{"id":17992,"date":"2026-09-03T01:18:47","date_gmt":"2026-09-03T01:18:47","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17992"},"modified":"2026-09-07T01:33:14","modified_gmt":"2026-09-07T01:33:14","slug":"sop-for-temperature-and-humidity-monitoring-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-temperature-and-humidity-monitoring-in-pharmaceutical-industry\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"17992\" class=\"elementor elementor-17992\" 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\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3002.<\/p><figure id=\"attachment_18013\" aria-describedby=\"caption-attachment-18013\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-18013\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry.jpg\" alt=\"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\" width=\"1000\" height=\"895\" title=\"\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry-500x448.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry-300x269.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry-768x687.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/09\/SOP-For-Temperature-and-Humidity-Monitoring-in-Pharmaceutical-Industry-13x12.jpg 13w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-18013\" class=\"wp-caption-text\"><em><strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u3002.<\/strong><\/em><\/figcaption><\/figure><h2><strong>1.0 \u76ee\u7684:<\/strong><\/h2><p>\u88fd\u85ac\u5de5\u5834\u5185\u306e\u88fd\u9020\u30a8\u30ea\u30a2\u3001\u4fdd\u7ba1\u30a8\u30ea\u30a2\u3001\u304a\u3088\u3073\u5b9f\u9a13\u5ba4\u306b\u304a\u3051\u308b\u6e29\u5ea6\u304a\u3088\u3073\u76f8\u5bfe\u6e7f\u5ea6\u306e\u65e5\u5e38\u7684\u306a\u76e3\u8996\u3001\u8a18\u9332\u3001\u304a\u3088\u3073\u78ba\u8a8d\u306e\u624b\u9806\u3092\u5b9a\u3081\u308b\u3002.<\/p><h2><strong>2.0 \u7bc4\u56f2:<\/strong><\/h2><p>\u672c\u624b\u9806\u306f\u3001\u751f\u7523\u30db\u30fc\u30eb\u3001\u539f\u6750\u6599\u5009\u5eab\u3001\u5b8c\u6210\u54c1\u5009\u5eab\u3001\u691c\u75ab\u5ba4\u3001\u51b7\u8535\u5ba4\u3001\u5b9f\u9a13\u5ba4\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u5ba4\u3001\u30a8\u30a2\u30ed\u30c3\u30af\u306a\u3069\u3001\u74b0\u5883\u6761\u4ef6\u306b\u3088\u3063\u3066\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u304c\u53ca\u3076\u53ef\u80fd\u6027\u306e\u3042\u308b\u3059\u3079\u3066\u306e\u6a5f\u5bc6\u533a\u57df\u304a\u3088\u3073\u7ba1\u7406\u533a\u57df\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p><h2><strong>3.0 \u8cac\u4efb:<\/strong><\/h2><p>\u30a8\u30ea\u30a2\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3001\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005\u3001\u5009\u5eab\u8cac\u4efb\u8005<\/p><h2><strong>4.0 \u8aac\u660e\u8cac\u4efb:<\/strong><\/h2><p>QA\u8cac\u4efb\u8005\u3002.<\/p><h2><strong>5.0 \u624b\u9806:<\/strong><\/h2><p>5.1 \u5404\u30b7\u30d5\u30c8\u306e\u958b\u59cb\u6642\u306b\u3001\u65e5\u3005\u306e\u76e3\u8996\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u78ba\u8a8d\u3059\u308b\u3002\u3053\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u306f\u3001\u5404\u5de1\u56de\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u5834\u6240\u3001\u30bb\u30f3\u30b5\u30fcID\u3001\u6e2c\u5b9a\u6642\u523b\u3001\u304a\u3088\u3073\u5f53\u76f4\u8005\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.2 QA\u4e8b\u52d9\u6240\u304b\u3089\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u8a18\u9332\u7c3f\u3092\u53d7\u3051\u53d6\u308b\u3002\u5404\u30a8\u30ea\u30a2\u306b\u306f\u3001\u6bce\u65e5\u306e\u8a18\u9332\u7528\u306b\u884c\u304c\u3042\u3089\u304b\u3058\u3081\u5370\u5237\u3055\u308c\u305f\u5c02\u7528\u306e\u8a18\u9332\u7c3f\u304c\u7528\u610f\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.3 \u6821\u6b63\u6e08\u307f\u306e\u3059\u3079\u3066\u306e\u6e29\u6e7f\u5ea6\u8a08\u304a\u3088\u3073\u30c7\u30b8\u30bf\u30eb\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u304c\u6b63\u5e38\u306b\u52d5\u4f5c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u6545\u969c\u3057\u3066\u3044\u308b\u6a5f\u5668\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u4f5c\u696d\u958b\u59cb\u524d\u306b\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\uff08QA\uff09\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.4 QA\u30aa\u30d5\u30a3\u30b9\u304b\u3089\u5404\u30a8\u30ea\u30a2\u3078\u3068\u7d9a\u304f\u30eb\u30fc\u30c8\u30de\u30c3\u30d7\u306b\u5f93\u3044\u3001\u6240\u5b9a\u306e\u9806\u5e8f\u3067\u79fb\u52d5\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u30eb\u30fc\u30c8\u306f\u3001\u30af\u30ea\u30fc\u30f3\u30be\u30fc\u30f3\u3068\u305d\u308c\u3088\u308a\u6e05\u6d44\u5ea6\u306e\u4f4e\u3044\u30be\u30fc\u30f3\u9593\u306e\u4ea4\u5dee\u6c5a\u67d3\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><h3><strong>5.5 \u53d7\u5165\u57fa\u6e96\uff1a<\/strong><\/h3><p>5.5.1 \u5404\u30a8\u30ea\u30a2\u306b\u306f\u3001\u6e29\u5ea6\u304a\u3088\u3073\u6e7f\u5ea6\u306b\u95a2\u3059\u308b\u72ec\u81ea\u306e\u8a31\u5bb9\u7bc4\u56f2\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u8a31\u5bb9\u7bc4\u56f2\u306f\u3001\u88fd\u54c1\u306e\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u304a\u3088\u3073GMP\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><h4><strong>5.5.2 \u5171\u7528\u90e8\u5206\u306e\u57fa\u6e96\u5024\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\uff1a<\/strong><\/h4><p>5.5.2.1 \u4e00\u822c\u7684\u306a\u88fd\u9020\u30fb\u5305\u88c5\u30a8\u30ea\u30a2\uff1a\u6e29\u5ea6 20\uff5e25\u00b0C\u3001\u76f8\u5bfe\u6e7f\u5ea6\uff08RH\uff09 45\uff5e65%\u3002.<\/p><p>5.5.2.2 \u539f\u6750\u6599\u5009\u5eab\u304a\u3088\u3073\u5b8c\u6210\u54c1\u5009\u5eab\uff1a\u6e29\u5ea625\u00b0C\u672a\u6e80\u3001\u76f8\u5bfe\u6e7f\u5ea660%\u672a\u6e80\u3002.<\/p><p>5.5.2.3 \u51b7\u8535\u4fdd\u7ba1\uff082\uff5e8\u00b0C\u306e\u5ba4\uff09\uff1a\u6e29\u5ea6\u306f2\uff5e8\u00b0C\u3002\u76f8\u5bfe\u6e7f\u5ea6\uff08RH\uff09\u306f\u53b3\u5bc6\u306a\u8981\u4ef6\u3067\u306f\u306a\u3044\u304c\u3001\u8a18\u9332\u306e\u305f\u3081\u306b\u6e2c\u5b9a\u5024\u3092\u8a18\u9332\u3059\u308b\u3002.<\/p><p>5.5.2.4 \u5ba4\u6e29\u304c\u7ba1\u7406\u3055\u308c\u305f\u5b9f\u9a13\u5ba4\uff1a\u6e29\u5ea6 20\uff5e25\u00b0C\u3001\u76f8\u5bfe\u6e7f\u5ea6 30\uff5e65%\u3002.<\/p><p>5.5.2.5 \u5b89\u5b9a\u6027\u8a66\u9a13\u5ba4\uff1a\u8a2d\u5b9a\u5024\u306fICH\u6761\u4ef6\u3054\u3068\u306b\u7570\u306a\u308b\uff0825\u00b0C\/60% RH\u300130\u00b0C\/65% RH\u300140\u00b0C\/75% RH\uff09\u3002.<\/p><p>5.5.3 \u7279\u5b9a\u306e\u88fd\u54c1\u3084\u5de5\u7a0b\u306b\u3064\u3044\u3066\u306f\u3001\u3088\u308a\u53b3\u3057\u3044\u57fa\u6e96\u304c\u9069\u7528\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u4e0a\u8a18\u306e\u4e00\u822c\u7684\u306a\u6570\u5024\u3067\u306f\u306a\u304f\u3001\u5fc5\u305a\u5f53\u8a72\u30a8\u30ea\u30a2\u306e\u63b2\u793a\u677f\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u57fa\u6e96\u306b\u5f93\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.5.4 \u5404\u30a8\u30ea\u30a2\u306b\u306f\u3001\u63aa\u7f6e\u57fa\u6e96\u5024\u306e\u5185\u5074\u306b\u8b66\u5831\u57fa\u6e96\u5024\u304c\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002\u6e2c\u5b9a\u5024\u304c\u8b66\u5831\u57fa\u6e96\u5024\u3092\u8d85\u3048\u305f\u5834\u5408\u3001\u76e3\u8996\u624b\u9806\u304c\u767a\u52d5\u3055\u308c\u308b\u3002\u6e2c\u5b9a\u5024\u304c\u63aa\u7f6e\u57fa\u6e96\u5024\u3092\u8d85\u3048\u305f\u5834\u5408\u3001\u9038\u8131\u5831\u544a\u66f8\u304c\u4f5c\u6210\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.6 \u76e3\u8996\u983b\u5ea6\uff1a<\/strong><\/h3><p>5.6.1 \u307b\u3068\u3093\u3069\u306e\u30a8\u30ea\u30a2\u3067\u306f\u30011\u30b7\u30d5\u30c8\u306b\u3064\u304d2\u56de\u3001\u624b\u52d5\u306b\u3088\u308b\u6e2c\u5b9a\u304c\u884c\u308f\u308c\u307e\u3059\u30021\u56de\u76ee\u306e\u6e2c\u5b9a\u306f\u30b7\u30d5\u30c8\u958b\u59cb\u5f8c1\u6642\u9593\u4ee5\u5185\u306b\u884c\u308f\u308c\u30012\u56de\u76ee\u306e\u6e2c\u5b9a\u306f\u30b7\u30d5\u30c8\u7d42\u4e86\u524d1\u6642\u9593\u4ee5\u5185\u306b\u884c\u308f\u308c\u307e\u3059\u3002.