30ea\u30b3\u30fc\u30eb\u30af\u30e9\u30b9\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u308b\uff1a<\/strong><\/h4><p>5.5.2.1 \u30af\u30e9\u30b9I\uff1a\u5f53\u8a72\u30ed\u30c3\u30c8\u306e\u4f7f\u7528\u306b\u3088\u308a\u3001\u6df1\u523b\u306a\u5065\u5eb7\u88ab\u5bb3\u3084\u6b7b\u4ea1\u306b\u3064\u306a\u304c\u308b\u304a\u305d\u308c\u306e\u3042\u308b\u88fd\u54c1\u3002\u4f8b\u3068\u3057\u3066\u306f\u3001\u6709\u52b9\u6210\u5206\u306e\u8aa4\u308a\u3001\u9ad8\u30ea\u30b9\u30af\u533b\u85ac\u54c1\u306e\u30e9\u30d9\u30eb\u8a18\u8f09\u306e\u8aa4\u308a\u3001\u307e\u305f\u306f\u6709\u6bd2\u306a\u4e0d\u7d14\u7269\u306e\u6df7\u5165\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u308b\u3002.<\/p><p>5.5.2.2 \u30af\u30e9\u30b9 II\uff1a\u4f7f\u7528\u306b\u3088\u308a\u3001\u4e00\u6642\u7684\u307e\u305f\u306f\u533b\u5b66\u7684\u306b\u56de\u5fa9\u53ef\u80fd\u306a\u5065\u5eb7\u88ab\u5bb3\u304c\u751f\u3058\u308b\u304a\u305d\u308c\u306e\u3042\u308b\u88fd\u54c1\u3002\u4f8b\u3068\u3057\u3066\u306f\u3001\u6709\u52b9\u6210\u5206\u542b\u6709\u91cf\u304c\u57fa\u6e96\u672a\u6e80\u306e\u88fd\u54c1\u3001\u6eb6\u51fa\u5ea6\u304c\u898f\u683c\u5916\u3067\u3042\u308b\u88fd\u54c1\u3001\u307e\u305f\u306f\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u533b\u85ac\u54c1\u306b\u304a\u3051\u308b\u8efd\u5fae\u306a\u8868\u793a\u8aa4\u308a\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u308b\u3002.<\/p><p>5.5.2.3 \u30af\u30e9\u30b9 III\uff1a\u5065\u5eb7\u3078\u306e\u60aa\u5f71\u97ff\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027\u306f\u4f4e\u3044\u3082\u306e\u306e\u3001\u54c1\u8cea\u898f\u683c\u3092\u5b8c\u5168\u306b\u6e80\u305f\u3057\u3066\u3044\u306a\u3044\u88fd\u54c1\u3002\u4f8b\u3068\u3057\u3066\u306f\u3001\u5916\u89b3\u4e0a\u306e\u6b20\u9665\u3001\u533b\u85ac\u54c1\u306e\u540c\u5b9a\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3055\u306a\u3044\u5370\u5237\u30df\u30b9\u3001\u307e\u305f\u306f\u8efd\u5fae\u306a\u5305\u88c5\u4e0a\u306e\u4e0d\u5177\u5408\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u308b\u3002.<\/p><p>5.5.3 \u3053\u306e\u5206\u985e\u306f\u3001\u88fd\u54c1\u306e\u30ea\u30b9\u30af\u3001\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u65e2\u77e5\u306e\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3092\u5be9\u67fb\u3057\u305f\u4e0a\u3067\u3001\u30ea\u30b3\u30fc\u30eb\u59d4\u54e1\u4f1a\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u308b\u3002.<\/p><p>5.5.4 2\u3064\u306e\u5206\u985e\u306e\u5883\u754c\u7dda\u4e0a\u306b\u3042\u308b\u4e8b\u4f8b\u306b\u3064\u3044\u3066\u306f\u3001\u5e38\u306b\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u65b9\u306e\u5206\u985e\u306b\u5272\u308a\u5f53\u3066\u3089\u308c\u308b\u3002\u30ea\u30b3\u30fc\u30eb\u306e\u6c7a\u5b9a\u306b\u304a\u3044\u3066\u306f\u3001\u3044\u304b\u306a\u308b\u5834\u5408\u306b\u304a\u3044\u3066\u3082\u3001\u60a3\u8005\u306e\u5b89\u5168\u304c\u5546\u696d\u7684\u5f71\u97ff\u3088\u308a\u3082\u512a\u5148\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.6 \u30ea\u30b3\u30fc\u30eb\u59d4\u54e1\u4f1a\uff1a<\/strong><\/h3><p>5.6.1 \u30ea\u30b3\u30fc\u30eb\u59d4\u54e1\u4f1a\u306f\u5e38\u8a2d\u306e\u7d44\u7e54\u3067\u3042\u308a\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u304b\u3089\u306e\u901a\u77e5\u3092\u53d7\u3051\u3066\u304b\u30894\u6642\u9593\u4ee5\u5185\u306b\u62db\u96c6\u3055\u308c\u308b\u3002\u540c\u59d4\u54e1\u4f1a\u306f\u3001\u3059\u3079\u3066\u306e\u30ea\u30b3\u30fc\u30eb\u63aa\u7f6e\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u6a29\u9650\u3092\u6709\u3059\u308b\u3002.