{"id":6152,"date":"2025-08-16T02:15:32","date_gmt":"2025-08-16T02:15:32","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=6152"},"modified":"2026-03-23T02:28:11","modified_gmt":"2026-03-23T02:28:11","slug":"dq-iq-oq-and-pq-in-pharmaceutical-industry-explained","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/dq-iq-oq-and-pq-in-pharmaceutical-industry-explained\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306e\u8aac\u660e"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"6152\" class=\"elementor elementor-6152\" 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\u306f\u53b3\u3057\u304f\u898f\u5236\u3055\u308c\u3066\u304a\u308a\u3001\u4e9b\u7d30\u306a\u4e0d\u4e00\u81f4\u3067\u3082 <strong>\u6df1\u523b\u306a\u554f\u984c\u3068\u516c\u8846\u885b\u751f\u4e0a\u306e\u61f8\u5ff5\u3002<\/strong> \u305d\u306e\u305f\u3081\u3001\u9069\u5207\u306a\u6a5f\u5668\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u306f\u5fc5\u9808\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6700\u7d42\u88fd\u54c1\u304c\u9ad8\u54c1\u8cea\u3067\u5b89\u5168\u306b\u6d88\u8cbb\u3067\u304d\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002\u6a5f\u5668\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u4e00\u822c\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<strong> DQ\uff08\u8a2d\u8a08\u9069\u683c\u6027\u8a55\u4fa1\uff09\u3001IQ\uff08\u8a2d\u7f6e\u9069\u683c\u6027\u8a55\u4fa1\uff09\u3001OQ\uff08\u904b\u8ee2\u9069\u683c\u6027\u8a55\u4fa1\uff09\u3001PQ\uff08\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff09<\/strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b DQ\u3001IQ\u3001OQ\u3001PQ \u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u306f\u3001\u8aad\u307f\u9032\u3081\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<figure id=\"attachment_6168\" aria-describedby=\"caption-attachment-6168\" style=\"width: 1417px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-6168\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry.jpg\" alt=\"DQ\u3001IQ\u3001OQ\u3001PQ\u306e\u5b9a\u7fa9\" width=\"1417\" height=\"827\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry.jpg 1417w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry-300x175.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry-1024x598.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry-768x448.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry-18x12.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/DQ-IQ-OQ-and-PQ-in-Pharmaceutical-Industry-600x350.jpg 600w\" sizes=\"(max-width: 1417px) 100vw, 1417px\" \/><figcaption id=\"caption-attachment-6168\" class=\"wp-caption-text\"><strong>DQ\u3001IQ\u3001OQ\u3001PQ\u306e\u5b9a\u7fa9<\/strong><\/figcaption><\/figure>\n<h2><strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b DQ\u3001IQ\u3001OQ\u3001PQ \u3068\u306f\u4f55\u3067\u3059\u304b? <\/strong><\/h2>\n<p>\u901a\u5e38\u3001\u9069\u683c\u6027\u8a55\u4fa1\u3068\u306f\u3001\u533b\u85ac\u54c1\u6a5f\u5668\u3092\u6587\u66f8\u5316\u3057\u3001 <strong>\u88dc\u52a9\u30b7\u30b9\u30c6\u30e0<\/strong> \u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u9069\u5408\u3057\u3001\u8981\u6c42\u901a\u308a\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u3053\u308c\u306b\u306f\u8907\u6570\u306e<strong> \u5074\u9762<\/strong>\u4f8b\u3048\u3070\u3001\u6a5f\u5668\u304c\u6b63\u3057\u304f\u8a2d\u7f6e\u3055\u308c\u3001\u8a2d\u8a08\u901a\u308a\u306b\u52d5\u4f5c\u3057\u3001\u671f\u5f85\u901a\u308a\u306e\u7d50\u679c\u304c\u5f97\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u306a\u3069\u3067\u3059\u3002DQ\u3001IQ\u3001OQ\u3001PQ\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u7406\u89e3\u3057\u3066\u3044\u305f\u3060\u304f\u305f\u3081\u306b\u3001\u305d\u308c\u305e\u308c\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3044\u305f\u3057\u307e\u3059\u3002<\/p>\n<h3><strong>\u8a2d\u8a08\u8cc7\u683c <\/strong><\/h3>\n<p>\u8a2d\u8a08\u9069\u683c\u6027\u78ba\u8a8d\uff08DQ\uff09\u3068\u306f\u3001\u6a5f\u5668\u306e\u8a2d\u8a08\u304c\u5fc5\u8981\u306a\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a3c\u3059\u308b\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u691c\u8a3c\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u308c\u306f\u901a\u5e38\u3001\u6a5f\u5668\u9069\u683c\u6027\u78ba\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u6700\u521d\u306e\u6bb5\u968e\u3067\u3042\u308a\u3001IQ\u3001OQ\u3001PQ\u306a\u3069\u306e\u5f8c\u7d9a\u6bb5\u968e\u306e\u57fa\u790e\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<figure id=\"attachment_6169\" aria-describedby=\"caption-attachment-6169\" style=\"width: 1070px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-6169\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification.jpg\" alt=\"\u8a2d\u8a08\u8cc7\u683c\" width=\"1070\" height=\"342\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification.jpg 1070w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification-300x96.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification-1024x327.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification-768x245.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification-18x6.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Design-Qualification-600x192.jpg 600w\" sizes=\"(max-width: 1070px) 100vw, 1070px\" \/><figcaption id=\"caption-attachment-6169\" class=\"wp-caption-text\"><strong>\u8a2d\u8a08\u9069\u683c\u6027\u306e\u8aac\u660e<\/strong><\/figcaption><\/figure>\n<p>DQ\u306e\u76ee\u6a19\u306f\u3001\u6a5f\u5668\u304c\u4ee5\u4e0b\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3059\u3002 <strong>\u898f\u5236\u304a\u3088\u3073\u696d\u754c\u57fa\u6e96\u3001<\/strong> \u4f8b\u3048\u3070\u3001 <strong>GMP\u307e\u305f\u306fFDA<\/strong>DQ \u306e\u5b9f\u884c\u65b9\u6cd5\u306e\u6982\u8981\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n<ol>\n<li><strong>\u30e6\u30fc\u30b6\u30fc\u8981\u4ef6\u4ed5\u69d8<\/strong>\u307e\u305a\u3001\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059 <a href=\"https:\/\/www.niimbl.org\/wp-content\/uploads\/2024\/03\/General_Equipment_URS.pdf\" target=\"_blank\" rel=\"noopener\"><u>\u30e6\u30fc\u30b6\u30fc\u8981\u4ef6\u4ed5\u69d8\uff08URS\uff09<\/u><\/a>\u3053\u308c\u306f\u3001\u6a5f\u5668\u306b\u671f\u5f85\u3055\u308c\u308b\u52d5\u4f5c\u3001\u74b0\u5883\u6761\u4ef6\u3001\u5b89\u5168\u6027\u3068\u898f\u5236\u9075\u5b88\u306e\u5fc5\u8981\u6027\u3092\u6982\u8aac\u3057\u305f\u6587\u66f8\u3067\u3059\u3002<\/li>\n<li><strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u8a55\u4fa1\u3068\u9078\u5b9a<\/strong>\u6b21\u306b\u3001\u3053\u308c\u3089\u306e\u8981\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3059\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9078\u629e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30ec\u30d3\u30e5\u30fc\u3092\u8aad\u3093\u3060\u308a\u3001\u4ed6\u306e\u88fd\u85ac\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u76f8\u8ac7\u3057\u305f\u308a\u3057\u3066\u3001\u4fe1\u983c\u3067\u304d\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u898b\u3064\u3051\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li><strong>\u6a5f\u5668\u8a2d\u8a08\u306e\u691c\u8a0e<\/strong>: \u53d6\u5f97\u3057\u305f\u3089\u3001\u6a5f\u5668\u306e\u8a2d\u8a08\u3092\u78ba\u8a8d\u3057\u3001URS\u306b\u5b9a\u3081\u3089\u308c\u305f\u6761\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u6750\u8cea\u3001\u5bf8\u6cd5\u3001\u5236\u5fa1\u3001\u5b89\u5168\u6a5f\u80fd\u306a\u3069\u3001\u3042\u3089\u3086\u308b\u5074\u9762\u304b\u3089\u6a5f\u5668\u3092\u5206\u6790\u3057\u3001\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u6700\u7d42\u8a2d\u8a08\u627f\u8a8d<\/strong>\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u6a5f\u5668\u306e\u6f5c\u5728\u7684\u306a\u554f\u984c\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u8abf\u6574\u3092\u884c\u3044\u3001\u6700\u7d42\u8a2d\u8a08\u3092\u627f\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>\u8a2d\u8a08\u9069\u683c\u6027\u8a55\u4fa1\uff08DQ\uff09\u4e2d\u306b\u906d\u9047\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u8ab2\u984c\u306b\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5236\u7d04\u3084 <strong>\u904e\u5270\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3002<\/strong><\/p>\n<p><strong>DQ\u3092\u5b9f\u884c\u3059\u308b\u30bf\u30a4\u30df\u30f3\u30b0<\/strong>\u8a2d\u8a08\u9069\u683c\u6027\u78ba\u8a8d\u306f\u3001\u88fd\u85ac\u30d7\u30ed\u30bb\u30b9\u7528\u306e\u65b0\u3057\u3044\u6a5f\u5668\u3092\u8cfc\u5165\u3059\u308b\u969b\u306b\u5fc5\u305a\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u65e2\u5b58\u306e\u6a5f\u5668\u3084\u88c5\u7f6e\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002 <strong>\u65b0\u3057\u3044\u30d7\u30ed\u30bb\u30b9\u3002<\/strong><\/p>\n<h3><strong>\u8a2d\u7f6e\u9069\u683c\u6027\u78ba\u8a8d\uff08IQ\uff09 <\/strong><\/h3>\n<p>\u8a2d\u7f6e\u9069\u683c\u6027\u78ba\u8a8d\u3068\u306f\u3001\u305d\u306e\u540d\u306e\u901a\u308a\u3001\u88fd\u85ac\u6a5f\u5668\u3001\u5668\u5177\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u88fd\u9020\u5143\u306e\u6307\u793a\u306b\u5f93\u3063\u3066\u6b63\u3057\u304f\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u3059\u3079\u3066\u306e\u91cd\u8981\u306a\u6a5f\u5668\u304c\u52b9\u7387\u7684\u306b\u7a3c\u50cd\u3057\u7d9a\u3051\u3001\u304a\u5ba2\u69d8\u306e\u30d3\u30b8\u30cd\u30b9\u304c <strong>\u30c0\u30a6\u30f3\u30bf\u30a4\u30e0\u306f\u767a\u751f\u3057\u307e\u305b\u3093\u3002<\/strong> \u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u8cc7\u683c\u8a8d\u5b9a\u306b\u542b\u307e\u308c\u308b\u4e3b\u306a\u624b\u9806\u306e\u6982\u8981\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n<figure id=\"attachment_6170\" aria-describedby=\"caption-attachment-6170\" style=\"width: 1070px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-6170\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification.jpg\" alt=\"\u8a2d\u7f6e\u9069\u683c\u6027\" width=\"1070\" height=\"342\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification.jpg 1070w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification-300x96.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification-1024x327.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification-768x245.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification-18x6.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Installation-Qualification-600x192.jpg 600w\" sizes=\"(max-width: 1070px) 100vw, 1070px\" \/><figcaption id=\"caption-attachment-6170\" class=\"wp-caption-text\"><strong>\u8a2d\u7f6e\u9069\u683c\u6027<\/strong><\/figcaption><\/figure>\n<ol>\n<li><strong>IQ\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u6e96\u5099<\/strong>\u8a73\u7d30\u306a\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u5668\u306b\u5bfe\u3057\u3066\u3069\u306e\u3088\u3046\u306a\u8a66\u9a13\u3084\u5b9f\u9a13\u3092\u884c\u3046\u3079\u304d\u304b\u3092\u660e\u78ba\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u636e\u4ed8\u6642\u9069\u683c\u6027\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306e\u7bc4\u56f2\u3001\u76ee\u7684\u3001\u304a\u3088\u3073\u53d7\u5165\u57fa\u6e96\u3092\u6982\u8aac\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u3082\u91cd\u8981\u306a\u306e\u306f\u3001\u5404\u6a5f\u5668\u3001\u305d\u306e\u636e\u4ed8\u30d7\u30ed\u30bb\u30b9\u3001\u304a\u3088\u3073\u91cd\u8981\u306a\u6587\u66f8\u306b\u3064\u3044\u3066\u306e\u8aac\u660e\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/li>\n<li><strong>\u6a5f\u5668\u8a2d\u7f6e\u306e\u691c\u8a3c<\/strong>\u6a5f\u5668\u306e\u91cd\u8981\u306a\u8a73\u7d30\uff08\u30e1\u30fc\u30ab\u30fc\u60c5\u5831\u3001\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3001\u578b\u756a\u306a\u3069\uff09\u3092\u3059\u3079\u3066\u6587\u66f8\u5316\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u8a2d\u7f6e\u5834\u6240\u3092\u614e\u91cd\u306b\u5206\u6790\u3057\u3001\u6307\u5b9a\u3055\u308c\u305f\u8981\u4ef6\u3092\u3059\u3079\u3066\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u96fb\u6c17\u3001\u7a7a\u8abf\u3001\u7d66\u6c34\u30b7\u30b9\u30c6\u30e0\u3092\u542b\u3080\u3059\u3079\u3066\u306e\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u304c\u6a5f\u80fd\u3057\u3001\u63a5\u7d9