<\/p><p>5.6.2 \u51b7\u8535\u5ba4\u3084\u7121\u83cc\u5ba4\u306a\u3069\u306e\u9ad8\u30ea\u30b9\u30af\u30a8\u30ea\u30a2\u3067\u306f\u3001\u7d99\u7d9a\u7684\u306a\u96fb\u5b50\u8a18\u9332\u306b\u52a0\u3048\u30011\u6642\u9593\u3054\u3068\u306e\u624b\u52d5\u306b\u3088\u308b\u70b9\u691c\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p><p>5.6.3 \u5b89\u5b9a\u6027\u8a66\u9a13\u5ba4\u306e\u30c7\u30fc\u30bf\u306f\u3001\u5185\u8535\u306e\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306b\u3088\u3063\u306615\u5206\u3054\u3068\u306b\u8a18\u9332\u3055\u308c\u308b\u3002\u306a\u304a\u30011\u65e52\u56de\u306f\u624b\u52d5\u306b\u3088\u308b\u78ba\u8a8d\u6e2c\u5b9a\u3082\u884c\u308f\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.6.4 \u4fdd\u7ba1\u30a8\u30ea\u30a2\u306b\u8a2d\u7f6e\u3055\u308c\u305f\u9023\u7d9a\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306f\u300124\u6642\u9593\u4f53\u5236\u30675\u5206\u9593\u9694\u3067\u8a18\u9332\u3092\u884c\u3046\u3002\u30c7\u30fc\u30bf\u306f\u90311\u56de\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3055\u308c\u3001\u50be\u5411\u306e\u78ba\u8a8d\u306b\u5229\u7528\u3055\u308c\u308b\u3002.<\/p><p>5.6.5 \u4ee5\u4e0b\u306e\u30c8\u30ea\u30ac\u30fc\u6761\u4ef6\u306e\u4e0b\u3067\u306f\u3001\u8ffd\u52a0\u306e\u6e2c\u5b9a\u304c\u5fc5\u8981\u3068\u306a\u308b\uff1a<\/p><p>5.6.5.1 \u7a7a\u8abf\u30b7\u30b9\u30c6\u30e0\u306e\u518d\u8d77\u52d5\u307e\u305f\u306f\u8a08\u753b\u7684\u306a\u505c\u6b62\u306e\u5f8c\u3002.<\/p><p>5.6.5.2 \u5efa\u7269\u306e\u7a7a\u8abf\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53b3\u3057\u3044\u6c17\u8c61\u72b6\u6cc1\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3002.<\/p><p>5.6.5.3 \u3069\u306e\u30c9\u30a2\u308210\u5206\u4ee5\u4e0a\u958b\u3044\u305f\u307e\u307e\u306b\u306a\u3063\u305f\u5f8c\u3002.<\/p><p>5.6.5.4 \u8868\u9762\u306b\u76ee\u306b\u898b\u3048\u308b\u7d50\u9732\u3084\u971c\u306e\u5c64\u304c\u5f62\u6210\u3055\u308c\u305f\u5834\u5408\u3002.<\/p><p>5.6.5.5 \u7a7a\u8abf\u6a5f\u306e\u4fdd\u5b88\u4f5c\u696d\u7d42\u4e86\u5f8c\u3002.<\/p><h3><strong>5.7 \u76e3\u8996\u6a5f\u5668\uff1a<\/strong><\/h3><h4><strong><b>5.7.1 \u58c1\u639b\u3051\u5f0f\u6e29\u6e7f\u5ea6\u8a08\uff1a<\/b><\/strong><\/h4><p>5.7.1.1 \u76e3\u8996\u5bfe\u8c61\u306e\u5404\u30a8\u30ea\u30a2\u306b\u306f\u3001\u6821\u6b63\u6e08\u307f\u306e\u58c1\u639b\u3051\u5f0f\u6e29\u6e7f\u5ea6\u8a08\u304c\u5c11\u306a\u304f\u3068\u30821\u53f0\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u306e\u88c5\u7f6e\u306f\u3001\u30c7\u30b8\u30bf\u30eb\u753b\u9762\u306b\u73fe\u5728\u306e\u6e29\u5ea6\u3068\u76f8\u5bfe\u6e7f\u5ea6\u3092\u8868\u793a\u3059\u308b\u3002.<\/p><p>5.7.1.2 \u672c\u88c5\u7f6e\u306f\u3001\u5e8a\u9762\u304b\u30891.5\uff5e1.8\u30e1\u30fc\u30c8\u30eb\u306e\u9ad8\u3055\u306b\u8a2d\u7f6e\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u9ad8\u3055\u306f\u3001\u5f53\u8a72\u30a8\u30ea\u30a2\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u4f5c\u696d\u9818\u57df\u306b\u5408\u81f4\u3057\u3066\u3044\u307e\u3059\u3002.