{"id":9682,"date":"2026-01-13T02:12:39","date_gmt":"2026-01-13T02:12:39","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=9682"},"modified":"2026-05-05T15:52:35","modified_gmt":"2026-05-05T15:52:35","slug":"sop-for-rapid-mixer-granulator","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-rapid-mixer-granulator\/","title":{"rendered":"\u9ad8\u901f\u30df\u30ad\u30b5\u30fc\u9020\u7c92\u6a5f\u306eSOP"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9682\" class=\"elementor elementor-9682\" 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<figure id=\"attachment_9684\" aria-describedby=\"caption-attachment-9684\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9684\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator.jpg\" alt=\"\u9ad8\u901f\u30df\u30ad\u30b5\u30fc\u9020\u7c92\u6a5f\u306eSOP\" width=\"1000\" height=\"993\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-500x497.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-100x100.jpg 100w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-300x298.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-150x150.jpg 150w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-768x763.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/01\/sop-for-rapid-mixer-granulator-12x12.jpg 12w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-9684\" class=\"wp-caption-text\"><em><strong>\u9ad8\u901f\u30df\u30ad\u30b5\u30fc\u9020\u7c92\u6a5f\u306e SOP\u3002.<\/strong><\/em><\/figcaption><\/figure><h2><strong><b>1.0 \u76ee\u7684:<\/b><\/strong><\/h2><p>1.1 \u3053\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3067\u306f\u3001Rapid Mixer Granulator \u3092\u5b89\u5168\u304b\u3064\u6b63\u3057\u304f\u64cd\u4f5c\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p><p>1.2 \u6bce\u56de\u3001\u3059\u3079\u3066\u306e\u30d0\u30c3\u30c1\u304b\u3089\u4e00\u8cab\u3057\u305f\u9846\u7c92\u304c\u5f97\u3089\u308c\u308b\u3053\u3068\u3092\u671b\u3093\u3067\u3044\u307e\u3059\u3002.<\/p><p>1.3 \u3053\u306e SOP \u306b\u5f93\u3046\u3053\u3068\u3067\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u304c\u4fdd\u8b77\u3055\u308c\u3001GMP \u8981\u4ef6\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p><h2><strong><b>2.0 \u7bc4\u56f2:<\/b><\/strong><\/h2><p>2.1 \u3053\u306e SOP \u306f\u3001\u751f\u7523\u90e8\u9580\u306e Rapid Mixer Granulator \u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p><p>2.2 RMG \u3092\u64cd\u4f5c\u3001\u6e05\u6383\u3001\u307e\u305f\u306f\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3059\u308b\u3068\u304d\u306b\u5fc5\u305a\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>2.3 \u3053\u308c\u306f\u9320\u5264\u304a\u3088\u3073\u30ab\u30d7\u30bb\u30eb\u5264\u306e\u3059\u3079\u3066\u306e\u6e7f\u5f0f\u9020\u7c92\u30d7\u30ed\u30bb\u30b9\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p><p>2.4 RMG \u3092\u6271\u3046\u3059\u3079\u3066\u306e\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3068\u5236\u4f5c\u30b9\u30bf\u30c3\u30d5\u306f\u3001\u3053\u306e\u624b\u9806\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><h2><strong><b>3.0 \u8cac\u4efb:<\/b><\/strong><\/h2><p>3.1 <strong><b>\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\uff1a<\/b><\/strong>\u00a0\u6a5f\u68b0\u3092\u7a3c\u50cd\u3055\u305b\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u76e3\u8996\u3057\u3001\u30a8\u30ea\u30a2\u3092\u6e05\u6f54\u306b\u4fdd\u3061\u307e\u3059\u3002.<\/p><p>3.2 <strong><b>\u751f\u7523\u5316\u5b66\u8005:<\/b><\/strong>\u00a0\u9020\u7c92\u3092\u76e3\u7763\u3057\u3001\u30d0\u30c3\u30c1\u8a18\u9332\u3092\u691c\u8a3c\u3057\u3001\u767a\u751f\u3057\u305f\u554f\u984c\u3092\u51e6\u7406\u3057\u307e\u3059\u3002.<\/p><p>3.3 <strong><b>IPQA:<\/b><\/strong>\u00a0\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3001\u6b21\u306e\u30d0\u30c3\u30c1\u306e\u524d\u306b\u6d17\u6d44\u72b6\u614b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>3.4 <strong><b>\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\uff1a<\/b><\/strong>\u00a0\u6a5f\u5668\u306e\u4fee\u7406\u304a\u3088\u3073\u5b9a\u671f\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002.