{"id":12075,"date":"2026-04-12T01:19:09","date_gmt":"2026-04-12T01:19:09","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=12075"},"modified":"2026-03-09T02:31:46","modified_gmt":"2026-03-09T02:31:46","slug":"user-requirement-specification-in-pharma-you-should-know","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/user-requirement-specification-in-pharma-you-should-know\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff08URS\uff09\u306b\u3064\u3044\u3066\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"12075\" class=\"elementor elementor-12075\" 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\u3067\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff08User Requirement Specification\uff09\u306e\u7565\u79f0\u3067\u3042\u308bURS\u306f\u3001\u3042\u3089\u3086\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u6700\u521d\u304b\u3064\u6700\u3082\u91cd\u8981\u306a\u6587\u66f8\u306e1\u3064\u3067\u3042\u308b\u3002.<\/p><figure id=\"attachment_12143\" aria-describedby=\"caption-attachment-12143\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-12143\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma.jpg\" alt=\"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\" width=\"1000\" height=\"532\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma-300x160.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma-768x409.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma-18x10.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/04\/User-Requirement-Specification-in-Pharma-600x319.jpg 600w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-12143\" class=\"wp-caption-text\"><em><strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8.<\/strong><\/em><\/figcaption><\/figure><p>\u6a5f\u5668\u3092\u8cfc\u5165\u3057\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u9078\u629e\u3057\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001URS\u306f\u30e6\u30fc\u30b6\u30fc\u304c\u30b7\u30b9\u30c6\u30e0\u306b\u4f55\u3092\u671f\u5f85\u3059\u308b\u304b\u3092\u6b63\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u3002URS\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3001\u898f\u5236\u4e0a\u306e\u671f\u5f85\u3001\u904b\u7528\u4e0a\u306e\u8981\u4ef6\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b\u3002.<\/p><p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bURS\uff08\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff09\u3068\u306f\u4f55\u304b\u3001\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b\u7591\u554f\u306b\u601d\u3063\u3066\u3044\u308b\u65b9\u3001\u3053\u306e\u30ac\u30a4\u30c9\u3092\u8aad\u3081\u3070\u77e5\u308b\u3079\u304d\u3053\u3068\u304c\u3059\u3079\u3066\u308f\u304b\u308a\u307e\u3059\u3002.<\/p><p>\u8a73\u7d30\u3092\u8aac\u660e\u3057\u3088\u3046\uff01<\/p><h2><strong><b>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bURS\uff08\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff09\u3068\u306f\uff1f<\/b><\/strong><\/h2><p>URS\u3068\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u304c\u30b7\u30b9\u30c6\u30e0\u306b\u671f\u5f85\u3059\u308b\u3053\u3068\u3092\u660e\u78ba\u306b\u8a18\u8ff0\u3057\u305f\u6587\u66f8\u3067\u3042\u308b\u3001, <a