<\/p><h4><strong>5.6.2 \u59d4\u54e1\u4f1a\u306e\u69cb\u6210\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\uff1a<\/strong><\/h4><p>5.6.2.1 \u4ee3\u8868\u53d6\u7de0\u5f79\u3001\u307e\u305f\u306f\u6307\u540d\u3055\u308c\u305f\u4ee3\u7406\u4eba\u304c\u8b70\u9577\u3092\u52d9\u3081\u308b\u3002.<\/p><p>5.6.2.2 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001\u66f8\u8a18\u304a\u3088\u3073\u8a18\u9332\u62c5\u5f53\u8005\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u62c5\u3046\u3002.<\/p><p>5.6.2.3 \u5bfe\u5916\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u62c5\u5f53\u3059\u308b\u898f\u5236\u696d\u52d9\u62c5\u5f53\u8005\u3002.<\/p><p>5.6.2.4 \u30d0\u30c3\u30c1\u5c65\u6b74\u304a\u3088\u3073\u88fd\u9020\u30ec\u30d3\u30e5\u30fc\u306e\u305f\u3081\u306e\u751f\u7523\u8cac\u4efb\u8005\u3002.<\/p><p>5.6.2.5 \u5206\u6790\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u62c5\u5f53\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u8cac\u4efb\u8005\u3002.<\/p><p>5.6.2.6 \u6d41\u901a\u30c1\u30a7\u30fc\u30f3\u304a\u3088\u3073\u9867\u5ba2\u5bfe\u5fdc\u3092\u62c5\u5f53\u3059\u308b\u55b6\u696d\u8cac\u4efb\u8005\u3002.<\/p><p>5.6.2.7 \u8cac\u4efb\u304a\u3088\u3073\u5951\u7d04\u5be9\u67fb\u306b\u95a2\u3059\u308b\u6cd5\u52d9\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3002.<\/p><p>5.6.3 \u59d4\u54e1\u4f1a\u59d4\u54e1\u9577\u306f\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u4ed6\u306e\u59d4\u54e1\u3092\u88dc\u5145\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u30af\u30e9\u30b9I\u306e\u30ea\u30b3\u30fc\u30eb\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306f\u3001\u533b\u7642\u9867\u554f\u304c1\u540d\u52a0\u308f\u308b\u3002.<\/p><p>5.6.4 \u59d4\u54e1\u4f1a\u306e\u6c7a\u5b9a\u306f\u3001\u53ef\u80fd\u306a\u9650\u308a\u5408\u610f\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u308b\u3002\u5408\u610f\u306b\u81f3\u3089\u306a\u3044\u5834\u5408\u306f\u3001\u8b70\u9577\u306f\u5404\u59d4\u54e1\u306e\u610f\u898b\u3092\u8074\u53d6\u3057\u305f\u4e0a\u3067\u3001\u6700\u7d42\u7684\u306a\u6c7a\u5b9a\u3092\u4e0b\u3059\u3002.<\/p><p>5.6.5 \u59d4\u54e1\u4f1a\u306e\u6c7a\u5b9a\u306f\u3059\u3079\u3066\u3001\u300c\u30ea\u30b3\u30fc\u30eb\u6c7a\u5b9a\u8a18\u9332\u300d\u306b\u8a18\u9332\u3055\u308c\u308b\u3002\u5404\u8a18\u9332\u306b\u306f\u3001\u6c7a\u5b9a\u5185\u5bb9\u3001\u51fa\u5e2d\u59d4\u54e1\u3001\u53cd\u5bfe\u610f\u898b\u306e\u6709\u7121\u3001\u304a\u3088\u3073\u65e5\u6642\u304c\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><p>5.6.6 \u6700\u521d\u306e\u59d4\u54e1\u4f1a\u4f1a\u8b70\u306b\u304a\u3044\u3066\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u533a\u5206\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u7bc4\u56f2\uff081\u30ed\u30c3\u30c8\u307e\u305f\u306f\u8907\u6570\u306e\u30ed\u30c3\u30c8\uff09\u3001\u304a\u3088\u3073\u30ea\u30b3\u30fc\u30eb\u306e\u6df1\u5ea6\uff08\u5378\u58f2\u3001\u5c0f\u58f2\u3001\u307e\u305f\u306f\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u30ec\u30d9\u30eb\uff09\u3092\u6c7a\u5b9a\u3059\u308b\u3002.