<\/p><h2><strong><b>4.0 \u8aac\u660e\u8cac\u4efb:<\/b><\/strong><\/h2><p>4.1 \u88fd\u9020\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u304c\u3053\u306e SOP \u3092\u6240\u6709\u3057\u307e\u3059\u3002.<\/p><p>4.2 \u88fd\u9020\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001\u3053\u306e\u624b\u9806\u306e\u5909\u66f4\u3092\u627f\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>4.3 \u88fd\u9020\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001RMG \u3092\u4f7f\u7528\u3059\u308b\u524d\u306b\u5168\u54e1\u304c\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u53d7\u3051\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/p><p>4.4 \u9038\u8131\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u3001\u78ba\u8a8d\u306e\u305f\u3081\u306b\u751f\u7523\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306b\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><h2><strong><b>5.0 \u624b\u9806:<\/b><\/strong><\/h2><h3><strong><b>5.1 \u64cd\u4f5c\u524d\u306e\u30c1\u30a7\u30c3\u30af:<\/b><\/strong><\/h3><p>5.1.1 \u307e\u305a\u3001\u6e05\u6383\u30a8\u30ea\u30a2\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u304d\u308c\u3044\u3067\u3059\u304b\uff1f\u3044\u3044\u3067\u3059\u306d\u3002\u6b21\u306b\u3001\u30de\u30b7\u30f3\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u300cCLEANED\uff08\u6e05\u6383\u6e08\u307f\uff09\u300d\u30e9\u30d9\u30eb\u304c\u8cbc\u3089\u308c\u3066\u3044\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.1.2 \u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3092\u958b\u304d\u307e\u3059\u3002\u65e5\u4ed8\u3001\u6642\u523b\u3001\u88fd\u54c1\u540d\u3001\u30d0\u30c3\u30c1\u756a\u53f7\u3001\u6c0f\u540d\u3092\u66f8\u304d\u7559\u3081\u307e\u3059\u3002.<\/p><p>5.1.3 \u5f15\u304d\u629c\u304f <strong>\u201c\u300c\u6383\u9664\u6e08\u307f\u300d\u201d<\/strong> \u30e9\u30d9\u30eb\u3002\u305d\u306e\u5834\u6240\u306b\u300c\u51e6\u7406\u4e2d\u300d\u306e\u30e9\u30d9\u30eb\u3092\u8cbc\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.1.4 \u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u8a3c\u660e\u66f8\u304c\u306a\u3044\u5834\u5408\u3001\u59cb\u52d5\u3067\u304d\u307e\u305b\u3093\u3002\u307e\u305aIPQA\u304b\u3089\u8a3c\u660e\u66f8\u3092\u53d6\u5f97\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.1.5 BMR\u3001\u3053\u306eSOP\u3001\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306a\u3069\u306e\u66f8\u985e\u3092\u96c6\u3081\u3001\u624b\u306e\u5c4a\u304f\u3068\u3053\u308d\u306b\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.1.6 \u5468\u56f2\u3092\u898b\u56de\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u524d\u306e\u30d0\u30c3\u30c1\u304b\u3089\u4f55\u304b\u307e\u3060\u6b8b\u3063\u3066\u3044\u308b\u3082\u306e\u304c\u3042\u308c\u3070\u53d6\u308a\u9664\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u4ea4\u5dee\u6c5a\u67d3\u306f\u6df1\u523b\u306a\u554f\u984c\u3067\u3059\u3002.<\/p><p>5.1.7 \u30dc\u30a6\u30eb\u3001\u30a4\u30f3\u30da\u30e9\u3001\u30c1\u30e7\u30c3\u30d1\u30fc\u304c\u9069\u5207\u306b\u53d6\u308a\u4ed8\u3051\u3089\u308c\u3001\u56fa\u5b9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><h3><strong><b>5.2 \u6ce8\u610f\u4e8b\u9805:<\/b><\/strong><\/h3><p>5.2.1 \u904b\u8ee2\u4e2d\u306f\u84cb\u304c\u9589\u3058\u305f\u72b6\u614b\u3092\u4fdd\u3061\u307e\u3059\u3002\u4f8b\u5916\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.2.2 \u5b89\u5168\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u306f\u30e6\u30fc\u30b6\u30fc\u306e\u5b89\u5168\u3092\u5b88\u308b\u305f\u3081\u306b\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7d76\u5bfe\u306b\u30d0\u30a4\u30d1\u30b9\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.3 \u6a5f\u68b0\u306e\u6539\u9020\u3092\u304a\u8003\u3048\u3067\u3059\u304b\uff1f\u3084\u3081\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305a\u306f\u66f8\u9762\u306b\u3088\u308b\u627f\u8a8d\u3092\u5f97\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.4 \u30a4\u30f3\u30da\u30e9\u3068\u30c1\u30e7\u30c3\u30d1\u30fc\u306f\u9ad8\u901f\u3067\u56de\u8ee2\u3057\u307e\u3059\u3002\u672c\u5f53\u306b\u901f\u3044\u3067\u3059\u3002\u56de\u8ee2\u4e2d\u306f\u7d76\u5bfe\u306b\u4e2d\u306b\u624b\u3092\u5165\u308c\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.5 \u90e8\u54c1\u306e\u53d6\u308a\u4ed8\u3051\u3001\u5206\u89e3\u3001\u6e05\u6383\u3092\u884c\u3046\u524d\u306b\u3001\u5fc5\u305a\u4e3b\u96fb\u6e90\u3092\u5207\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u5fc5\u305a\u3053\u306e\u64cd\u4f5c\u3092\u884c\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.6 \u5b89\u5168\u88c5\u7f6e\u3092\u7121\u52b9\u306b\u3057\u305f\u308a\u3001\u6539\u3056\u3093\u3057\u305f\u308a\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u5b89\u5168\u88c5\u7f6e\u306f\u5fc5\u9808\u3067\u3059\u3002.<\/p><p>5.2.7 \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u306f\u3001\u67d4\u3089\u304b\u3044\u4e7e\u3044\u305f\u5e03\u3067\u62ed\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u6db2\u4f53\u306f\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.8 \u9577\u6642\u9593\u904b\u8ee2\u3059\u308b\u3068\u6a5f\u68b0\u304c\u71b1\u304f\u306a\u308a\u307e\u3059\u3002\u91d1\u5c5e\u9762\u306b\u89e6\u308c\u308b\u524d\u306b\u6a5f\u68b0\u304c\u51b7\u3081\u308b\u307e\u3067\u304a\u5f85\u3061\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.9 \u500b\u4eba\u7528\u4fdd\u8b77\u5177\uff08PPE\uff09\u306e\u7740\u7528\u306f\u5fc5\u9808\u3067\u3059\uff08\u624b\u888b\u3001\u5b89\u5168\u30e1\u30ac\u30cd\u3001\u9632\u5875\u30de\u30b9\u30af\uff09\u3002\u3059\u3079\u3066\u7740\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.2.10 \u30dc\u30a6\u30eb\u306b\u8a70\u3081\u8fbc\u307f\u3059\u304e\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u898f\u5b9a\u306e\u5bb9\u91cf\u3092\u5b88\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u305d\u3046\u3067\u306a\u3044\u3068\u3001\u7c92\u5ea6\u304c\u60aa\u304f\u306a\u308a\u307e\u3059\u3002.<\/p><p>5.2.11 \u6563\u3089\u304b\u3063\u305f\u5834\u6240\u306f\u30df\u30b9\u3092\u62db\u304d\u307e\u3059\u3002\u6574\u7406\u6574\u9813\u3092\u5fc3\u304c\u3051\u307e\u3057\u3087\u3046\u3002.<\/p><h3><strong><b>5.3 \u5b89\u5168\u30b7\u30b9\u30c6\u30e0\u306e\u30c1\u30a7\u30c3\u30af:<\/b><\/strong><\/h3><p>5.3.1 \u3053\u308c\u3089\u306e\u30c6\u30b9\u30c8\u3092\u9031\u306b1\u56de\u5b9f\u884c\u3057\u3001\u3059\u3079\u3066\u3092\u6587\u66f8\u5316\u3057\u307e\u3059\u3002.<\/p><p>5.3.1.1 \u4e3b\u96fb\u6e90\u30b9\u30a4\u30c3\u30c1\u3092\u8a66\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u77ac\u6642\u306b\u96fb\u6e90\u304c\u5207\u308c\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.3.1.2 \u7dca\u6025\u505c\u6b62\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6a5f\u68b0\u306f\u76f4\u3061\u306b\u505c\u6b62\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.3.1.3 \u904b\u8ee2\u4e2d\u306b\u84cb\u3092\u958b\u3051\u3066\u304f\u3060\u3055\u3044\u3002\u30a4\u30f3\u30da\u30e9\u3068\u30c1\u30e7\u30c3\u30d1\u30fc\u306f\u3059\u3050\u306b\u505c\u6b62\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.3.1.4 \u904e\u8ca0\u8377\u30ea\u30ec\u30fc\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u904e\u8ca0\u8377\u6642\u306b\u30c8\u30ea\u30c3\u30d7\u3057\u307e\u3059\u304b\uff1f\u30c8\u30ea\u30c3\u30d7\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.3.1.5 \u3059\u3079\u3066\u306e\u8868\u793a\u706f\u3068\u30a2\u30e9\u30fc\u30e0\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u70b9\u706f\u3057\u3001\u6b63\u5e38\u306b\u52d5\u4f5c\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/p><h3><strong><b>5.4 \u6a5f\u68b0\u90e8\u54c1:<\/b><\/strong><\/h3><p>5.4.1 <strong><b>\u30df\u30ad\u30b7\u30f3\u30b0\u30dc\u30a6\u30eb:<\/b><\/strong>\u00a0\u3053\u3053\u3067\u3059\u3079\u3066\u306e\u4f5c\u696d\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u7c89\u672b\u304c\u6295\u5165\u3055\u308c\u3001\u9846\u7c92\u304c\u6392\u51fa\u3055\u308c\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u6e29\u5ea6\u8abf\u7bc0\u3067\u304d\u308b\u3088\u3046\u30b8\u30e3\u30b1\u30c3\u30c8\u304c\u4ed8\u3044\u3066\u3044\u307e\u3059\u3002.