href=\"https:\/\/pharmamachinecn.com\/ja\/pharmaceutical-equipment-list\/\"><u>\u88c5\u7f6e<\/u><\/a>, \u307e\u305f\u306f\u30d7\u30ed\u30bb\u30b9\u3002\u8a2d\u8a08\u3001\u8cfc\u5165\u3001\u8a2d\u7f6e\u3055\u308c\u308b\u524d\u306b\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u30cb\u30fc\u30ba\u3092\u8aac\u660e\u3057\u307e\u3059\u3002\u7c21\u5358\u306b\u8a00\u3046\u3068\u3001URS\u306f\u4e00\u3064\u306e\u57fa\u672c\u7684\u306a\u8cea\u554f\u306b\u7b54\u3048\u308b\u3082\u306e\u3067\u3059\uff1a<\/p><p><em><i><strong>\u5b89\u5168\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u305f\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u4f55\u3092\u3059\u3079\u304d\u304b\uff1f<\/strong> <\/i><\/em><\/p><p>URS\u306f\u30e6\u30fc\u30b6\u30fc\u306e\u8996\u70b9\u304b\u3089\u66f8\u304b\u308c\u308b\u3002\u65e5\u5e38\u696d\u52d9\u3001\u88fd\u54c1\u54c1\u8cea\u3001\u898f\u5236\u9075\u5b88\u306e\u305f\u3081\u306b\u5fc5\u8981\u306a\u3053\u3068\u306b\u4e3b\u773c\u304c\u7f6e\u304b\u308c\u3066\u3044\u308b\u3002.<\/p><p>\u4f8b\u3048\u3070\u3001URS\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u30c7\u30fc\u30bf\u3092\u6b63\u78ba\u306b\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3001\u4e0d\u6b63\u30a2\u30af\u30bb\u30b9\u3092\u5236\u9650\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3001GMP\u6587\u66f8\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3001\u306a\u3069\u3068\u8a18\u8f09\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p><h2><strong><b>\u88fd\u85ac\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067URS\u304c\u5fc5\u8981\u3068\u3055\u308c\u308b\u306e\u306f\u3069\u306e\u3088\u3046\u306a\u5834\u5408\u304b\uff1f<\/b><\/strong><\/h2><p>\u30b7\u30b9\u30c6\u30e0\u3001\u6a5f\u5668\u3001\u5de5\u7a0b\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u5fc5\u305aURS\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u304a\u3044\u3066\u3001URS\u306f\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u3044\u3002URS\u306f\u6b21\u306e\u3088\u3046\u306a\u72b6\u6cc1\u3067\u5fc5\u8981\u3068\u3055\u308c\u308b\u5fc5\u9808\u306e\u6587\u66f8\u3067\u3042\u308b\uff1a<\/p><ul><li><b><\/b><strong><b>\u8a2d\u5099\u8cfc\u5165<\/b><\/strong>:\u88fd\u9020\u6a5f\u5668\u3001\u5305\u88c5\u6a5f\u5668\u3001\u691c\u67fb\u6a5f\u5668\u3092\u8cfc\u5165\u3059\u308b\u5834\u5408\u3001\u30d9\u30f3\u30c0\u30fc\u3092\u9078\u629e\u3059\u308b\u524d\u306b\u3001\u30e6\u30fc\u30b6\u30fc\u304c\u4f55\u3092\u671f\u5f85\u3059\u308b\u304b\u3092\u5b9a\u7fa9\u3059\u308b\u306e\u304cURS\u3067\u3042\u308b\u3002.<\/li><li><b><\/b><strong><b>\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:LIMS\u3001MES\u3001ERP\u306a\u3069\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u306fURS\u304c\u5fc5\u8981\u3067\u3059\u3001, <a href=\"https:\/\/inductiveautomation.com\/resources\/article\/what-is-scada\" target=\"_blank\" rel=\"noopener\"><u>SCADA<\/u><\/a>, \u305d\u3057\u3066\u30c7\u30fc\u30bf\u30ed\u30ac\u30fc\u3002.<\/li><li><b><\/b><strong><b>\u516c\u76ca\u4e8b\u696d\u3068\u91cd\u8981\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:HVAC\u3001\u7d14\u6c34\u3001\u5727\u7e2e\u7a7a\u6c17\u3001\u30af\u30ea\u30fc\u30f3\u30fb\u30b9\u30c1\u30fc\u30e0\u306a\u3069\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u305f\u3081\u3001URS\u3092\u5fc5\u8981\u3068\u3059\u308b\u3002.<\/li><li><b><\/b><strong><b>\u88fd\u9020\u30e9\u30a4\u30f3\uff1a <\/b><\/strong>URS\u306f\u3001\u65b0\u3057\u3044\u751f\u7523\u30e9\u30a4\u30f3\u3001\u30e9\u30a4\u30f3\u306e\u62e1\u5f35\u3001\u307e\u305f\u306f\u5927\u898f\u6a21\u306a\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u306b\u5fc5\u8981\u3067\u3059\u3002.