<\/p><p>5.6.7 \u59d4\u54e1\u4f1a\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u624b\u7d9a\u304d\u304c\u9032\u884c\u4e2d\u306e\u9593\u3001\u5c11\u306a\u304f\u3068\u3082\u9031\u306b1\u56de\u958b\u50ac\u3055\u308c\u308b\u3002\u7dca\u6025\u4f1a\u8b70\u306f\u3001\u59d4\u54e1\u9577\u307e\u305f\u306f\u59d4\u54e12\u540d\u306b\u3088\u3063\u3066\u3044\u3064\u3067\u3082\u62db\u96c6\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p><p>5.7 \u898f\u5236\u5f53\u5c40\u3078\u306e\u5c4a\u51fa\uff1a<\/p><p>5.7.1 \u78ba\u5b9a\u3057\u305f\u30ea\u30b3\u30fc\u30eb\u306f\u3001\u95a2\u4fc2\u3059\u308b\u898f\u5236\u5f53\u5c40\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5831\u544a\u671f\u9650\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u5206\u985e\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u3002.<\/p><h4><strong>5.7.2 \u901a\u77e5\u306e\u671f\u9650\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/strong><\/h4><p>5.7.2.1 \u30af\u30e9\u30b9I\u30ea\u30b3\u30fc\u30eb\uff1a\u6c7a\u5b9a\u304b\u308924\u6642\u9593\u4ee5\u5185\u306b\u6240\u7ba1\u5f53\u5c40\u306b\u901a\u77e5\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.7.2.2 \u30af\u30e9\u30b9 II \u30ea\u30b3\u30fc\u30eb\uff1a72 \u6642\u9593\u4ee5\u5185\u306b\u901a\u77e5\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.7.2.3 \u30af\u30e9\u30b9III\u306e\u30ea\u30b3\u30fc\u30eb\uff1a7\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u901a\u77e5\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.7.3 \u898f\u5236\u5bfe\u5fdc\u62c5\u5f53\u8005\u306f\u3001\u627f\u8a8d\u6e08\u307f\u306e\u66f8\u5f0f\u3092\u7528\u3044\u3066\u898f\u5236\u5f53\u5c40\u5411\u3051\u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3002\u3053\u306e\u901a\u77e5\u66f8\u306b\u306f\u3001\u88fd\u54c1\u306e\u8a73\u7d30\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u6b20\u9665\u306e\u8aac\u660e\u3001\u5065\u5eb7\u30ea\u30b9\u30af\u3001\u304a\u3088\u3073\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u30ea\u30b3\u30fc\u30eb\u306e\u7bc4\u56f2\u304c\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><p>5.7.4 \u9069\u683c\u62c5\u5f53\u8005\u306f\u3001\u901a\u77e5\u66f8\u3092\u9001\u4ed8\u3059\u308b\u524d\u306b\u3053\u308c\u306b\u7f72\u540d\u3059\u308b\u3002\u7f72\u540d\u6e08\u307f\u306e\u5199\u3057\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u30fb\u30de\u30b9\u30bf\u30fc\u30fb\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u7ba1\u3055\u308c\u308b\u3002.<\/p><p>5.7.5 \u5f53\u5c40\u304b\u3089\u306e\u8ffd\u52a0\u60c5\u5831\u306e\u7167\u4f1a\u306b\u306f\u300124\u6642\u9593\u4ee5\u5185\u306b\u56de\u7b54\u3059\u308b\u3002\u3059\u3079\u3066\u306e\u901a\u4fe1\u8a18\u9332\u306f\u8a18\u9332\u3055\u308c\u3001\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u7ba1\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.8 \u9867\u5ba2\u304a\u3088\u3073\u8ca9\u58f2\u4ee3\u7406\u5e97\u3078\u306e\u901a\u77e5\uff1a<\/strong><\/h3><p>5.8.1 \u55b6\u696d\u30c1\u30fc\u30e0\u306f\u3001\u51fa\u8377\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30ed\u30c3\u30c8\u306b\u3064\u3044\u3066\u3001\u6700\u65b0\u306e\u914d\u5e03\u30ea\u30b9\u30c8\u3092\u7ba1\u7406\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u30ea\u30b9\u30c8\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u306b\u95a2\u3059\u308b\u9023\u7d61\u3092\u884c\u3046\u969b\u306e\u8d77\u70b9\u3068\u306a\u308b\u3002.