<\/p><p>5.4.2 <strong><b>\u30a4\u30f3\u30da\u30e9:<\/b><\/strong>\u00a0\u5e95\u306b\u3042\u308b\u5927\u304d\u306a\u5203\u3002\u3053\u308c\u304c\u56de\u8ee2\u3057\u3066\u7c89\u672b\u3092\u6df7\u305c\u5408\u308f\u305b\u3001\u30bf\u30f3\u30d6\u30ea\u30f3\u30b0\u52b9\u679c\u3092\u751f\u307f\u51fa\u3057\u307e\u3059\u3002.<\/p><p>5.4.3 <strong><b>\u30c1\u30e7\u30c3\u30d1\u30fc\uff1a<\/b><\/strong>\u00a0\u5074\u58c1\u306b\u53d6\u308a\u4ed8\u3051\u3089\u308c\u305f\u5c0f\u578b\u306e\u30d6\u30ec\u30fc\u30c9\u3002\u8d85\u9ad8\u901f\u56de\u8ee2\u3057\u3001\u6e7f\u5f0f\u7c89\u7815\u6642\u306b\u584a\u3092\u7815\u304d\u307e\u3059\u3002.<\/p><p>5.4.4 <strong><b>\u84cb\uff1a<\/b><\/strong>\u00a0\u904b\u8ee2\u4e2d\u306f\u30dc\u30a6\u30eb\u3092\u8986\u3044\u307e\u3059\u3002\u30d0\u30a4\u30f3\u30c0\u30fc\u6eb6\u6db2\u3092\u6dfb\u52a0\u3059\u308b\u305f\u3081\u306e\u30dd\u30fc\u30c8\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>5.4.5 <strong><b>\u30d0\u30a4\u30f3\u30c0\u30fc\u8ffd\u52a0\u30dd\u30fc\u30c8:<\/b><\/strong>\u00a0\u84cb\u306e\u958b\u53e3\u90e8\u3067\u3001\u9020\u7c92\u6db2\u3092\u6ce8\u3044\u3060\u308a\u3001\u30b9\u30d7\u30ec\u30fc\u3057\u305f\u308a\u3057\u307e\u3059\u3002.<\/p><p>5.4.6 <strong><b>\u6392\u51fa\u30d0\u30eb\u30d6:<\/b><\/strong>\u00a0\u30dc\u30a6\u30eb\u306e\u5e95\u306b\u3042\u308a\u307e\u3059\u3002\u958b\u3051\u308b\u3068\u3001\u6e7f\u3063\u305f\u9846\u7c92\u3092\u5bb9\u5668\u307e\u305f\u306f\u30c8\u30ec\u30a4\u306b\u79fb\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p><h3>5.4.7 <strong><b>\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/b><\/strong><\/h3><p><strong> \u30d1\u30cd\u30eb\uff1a<\/strong> \u30a4\u30f3\u30da\u30e9\u901f\u5ea6\u3001\u30c1\u30e7\u30c3\u30d1\u30fc\u901f\u5ea6\u3001\u30bf\u30a4\u30de\u30fc\u3001\u958b\u59cb\/\u505c\u6b62\u30dc\u30bf\u30f3\u3001\u7dca\u6025\u505c\u6b62\u306a\u3069\u3001\u3059\u3079\u3066\u306e\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u53ce\u7d0d\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><h3>5.4.8 <b>\u30a2\u30f3\u30da\u30a2<br \/><\/b><\/h3><p><b>\u30e1\u30fc\u30bf\u30fc:<\/b><span style=\"font-size: 16px;\">\u00a0<\/span>\u30a4\u30f3\u30da\u30e9\u30e2\u30fc\u30bf\u30fc\u306e\u96fb\u6d41\u6d88\u8cbb\u91cf\u3092\u8868\u793a\u3057\u307e\u3059\u3002\u9846\u7c92\u5f62\u6210\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p><h3><strong><b>5.5 \u7d44\u307f\u7acb\u3066:<\/b><\/strong><\/h3><p>5.5.1 \u7d44\u307f\u7acb\u3066\u308b\u524d\u306b\u5fc5\u305a\u96fb\u6e90\u3092\u5207\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.5.2 \u30df\u30ad\u30b7\u30f3\u30b0\u30dc\u30a6\u30eb\u3092\u30d9\u30fc\u30b9\u306b\u4e0b\u308d\u3057\u307e\u3059\u3002\u3057\u3063\u304b\u308a\u3068\u56fa\u5b9a\u3055\u308c\u3001\u5e73\u3089\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.5.3 \u30a4\u30f3\u30da\u30e9\u3092\u30c9\u30e9\u30a4\u30d6\u30b7\u30e3\u30d5\u30c8\u306b\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002\u307e\u305a\u624b\u3067\u7de0\u3081\u4ed8\u3051\u3001\u6b21\u306b\u5de5\u5177\u3067\u56fa\u5b9a\u3057\u307e\u3059\u3002\u8efd\u304f\u63fa\u3059\u3063\u3066\u307f\u3066\u304f\u3060\u3055\u3044\u3002\u6c7a\u3057\u3066\u52d5\u304b\u3055\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.5.4 \u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u30b5\u30a4\u30c9\u30b7\u30e3\u30d5\u30c8\u306b\u53d6\u308a\u4ed8\u3051\u3001\u3057\u3063\u304b\u308a\u3068\u30ed\u30c3\u30af\u3057\u307e\u3059\u3002.<\/p><p>5.5.5 \u84cb\u3092\u4e0a\u306b\u7f6e\u304d\u3001\u30ed\u30c3\u30af\u30af\u30e9\u30f3\u30d7\u3092\u3059\u3079\u3066\u7de0\u3081\u307e\u3059\u3002.<\/p><p>5.5.6 \u6392\u51fa\u30d0\u30eb\u30d6\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u9589\u3058\u3089\u308c\u3066\u3044\u307e\u3059\u304b\uff1f\u9069\u5207\u306b\u5bc6\u9589\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f\u554f\u984c\u3042\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.5.7 \u30d0\u30a4\u30f3\u30c0\u30fc\u30b9\u30d7\u30ec\u30fc\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u30ce\u30ba\u30eb\u3068\u30c1\u30e5\u30fc\u30d6\u3092\u63a5\u7d9a\u3057\u307e\u3059\u3002\u8a70\u307e\u308a\u304c\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.5.8 \u3059\u3079\u3066\u306e\u30ac\u30fc\u30c9\u306f\u53d6\u308a\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u304b? \u84cb\u306e\u30bb\u30f3\u30b5\u30fc\u306f\u4f5c\u52d5\u3057\u3066\u3044\u307e\u3059\u304b? \u6b21\u306b\u9032\u3080\u524d\u306b\u3082\u3046\u4e00\u5ea6\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><h3><strong><b>5.6 \u64cd\u4f5c:<\/b><\/strong><\/h3><p>5.6.1 \u4e3b\u96fb\u6e90\u3092\u30aa\u30f3\u306b\u3057\u307e\u3059\u3002.