<\/li><li><b><\/b><strong><b>\u691c\u8a3c\u6e08\u307f\u30b7\u30b9\u30c6\u30e0<\/b><\/strong>:\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408 <a href=\"https:\/\/pharmamachinecn.com\/ja\/dq-iq-oq-and-pq-in-pharmaceutical-industry-explained\/\"><u>IQ\u3001OQ\u3001\u307e\u305f\u306fPQ<\/u><\/a>, URS\u304c\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/li><\/ul><h2><strong><b>URS\u306e\u4f5c\u6210\u8cac\u4efb\u306f\u8ab0\u304c\u8ca0\u3046\u306e\u304b\uff1f<\/b><\/strong><\/h2><p>URS \u306f\u30e6\u30fc\u30b6\u30fc\u304c\u6240\u6709\u3059\u308b\u6587\u66f8\u3067\u3042\u308a\u3001\u7b2c\u4e00\u7fa9\u7684\u306a\u8cac\u4efb\u306f\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306b\u3042\u308b\u3002\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u3068\u306f\u3001\u65e5\u3005\u306e\u88fd\u85ac\u696d\u52d9\u306b\u304a\u3044\u3066\u30b7\u30b9\u30c6\u30e0\u3092\u64cd\u4f5c\u3001\u7dad\u6301\u3001\u307e\u305f\u306f\u4f9d\u5b58\u3059\u308b\u4eba\u3005\u3067\u3042\u308b\u3002.<\/p><p>\u30e6\u30fc\u30b6\u30fc\u304cURS\u3092\u4e3b\u5c0e\u3059\u308b\u4e00\u65b9\u3067\u3001\u901a\u5e38\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u8907\u6570\u306e\u30c1\u30fc\u30e0\u304c\u95a2\u4e0e\u3059\u308b\u3002 <a href=\"https:\/\/simplerqms.com\/pharmaceutical-quality-assurance\/\" target=\"_blank\" rel=\"noopener\"><u>\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09<\/u><\/a>, \u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30fb\u30c1\u30fc\u30e0\u3001IT\u30c1\u30fc\u30e0\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30fb\u30c1\u30fc\u30e0\u3002.<\/p><p>\u30d9\u30f3\u30c0\u30fc\u3084\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3082\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u304c\u3001URS\u3092\u6240\u6709\u3059\u3079\u304d\u3067\u306f\u306a\u3044\u3002\u8cac\u4efb\u306f\u5e38\u306b\u88fd\u85ac\u4f1a\u793e\u306b\u3042\u308b\u3002.<\/p><h2><strong><b>\u533b\u85ac\u54c1URS\u6587\u66f8\u306e\u4e3b\u306a\u69cb\u6210\u8981\u7d20<\/b><\/strong><\/h2><p>URS\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u304c\u660e\u78ba\u306b\u306a\u3063\u305f\u3089\u3001\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u305d\u306e\u6587\u66f8\u306b\u4f55\u3092\u76db\u308a\u8fbc\u3080\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u88fd\u85ac\u4f1a\u793e\u306eURS\u306f\u8ad6\u7406\u7684\u306a\u69cb\u9020\u306b\u306a\u3063\u3066\u304a\u308a\u3001\u30e6\u30fc\u30b6\u30fc\u30cb\u30fc\u30ba\u3092\u660e\u78ba\u306b\u6349\u3048\u3001\u30ec\u30d3\u30e5\u30fc\u3057\u3084\u3059\u304f\u3001\u5f8c\u3067\u691c\u8a3c\u3057\u3084\u3059\u3044\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002.<\/p><p>\u3053\u308c\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u85acURS\u306e\u4e3b\u8981\u306a\u69cb\u6210\u8981\u7d20\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3088\u3046\u3002.<\/p><h3><strong><b>1.\u7bc4\u56f2\u3068\u76ee\u7684<\/b><\/strong><\/h3><p>\u30b9\u30b3\u30fc\u30d7\u3068\u76ee\u7684\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u306a\u305cURS\u3092\u66f8\u304f\u306e\u304b\u3001\u4f55\u3092\u30ab\u30d0\u30fc\u3059\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b\u3002\u3053\u308c\u306f\u6587\u66f8\u306e\u51fa\u767a\u70b9\u3067\u3042\u308b\u3002\u8ab0\u3082\u304c\u30b7\u30b9\u30c6\u30e0\u306e\u5883\u754c\u3092\u7406\u89e3\u3057\u3001\u5f8c\u306e\u6df7\u4e71\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p><p>\u7c21\u5358\u306b\u8a00\u3048\u3070\u3001\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u6b21\u306e\u3088\u3046\u306a\u8cea\u554f\u306b\u7b54\u3048\u308b\uff1a<\/p><ul><li>\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u3084\u6a5f\u5668\u306f\u4f55\u306b\u4f7f\u7528\u3055\u308c\u308b\u306e\u304b\uff1f<\/li><li>\u3069\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li><li>\u4f55\u304c\u542b\u307e\u308c\u3001\u4f55\u304c\u542b\u307e\u308c\u306a\u3044\u306e\u304b\uff1f<\/li><\/ul><p>\u4f8b\u3048\u3070\u3001\u9069\u7528\u7bc4\u56f2\u306b\u306f\u3001URS \u304c\u9320\u5264\u5727\u7e2e\u6a5f\u306e\u307f\u306b\u9069\u7528\u3055\u308c\u3001\u4e0b\u6d41\u306e\u5305\u88c5\u306b\u306f\u9069\u7528\u3055\u308c\u306a\u3044\u3053\u3068\u3092\u8a18 \u8f09\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u76ee\u7684\uff08Purpose\uff09\u306f\u3001\u305d\u306e\u30b7\u30b9\u30c6\u30e0\u306e\u696d\u52d9\u4e0a\u307e\u305f\u306f GMP \u4e0a\u306e\u7406\u7531\u3092\u8aac\u660e\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/what-is-pharmaceutical-manufacturing\/\"><u>\u88fd\u9020\u696d<\/u><\/a>.<\/p><h3><strong><b>2.\u30b7\u30b9\u30c6\u30e0\u6982\u8981<\/b><\/strong><\/h3><p>\u30b7\u30b9\u30c6\u30e0\u6982\u8981\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u306e\u30cf\u30a4\u30ec\u30d9\u30eb\u306a\u8aac\u660e\u3092\u5e73\u6613\u306a\u8a00\u8449\u3067\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002\u6280\u8853\u7684\u306a\u8a73\u7d30\u306b\u8e0f\u307f\u8fbc\u3080\u3053\u3068\u306a\u304f\u3001\u57fa\u672c\u7684\u306a\u7406\u89e3\u3092\u8aad\u8005\u306b\u63d0\u4f9b\u3059\u308b\u3002.<\/p><h4><strong>\u3053\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u306f\u901a\u5e38\u3001\u3053\u3046\u8aac\u660e\u3059\u308b\uff1a<\/strong><\/h4><ul><li><strong>\u30b7\u30b9\u30c6\u30e0\u3084\u6a5f\u5668\u306e\u7a2e\u985e\u3002.<\/strong><\/li><li><strong>\u3069\u3053\u3067\u4f7f\u308f\u308c\u308b\u304b.<\/strong><\/li><li><strong>\u5168\u4f53\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306b\u3069\u306e\u3088\u3046\u306b\u7d44\u307f\u8fbc\u3080\u304b\u3002.<\/strong><\/li><\/ul><p>\u4f8b\u30b7\u30b9\u30c6\u30e0\u306f\u5009\u5eab\u3067\u4f7f\u7528\u3055\u308c\u308b\u81ea\u52d5\u6e29\u5ea6\u76e3\u8996\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308b\u3068\u8aac\u660e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p><h3><strong><b>3.\u6a5f\u80fd\u8981\u4ef6<\/b><\/strong><\/h3><p>\u6a5f\u80fd\u8981\u4ef6\u306f\u3001\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u30b7\u30b9\u30c6\u30e0\u304c\u4f55\u3092\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u8a18\u8ff0\u3059\u308b\u3002\u3053\u308c\u306fURS\u306e\u6700\u3082\u91cd\u8981\u306a\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u4e00\u3064\u3067\u3042\u308b\u3002.<\/p><p>\u3053 \u308c \u3089 \u306e\u8981\u4ef6\u306f\u3001 \u30e6\u30fc\u30b6\u30fc\u306e\u7acb\u5834\u3067\u8a18\u8ff0 \u3055 \u308c\u3001 \u30a2 \u30af \u30b7 \u30e7 \u30f3\u304a \u3088 \u3073\u7d50\u679c\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3059\u3002\u4f8b \u3068 \u3057 \u3066\u306f\u3001 \u30c7\u30fc \u30bf \u306e\u8a18\u9332\u3001 \u30ec \u30dd\u30fc \u30c8 \u306e\u751f\u6210\u3001 \u30d7 \u30ed \u30bb \u30b9 \u30fb \u30d1 \u30e9 \u30e1 \u30fc \u30bf \u30fc\u306e\u5236\u5fa1\u3001 \u30a2 \u30e9\u30fc\u30e0\u306e\u767a\u5831\u306a \u3069 \u304c\u6319\u3052 \u3089 \u308c\u307e\u3059\u3002.<\/p><h3><strong><b>4.\u898f\u5236\u304a\u3088\u3073GMP\u8981\u4ef6<\/b><\/strong><\/h3><p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u898f\u5236\u304a\u3088\u3073GMP\u3078\u306e\u671f\u5f85\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b\u3002\u88fd\u85ac\u696d\u754c\u3067\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u4efb\u610f\u3067\u306f\u306a\u3044\u305f\u3081\u3001\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u660e\u78ba\u306b\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>\u4e00\u822c\u7684\u306a\u4f8b\u3068\u3057\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/gmp-for-pharmaceutical-manufacturing\/\"><u>GMP\u539f\u5247<\/u><\/a>, \u76e3\u67fb\u8a3c\u8de1\u306e\u5229\u7528\u53ef\u80fd\u6027\u3001\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u9069\u5207\u306a\u6587\u66f8\u5316\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u691c\u67fb\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306b\u5fdc\u3048\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002.