<\/p><p>5.8.2 \u627f\u8a8d\u6e08\u307f\u306e\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u4f7f\u7528\u3057\u3066\u3001\u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u3092\u4f5c\u6210\u3059\u308b\u3002\u901a\u77e5\u306b\u306f\u3001\u88fd\u54c1\u540d\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u6709\u52b9\u671f\u9650\u3001\u6b20\u9665\u306e\u7a2e\u985e\u3001\u53d7\u9818\u8005\u306b\u6c42\u3081\u3089\u308c\u308b\u5bfe\u5fdc\u3001\u304a\u3088\u3073\u30ea\u30b3\u30fc\u30eb\u62c5\u5f53\u8005\u306e\u9023\u7d61\u5148\u3092\u8a18\u8f09\u3059\u308b\u3002.<\/p><p>5.8.3 \u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u306f\u3001\u5b9f\u7528\u4e0a\u6700\u3082\u8fc5\u901f\u306a\u65b9\u6cd5\u3067\u9001\u4ed8\u3059\u308b\u3002\u53d6\u5f15\u5148\u306b\u5bfe\u3057\u3066\u306f\u3001\u96fb\u5b50\u30e1\u30fc\u30eb\u304a\u3088\u3073\u30d5\u30a1\u30c3\u30af\u30b9\u3092\u4f7f\u7528\u3059\u308b\u3002\u66f8\u7559\u90f5\u4fbf\u306f\u3001\u4e88\u5099\u624b\u6bb5\u304a\u3088\u3073\u516c\u5f0f\u8a18\u9332\u3068\u3057\u3066\u4f7f\u7528\u3059\u308b\u3002.<\/p><p>5.8.4 \u66f8\u9762\u306b\u3088\u308b\u901a\u77e5\u3092\u9001\u4ed8\u3057\u305f\u5f8c\u3001\u5404\u9867\u5ba2\u306b\u96fb\u8a71\u3067\u9023\u7d61\u3059\u308b\u3002\u53e3\u982d\u3067\u306e\u9023\u7d61\u306b\u3088\u308a\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u901a\u77e5\u304c\u78ba\u5b9f\u306b\u53d7\u3051\u53d6\u3089\u308c\u3001\u7406\u89e3\u3055\u308c\u305f\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p><p>5.8.5 \u5c0f\u58f2\u6bb5\u968e\u3067\u306e\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u3044\u3066\u306f\u3001\u696d\u754c\u8a8c\u3068\u9023\u643a\u3057\u3066\u516c\u544a\u3092\u63b2\u8f09\u3059\u308b\u3002\u3053\u306e\u516c\u544a\u306f\u3001\u898f\u5236\u5f53\u5c40\u304c\u5b9a\u3081\u305f\u671f\u9650\u5185\u306b\u696d\u754c\u8a8c\u306b\u63b2\u8f09\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.8.6 \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u3092\u5bfe\u8c61\u3068\u3059\u308b\u30af\u30e9\u30b9I\u306e\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u3044\u3066\u306f\u3001\u627f\u8a8d\u3055\u308c\u305f\u5358\u4e00\u306e\u5e83\u5831\u62c5\u5f53\u8005\u3092\u901a\u3058\u3066\u30e1\u30c7\u30a3\u30a2\u3078\u306e\u5bfe\u5fdc\u3092\u884c\u3046\u3053\u3068\u3002\u4ed6\u306e\u8077\u54e1\u306b\u3088\u308b\u975e\u516c\u5f0f\u306a\u767a\u8a00\u306f\u4e00\u5207\u8a8d\u3081\u306a\u3044\u3053\u3068\u3002.<\/p><h3>5.9 \u88fd\u54c1\u306e\u56de\u53ce\u304a\u3088\u3073\u9694\u96e2\uff1a<\/h3><p>5.9.1 \u5009\u5eab\u5185\u306b\u30ea\u30b3\u30fc\u30eb\u5c02\u7528\u306e\u9694\u96e2\u30a8\u30ea\u30a2\u3092\u8a2d\u7f6e\u3059\u308b\u3002\u5f53\u8a72\u30a8\u30ea\u30a2\u306b\u306f\u8d64\u3044\u300cRECALL\u300d\u306e\u30e9\u30d9\u30eb\u3092\u660e\u78ba\u306b\u8868\u793a\u3057\u3001\u9375\u3092\u304b\u3051\u3066\u7ba1\u7406\u3059\u308b\u3002.