<\/p><p>5.6.2 \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u304c\u70b9\u706f\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u8868\u793a\u304c\u6b63\u3057\u304f\u8868\u793a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.6.3 \u8a08\u91cf\u3057\u305f\u7c89\u672b\u3092BMR\u306b\u5f93\u3063\u3066\u30dc\u30a6\u30eb\u306b\u5165\u308c\u307e\u3059\u3002\u4e00\u5ea6\u306b\u5168\u90e8\u5165\u308c\u305a\u3001\u91cf\u304c\u591a\u3044\u5834\u5408\u306f\u5c11\u3057\u305a\u3064\u52a0\u3048\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.6.4 \u84cb\u3092\u3057\u3063\u304b\u308a\u9589\u3081\u3066\u30ed\u30c3\u30af\u3057\u307e\u3059\u3002.<\/p><h3>5.6.5 <strong><b>\u4e7e\u5f0f\u6df7\u5408\uff1a<\/b><\/strong><\/h3><p>5.6.5.1 BMR\u306b\u5f93\u3063\u3066\u30a4\u30f3\u30da\u30e9\u901f\u5ea6\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002\u901a\u5e38\u306f\u4f4e\u901f\u304b\u3089\u4e2d\u901f\u306b\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/p><p>5.6.5.2 \u4e7e\u5f0f\u6df7\u5408\u4e2d\u306f\u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u505c\u6b62\u3057\u3066\u304f\u3060\u3055\u3044\u3002BMR\u306e\u6307\u793a\u306b\u5f93\u3063\u3066\u4f4e\u901f\u3067\u904b\u8ee2\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.6.5.3 \u30d0\u30c3\u30c1\u30ec\u30b3\u30fc\u30c9\u306b\u6307\u5b9a\u3055\u308c\u305f\u6642\u9593\u3001\u6df7\u5408\u3057\u307e\u3059\u3002\u901a\u5e38\u306f3\uff5e5\u5206\u3067\u3059\u3002.<\/p><p>5.6.5.4 \u3053\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u4e7e\u71e5\u6750\u6599\u3092\u5747\u4e00\u306b\u6df7\u305c\u5408\u308f\u305b\u307e\u3059\u3002.<\/p><h3>5.6.6 <strong><b>\u30d0\u30a4\u30f3\u30c0\u30fc\u306e\u8ffd\u52a0:<\/b><\/strong><\/h3><p>5.6.6.1 BMR\u306b\u5f93\u3063\u3066\u30d0\u30a4\u30f3\u30c0\u30fc\u6eb6\u6db2\u3092\u8abf\u88fd\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u6ffe\u904e\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.6.6.2 \u30a4\u30f3\u30da\u30e9\u3092\u56de\u8ee2\u3055\u305b\u306a\u304c\u3089\u3001\u30dd\u30fc\u30c8\u304b\u3089\u30d0\u30a4\u30f3\u30c0\u30fc\u3092\u3086\u3063\u304f\u308a\u3068\u8ffd\u52a0\u3057\u307e\u3059\u3002.<\/p><p>5.6.6.3 \u3086\u3063\u304f\u308a\u3068\u6ce8\u304e\u307e\u3057\u3087\u3046\u3002\u4e00\u5ea6\u306b\u5168\u90e8\u5165\u308c\u308b\u3068\u30c0\u30de\u304c\u3067\u304d\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p><p>5.6.6.4 \u30b9\u30d7\u30ec\u30fc\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306f\u3001\u6d41\u91cf\u3092\u8a2d\u5b9a\u3057\u3001\u30b9\u30d7\u30ec\u30fc\u30b7\u30b9\u30c6\u30e0\u304c\u6a5f\u80fd\u3059\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/p><h3>5.6.7 <strong><b>\u30a6\u30a7\u30c3\u30c8\u30de\u30c3\u30b7\u30f3\u30b0\uff1a<\/b><\/strong><\/h3><p>5.6.7.1 \u3059\u3079\u3066\u306e\u30d0\u30a4\u30f3\u30c0\u30fc\u304c\u5165\u3063\u305f\u3089\u3001BMR \u306e\u6307\u793a\u306b\u5f93\u3063\u3066\u30a4\u30f3\u30da\u30e9\u306e\u901f\u5ea6\u3092\u4e0a\u3052\u307e\u3059\u3002.<\/p><p>5.6.7.2 \u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u30aa\u30f3\u306b\u3057\u307e\u3059\u3002\u584a\u3092\u7815\u304d\u3001\u6c34\u5206\u3092\u5206\u6563\u3055\u305b\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p><p>5.6.7.3 \u96fb\u6d41\u8a08\u3092\u898b\u3066\u304f\u3060\u3055\u3044\u3002\u9846\u7c92\u304c\u5f62\u6210\u3055\u308c\u5bc6\u5ea6\u304c\u5897\u3059\u306b\u3064\u308c\u3066\u96fb\u6d41\u304c\u5897\u52a0\u3057\u307e\u3059\u3002.<\/p><p>5.6.7.4 \u7d42\u70b9\u306b\u9054\u3059\u308b\u307e\u3067\u6df7\u305c\u307e\u3059\u3002\u6642\u9593\u3001\u96fb\u6d41\u3001\u307e\u305f\u306f\u8996\u899a\u306b\u57fa\u3065\u3044\u3066\u8abf\u6574\u3067\u304d\u307e\u3059\u3002.