<\/p><h3><strong><b>5.\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306e\u5fc5\u8981\u6027<\/b><\/strong><\/h3><p>\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001GMP\u30c7\u30fc\u30bf\u306e\u4fdd\u8b77\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u308b\u3002\u3053\u308c\u306f\u7279\u306b\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u3055\u308c\u305f\u30b7\u30b9\u30c6\u30e0\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3042\u308b\u3002.<\/p><p>\u30e6\u30fc\u30b6\u30fc\u30fb\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u30d1\u30b9\u30ef\u30fc\u30c9\u30fb\u30eb\u30fc\u30eb\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u30c7\u30fc\u30bf\u30fb\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3001\u30c7\u30fc\u30bf\u306e\u640d\u5931\u3084\u4e0d\u6b63\u306a\u5909\u66f4\u306b\u5bfe\u3059\u308b\u4fdd\u8b77\u306a\u3069\u306e\u8981\u4ef6\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u308b\u3002\u305d\u306e\u76ee\u7684\u306f\u3001\u30c7\u30fc\u30bf\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u3001\u6b63\u78ba\u3067\u5b8c\u5168\u306a\u4fe1\u983c\u3067\u304d\u308b\u30c7\u30fc\u30bf\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/p><h3><strong><b>6.\u904b\u7528\u304a\u3088\u3073\u74b0\u5883\u8981\u4ef6<\/b><\/strong><\/h3><p>\u904b\u7528\u304a\u3088\u3073\u74b0\u5883\u8981\u4ef6\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u5b9f\u969b\u306e\u4f7f\u7528\u74b0\u5883\u3067\u3069\u306e\u3088\u3046\u306b\u6a5f\u80fd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u5b9a\u7fa9\u3059\u308b\u3002.<\/p><p>\u3053\u308c\u306b\u306f\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u96fb\u6e90\u3001\u8ca0\u8377\u5bb9\u91cf\u306a\u3069\u306e\u52d5\u4f5c\u6761\u4ef6\u304c\u542b\u307e\u308c\u308b\u3002\u307e\u305f\u3001\u4f7f\u3044\u3084\u3059\u3055\u3001\u6e05\u6383\u306e\u5fc5\u8981\u6027\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u5b89\u5168\u6027\u306a\u3069\u3082\u542b\u307e\u308c\u307e\u3059\u3002.<\/p><h2><strong><b>\u88fd\u85ac\u4f1a\u793e\u306eURS\u6587\u66f8\u306b\u3088\u304f\u3042\u308b\u9593\u9055\u3044<\/b><\/strong><\/h2><p>URS\u306f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u7c21\u7d20\u5316\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3042\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u591a\u304f\u306e\u88fd\u85ac\u30c1\u30fc\u30e0\u306f\u4f55\u5ea6\u3082\u540c\u3058\u5931\u6557\u3092\u3057\u3066\u82e6\u52b4\u3057\u3066\u3044\u308b\u3002\u540c\u3058\u904e\u3061\u3092\u72af\u3057\u305f\u304f\u306a\u3044\u306e\u3067\u3042\u308c\u3070\u3001\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068\u304c\u3042\u308b\uff1a<\/p><h3><strong><b>1.\u8a2d\u8a08\u30ec\u30d9\u30eb\u306e\u8981\u4ef6\u3092\u66f8\u304f<\/b><\/strong><\/h3><p>\u6700\u3082\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u306e\u4e00\u3064\u306f\u3001URS\u3092\u6280\u8853\u6587\u66f8\u306b\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u3067\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u306f\u30b7\u30b9\u30c6\u30e0\u304c\u4f55\u3092\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3067\u306f\u306a\u304f\u3001\u3069\u306e\u3088\u3046\u306b\u69cb\u7bc9\u3055\u308c\u308b\u3079\u304d\u304b\u3092\u8aac\u660e\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u3002.