<\/p><p>5.9.2 \u8fd4\u54c1\u3055\u308c\u305f\u88fd\u54c1\u306f\u3001\u5dee\u51fa\u4eba\u306b\u3088\u308b\u8a18\u5165\u6e08\u307f\u306e\u8fd4\u54c1\u30d5\u30a9\u30fc\u30e0\u304c\u6dfb\u4ed8\u3055\u308c\u305f\u72b6\u614b\u3067\u691c\u75ab\u30a8\u30ea\u30a2\u306b\u5230\u7740\u3059\u308b\u3002\u3053\u306e\u30d5\u30a9\u30fc\u30e0\u306b\u306f\u3001\u5dee\u51fa\u4eba\u306e\u8a73\u7d30\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u8fd4\u54c1\u6570\u91cf\u3001\u8fd4\u54c1\u65e5\u3001\u304a\u3088\u3073\u8fd4\u54c1\u6642\u306e\u88fd\u54c1\u306e\u72b6\u614b\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.9.3 \u914d\u5e03\u30ea\u30b9\u30c8\u3092\u7528\u3044\u3066\u3001\u8fd4\u5374\u6570\u91cf\u3068\u914d\u5e03\u6570\u91cf\u3092\u7167\u5408\u3059\u308b\u3002\u56de\u53ce\u7387\u3092\u3001\u7dcf\u914d\u5e03\u6570\u91cf\u306b\u5bfe\u3059\u308b\u5272\u5408\u3068\u3057\u3066\u7b97\u51fa\u3059\u308b\u3002.<\/p><p>5.9.4 \u30ea\u30b3\u30fc\u30eb\u5bfe\u8c61\u88fd\u54c1\u3092\u3001\u3044\u304b\u306a\u308b\u6642\u70b9\u306b\u304a\u3044\u3066\u3082\u6b63\u5e38\u306a\u5728\u5eab\u3068\u6df7\u5408\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u9694\u96e2\u30a8\u30ea\u30a2\u306f\u7269\u7406\u7684\u306b\u5206\u96e2\u3055\u308c\u3066\u304a\u308a\u3001\u72ec\u81ea\u306e\u5728\u5eab\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u5099\u3048\u3066\u3044\u308b\u3002\u7acb\u3061\u5165\u308a\u306f\u3001\u6307\u5b9a\u3055\u308c\u305f\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u62c5\u5f53\u8005\u304a\u3088\u3073\u5009\u5eab\u62c5\u5f53\u8005\u306b\u9650\u5b9a\u3055\u308c\u308b\u3002.<\/p><p>5.9.5 \u8fd4\u54c1\u3055\u308c\u305f\u88fd\u54c1\u306f\u3001\u5143\u306e\u4fdd\u7ba1\u4ed5\u69d8\u306e\u6761\u4ef6\u3068\u540c\u3058\u6761\u4ef6\u4e0b\u3067\u4fdd\u7ba1\u3059\u308b\u3053\u3068\u3002\u30ea\u30b3\u30fc\u30eb\u3055\u308c\u305f\u30ef\u30af\u30c1\u30f3\u306f\u3001\u6700\u7d42\u51e6\u5206\u304c\u884c\u308f\u308c\u308b\u307e\u3067\u30b3\u30fc\u30eb\u30c9\u30c1\u30a7\u30fc\u30f3\u3092\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u30ea\u30b3\u30fc\u30eb\u3055\u308c\u305f\u7d4c\u53e3\u56fa\u5f62\u88fd\u5264\u306f\u3001\u5f15\u304d\u7d9a\u304d\u6e7f\u6c17\u3084\u5149\u304b\u3089\u4fdd\u8b77\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p><p>5.9.6 QA\u306f\u3001\u9694\u96e2\u63aa\u7f6e\u304b\u308930\u65e5\u4ee5\u5185\u306b\u3001\u8fd4\u54c1\u3055\u308c\u305f\u88fd\u54c1\u306e\u51e6\u5206\u65b9\u6cd5\u3092\u6c7a\u5b9a\u3059\u308b\u3002\u51e6\u5206\u65b9\u6cd5\u3068\u3057\u3066\u306f\u3001\u518d\u52a0\u5de5\uff08\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u304c\u5f97\u3089\u308c\u305f\u9650\u5b9a\u7684\u306a\u5834\u5408\u306b\u9650\u308b\uff09\u3001\u8ffd\u52a0\u8a66\u9a13\u3001\u307e\u305f\u306f\u5ec3\u68c4\u304c\u3042\u308b\u3002.<\/p><p>5.9.7 \u30ea\u30b3\u30fc\u30eb\u5bfe\u8c61\u88fd\u54c1\u306e\u5ec3\u68c4\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u62c5\u5f53\u8005\u304c\u7acb\u3061\u4f1a\u3044\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u898f\u5236\u5f53\u5c40\u306e\u691c\u67fb\u5b98\u3082\u7acb\u3061\u4f1a\u3046\u3002\u5ec3\u68c4\u306e\u90fd\u5ea6\u3001\u300c\u5ec3\u68c4\u8a3c\u660e\u66f8\u300d\u304c\u767a\u884c\u3055\u308c\u3001\u305d\u3053\u306b\u306f\u5ec3\u68c4\u65b9\u6cd5\u3001\u6570\u91cf\u3001\u65e5\u4ed8\u3001\u304a\u3088\u3073\u7acb\u3061\u4f1a\u8005\u306e\u7f72\u540d\u304c\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><p>5.9.8 \u88fd\u54c1\u306e\u7a2e\u985e\u3054\u3068\u306b\u3001\u627f\u8a8d\u3055\u308c\u305f\u5ec3\u68c4\u65b9\u6cd5\u3092\u7528\u3044\u308b\u3053\u3068\u3002\u56fa\u5f62\u88fd\u5264\u306b\u3064\u3044\u3066\u306f\u3001\u713c\u5374\u304c\u6a19\u6e96\u7684\u306a\u65b9\u6cd5\u3067\u3042\u308b\u3002\u7279\u5b9a\u306e\u6db2\u4f53\u306b\u3064\u3044\u3066\u306f\u3001\u5ec3\u68c4\u524d\u306b\u7ba1\u7406\u3055\u308c\u305f\u5316\u5b66\u7684\u51e6\u7406\u3092\u884c\u3046\u3002.