<\/p><p>5.6.7.5 \u904e\u5270\u306a\u9020\u7c92\u306f\u30d0\u30c3\u30c1\u3092\u53f0\u7121\u3057\u306b\u3057\u307e\u3059\u3002\u76ee\u6a19\u5024\u306b\u9054\u3057\u305f\u3089\u505c\u6b62\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><h3>5.6.8 <strong><b>\u9846\u7c92\u6392\u51fa\uff1a<\/b><\/strong><\/h3><p>5.6.8.1 \u30a4\u30f3\u30da\u30e9\u3068\u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u505c\u6b62\u3057\u307e\u3059\u3002.<\/p><p>5.6.8.2 \u84cb\u3092\u958b\u3051\u3066\u9846\u7c92\u306e\u72b6\u614b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u5747\u4e00\u306a\u72b6\u614b\u3067\u3042\u308a\u3001\u8efd\u304f\u63e1\u308b\u3068\u307e\u3068\u307e\u3063\u3066\u3044\u308b\u306f\u305a\u3067\u3059\u3002.<\/p><p>5.6.8.3 \u6392\u51fa\u30d0\u30eb\u30d6\u306e\u4e0b\u306b\u6e05\u6f54\u306a\u5bb9\u5668\u307e\u305f\u306f\u30c8\u30ec\u30a4\u3092\u7f6e\u304d\u307e\u3059\u3002.<\/p><p>5.6.8.4 \u6392\u51fa\u30d0\u30eb\u30d6\u3092\u958b\u304d\u3001\u30a4\u30f3\u30da\u30e9\u3092\u4f4e\u901f\u3067\u56de\u8ee2\u3055\u305b\u3066\u9846\u7c92\u3092\u62bc\u3057\u51fa\u3057\u307e\u3059\u3002.<\/p><p>5.6.8.5 \u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u30dc\u30a6\u30eb\u306e\u58c1\u306b\u4ed8\u7740\u3057\u3066\u3044\u308b\u7269\u8cea\u3092\u524a\u308a\u53d6\u308a\u307e\u3059\u3002.<\/p><p>5.6.9 \u958b\u59cb\u6642\u9593\u3001\u7d42\u4e86\u6642\u9593\u3001\u30a4\u30f3\u30da\u30e9\u901f\u5ea6\u3001\u30c1\u30e7\u30c3\u30d1\u30fc\u901f\u5ea6\u3001\u6df7\u5408\u6642\u9593\u3001\u89b3\u5bdf\u4e8b\u9805\u306a\u3069\u3059\u3079\u3066\u3092\u6587\u66f8\u5316\u3057\u307e\u3059\u3002.<\/p><h3><strong><b>5.7 \u30d7\u30ed\u30bb\u30b9\u4e2d\u306e\u30c1\u30a7\u30c3\u30af:<\/b><\/strong><\/h3><p>5.7.1 BMR \u3067\u5b9a\u7fa9\u3055\u308c\u305f\u30b9\u30c6\u30fc\u30b8\u3067\u9846\u7c92\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.7.2 \u4e7e\u5f0f\u6df7\u5408\u5f8c: \u8272\u304c\u5747\u4e00\u3067\u3001\u76ee\u306b\u898b\u3048\u308b\u584a\u304c\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.7.3 \u6e7f\u5f0f\u30de\u30c3\u30b7\u30f3\u30b0\u4e2d\u306b\u3001\u5c0f\u3055\u306a\u30b5\u30f3\u30d7\u30eb\u3092\u7d5e\u308b\u3002\u5f62\u306f\u4fdd\u305f\u308c\u308b\u304c\u3001\u7c21\u5358\u306b\u5d29\u308c\u308b\u72b6\u614b\u3067\u3042\u308b\u3079\u304d\u3067\u3042\u308b\u3002.<\/p><p>5.7.4 \u6700\u7d42\u9846\u7c92\uff1a\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5916\u89b3\u3001\u611f\u89e6\u3001\u6c34\u5206\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.7.5 \u3059\u3079\u3066\u306e\u89b3\u5bdf\u7d50\u679c\u3092\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\u30d5\u30a9\u30fc\u30e0\u306b\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p><p>5.7.6 \u4f55\u304b\u304a\u304b\u3057\u3044\u70b9\u306b\u6c17\u3065\u304d\u307e\u3057\u305f\u304b? \u3059\u3050\u306b\u505c\u6b62\u3057\u3066\u4e0a\u53f8\u306b\u9023\u7d61\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><h3><strong><b>5.8 \u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u624b\u9806:<\/b><\/strong><\/h3><p>5.8.1 \u30dc\u30a6\u30eb\u304b\u3089\u3059\u3079\u3066\u306e\u9846\u7c92\u304c\u6392\u51fa\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p><p>5.8.2 \u30a4\u30f3\u30da\u30e9\u3068\u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u5b8c\u5168\u306b\u505c\u6b62\u3057\u307e\u3059\u3002.<\/p><p>5.8.3 \u4e3b\u96fb\u6e90\u3092\u30aa\u30d5\u306b\u3057\u307e\u3059\u3002.<\/p><p>5.8.4 BMR\u306b\u5f93\u3063\u3066\u3001\u6e7f\u3063\u305f\u9846\u7c92\u3092\u4e7e\u71e5\u30c8\u30ec\u30a4\u307e\u305f\u306f\u6d41\u52d5\u5e8a\u4e7e\u71e5\u6a5f\u306b\u79fb\u3057\u307e\u3059\u3002.<\/p><p>5.8.5 BMR\u3068\u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3092\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u7a7a\u6b04\u306f\u8a18\u5165\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><h3><strong><b>5.9 \u6e05\u6383\u624b\u9806:<\/b><\/strong><\/h3><p>5.9.1 \u96fb\u6e90\u3092\u5207\u65ad\u3057\u307e\u3059\u3002\u3053\u3053\u3067\u306f\u8fd1\u9053\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.9.2 \u84cb\u3092\u958b\u3051\u3066\u30dc\u30a6\u30eb\u306b\u6b8b\u3063\u305f\u6750\u6599\u3092\u53d6\u308a\u9664\u304d\u307e\u3059\u3002.