<\/p><p>\u4f8b\u3048\u3070\u3001\u7279\u5b9a\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u30e2\u30c7\u30eb\u3001\u307e\u305f\u306f\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u30ed\u30b8\u30c3\u30af\u306b\u8a00\u53ca\u3059\u308b\u3053\u3068\u306f\u3001URS\u3067\u306f\u306a\u304f\u5f8c\u306e\u6587\u66f8\u306b\u5c5e\u3059\u308b\u3002URS\u306f\u30e6\u30fc\u30b6\u30fc\u4e2d\u5fc3\u3067\u3042\u308a\u7d9a\u3051\u308b\u3079\u304d\u3067\u3059\u3002.<\/p><h3><strong><b>2.\u66d6\u6627\u307e\u305f\u306f\u4e0d\u660e\u78ba\u306a\u8981\u4ef6\u306e\u4f7f\u7528<\/b><\/strong><\/h3><p>\u4e00\u822c\u7684\u3059\u304e\u308b\u8981\u4ef6\u306f\u3001\u30c6\u30b9\u30c8\u3084\u691c\u8a3c\u304c\u96e3\u3057\u3044\u3002\u30b7\u30b9\u30c6\u30e0\u306f\u30e6\u30fc\u30b6\u30fc\u30d5\u30ec\u30f3\u30c9\u30ea\u30fc\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u300d\u3068\u304b\u300c\u30b7\u30b9\u30c6\u30e0\u306f\u4fe1\u983c\u3067\u304d\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u300d\u3068\u3044\u3046\u3088\u3046\u306a\u8a18\u8ff0\u306f\u3001\u671f\u5f85\u3092\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<a href=\"https:\/\/pharmamachinecn.com\/ja\/what-is-pharmaceutical-process-validation\/\"><u>\u691c\u8a3c<\/u><\/a>\u00a0\u3042\u308b\u3044\u306f\u3001\u65e9\u671f\u306b\u691c\u67fb\u306b\u53c2\u52a0\u3055\u305b\u308b\u3002.<\/p><h3><strong><b>5.\u4e0d\u5341\u5206\u306a\u30e6\u30fc\u30b6\u30fc\u53c2\u52a0<\/b><\/strong><\/h3><p>URS\u6587\u66f8\u304c\u5b9f\u969b\u306e\u30e6\u30fc\u30b6\u30fc\u304b\u3089\u306e\u610f\u898b\u306a\u3057\u306b\u66f8\u304b\u308c\u305f\u5834\u5408\u3001\u91cd\u8981\u306a\u8981\u4ef6\u304c\u898b\u843d\u3068\u3055\u308c\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308b\u3002\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3001\u30e9\u30dc\u30b9\u30bf\u30c3\u30d5\u3001\u30b9\u30fc\u30d1\u30fc\u30d0\u30a4\u30b6\u30fc\u306f\u65e5\u3005\u306e\u8ab2\u984c\u3092\u8ab0\u3088\u308a\u3082\u7406\u89e3\u3057\u3066\u3044\u308b\u3002.<\/p><p>\u30e6\u30fc\u30b6\u30fc\u306e\u95a2\u4e0e\u304c\u4e0d\u5341\u5206\u3060\u3068\u3001\u6280\u8853\u7684\u306b\u306f\u6a5f\u80fd\u3057\u3066\u3082\u5b9f\u969b\u306e\u904b\u7528\u3067\u306f\u5931\u6557\u3059\u308b\u30b7\u30b9\u30c6\u30e0\u306b\u306a\u3063\u3066\u3057\u307e\u3046\u3002.<\/p><h2><strong><b>\u3088\u304f\u3042\u308b\u8cea\u554f<\/b><\/strong><\/h2><h3><strong><b>1.URS\u304c \u201c\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u790e \u201d\u3068\u3055\u308c\u308b\u7406\u7531\u306f\uff1f<\/b><\/strong><\/h3><p>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u305d\u306e\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u8a3c\u660e\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001URS\u306f\u305d\u306e\u300c\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u300d\u3092\u6e2c\u5b9a\u53ef\u80fd\u306a\u8a00\u8449\u3067\u5b9a\u7fa9\u3057\u305f\u6587\u66f8\u3067\u3042\u308b\u3002\u5305\u62ec\u7684\u306aURS\u304c\u306a\u3051\u308c\u3070\u3001\u6b63\u78ba\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3082\u3001\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\uff08PQ\uff09\u306e\u305f\u3081\u306e\u610f\u5473\u306e\u3042\u308b\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3092\u78ba\u7acb\u3059\u308b\u3053\u3068\u3082\u4e0d\u53ef\u80fd\u3067\u3059\u3002.<\/p><h3><strong><b>2.