<\/p><h3><strong>5.10 \u30ea\u30b3\u30fc\u30eb\u306e\u6709\u52b9\u6027\u78ba\u8a8d\uff1a<\/strong><\/h3><p>5.10.1 \u6709\u52b9\u6027\u30c1\u30a7\u30c3\u30af\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u304c\u5bfe\u8c61\u8005\u306b\u3069\u306e\u7a0b\u5ea6\u5230\u9054\u3057\u305f\u304b\u3092\u6e2c\u5b9a\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u30c1\u30a7\u30c3\u30af\u306f\u3001\u6700\u521d\u306e\u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u304b\u308914\u65e5\u4ee5\u5185\u306b\u958b\u59cb\u3055\u308c\u307e\u3059\u3002.<\/p><p>5.10.2 \u914d\u5e03\u30ea\u30b9\u30c8\u8f09\u306e\u9867\u5ba2\u306e\u4e2d\u304b\u3089\u300110%\u306e\u7121\u4f5c\u70ba\u62bd\u51fa\u3092\u884c\u3044\u307e\u3059\u3002\u5404\u9867\u5ba2\u306b\u9023\u7d61\u3092\u53d6\u308a\u3001\u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u306e\u53d7\u9818\u72b6\u6cc1\u304a\u3088\u3073\u8b1b\u3058\u305f\u63aa\u7f6e\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.10.3 \u8a31\u5bb9\u3055\u308c\u308b\u6700\u4f4e\u6709\u52b9\u6027\u306f\u3001\u30af\u30e9\u30b9I\u306e\u30ea\u30b3\u30fc\u30eb\u3067\u306f95%\u3001\u30af\u30e9\u30b9II\u3067\u306f90%\u3001\u30af\u30e9\u30b9III\u3067\u306f80%\u3067\u3042\u308b\u3002.<\/p><p>5.10.4 \u6709\u52b9\u7387\u304c\u57fa\u6e96\u5024\u3092\u4e0b\u56de\u3063\u305f\u5834\u5408\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u53d6\u308a\u7d44\u307f\u3092\u62e1\u5927\u3059\u308b\u3002\u5177\u4f53\u7684\u306a\u65b9\u6cd5\u3068\u3057\u3066\u306f\u30012\u56de\u76ee\u306e\u901a\u77e5\u3001\u4e3b\u8981\u9867\u5ba2\u3078\u306e\u76f4\u63a5\u8a2a\u554f\u3001\u3042\u308b\u3044\u306f\u3088\u308a\u5e83\u7bc4\u306a\u5e83\u5831\u6d3b\u52d5\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u308b\u3002.<\/p><p>5.10.5 \u6709\u52b9\u6027\u78ba\u8a8d\u306e\u7d50\u679c\u306f\u3059\u3079\u3066\u3001\u300c\u30ea\u30b3\u30fc\u30eb\u6709\u52b9\u6027\u5831\u544a\u66f8\u300d\u306b\u8a18\u8f09\u3059\u308b\u3002\u3053\u306e\u5831\u544a\u66f8\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u59d4\u54e1\u4f1a\u306b\u63d0\u51fa\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u8981\u8acb\u304c\u3042\u3063\u305f\u5834\u5408\u306b\u306f\u898f\u5236\u5f53\u5c40\u306b\u3082\u63d0\u51fa\u3059\u308b\u3002.<\/p><h3><strong>5.11 \u6839\u672c\u539f\u56e0\u3068\u662f\u6b63\u63aa\u7f6e\uff1a<\/strong><\/h3><p>5.11.1 \u30ea\u30b3\u30fc\u30eb\u8abf\u67fb\u306f\u3001\u30ea\u30b3\u30fc\u30eb\u63aa\u7f6e\u3068\u4e26\u884c\u3057\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3002\u3053\u306e\u8abf\u67fb\u306b\u3088\u308a\u3001\u6b20\u9665\u306e\u6839\u672c\u539f\u56e0\u3092\u7279\u5b9a\u3057\u3001\u518d\u767a\u3092\u9632\u6b62\u3059\u308b\u305f\u3081\u306e\u662f\u6b63\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u3002.<\/p><p>5.11.2 \u8abf\u67fb\u30c1\u30fc\u30e0\u306fQA\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u304c\u7387\u3044\u3001\u5f71\u97ff\u3092\u53d7\u3051\u305f\u5404\u6a5f\u80fd\u5206\u91ce\u306e\u6280\u8853\u5c02\u9580\u5bb6\u3067\u69cb\u6210\u3055\u308c\u308b\u3002.