<\/p><p>5.7.1.3 \u672c\u6a5f\u306f\u3001\u30c9\u30a2\u3001\u901a\u6c17\u53e3\u3001\u71b1\u6e90\u3001\u307e\u305f\u306f\u5916\u58c1\u304b\u3089\u5c11\u306a\u304f\u3068\u30821\u30e1\u30fc\u30c8\u30eb\u96e2\u3057\u3066\u8a2d\u7f6e\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u308c\u3089\u306e\u3044\u305a\u308c\u304b\u306b\u8fd1\u3065\u3051\u308b\u3068\u3001\u305d\u306e\u5834\u6240\u3067\u306e\u6e2c\u5b9a\u5024\u306b\u8aa4\u5dee\u304c\u751f\u3058\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>5.7.1.4 \u5de1\u56de\u70b9\u691c\u306e\u969b\u3001\u5404\u88c5\u7f6e\u306e\u6821\u6b63\u30b9\u30c6\u30c3\u30ab\u30fc\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3002\u6821\u6b63\u671f\u9650\u3092\u904e\u304e\u305f\u88c5\u7f6e\u306f\u3001\u516c\u5f0f\u306e\u6e2c\u5b9a\u306b\u306f\u4f7f\u7528\u3067\u304d\u306a\u3044\u3002.<\/p><h4><strong><b>5.7.2 \u643a\u5e2f\u578b\u57fa\u6e96\u6e29\u6e7f\u5ea6\u8a08\uff1a<\/b><\/strong><\/h4><p>5.7.2.1 \u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005\u306f\u3001\u629c\u304d\u53d6\u308a\u691c\u67fb\u3084\u58c1\u9762\u8a2d\u7f6e\u578b\u88c5\u7f6e\u3068\u306e\u7167\u5408\u3092\u884c\u3046\u305f\u3081\u306b\u3001\u643a\u5e2f\u578b\u57fa\u6e96\u88c5\u7f6e\u3092\u643a\u884c\u3059\u308b\u3002.<\/p><p>5.7.2.2 \u643a\u5e2f\u578b\u88c5\u7f6e\u306f\u3001\u3088\u308a\u53b3\u683c\u306a\u6821\u6b63\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u5b9a\u3081\u3089\u308c\u3066\u304a\u308a\u3001\u6e2c\u5b9a\u5024\u306b\u95a2\u3059\u308b\u7d1b\u4e89\u304c\u751f\u3058\u305f\u5834\u5408\u306b\u306f\u3001\u57fa\u6e96\u5668\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u679c\u305f\u3059\u3002.<\/p><p>5.7.2.3 \u6e2c\u5b9a\u5024\u3092\u8a18\u9332\u3059\u308b\u524d\u306b\u3001\u65b0\u3057\u3044\u5834\u6240\u3067\u30dd\u30fc\u30bf\u30d6\u30eb\u88c5\u7f6e\u3092\u5c11\u306a\u304f\u3068\u308210\u5206\u9593\u3001\u5e73\u8861\u72b6\u614b\u306b\u3057\u3066\u304a\u304f\u3053\u3068\u3002\u8a2d\u7f6e\u5834\u6240\u3092\u6025\u306b\u5909\u66f4\u3059\u308b\u3068\u3001\u4e00\u6642\u7684\u306a\u6e2c\u5b9a\u5024\u306e\u305a\u308c\u304c\u751f\u3058\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p><p>5.7.2.4 \u30d7\u30ed\u30fc\u30d6\u306f\u614e\u91cd\u306b\u53d6\u308a\u6271\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u30bb\u30f3\u30b5\u30fc\u306e\u5148\u7aef\u306b\u306f\u89e6\u308c\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u4f53\u6e29\u306b\u3088\u3063\u3066\u3001\u6570\u5206\u9593\u3001\u6e2c\u5b9a\u5024\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002.<\/p><h4><strong><b>5.7.3 \u9023\u7d9a\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\uff1a<\/b><\/strong><\/h4><p>5.7.3.1 \u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u3068\u306f\u3001\u4fdd\u7ba1\u5834\u6240\u306b\u8a2d\u7f6e\u3055\u308c\u3001\u4e00\u5b9a\u9593\u9694\u3067\u6e29\u5ea6\u304a\u3088\u3073\u76f8\u5bfe\u6e7f\u5ea6\u3092\u8a18\u9332\u3059\u308b\u3001\u5c0f\u578b\u306e\u96fb\u6c60\u99c6\u52d5\u88c5\u7f6e\u3067\u3042\u308b\u3002.<\/p><p>5.7.3.2 \u5404\u30ed\u30ac\u30fc\u306b\u306f\u3001\u7279\u5b9a\u306e\u5834\u6240\u3068\u7d10\u3065\u304f\u4e00\u610f\u306eID\u304c\u4ed8\u4e0e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5909\u66f4\u7ba1\u7406\u30d5\u30a9\u30fc\u30e0\u306a\u3057\u306b\u3001\u30ed\u30ac\u30fc\u3092\u5225\u306e\u30a8\u30ea\u30a2\u3078\u79fb\u52d5\u3055\u305b\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.7.3.3 \u30d9\u30f3\u30c0\u30fc\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u4f7f\u7528\u3057\u3066\u3001\u6bce\u9031\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306e\u30c7\u30fc\u30bf\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u305f\u5404\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u30d5\u30a1\u30a4\u30eb\u540d\u306b\u30c7\u30fc\u30bf\u30ed\u30ac\u30fcID\u3001\u8a2d\u7f6e\u5834\u6240\u3001\u65e5\u4ed8\u3092\u542b\u3081\u3066\u4fdd\u5b58\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u9031\u6b21\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u300c\u9031\u6b21\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u30ec\u30dd\u30fc\u30c8\u300d\u306e\u4e00\u90e8\u3068\u306a\u308a\u307e\u3059\u3002.