\u6a5f\u80fd\u8981\u4ef6\u3068\u6027\u80fd\u8981\u4ef6\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/b><\/strong><\/h3><p>\u6a5f\u80fd\u8981\u4ef6\u306f\u3001\u201c\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u306f10\u79d2\u3054\u3068\u306b\u6e29\u5ea6\u3092\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044 \u201d\u306a\u3069\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u4f55\u3092\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u8a18\u8ff0\u3059\u308b\u3002\u4f8b\u3048\u3070\u3001\u201c\u6e29\u5ea6\u306f\u30bb\u30c3\u30c8\u30dd\u30a4\u30f3\u30c8\u306e\u00b10.5\u2218C\u4ee5\u5185\u306b\u4fdd\u305f\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u201d\u3002\u201d<\/p><h3><strong><b>3.URS\u304c\u6b63\u5f0f\u306b\u627f\u8a8d\u3055\u308c\u305f\u5f8c\u306b\u3001URS\u3092\u4fee\u6b63\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u3059\u304b\uff1f<\/b><\/strong><\/h3><p>\u627f\u8a8d\u3055\u308c\u305f URS \u306b\u5bfe\u3059\u308b\u5909\u66f4\u306f\u8a8d\u3081\u3089\u308c\u308b\u304c\u3001\u6b63\u5f0f\u306a\u5909\u66f4\u7ba1\u7406\u624b\u9806\u3092\u901a\u3058\u3066\u7ba1\u7406\u3055\u308c\u306a\u3051\u308c \u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u5168\u4f53\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u72b6\u6cc1\u306b\u5bfe\u3059\u308b\u5909\u66f4\u306e\u5f71\u97ff\u304c\u5341\u5206\u306b\u8a55\u4fa1\u3055\u308c\u3001\u6587\u66f8\u5316\u3055\u308c\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u308b\u3002.<\/p><h2><strong><b>\u5f37\u529b\u306aURS\u3092\u5b9f\u884c\u3067\u5931\u6557\u3055\u305b\u308b\u306a<\/b><\/strong><\/h2><p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bURS\uff08\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff09\u306f\u3001\u3059\u3079\u3066\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u304c\u5f62\u306b\u306a\u308b\u5834\u6240\u3067\u3059\u3002\u5f37\u529b\u306aURS\u3092\u6301\u3064\u3053\u3068\u3067\u65b9\u5411\u6027\u304c\u5b9a\u307e\u308a\u307e\u3059\u304c\u3001\u5b9f\u884c\u3053\u305d\u304c\u6210\u529f\u3092\u5de6\u53f3\u3057\u307e\u3059\u3002.<\/p><p>\u305d\u3053\u3067\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u306e\u3088\u3046\u306a\u9069\u5207\u306a\u6a5f\u5668\u30d1\u30fc\u30c8\u30ca\u30fc\u304c\u91cd\u8981\u306b\u306a\u308b\u3002.<\/p><p>30\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u3092\u6301\u3064\u5f53\u793e\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u6587\u66f8\u5316\u3055\u308c\u305f\u8981\u4ef6\u3092\u4fe1\u983c\u6027\u306e\u9ad8\u3044GMP\u6e96\u62e0\u306e\u8981\u4ef6\u306b\u5909\u3048\u308b\u304a\u624b\u4f1d\u3044\u3092\u3057\u307e\u3059\u3002 <a href=\"https:\/\/pharmamachinecn.com\/ja\/pharmaceutical-production-line\/\"><u>\u751f\u7523\u30b7\u30b9\u30c6\u30e0<\/u><\/a>. .\u30e1\u30fc\u30ab\u30fc\u3068\u5bc6\u63a5\u306b\u5354\u529b\u3057\u3001\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305f\u8a2d\u5099\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3068\u751f\u7523\u8a08\u753b\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p><p><a href=\"https:\/\/pharmamachinecn.com\/ja\/contact-us\/\"><u>\u304a\u554f\u3044\u5408\u308f\u305b<\/u><\/a>\u00a0\u6b21\u306e\u6bb5\u968e\u3078\u306e\u5c0e\u5165\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002.<\/p><h2><strong>\u53c2\u8003\u6587\u732e:<\/strong><\/h2><p><a href=\"https:\/\/gmpinsiders.com\/how-to-write-user-requirement-specification-urs\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>GMP\u306b\u6e96\u62e0\u3057\u305f\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff08URS\uff09\u306e\u66f8\u304d\u65b9<\/strong><\/em><\/span><\/a>.<\/p><p><a href=\"https:\/\/zamann-pharma.com\/glossary\/user-requirements-specification-urs\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8\uff08URS\uff09\u3002.