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3055\u3089\u306b\u3001\u3059\u3079\u3066\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u304c\u8a2d\u8a08\u3069\u304a\u308a\u306b\u9069\u5207\u306b\u7d44\u307f\u7acb\u3066\u3089\u308c\u3001\u53d6\u308a\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li><strong>\u6a5f\u5668\u306e\u6a5f\u80fd\u30c6\u30b9\u30c8<\/strong>\u88fd\u85ac\u6a5f\u68b0\u304c\u901a\u5e38\u306e\u72b6\u6cc1\u4e0b\u3067\u671f\u5f85\u901a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30a2\u30e9\u30fc\u30e0\u3084\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u306a\u3069\u306e\u4e3b\u8981\u6a5f\u80fd\u306e\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u9069\u5207\u306a\u52d5\u4f5c\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u8a73\u7d30\u306aIQ\u30ec\u30dd\u30fc\u30c8\u3092\u4f5c\u6210\u3059\u308b<\/strong>\u30b7\u30b9\u30c6\u30e0\u306b\u7570\u5e38\u304c\u306a\u3044\u304b\u76e3\u8996\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6b63\u5e38\u306b\u52d5\u4f5c\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u8a73\u7d30\u306aIQ\u30ec\u30dd\u30fc\u30c8\u3092\u4f5c\u6210\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ec\u30dd\u30fc\u30c8\u306b\u306f\u3001\u89b3\u5bdf\u7d50\u679c\u3001\u7d50\u679c\u3001\u7570\u5e38\u3001\u305d\u3057\u3066\u5b9f\u65bd\u3057\u305f\u662f\u6b63\u63aa\u7f6e\u304c\u8a18\u8f09\u3055\u308c\u307e\u3059\u3002\u9069\u5207\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u3057\u3066\u3001SOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u3068\u30e6\u30fc\u30b6\u30fc\u30de\u30cb\u30e5\u30a2\u30eb\u304c\u5fc5\u9808\u3067\u3059\u3002\u305d\u306e\u5f8c\u3001\u30ec\u30dd\u30fc\u30c8\u306f\u8cc7\u683c\u306e\u3042\u308b\u62c5\u5f53\u8005\u306b\u3088\u3063\u3066\u30ec\u30d3\u30e5\u30fc\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306b\u304a\u3051\u308b\u8a2d\u7f6e\u9069\u683c\u6027\u8a55\u4fa1\u306b\u3082\u8ab2\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u63a5\u7d9a\u306e\u4e0d\u5099\u3001\u6587\u66f8\u306e\u4e0d\u6b63\u78ba\u3055\u3001\u95a2\u4fc2\u8005\u9593\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u4e0d\u8db3\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002<\/p>\n<p><strong>IQ\u3092\u5b9f\u884c\u3059\u308b\u30bf\u30a4\u30df\u30f3\u30b0<\/strong>: \u8a2d\u7f6e\u9069\u683c\u6027\u691c\u67fb\u306f\u3001\u65b0\u3057\u3044\u6a5f\u5668\u3092\u5c0e\u5165\u3059\u308b\u5834\u5408\u3084\u65e2\u5b58\u306e\u6a5f\u5668\u3092\u4ea4\u63db\u3059\u308b\u5834\u5408\u306b\u306f\u5fc5\u305a\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002<\/p>\n<h3><strong>\u904b\u7528\u9069\u683c\u6027\u78ba\u8a8d\uff08OQ\uff09 <\/strong><\/h3>\n<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u904b\u8ee2\u9069\u683c\u6027\u78ba\u8a8d\u3068\u306f\u3001\u3059\u3079\u3066\u306e\u6a5f\u5668\u304c\u4e8b\u524d\u306b\u5b9a\u3081\u3089\u308c\u305f\u6761\u4ef6\u4e0b\u3067\u30b9\u30e0\u30fc\u30ba\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u70b9\u691c\u3067\u3059\u3002\u6a5f\u5668\u304c\u898f\u5b9a\u901a\u308a\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u8907\u6570\u306e\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u9ad8\u54c1\u8cea\u306a\u533b\u85ac\u54c1\u88fd\u9020\u304c\u5b9f\u73fe\u3057\u3001\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u30c0\u30a6\u30f3\u30bf\u30a4\u30e0\u3084\u30ea\u30b3\u30fc\u30eb\u3092\u9632\u6b62\u3067\u304d\u307e\u3059\u3002\u904b\u8ee2\u9069\u683c\u6027\u78ba\u8a8d\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u6bb5\u968e\u7684\u306b\u898b\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n<figure id=\"attachment_6171\" aria-describedby=\"caption-attachment-6171\" style=\"width: 1070px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6171\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification.jpg\" alt=\"\u904b\u7528\u9069\u683c\u6027\" width=\"1070\" height=\"342\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification.jpg 1070w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification-300x96.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification-1024x327.