<\/p><p>5.11.3 \u30d5\u30a3\u30c3\u30b7\u30e5\u30dc\u30fc\u30f3\u56f3\u3084\u300c5\u3064\u306e\u306a\u305c\u300d\u5206\u6790\u306a\u3069\u306e\u69cb\u9020\u5316\u3055\u308c\u305f\u6839\u672c\u539f\u56e0\u5206\u6790\u30c4\u30fc\u30eb\u3092\u4f7f\u7528\u3059\u308b\u3002\u63a1\u7528\u3057\u305f\u30c4\u30fc\u30eb\u306f\u3001\u8abf\u67fb\u7d50\u679c\u3068\u3068\u3082\u306b\u30ea\u30b3\u30fc\u30eb\u30d5\u30a1\u30a4\u30eb\u306e\u4e00\u90e8\u3068\u3057\u3066\u8a18\u9332\u3055\u308c\u308b\u3002.<\/p><p>5.11.4 \u662f\u6b63\u63aa\u7f6e\u306f\u3001\u5f53\u9762\u306e\u6b20\u9665\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u88fd\u54c1\u3084\u30ed\u30c3\u30c8\u306b\u304a\u3051\u308b\u540c\u69d8\u306e\u30ea\u30b9\u30af\u306b\u5bfe\u51e6\u3059\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u65bd\u8a2d\u306eGMP\u67a0\u7d44\u307f\u306e\u4e0b\u3067\u8ffd\u8de1\u3067\u304d\u308b\u3088\u3046\u3001CAPA\u30b7\u30b9\u30c6\u30e0\u306b\u63aa\u7f6e\u5185\u5bb9\u3092\u8a18\u9332\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.11.5 90\u65e5\u5f8c\u306b\u3001\u5404\u662f\u6b63\u63aa\u7f6e\u306e\u6709\u52b9\u6027\u3092\u691c\u8a3c\u3059\u308b\u3002\u691c\u8a3c\u306b\u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u5834\u5408\u306f\u3001\u65b0\u305f\u306a\u8abf\u67fb\u30b5\u30a4\u30af\u30eb\u304c\u958b\u59cb\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.12 \u30ea\u30b3\u30fc\u30eb\u8a13\u7df4\u306e\u6a21\u64ec\u6f14\u7fd2\uff1a<\/strong><\/h3><p>5.12.1 \u5f53\u5de5\u5834\u3067\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u5e74\u306b1\u56de\u3001\u30ea\u30b3\u30fc\u30eb\u6a21\u64ec\u8a13\u7df4\u3092\u5b9f\u65bd\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u8a13\u7df4\u3067\u306f\u3001\u5b9f\u969b\u306e\u9867\u5ba2\u3092\u5dfb\u304d\u8fbc\u3080\u3053\u3068\u306a\u304f\u3001\u30ea\u30b3\u30fc\u30eb\u4f53\u5236\u306e\u691c\u8a3c\u3092\u884c\u3046\u3002.<\/p><p>5.12.2 \u3053\u306e\u6f14\u7fd2\u3067\u306f\u3001\u904e\u53bb12\u304b\u6708\u9593\u306e\u751f\u7523\u30ed\u30c3\u30c8\u306e\u4e2d\u304b\u3089\u30e9\u30f3\u30c0\u30e0\u306b1\u3064\u3092\u9078\u629e\u3057\u307e\u3059\u3002\u30c1\u30fc\u30e0\u306f\u3001\u6d41\u901a\u30ea\u30b9\u30c8\u3092\u901a\u3058\u3066\u305d\u306e\u30ed\u30c3\u30c8\u304c\u6700\u7d42\u9867\u5ba2\u306b\u5c4a\u304f\u307e\u3067\u306e\u6d41\u308c\u3092\u8ffd\u8de1\u3057\u307e\u3059\u3002.<\/p><p>5.12.3 \u3053\u306e\u6f14\u7fd2\u306e\u76ee\u6a19\u306f\u300124\u6642\u9593\u4ee5\u5185\u306b\u3001\u6d41\u901a\u8a18\u9332\u3092\u901a\u3058\u3066\u3001\u9078\u5b9a\u3055\u308c\u305f\u30ed\u30c3\u30c8\u306e\u3046\u3061\u5c11\u306a\u304f\u3068\u308295%\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u76ee\u6a19\u3092\u9054\u6210\u3067\u304d\u306a\u304b\u3063\u305f\u6f14\u7fd2\u306b\u3064\u3044\u3066\u306f\u3001\u6d41\u901a\u30ea\u30b9\u30c8\u307e\u305f\u306f\u30ea\u30b3\u30fc\u30eb\u30d7\u30ed\u30bb\u30b9\u306e\u6539\u5584\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p><p>5.12.4 \u8a13\u7df4\u306e\u7d50\u679c\u3092\u300c\u6a21\u64ec\u30ea\u30b3\u30fc\u30eb\u5831\u544a\u66f8\u300d\u306b\u8a18\u9332\u3059\u308b\u3002\u4e0d\u5099\u4e8b\u9805\u304a\u3088\u3073\u662f\u6b63\u63aa\u7f6e\u306b\u3064\u3044\u3066\u306f\u3001CAPA\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3059\u308b\u3002.