<\/p><p>5.7.3.4 \u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u305f\u30c7\u30fc\u30bf\u3092\u78ba\u8a8d\u3057\u3001\u8b66\u5831\u5024\u307e\u305f\u306f\u63aa\u7f6e\u57fa\u6e96\u5024\u3092\u8d85\u3048\u305f\u6e2c\u5b9a\u5024\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3059\u308b\u3002\u57fa\u6e96\u5024\u3092\u8d85\u3048\u305f\u5404\u4e8b\u4f8b\u306b\u3064\u3044\u3066\u3001\u958b\u59cb\u6642\u523b\u3001\u7d42\u4e86\u6642\u523b\u3001\u304a\u3088\u3073\u7d99\u7d9a\u6642\u9593\u3092\u8a18\u9332\u3059\u308b\u3002.<\/p><p>5.7.3.5 \u30d0\u30c3\u30c6\u30ea\u30fc\u6b8b\u91cf\u4f4e\u4e0b\u30a4\u30f3\u30b8\u30b1\u30fc\u30bf\u30fc\u304c\u70b9\u706f\u3057\u305f\u3089\u3001\u30ed\u30ac\u30fc\u306e\u30d0\u30c3\u30c6\u30ea\u30fc\u3092\u4ea4\u63db\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30d0\u30c3\u30c6\u30ea\u30fc\u5207\u308c\u306b\u3088\u308b\u30c7\u30fc\u30bf\u6b20\u843d\u306f\u3001\u9038\u8131\u3068\u3057\u3066\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p><h4><strong><b>5.7.4 \u30d3\u30eb\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08BMS\uff09\u306e\u30bb\u30f3\u30b5\u30fc\uff1a<\/b><\/strong><\/h4><p>5.7.4.1 BMS\u306f\u3001HVAC\u3067\u5236\u5fa1\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30a8\u30ea\u30a2\u3092\u4e2d\u592e\u76e3\u8996\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306b\u63a5\u7d9a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u30bb\u30f3\u30b5\u30fc\u304b\u3089\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u6e2c\u5b9a\u5024\u304c1\u3064\u306e\u753b\u9762\u306b\u8868\u793a\u3055\u308c\u307e\u3059\u3002.<\/p><p>5.7.4.2 \u3044\u305a\u308c\u304b\u306e\u6e2c\u5b9a\u5024\u304c\u8b66\u544a\u5024\u307e\u305f\u306f\u63aa\u7f6e\u5024\u3092\u8d8a\u3048\u305f\u5834\u5408\u3001BMS\u306f\u5f53\u76f4\u306e\u6280\u8853\u8005\u306b\u81ea\u52d5\u30a2\u30e9\u30fc\u30e0\u3092\u9001\u4fe1\u3059\u308b\u3002.<\/p><p>5.7.4.3 \u671d\u306e\u5de1\u56de\u6642\u306b\u306f\u3001\u5404\u30a8\u30ea\u30a2\u306eBMS\u306e\u6e2c\u5b9a\u5024\u3068\u58c1\u9762\u30c7\u30a3\u30b9\u30d7\u30ec\u30a4\u306e\u8868\u793a\u5024\u3092\u7167\u5408\u3059\u308b\u30021\u00b0C\u307e\u305f\u306f5% RH\u3092\u8d85\u3048\u308b\u5dee\u7570\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u30b5\u30fc\u30d3\u30b9\u696d\u8005\u306b\u9023\u7d61\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p><p>5.7.4.4 \u6bce\u65e5\u5348\u524d8\u6642\u306b\u65e5\u6b21BMS\u30ec\u30dd\u30fc\u30c8\u3092\u5370\u5237\u3059\u308b\u3002\u5370\u5237\u3057\u305f\u30ec\u30dd\u30fc\u30c8\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u306b\u3088\u308b\u78ba\u8a8d\u5f8c\u3001\u65e5\u6b21\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u7528\u30d0\u30a4\u30f3\u30c0\u30fc\u306b\u4fdd\u7ba1\u3059\u308b\u3002.<\/p><h3><strong>5.8 \u6e2c\u5b9a\u5024\u306e\u8aad\u307f\u53d6\u308a\uff1a<\/strong><\/h3><p>5.8.1 \u6240\u5b9a\u306e\u30a8\u30a2\u30ed\u30c3\u30af\u3092\u901a\u3063\u3066\u305d\u306e\u30a8\u30ea\u30a2\u306b\u5165\u308a\u3001\u305d\u306e\u30be\u30fc\u30f3\u306e\u7740\u8863\u624b\u9806\u306b\u5f93\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.8.2 \u4f53\u6e29\u30fb\u6e7f\u5ea6\u8a08\u306e\u524d\u306b\u7acb\u3061\u3001\u81ea\u5206\u306e\u4f53\u3067\u30bb\u30f3\u30b5\u30fc\u3092\u906e\u3089\u306a\u3044\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u4f53\u306e\u71b1\u3084\u606f\u304c\u6e2c\u5b9a\u5024\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>5.8.3 \u8868\u793a\u304c\u5b89\u5b9a\u3059\u308b\u307e\u306730\u79d2\u9593\u5f85\u3061\u307e\u3059\u3002\u9762\u7a4d\u306e\u72b6\u614b\u304c\u5909\u5316\u3059\u308b\u969b\u3001\u30c7\u30b8\u30bf\u30eb\u8868\u793a\u304c2\u3064\u306e\u5024\u306e\u9593\u3067\u3061\u3089\u3064\u304f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>5.8.4 \u307e\u305a\u6e29\u5ea6\u3092\u8aad\u307f\u53d6\u308a\u3001\u6b21\u306b\u6e7f\u5ea6\u3092\u8aad\u307f\u53d6\u308a\u307e\u3059\u3002\u4e21\u65b9\u306e\u5024\u3092\u5c0f\u6570\u70b9\u4ee5\u4e0b1\u6841\u307e\u3067\u8a18\u9332\u3057\u3001\u73fe\u5728\u306e\u6642\u9593\u5e2f\u306b\u5bfe\u5fdc\u3059\u308b\u8a18\u9332\u8868\u306e\u884c\u306b\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p><p>5.8.5 \u5404\u5024\u306e\u6a2a\u306b\u3001\u30bb\u30f3\u30b5\u30fcID\u3001\u8aad\u307f\u53d6\u308a\u6642\u523b\u3001\u304a\u3088\u3073\u62c5\u5f53\u8005\u306eID\u3092\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3059\u3079\u3066\u306e\u8a18\u9332\u306f\u3001\u7279\u5b9a\u306e\u30bb\u30f3\u30b5\u30fc\u304a\u3088\u3073\u62c5\u5f53\u8005\u306b\u7d10\u3065\u3051\u3089\u308c\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.8.6 \u822a\u6d77\u65e5\u8a8c\u3078\u306e\u8a18\u5165\u306b\u306f\u3001\u9752\u307e\u305f\u306f\u9ed2\u306e\u30a4\u30f3\u30af\u306e\u307f\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3002\u925b\u7b46\u306f\u7d76\u5bfe\u306b\u4f7f\u7528\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u4fee\u6b63\u6db2\u3082\u7d76\u5bfe\u306b\u4f7f\u7528\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u8aa4\u308a\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u8aa4\u3063\u305f\u8a18\u5165\u90e8\u5206\u306b\u4e00\u672c\u306e\u7dda\u3092\u5f15\u3044\u3066\u6d88\u3057\u3001\u305d\u306e\u4e0a\u306b\u6b63\u3057\u3044\u6570\u5024\u3092\u8a18\u5165\u3057\u3001\u30a4\u30cb\u30b7\u30e3\u30eb\u3068\u65e5\u4ed8\u3092\u6dfb\u3048\u308b\u3053\u3068\u3002.<\/p><p>5.8.7 \u6e2c\u5b9a\u304c\u5b8c\u4e86\u3057\u305f\u3089\u3001\u305d\u306e\u884c\u306b\u7f72\u540d\u3068\u65e5\u4ed8\u3092\u8a18\u5165\u3059\u308b\u3053\u3068\u3002\u7f72\u540d\u306e\u306a\u3044\u884c\u306f\u6709\u52b9\u306a\u8a18\u9332\u3068\u306f\u307f\u306a\u3055\u308c\u306a\u3044\u3002.<\/p><h3><strong>5.9 \u30a8\u30af\u30b9\u30ab\u30fc\u30b7\u30e7\u30f3\u306e\u51e6\u7406\uff1a<\/strong><\/h3><p>5.9.1 \u9038\u8131\u3068\u306f\u3001\u305d\u306e\u533a\u57df\u306e\u8a31\u5bb9\u7bc4\u56f2\u3092\u8d85\u3048\u308b\u3042\u3089\u3086\u308b\u6e2c\u5b9a\u5024\u3092\u6307\u3059\u3002\u3059\u3079\u3066\u306e\u9038\u8131\u306b\u3064\u3044\u3066\u3001\u8abf\u67fb\u3092\u884c\u3044\u3001\u8a18\u9332\u3092\u6b8b\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.9.2 \u9038\u8131\u304c\u767a\u898b\u3055\u308c\u305f\u5834\u5408\u306f\u3001\u4ee5\u4e0b\u306e\u624b\u9806\u3092\u9806\u306b\u5b9f\u884c\u3059\u308b\u3053\u3068\u3002<\/p><p>5.9.2.1 \u30bb\u30f3\u30b5\u30fc\u306e\u6545\u969c\u3092\u9664\u5916\u3059\u308b\u305f\u3081\u3001\u643a\u5e2f\u578b\u57fa\u6e96\u88c5\u7f6e\u3092\u4f7f\u7528\u3057\u3066\u518d\u5ea6\u6e2c\u5b9a\u3092\u884c\u3046\u3002.<\/p><p>5.9.2.2 2\u56de\u76ee\u306e\u6e2c\u5b9a\u3067\u3082\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3044\u5834\u5408\u306f\u300115\u5206\u4ee5\u5185\u306b\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u304a\u3088\u3073\u30b7\u30d5\u30c8\u8cac\u4efb\u8005\u306b\u5831\u544a\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.9.2.3 \u5f53\u8a72\u30a8\u30ea\u30a2\u5185\u306e\u88fd\u54c1\u306e\u3046\u3061\u3001\u8a31\u5bb9\u7bc4\u56f2\u5916\u306e\u72b6\u614b\u306b\u3055\u3089\u3055\u308c\u305f\u3082\u306e\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3059\u308b\u3002\u5f71\u97ff\u3092\u53d7\u3051\u305f\u88fd\u54c1\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u306b\u3088\u308b\u5be9\u67fb\u304c\u5b8c\u4e86\u3059\u308b\u307e\u3067\u9694\u96e2\u3059\u308b\u3002.<\/p><p>5.9.2.4 \u7570\u5e38\u306e\u6839\u672c\u539f\u56e0\u3092\u8abf\u67fb\u3059\u308b\u3088\u3046\u3001HVAC\u6280\u8853\u8005\u306b\u901a\u77e5\u3059\u308b\u3002.