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification-768x245.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification-18x6.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Operational-Qualification-600x192.jpg 600w\" sizes=\"(max-width: 1070px) 100vw, 1070px\" \/><figcaption id=\"caption-attachment-6171\" class=\"wp-caption-text\"><strong>\u904b\u7528\u9069\u683c\u6027<\/strong><\/figcaption><\/figure>\n<ol>\n<li><strong>\u904b\u7528\u9069\u683c\u6027\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b<\/strong>\u307e\u305a\u3001OQ\u306e\u8a73\u7d30\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3057\u3001\u5b9f\u65bd\u3059\u3079\u304d\u30c6\u30b9\u30c8\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u76ee\u7684\u3001\u53d7\u5165\u308c\u57fa\u6e96\u3001\u305d\u3057\u3066\u30c6\u30b9\u30c8\u306e\u8cac\u4efb\u3092\u660e\u78ba\u306b\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li><strong>OQ\u30c6\u30b9\u30c8\u306e\u6e96\u5099\u3068\u5b9f\u884c<\/strong>\u6b21\u306b\u3001\u6a5f\u5668\u306e\u30ad\u30e3\u30ea\u30d6\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u884c\u3044\u3001\u3059\u3079\u3066\u306e\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u304c\u63a5\u7d9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u518d\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u80fd\u30c1\u30a7\u30c3\u30af\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30c6\u30b9\u30c8\u3001\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u30c6\u30b9\u30c8\u306a\u3069\u3092\u3001\u901a\u5e38\u306e\u72b6\u6cc1\u3068\u53b3\u3057\u3044\u72b6\u6cc1\u306e\u4e21\u65b9\u3067\u5b9f\u65bd\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5b89\u5168\u88c5\u7f6e\u306b\u904e\u8ca0\u8377\u3092\u304b\u3051\u306a\u3044\u3088\u3046\u306b\u6ce8\u610f\u3057\u3001\u30a2\u30e9\u30fc\u30e0\u3001\u7dca\u6025\u505c\u6b62\u30dc\u30bf\u30f3\u3001\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u3092\u70b9\u691c\u3057\u3066\u3001\u5f8c\u3005\u306e\u4e8b\u6545\u3092\u9632\u304e\u307e\u3057\u3087\u3046\u3002<\/li>\n<li><strong>\u7d50\u679c\u3092\u78ba\u8a8d\u3057\u3001\u9038\u8131\u3092\u8a18\u9332\u3059\u308b<\/strong>\u4e00\u8cab\u6027\u3068\u518d\u73fe\u6027\u306e\u3042\u308b\u7d50\u679c\u304c\u5f97\u3089\u308c\u308b\u307e\u3067\u3001\u8907\u6570\u56de\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6a5f\u5668\u306e\u52d5\u4f5c\u306b\u4f55\u3089\u304b\u306e\u9038\u8131\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u8a18\u9332\u3057\u3001\u76f4\u3061\u306b\u662f\u6b63\u63aa\u7f6e\u3092\u8b1b\u3058\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li><strong>\u8a73\u7d30\u306aOQ\u30ec\u30dd\u30fc\u30c8\u3092\u4f5c\u6210\u3059\u308b<\/strong>\u6700\u5f8c\u306b\u3001\u5b9f\u65bd\u3057\u305f\u30c6\u30b9\u30c8\u3001\u305d\u306e\u7d50\u679c\u3001\u9038\u8131\u3001\u305d\u3057\u3066\u5b9f\u65bd\u3057\u305f\u662f\u6b63\u63aa\u7f6e\u3092\u8a73\u7d30\u306b\u8a18\u8f09\u3057\u305f\u8a73\u7d30\u306a\u904b\u7528\u9069\u683c\u6027\u8a55\u4fa1\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u4eca\u5f8c\u306e\u9069\u683c\u6027\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3082\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>\u53d7\u3051\u5165\u308c\u57fa\u6e96\u3068\u5b9f\u884c\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u30c6\u30b9\u30c8\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u306e\u306b\u82e6\u52b4\u3059\u308b\u3053\u3068\u306f\u3001\u904b\u7528\u9069\u683c\u6027\u8a55\u4fa1\u306e\u8ab2\u984c\u306e 1 \u3064\u3067\u3059\u3002<\/p>\n<p><strong>\u64cd\u4f5c\u9069\u683c\u6027\u78ba\u8a8d\u3092\u5b9f\u65bd\u3059\u308b\u30bf\u30a4\u30df\u30f3\u30b0<\/strong>OQ \u306f\u8a2d\u7f6e\u9069\u683c\u6027\u8a55\u4fa1\u6bb5\u968e\u306e\u76f4\u5f8c\u306b\u5b9f\u884c\u3055\u308c\u3001\u6a5f\u5668\u304a\u3088\u3073\u88c5\u7f6e\u306e\u610f\u56f3\u3055\u308c\u305f\u52d5\u4f5c\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002<\/p>\n<h3><strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09 <\/strong><\/h3>\n<p>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u9069\u683c\u6027\u8a55\u4fa1\u3068\u306f\u3001\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3067\u8981\u6c42\u3055\u308c\u308b\u4ed5\u69d8\u306b\u5f93\u3063\u3066\u3001\u4e00\u5b9a\u671f\u9593\u306b\u308f\u305f\u3063\u3066\u6a5f\u5668\u306e\u4e00\u8cab\u3057\u305f\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u3092\u6307\u3057\u307e\u3059\u3002<\/p>\n<figure id=\"attachment_6172\" aria-describedby=\"caption-attachment-6172\" style=\"width: 1070px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6172\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification.jpg\" alt=\"\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8cc7\u683c\" width=\"1070\" height=\"342\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification.jpg 1070w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification-300x96.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification-1024x327.jpg 1024w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification-768x245.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification-18x6.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/Performance-Qualification-600x192.jpg 600w\" sizes=\"(max-width: 1070px) 100vw, 1070px\" \/><figcaption id=\"caption-attachment-6172\" class=\"wp-caption-text\"><strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8cc7\u683c<\/strong><\/figcaption><\/figure>\n<p>\u7c21\u5358\u306b\u8a00\u3048\u3070\u3001\u533b\u85ac\u54c1\u88fd\u9020\u8a2d\u5099\u3084\u5668\u5177\u304c\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u305f\u88fd\u54c1\u3092\u751f\u7523\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a3c\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u54c1\u8cea\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u30ac\u30a4\u30c9\u3092\u4ee5\u4e0b\u306b\u793a\u3057\u307e\u3059\u3002<\/p>\n<ol>\n<li><strong>\u76ee\u6a19\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b: <\/strong>\u307e\u305a\u7b2c\u4e00\u306b\u3001PQ\u306e\u76ee\u7684\u3068\u7bc4\u56f2\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u9069\u683c\u6027\u78ba\u8a8d\u306e\u5bfe\u8c61\u3068\u306a\u308b\u4e3b\u8981\u306a\u6a5f\u5668\u3001\u78ba\u8a8d\u3059\u3079\u304d\u6027\u80fd\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u305d\u3057\u3066\u6e80\u305f\u3059\u3079\u304d\u5177\u4f53\u7684\u306a\u57fa\u6e96\u3092\u6982\u8aac\u3057\u305f\u6587\u66f8\u306e\u4f5c\u6210\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n<li><strong>\u6a5f\u5668\u3092\u6e96\u5099\u3059\u308b: <\/strong>\u307e\u305f\u3001\u3059\u3079\u3066\u306e\u6a5f\u5668\u304c\u9069\u5207\u306b\u8a2d\u7f6e\u3055\u308c\u3001\u8abf\u6574\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3084\u8abf\u6574\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001PQ\u4e2d\u306b\u554f\u984c\u304c\u767a\u751f\u3057\u306a\u3044\u3088\u3046\u306b\u4e8b\u524d\u306b\u5b9f\u65bd\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<li><strong>\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3059\u308b: <\/strong>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u901a\u308a\u3001\u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u6a5f\u5668\u3092\u901a\u5e38\u306e\u72b6\u614b\u3067\u7a3c\u50cd\u3055\u305b\u3001\u3059\u3079\u3066\u306e\u6027\u80fd\u30c7\u30fc\u30bf\u3092\u8a18\u9332\u3057\u307e\u3059\u3002\u305d\u306e\u5f8c\u3001\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3057\u3066\u3001\u6a5f\u5668\u304c\u6307\u5b9a\u3055\u308c\u305f\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3001\u307e\u305f\u306f\u6ce8\u610f\u304c\u5fc5\u8981\u306a\u9038\u8131\u304c\u306a\u3044\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u6700\u7d42\u6587\u66f8\u3068\u627f\u8a8d: <\/strong>\u7d50\u679c\u3092\u6027\u80fd\u9069\u683c\u6027\u5831\u544a\u66f8\u306b\u6587\u66f8\u5316\u3057\u307e\u3059\u3002\u8a66\u9a13\u6761\u4ef6\u3001\u7d50\u679c\u3001\u9038\u8131\u3001\u305d\u3057\u3066\u6a5f\u5668\u304c\u9069\u683c\u304b\u3069\u3046\u304b\u306e\u6700\u7d42\u7684\u306a\u7d50\u8ad6\u3092\u8a18\u8f09\u3057\u307e\u3059\u3002\u4fdd\u8a3c\u30c1\u30fc\u30e0\u3084\u898f\u5236\u5f53\u5c40\u306a\u3069\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u304b\u3089\u627f\u8a8d\u3092\u5f97\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ol>\n<p>\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\u306b\u306f\u3001\u5b9f\u969b\u306e\u751f\u7523\u6761\u4ef6\u3092\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3059\u308b\u306e\u304c\u96e3\u3057\u3044\u306a\u3069\u3001\u3044\u304f\u3064\u304b\u306e\u8ab2\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u6642\u9593\u3068\u30ea\u30bd\u30fc\u30b9\u3092\u5927\u91cf\u306b\u6d88\u8cbb\u3057\u307e\u3059\u3002<\/p>\n<p><strong>\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u9069\u683c\u6027\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b\u30bf\u30a4\u30df\u30f3\u30b0<\/strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306e\u4e2d\u3067\u3001PQ\u306f\u6700\u5f8c\u306b\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u307e\u3059\u3002PQ\u3067\u306f\u3001\u751f\u7523\u6750\u6599\u3001\u4ee3\u66ff\u54c1\u3001\u6a21\u64ec\u88fd\u54c1\u3092\u7528\u3044\u3066\u3001\u5b9f\u969b\u306e\u8a66\u9a13\u74b0\u5883\u3092\u518d\u73fe\u3057\u307e\u3059\u3002<\/p>\n<h2><strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306e\u5229\u70b9<\/strong><\/h2>\n<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306f\u3001\u88fd\u54c1\u306e\u4e00\u8cab\u6027\u3068\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b\u4e0a\u3067\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u305d\u308c\u305e\u308c\u306e\u30e1\u30ea\u30c3\u30c8\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b<\/strong>: \u88fd\u85ac\u696d\u754c\u306b\u306f <a href=\"https:\/\/www.netscout.com\/blog\/beating-high-cost-manufacturing-downtime\" target=\"_blank\" rel=\"noopener\"><u>\u30c0\u30a6\u30f3\u30bf\u30a4\u30e01\u6642\u9593\u3042\u305f\u308a$100,000\u304a\u3088\u3073$500,000<\/u><\/a>\u6b8b\u5ff5\u306a\u304c\u3089\u3001\u305d\u308c\u306f\u4e8b\u5b9f\u3067\u3059\uff01\u3057\u304b\u3057\u3001\u88fd\u85ac\u696d\u754c\u3067\u306fDQ\u3001IQ\u3001OQ\u3001PQ\u3068\u3044\u3063\u305f\u30a2\u30d7\u30ed\u30fc\u30c1\u306b\u3088\u3063\u3066\u3001\u3053\u306e\u30ea\u30b9\u30af\u306f\u5927\u5e45\u306b\u8efd\u6e1b\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u3001\u904b\u7528\u4e0a\u306e\u554f\u984c\u3001\u8a2d\u7f6e\u30df\u30b9\u3092\u65e9\u671f\u306b\u89e3\u6c7a\u3057\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u30d0\u30c3\u30c1\u4e0d\u826f\u3001\u6a5f\u5668\u306e\u6545\u969c\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u304c\u6700\u5c0f\u9650\u306b\u6291\u3048\u3089\u308c\u307e\u3059\u3002<\/li>\n<li><strong>\u898f\u5236\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bDQ\u3001IQ\u3001OQ\u3001PQ\u306f\u3001\u9069\u6b63\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09\u306e\u78ba\u7acb\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u5b9a\u671f\u7684\u306a\u691c\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3001FDA\u3084EMA\u306a\u3069\u306e\u56fd\u969b\u7684\u306a\u5b89\u5168\u6027\u304a\u3088\u3073\u6a5f\u5668\u691c\u8a3c\u57fa\u6e96\u3092\u9075\u5b88\u3067\u304d\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u6700\u7d42\u6d88\u8cbb\u8005\u306f\u9ad8\u54c1\u8cea\u306a\u88fd\u54c1\u3092\u53d7\u3051\u53d6\u308b\u3053\u3068\u304c\u3067\u304d\u3001\u4f01\u696d\u306e\u8a55\u5224\u5411\u4e0a\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<h2><strong>\u3088\u304f\u3042\u308b\u8cea\u554f <\/strong><\/h2>\n<h3><strong>\u30de\u30b7\u30f3\u3092\u79fb\u52d5\u3059\u308b\u5834\u5408\u3001PQ \u3092\u7e70\u308a\u8fd4\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b? <\/strong><\/h3>\n<p>\u306f\u3044\u3001\u6a5f\u68b0\u3092\u79fb\u52d5\u3057\u305f\u5834\u5408\u306fPQ\u3092\u518d\u5ea6\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u79fb\u52d5\u3084\u74b0\u5883\u306e\u5909\u5316\u306b\u3088\u3063\u3066\u554f\u984c\u304c\u767a\u751f\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u3053\u306e\u624b\u9806\u3092\u518d\u5ea6\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3001\u6a5f\u5668\u304c\u6b63\u5e38\u306b\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002<\/p>\n<h3><strong>IQ \u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u30ec\u30dd\u30fc\u30c8\u3092\u627f\u8a8d\u3059\u308b\u306e\u306f\u8ab0\u3067\u3059\u304b? <\/strong><\/h3>\n<p>\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30fb\u8a2d\u8a08\u90e8\u9580\u306f\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u8a2d\u7f6e\u9069\u683c\u6027\u78ba\u8a8d\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u30ec\u30dd\u30fc\u30c8\u3092\u7b56\u5b9a\u30fb\u627f\u8a8d\u3057\u307e\u3059\u3002\u5f7c\u3089\u306f\u4e3b\u8981\u306a\u88fd\u9020\u30fb\u8a2d\u8a08\u6bb5\u968e\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u30d7\u30ed\u30bb\u30b9\u3068\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<h3><strong>IQ \u3084 DQ \u306a\u3069\u306e\u3044\u305a\u308c\u304b\u306e\u30b9\u30c6\u30fc\u30b8\u304c\u5931\u6557\u3057\u305f\u5834\u5408\u306f\u3069\u3046\u306a\u308a\u307e\u3059\u304b? <\/strong><\/h3>\n<p>IQ\u3084DQ\u306a\u3069\u306e\u3044\u305a\u308c\u304b\u306e\u6bb5\u968e\u3067\u4e0d\u5408\u683c\u306b\u306a\u3063\u305f\u5834\u5408\u3001\u6a5f\u5668\u306b\u554f\u984c\u304c\u3042\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u3001\u65e9\u6025\u306a\u5bfe\u5fdc\u304c\u5fc5\u8981\u3067\u3059\u3002\u662f\u6b63\u63aa\u7f6e\u3092\u8b1b\u3058\u305f\u5f8c\u3001\u6b21\u306e\u6bb5\u968e\u306b\u9032\u3080\u524d\u306b\u6a5f\u5668\u3092\u518d\u30c6\u30b9\u30c8\u3057\u3001\u518d\u627f\u8a8d\u3092\u53d7\u3051\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h2><strong>\u7d50\u8ad6 <\/strong><\/h2>\n<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3044\u3066\u3001DQ\u3001IQ\u3001OQ\u3001PQ\u306f\u3001\u6d88\u8cbb\u8005\u306b\u5b89\u5168\u306a\u88fd\u54c1\u3092\u63d0\u4f9b\u3057\u3001\u7af6\u4e89\u529b\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u9808\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u3059\u3002\u88fd\u85ac\u6a5f\u5668\u306e\u8a2d\u8a08\u8981\u4ef6\u3092\u6e80\u305f\u3059\u512a\u308c\u305f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u304a\u63a2\u3057\u3067\u3059\u304b\uff1f <a href=\"https:\/\/pharmamachinecn.com\/ja\/\"><span style=\"text-decoration: underline;\"><strong>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u3002<\/strong><\/span><\/a> \u304a\u5ba2\u69d8\u72ec\u81ea\u306e\u6a5f\u5668\u30cb\u30fc\u30ba\u306b\u3064\u3044\u3066\u3054\u76f8\u8ac7\u3044\u305f\u3060\u304f\u306b\u306f\u3001\u4eca\u3059\u3050\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n<h2><b>\u8457\u4f5c\u6a29\u306b\u3064\u3044\u3066\u00a0<\/b><\/h2>\n<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>\n<h2><b>\u514d\u8cac\u4e8b\u9805:<\/b><\/h2>\n<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>\n<h1><!-- \/wp:paragraph --><\/h1>\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>The pharmaceutical industry is highly regulated, as even a minor inconsistency can lead to serious issues and public health concerns. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6168,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","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":"","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":""}},"ast-content-background-meta":{"desktop":{"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":""},"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-6152","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\/6152","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=6152"}],"version-history":[{"count":12,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/6152\/revisions"}],"predecessor-version":[{"id":13674,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/6152\/revisions\/13674"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/6168"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=6152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=6152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=6152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}