<\/strong><\/em><\/span><\/a><\/p><p><a href=\"https:\/\/eupry.com\/regulations-temperature-compliance\/urs-storage-areas-tcus\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>\u533b\u85ac\u54c1\u4fdd\u7ba1\u5eab\u3068TCU\u306eURS\u306e\u66f8\u304d\u65b9<\/strong><\/em><\/span><\/a>.<\/p><p><a href=\"https:\/\/ispe.org\/pharmaceutical-engineering\/ispeak\/qa-user-requirements-specifications-related-commissioning\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em><strong>Q&amp;A\uff1a\u30b3\u30df\u30c3\u30b7\u30e7\u30cb\u30f3\u30b0\u3068\u30af\u30aa\u30ea\u30d5\u30a3\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u9023\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8\u66f8<\/strong><\/em><\/span><\/a>.<\/p><h2><b>\u8457\u4f5c\u6a29\u306b\u3064\u3044\u3066\u00a0<\/b><\/h2><p>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u30fb\u30b0\u30eb\u30fc\u30d7\u306e\u66f8\u9762\u306b\u3088\u308b\u4e8b\u524d\u306e\u660e\u793a\u7684\u306a\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u672c\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u4e0a\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u8907\u88fd\u3001\u5909\u66f4\u3001\u516c\u958b\u3001\u8868\u793a\u3001\u9001\u4fe1\u3001\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u5229\u7528\u3057\u305f\u308a\u3001\u305d\u306e\u3088\u3046\u306a\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u4f7f\u7528\u3057\u3066\u4f55\u3089\u304b\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u69cb\u7bc9\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u4f7f\u7528\u8a31\u53ef\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a <a href=\"mailto:info@pharmamachinecn.com\"><span style=\"text-decoration: underline;\">info@pharmamachinecn.com<\/span><\/a><\/p><h2><b>\u514d\u8cac\u4e8b\u9805:<\/b><\/h2><p>\u672c\u8a18\u4e8b\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u306f\u3001\u4e00\u822c\u7684\u306a\u60c5\u5831\u63d0\u4f9b\u306e\u307f\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u3044\u304b\u306a\u308b\u60c5\u5831\u306b\u3064\u3044\u3066\u3082\u3001\u305d\u306e\u6b63\u78ba\u6027\u3001\u59a5\u5f53\u6027\u3001\u9069\u6642\u6027\u3001\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u307e\u305f\u3001\u672c\u8a18\u4e8b\u306e\u5185\u5bb9\u306e\u8aa4\u8b2c\u307e\u305f\u306f\u8131\u6f0f\u306b\u3064\u3044\u3066\u4e00\u5207\u306e\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u305b\u3093\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>In the pharmaceutical industry, URS, short for User Requirement Specification, is one of the first and most important documents in [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":12143,"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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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[61],"tags":[],"class_list":["post-12075","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/12075","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/comments?post=12075"}],"version-history":[{"count":10,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/12075\/revisions"}],"predecessor-version":[{"id":12843,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/12075\/revisions\/12843"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/12143"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=12075"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=12075"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=12075"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}