<\/p><p>5.9.2.5 \u5f53\u8a72\u533a\u57df\u304c\u8a31\u5bb9\u7bc4\u56f2\u5185\u306b\u623b\u308b\u307e\u3067\u300130\u5206\u9593\u9694\u3067\u76e3\u8996\u3092\u7d99\u7d9a\u3059\u308b\u3002.<\/p><p>5.9.3 \u74b0\u5883\u5909\u52d5\u8abf\u67fb\u7968\u306b\u8abf\u67fb\u5185\u5bb9\u3092\u8a18\u9332\u3059\u308b\u3002\u3053\u306e\u8abf\u67fb\u7968\u306b\u306f\u3001\u65e5\u4ed8\u3001\u6642\u523b\u3001\u7d99\u7d9a\u6642\u9593\u3001\u5bfe\u8c61\u30a8\u30ea\u30a2\u3001\u30bb\u30f3\u30b5\u30fcID\u3001\u6e2c\u5b9a\u5024\u3001\u884c\u52d5\u57fa\u6e96\u5024\u3001\u304a\u3088\u3073\u88fd\u54c1\u3078\u306e\u5f71\u97ff\u3092\u8a18\u8f09\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.9.4 \u4e8b\u8c61\u767a\u751f\u5f8c24\u6642\u9593\u4ee5\u5185\u306b\u3001\u5f53\u8a72\u30d5\u30a9\u30fc\u30e0\u3092QA\u306b\u63d0\u51fa\u3057\u3066\u304f\u3060\u3055\u3044\u3002QA\u306f\u3001\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304d\u3001\u5f71\u97ff\u3092\u53d7\u3051\u305f\u88fd\u54c1\u306e\u30ea\u30ea\u30fc\u30b9\u53ef\u5426\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002.<\/p><p>5.9.5 4\u6642\u9593\u3092\u8d85\u3048\u308b\u9038\u8131\u3001\u307e\u305f\u306f\u5b8c\u6210\u54c1\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u9038\u8131\u306b\u3064\u3044\u3066\u306f\u3001\u73fe\u5834\u306e\u9038\u8131\u5bfe\u5fdc\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u57fa\u3065\u304d\u3001\u6b63\u5f0f\u306a\u9038\u8131\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><h3><strong>5.10 \u6e2c\u5b9a\u5668\u306e\u6821\u6b63\uff1a<\/strong><\/h3><p>5.10.1 \u3059\u3079\u3066\u306e\u6e29\u6e7f\u5ea6\u8a08\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306f\u3001\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u5916\u90e8\u6a5f\u95a2\u3001\u307e\u305f\u306f\u73fe\u5834\u306e\u6821\u6b63\u5b9f\u9a13\u5ba4\u306b\u3088\u3063\u3066\u6821\u6b63\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.10.2 \u6821\u6b63\u306e\u983b\u5ea6\u306f\u3001\u58c1\u639b\u3051\u578b\u88c5\u7f6e\u306b\u3064\u3044\u3066\u306f6\u304b\u6708\u306b1\u56de\u3001\u643a\u5e2f\u578b\u57fa\u6e96\u88c5\u7f6e\u306b\u3064\u3044\u3066\u306f3\u304b\u6708\u306b1\u56de\u3068\u3059\u308b\u3002.<\/p><p>5.10.3 \u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306f\u30012\u3064\u306e\u6e29\u5ea6\u70b9\uff08\u52d5\u4f5c\u7bc4\u56f2\u306e\u4e0b\u9650\u304a\u3088\u3073\u4e0a\u9650\uff09\u304a\u3088\u30732\u3064\u306e\u6e7f\u5ea6\u70b9\uff08\u6a19\u6e96\u98fd\u548c\u5869\u57fa\u6e96\u306b\u5408\u81f4\u3059\u308b33% RH\u304a\u3088\u307375% RH\uff09\u306b\u304a\u3044\u3066\u6821\u6b63\u3055\u308c\u308b\u3002.<\/p><p>5.10.4 \u5404\u6e2c\u5b9a\u5668\u306b\u3064\u3044\u3066\u3001\u6e2c\u5b9a\u5668\u6821\u6b63\u8a3c\u660e\u66f8\u304c\u767a\u884c\u3055\u308c\u308b\u3002\u3053\u306e\u8a3c\u660e\u66f8\u306b\u306f\u3001\u521d\u671f\u6e2c\u5b9a\u5024\u3001\u6821\u6b63\u5f8c\u306e\u6e2c\u5b9a\u5024\u3001\u304a\u3088\u3073\u9069\u7528\u3055\u308c\u305f\u88dc\u6b63\u4fc2\u6570\u304c\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><p>5.10.5 \u6821\u6b63\u304c\u6b63\u5e38\u306b\u5b8c\u4e86\u3057\u305f\u3089\u3001\u5404\u6a5f\u5668\u306b\u6821\u6b63\u30e9\u30d9\u30eb\u3092\u8cbc\u4ed8\u3059\u308b\u3002\u3053\u306e\u30e9\u30d9\u30eb\u306b\u306f\u3001\u6821\u6b63\u65e5\u3001\u6b21\u56de\u306e\u6821\u6b63\u4e88\u5b9a\u65e5\u3001\u304a\u3088\u3073\u8a3c\u660e\u66f8\u756a\u53f7\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.10.6 \u6821\u6b63\u306b\u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u6e2c\u5b9a\u5668\u306f\u3001\u76f4\u3061\u306b\u4f7f\u7528\u3092\u4e2d\u6b62\u3057\u3001\u4fee\u7406\u307e\u305f\u306f\u4ea4\u63db\u306e\u305f\u3081\u306b\u9001\u4ed8\u3059\u308b\u3002\u6821\u6b63\u306b\u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u5834\u5408\u3001\u524d\u56de\u306e\u5408\u683c\u4ee5\u964d\u306b\u53d6\u5f97\u3057\u305f\u30c7\u30fc\u30bf\u306e\u9061\u53ca\u7684\u306a\u691c\u8a3c\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308b\u3002.<\/p><h3><strong>5.11 \u30c7\u30fc\u30bf\u306e\u78ba\u8a8d\u3068\u50be\u5411\u5206\u6790\uff1a<\/strong><\/h3><p>5.11.1 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u306f\u3001\u6bce\u65e5\u306e\u8a18\u9332\u7c3f\u3078\u306e\u8a18\u8f09\u4e8b\u9805\u3092\u3001\u7fcc\u55b6\u696d\u65e5\u306e\u7d42\u308f\u308a\u307e\u3067\u306b\u3059\u3079\u3066\u78ba\u8a8d\u3059\u308b\u3002\u7f72\u540d\u5165\u308a\u306e\u78ba\u8a8d\u66f8\u306b\u3088\u308a\u3001\u3059\u3079\u3066\u306e\u6e2c\u5b9a\u5024\u304c\u8a31\u5bb9\u7bc4\u56f2\u5185\u306b\u3042\u308b\u3053\u3068\u304c\u78ba\u8a8d\u3055\u308c\u308b\u3002.<\/p><p>5.11.2 \u6bce\u9031\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3055\u308c\u305f\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306e\u30c7\u30fc\u30bf\u306f\u3001\u5404\u30a8\u30ea\u30a2\u3054\u3068\u306b\u50be\u5411\u30b0\u30e9\u30d5\u306b\u30d7\u30ed\u30c3\u30c8\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30b0\u30e9\u30d5\u306b\u306f\u3001\u5404\u65e5\u306e\u6700\u5927\u5024\u3001\u6700\u5c0f\u5024\u3001\u304a\u3088\u3073\u5e73\u5747\u5024\u304c\u8868\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><p>5.11.3 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u304c\u6708\u6b21\u50be\u5411\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3002\u3053\u306e\u5831\u544a\u66f8\u3067\u306f\u3001\u9038\u8131\u304c\u767a\u751f\u3057\u3066\u3044\u306a\u304f\u3066\u3082\u3001\u884c\u52d5\u9650\u754c\u5024\u3078\u306e\u9038\u8131\u50be\u5411\u304c\u898b\u3089\u308c\u308b\u9818\u57df\u3092\u6307\u6458\u3059\u308b\u3002.<\/p><p>5.11.4 \u56db\u534a\u671f\u3054\u3068\u306e\u7d4c\u55b6\u691c\u8a0e\u59d4\u54e1\u4f1a\u3067\u306f\u3001\u3059\u3079\u3066\u306e\u300c\u6708\u6b21\u50be\u5411\u5831\u544a\u66f8\u300d\u3092\u7cbe\u67fb\u3059\u308b\u3002\u7d44\u7e54\u7684\u306a\u554f\u984c\u306b\u3064\u3044\u3066\u306f\u3001\u8cac\u4efb\u8005\u3068\u662f\u6b63\u306e\u76ee\u6a19\u671f\u9650\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u308b\u3002.<\/p><p>5.11.5 \u3059\u3079\u3066\u306e\u6e29\u5ea6\u304a\u3088\u3073\u6e7f\u5ea6\u306e\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\u5b58\u3055\u308c\u308b\u3082\u306e\u3068\u3059\u308b\u3002.<\/p><h3><strong>5.12 \u8a18\u9332:<\/strong><\/h3><p>5.12.1 \u6e29\u5ea6\u30fb\u6e7f\u5ea6\u8a18\u9332\u7c3f\u3002.<\/p><h4><strong>5.12.2 BMS\u306e\u65e5\u6b21\u30ec\u30dd\u30fc\u30c8<\/strong><\/h4><p>5.12.3 \u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u306e\u9031\u6b21\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u30ec\u30dd\u30fc\u30c8\u3002.<\/p><p>5.12.4 \u74b0\u5883\u8abf\u67fb\u5831\u544a\u66f8\u3002.<\/p><p>5.12.5 \u8a08\u6e2c\u5668\u306e\u6821\u6b63\u8a3c\u660e\u66f8\u3002.<\/p><p>5.12.6 \u6708\u6b21\u30c8\u30ec\u30f3\u30c9\u30ec\u30dd\u30fc\u30c8\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 RH\uff1a<\/strong> \u76f8\u5bfe\u6e7f\u5ea6\u3002.<\/p><p><strong>6.4 \u7a7a\u8abf\u8a2d\u5099\uff1a<\/strong> \u6696\u623f\u3001\u63db\u6c17\u3001\u7a7a\u8abf\u3002.<\/p><p><strong>6.5 BMS\uff1a<\/strong> \u30d3\u30eb\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3002.<\/p><p><strong>6.6 GMP\uff1a<\/strong> \u9069\u6b63\u88fd\u9020\u898f\u7bc4\u3002.<\/p><p><strong>6.7 ICH\uff1a<\/strong> \u56fd\u969b\u8abf\u548c\u4f1a\u8b70\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 Temperature and Humidity Monitoring in the Pharmaceutical Industry. 1.0 OBJECTIVE: To define the procedure for routine [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":18013,"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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