<\/p><p>5.9.3 \u30a4\u30f3\u30da\u30e9\u3092\u53d6\u308a\u5916\u3057\u307e\u3059\u3002\u30c1\u30e7\u30c3\u30d1\u30fc\u3082\u53d6\u308a\u5916\u3057\u307e\u3059\u3002.<\/p><p>5.9.4 \u30dc\u30a6\u30eb\u3001\u30a4\u30f3\u30da\u30e9\u30fc\u3001\u30c1\u30e7\u30c3\u30d1\u30fc\u3001\u84cb\u3092\u7cbe\u88fd\u6c34\u3067\u6d17\u3044\u3001\u7c98\u7740\u6027\u306e\u6b8b\u7559\u7269\u3092\u3053\u3059\u308a\u843d\u3068\u3057\u307e\u3059\u3002.<\/p><p>5.9.5 \u6e05\u6383SOP\u306b\u6307\u5b9a\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u627f\u8a8d\u3055\u308c\u305f\u6d17\u6d44\u5264\u3092\u4f7f\u7528\u3057\u3066\u6d17\u6d44\u3092\u7d9a\u884c\u3057\u307e\u3059\u3002.<\/p><p>5.9.6 \u3059\u3079\u3066\u3092\u7cbe\u88fd\u6c34\u3067\u5341\u5206\u306b\u3059\u3059\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u77f3\u9e78\u306e\u6b8b\u7559\u7269\u306f\u6b8b\u3055\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.9.7 \u6d88\u6bd2\u306e\u305f\u3081\u300170% IPA \u3067\u62ed\u304d\u307e\u3059\u3002.<\/p><p>5.9.8 \u7d44\u307f\u7acb\u3066\u308b\u524d\u306b\u3001\u3059\u3079\u3066\u306e\u90e8\u54c1\u3092\u5b8c\u5168\u306b\u4e7e\u71e5\u3055\u305b\u3066\u304f\u3060\u3055\u3044\u3002\u6e7f\u6c17\u306f\u9306\u3084\u6c5a\u67d3\u306e\u539f\u56e0\u3068\u306a\u308a\u307e\u3059\u3002.<\/p><p>5.9.9 \u6a5f\u68b0\u306e\u5916\u90e8\u8868\u9762\u3092\u6e7f\u3089\u305b\u305f\u5e03\u3067\u62ed\u3044\u3066\u304b\u3089\u4e7e\u71e5\u3055\u305b\u307e\u3059\u3002.<\/p><p>5.9.10 \u3059\u3079\u3066\u304c\u4e7e\u3044\u305f\u3089\u3001\u30a4\u30f3\u30da\u30e9\u3068\u30c1\u30e7\u30c3\u30d1\u30fc\u3092\u518d\u5ea6\u7d44\u307f\u7acb\u3066\u307e\u3059\u3002.<\/p><p>5.9.11 QA\u306b\u9023\u7d61\u3057\u3066\u691c\u67fb\u3092\u53d7\u3051\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u305f\u3089\u3001\u300cCLEANED\uff08\u6d17\u6d44\u6e08\u307f\uff09\u300d\u30e9\u30d9\u30eb\u3092\u8cbc\u4ed8\u3057\u307e\u3059\u3002.<\/p><p>5.9.12 \u3059\u3079\u3066\u306e\u6e05\u6383\u306e\u8a73\u7d30\u3092\u6a5f\u5668\u6e05\u6383\u30ed\u30b0\u306b\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p><h3><strong><b>5.10 \u30c8\u30e9\u30d6\u30eb\u30b7\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0:<\/b><\/strong><\/h3><p>5.10.1 <strong><b>\u584a\u72b6\u306e\u9846\u7c92\uff1a<\/b><\/strong>\u00a0\u30d0\u30a4\u30f3\u30c0\u30fc\u306e\u8ffd\u52a0\u304c\u65e9\u3059\u304e\u307e\u3059\u304b\uff1f\u30c1\u30e7\u30c3\u30d1\u30fc\u304c\u4f5c\u52d5\u3057\u3066\u3044\u307e\u305b\u3093\u304b\uff1f\u6b21\u56de\u306f\u4e21\u65b9\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.10.2 <strong><b>\u9846\u7c92\u304c\u6e7f\u308a\u3059\u304e\u3066\u3044\u308b:<\/b><\/strong>\u00a0\u30d0\u30a4\u30f3\u30c0\u30fc\u304c\u591a\u3059\u304e\u307e\u3059\u3002\u307e\u305f\u306f\u3001\u30d0\u30a4\u30f3\u30c0\u30fc\u3092\u8ffd\u52a0\u3057\u305f\u5f8c\u3001\u6df7\u5408\u306b\u6642\u9593\u304c\u304b\u304b\u308a\u3059\u304e\u307e\u3057\u305f\u3002.<\/p><p>5.10.3 <strong><b>\u9846\u7c92\u304c\u4e7e\u71e5\u3057\u3059\u304e\u3066\u3044\u308b\u304b\u7c89\u3063\u307d\u3044\uff1a<\/b><\/strong>\u00a0\u30d0\u30a4\u30f3\u30c0\u30fc\u304c\u8db3\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u306f\u3001\u30d0\u30a4\u30f3\u30c0\u30fc\u304c\u9069\u5207\u306b\u914d\u5206\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002.<\/p><p>5.10.4 <strong><b>\u30a4\u30f3\u30da\u30e9\u304c\u56de\u8ee2\u3057\u306a\u3044:<\/b><\/strong>\u00a0\u96fb\u6e90\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u904e\u8ca0\u8377\u30ea\u30ec\u30fc\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u7dca\u6025\u505c\u6b62\u30b9\u30a4\u30c3\u30c1\u306f\u62bc\u3055\u308c\u307e\u3057\u305f\u304b\uff1f<\/p><p>5.10.5 <strong><b>\u30c1\u30e7\u30c3\u30d1\u30fc\u304c\u56de\u8ee2\u3057\u306a\u3044:<\/b><\/strong>\u00a0\u30a4\u30f3\u30da\u30e9\u3068\u540c\u3058\u70b9\u691c\u3092\u884c\u3044\u307e\u3059\u3002\u30c1\u30e7\u30c3\u30d1\u30fc\u304c\u6b63\u3057\u304f\u56fa\u5b9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3082\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.10.6 <strong><b>\u6392\u51fa\u30d0\u30eb\u30d6\u304c\u8a70\u307e\u3063\u305f\u5834\u5408\uff1a<\/b><\/strong>\u00a0\u304a\u305d\u3089\u304f\u7269\u8cea\u304c\u84c4\u7a4d\u3057\u3066\u3044\u308b\u306e\u3067\u3057\u3087\u3046\u3002\u624b\u52d5\u3067\u9664\u53bb\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.10.7 <strong><b>\u7570\u5e38\u306a\u9a12\u97f3\u3084\u632f\u52d5:<\/b><\/strong>\u00a0\u76f4\u3061\u306b\u505c\u6b62\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u90e8\u54c1\u304c\u7de9\u3093\u3067\u3044\u308b\u304b\u3001\u30d9\u30a2\u30ea\u30f3\u30b0\u304c\u6469\u8017\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><h3><strong><b>5.11 \u8853\u5f8c:<\/b><\/strong><\/h3><p>5.11.1 \u30d0\u30c3\u30c1\u304c\u7d42\u4e86\u3057\u307e\u3057\u305f\u304b\uff1f\u6a5f\u68b0\u306b\u300c\u6d17\u6d44\u4e2d\u300d\u30e9\u30d9\u30eb\u3092\u8cbc\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.11.2 \u30bb\u30af\u30b7\u30e7\u30f35.9\u306b\u5f93\u3063\u3066RMG\u3092\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3057\u307e\u3059\u3002.<\/p><p>5.11.3 \u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3001BMR\u3001\u9038\u8131\u30ec\u30dd\u30fc\u30c8\u306a\u3069\u3001\u3059\u3079\u3066\u306e\u66f8\u985e\u3092\u5b8c\u6210\u3055\u305b\u307e\u3059\u3002.<\/p><p>5.11.4 \u30a8\u30ea\u30a2\u3092\u6e05\u6f54\u306b\u3057\u3001\u6b21\u306e\u30d0\u30c3\u30c1\u306e\u6e96\u5099\u3092\u6574\u3048\u3066\u304a\u304d\u307e\u3059\u3002.<\/p><h3><strong><b>5.12 \u8a18\u9332:<\/b><\/strong><\/h3><p>5.12.1 \u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3002.<\/p><p>5.12.2 \u6a5f\u5668\u6e05\u6383\u30ed\u30b0\u3002.<\/p><p>5.12.3 \u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332.<\/p><p>5.12.4 \u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\u8a18\u9332\u3002.<\/p><p>5.12.5 \u9038\u8131\u30ec\u30dd\u30fc\u30c8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09\u3002.<\/p><h2><strong><b>6.0 \u7565\u8a9e:<\/b><\/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 BMR:<\/strong> \u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332\u3002.<\/p><p><strong>6.3 IPQA:<\/strong> \u5de5\u7a0b\u5185\u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p><p><strong>6.4 \u500b\u4eba\u7528\u4fdd\u8b77\u5177:<\/strong> \u500b\u4eba\u7528\u4fdd\u8b77\u5177\u3002.<\/p><p><strong>6.5 IPA:<\/strong> \u30a4\u30bd\u30d7\u30ed\u30d4\u30eb\u30a2\u30eb\u30b3\u30fc\u30eb\u3002.<\/p><p><strong>6.6 RMG:<\/strong> \u9ad8\u901f\u30df\u30ad\u30b5\u30fc\u9020\u7c92\u6a5f\u3002.<\/p><p><strong>6.7 \u54c1\u8cea\u4fdd\u8a3c:<\/strong> \u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p><p><strong>6.8 GMP:<\/strong> \u9069\u6b63\u88fd\u9020\u898f\u7bc4\u3002.<\/p><h2><strong><b>7.0 \u53c2\u8003\u6587\u732e:<\/b><\/strong><\/h2><p>7.1 \u30e1\u30fc\u30ab\u30fc\u306e\u6a5f\u5668\u30de\u30cb\u30e5\u30a2\u30eb<\/p><p>7.2 GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/p><p>7.3 \u5185\u90e8\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u6587\u66f8<\/p><p>7.4 \u6d17\u6d44\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30c8\u30b3\u30eb<\/p><h2><strong><b>8.0 \u6539\u8a02\u5c65\u6b74:<\/b><\/strong><\/h2><div style=\"overflow-x: auto; width: 100%;\"><table style=\"min-width: 700px; border-collapse: collapse;\"><tbody><tr><td><strong><b>\u6539\u8a02\u756a\u53f7.<\/b><\/strong><\/td><td><strong><b>\u65e5\u4ed8<\/b><\/strong><\/td><td><strong><b>\u5909\u66f4\u306e\u8aac\u660e<\/b><\/strong><\/td><td><strong><b>\u306b\u3088\u3063\u3066\u6e96\u5099\u3055\u308c\u305f<\/b><\/strong><\/td><td><strong><b>\u627f\u8a8d\u8005<\/b><\/strong><\/td><\/tr><tr><td>00<\/td><td>\u65e5\/\u6708\/\u5e74<\/td><td>\u521d\u671f\u30ea\u30ea\u30fc\u30b9<\/td><td>\u00a0<\/td><td>\u00a0<\/td><\/tr><\/tbody><\/table><\/div>\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>1.0 OBJECTIVE: 1.1 This document explains how to operate the Rapid Mixer Granulator safely and correctly. 1.2 We want consistent [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":9684,"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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