<\/p><h3><strong>5.13 \u30ea\u30b3\u30fc\u30eb\u306e\u7d42\u4e86\uff1a<\/strong><\/h3><p>5.13.1 \u30ea\u30b3\u30fc\u30eb\u306f\u3001\u8fd4\u54c1\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u88fd\u54c1\u306b\u3064\u3044\u3066\u78ba\u8a8d\u304c\u5b8c\u4e86\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u304c\u691c\u8a3c\u3055\u308c\u305f\u5f8c\u306b\u306e\u307f\u7d42\u4e86\u3068\u3059\u308b\u3002.<\/p><p>5.13.2 \u5f53\u8a72\u4e8b\u8c61\u3001\u56de\u53ce\u7387\u3001\u6709\u52b9\u7387\u3001\u6839\u672c\u539f\u56e0\u3001\u304a\u3088\u3073\u5b9f\u65bd\u3055\u308c\u305f\u662f\u6b63\u63aa\u7f6e\u3092\u307e\u3068\u3081\u305f\u6700\u7d42\u30ea\u30b3\u30fc\u30eb\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3002.<\/p><p>5.13.3 \u5831\u544a\u66f8\u306b\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u3001\u6709\u8cc7\u683c\u8005\u3001\u304a\u3088\u3073\u4ee3\u8868\u53d6\u7de0\u5f79\u304c\u7f72\u540d\u3059\u308b\u3002.<\/p><p>5.13.4 \u6700\u7d42\u30ea\u30b3\u30fc\u30eb\u5831\u544a\u66f8\u3092\u898f\u5236\u5f53\u5c40\u306b\u63d0\u51fa\u3059\u308b\u3002\u5f53\u5c40\u306f\u3001\u5831\u544a\u66f8\u306e\u5185\u5bb9\u306b\u554f\u984c\u304c\u306a\u3044\u3068\u5224\u65ad\u3057\u305f\u5834\u5408\u3001\u6b63\u5f0f\u306a\u7d42\u4e86\u901a\u77e5\u66f8\u3092\u767a\u884c\u3059\u308b\u3002.<\/p><p>5.13.5 \u3059\u3079\u3066\u306e\u30ea\u30b3\u30fc\u30eb\u8a18\u9332\u306f\u3001\u6700\u4f4e5\u5e74\u9593\u3001\u307e\u305f\u306f\u88fd\u54c1\u306e\u4fdd\u5b58\u671f\u9593\u306b1\u5e74\u3092\u52a0\u3048\u305f\u671f\u9593\u306e\u3046\u3061\u3001\u3044\u305a\u308c\u304b\u9577\u3044\u65b9\u306e\u671f\u9593\u3001\u4fdd\u7ba1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><h3><strong>5.14 \u8a18\u9332\uff1a<\/strong><\/h3><p>5.14.1 \u30ea\u30b3\u30fc\u30eb\u6c7a\u5b9a\u30ed\u30b0\u3002.<\/p><p>5.14.2 \u898f\u5236\u306b\u57fa\u3065\u304f\u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u66f8\u3002.<\/p><p>5.14.3 \u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306e\u547c\u3073\u51fa\u3057\u3002.<\/p><p>5.14.4 \u914d\u5e03\u30ea\u30b9\u30c8\u3002.<\/p><p>5.14.5 \u30ea\u30b3\u30fc\u30eb\u901a\u77e5\u3002.<\/p><p>5.14.6 \u8fd4\u54c1\u7533\u8fbc\u66f8\u3002.<\/p><p>5.14.7 \u5ec3\u68c4\u8a3c\u660e\u66f8\u3002.<\/p><p>5.14.8 \u30ea\u30b3\u30fc\u30eb\u306e\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u5831\u544a\u66f8\u3002.<\/p><p>5.14.9 \u6a21\u64ec\u30ea\u30b3\u30fc\u30eb\u5831\u544a\u66f8\u3002.<\/p><p>5.14.10 \u6700\u7d42\u30ea\u30b3\u30fc\u30eb\u5831\u544a\u66f8\u3002.<\/p><h2><strong>6.0 \u7565\u8a9e:<\/strong><\/h2><p><strong>6.1 \u6a19\u6e96\u64cd\u4f5c\u624b\u9806:<\/strong> \u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u3002.<\/p><p><strong>6.2 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\uff1a<\/strong> \u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p><p><strong>6.3 QP\uff1a<\/strong> \u6709\u8cc7\u683c\u8005\u3002.<\/p><p><strong>6.4 CAPA\uff1a<\/strong> \u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3002.<\/p><p><strong>6.5 GMP\uff1a<\/strong> \u9069\u6b63\u88fd\u9020\u898f\u7bc4\u3002.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Standard operating procedure of Product Recall in the Pharmaceutical Industry. 1.0 OBJECTIVE: To establish a controlled procedure for the prompt [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17886,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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