{"id":5096,"date":"2026-03-16T16:30:44","date_gmt":"2026-03-16T08:30:44","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5096"},"modified":"2026-03-16T16:30:44","modified_gmt":"2026-03-16T08:30:44","slug":"understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/","title":{"rendered":"\u533b\u85ac\u54c1\u6a5f\u5668\u8abf\u9054\u306b\u304a\u3051\u308b FAT\u3001SAT\u3001IQ\u3001OQ\u3001\u304a\u3088\u3073 PQ \u3092\u7406\u89e3\u3059\u308b: \u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u6b21<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u30c6\u30fc\u30d6\u30eb\u3092\u5207\u308a\u66ff\u3048\u307e\u3059\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">\u30c8\u30b0\u30eb<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Introduction\" >\u5c0e\u5165<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_1_Pre-Delivery_Testing_FAT\" >\u30d5\u30a7\u30fc\u30ba 1: \u914d\u4fe1\u524d\u30c6\u30b9\u30c8 (FAT)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_2_Post-Delivery_Testing_SAT\" >\u30d5\u30a7\u30fc\u30ba 2: \u7d0d\u54c1\u5f8c\u30c6\u30b9\u30c8 (SAT)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Phase_3_The_Qualification_Lifecycle_IQ_OQ_PQ\" >\u30d5\u30a7\u30fc\u30ba 3: \u8cc7\u683c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb (IQ\u3001OQ\u3001PQ)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Why_Documentation_is_the_Real_Bottleneck_in_Procurement\" >\u306a\u305c\u6587\u66f8\u5316\u304c\u8abf\u9054\u306b\u304a\u3051\u308b\u672c\u5f53\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u306a\u306e\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Seamless_Compliance_with_JIANPAI_Pharmaceutical_Equipment\" >JIANPAI\u88fd\u85ac\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/understanding-fat-sat-iq-oq-and-pq-in-pharmaceutical-equipment-procurement-a-comprehensive-guide\/#Frequently_Asked_Questions_FAQs\" >\u3088\u304f\u3042\u308b\u8cea\u554f (FAQ)<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Introduction\"><\/span><span class=\"ng-star-inserted\">\u5c0e\u5165<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u533b\u85ac\u54c1\u88fd\u9020\u696d\u754c\u3067\u306f\u3001\u9ad8\u305b\u3093\u65ad\u30df\u30ad\u30b5\u30fc\u3001\u6d41\u52d5\u5e8a\u4e7e\u71e5\u6a5f\u3001\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306a\u3069\u3001\u65b0\u3057\u3044\u6a5f\u5668\u3092\u8cfc\u5165\u3059\u308b\u3053\u3068\u306f\u3001\u6a19\u6e96\u7684\u306a\u7523\u696d\u6a5f\u68b0\u3092\u8cfc\u5165\u3059\u308b\u3053\u3068\u3068\u306f\u6839\u672c\u7684\u306b\u7570\u306a\u308a\u307e\u3059\u3002\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3068\u30e2\u30fc\u30bf\u30fc\u3092\u8cfc\u5165\u3059\u308b\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3042\u306a\u305f\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8cb7\u3063\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FDA\u3001EMA\u3001WHO \u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u306f\u3001\u6a5f\u68b0\u304c\u4ed5\u69d8\u306b\u5f93\u3063\u3066\u69cb\u7bc9\u3055\u308c\u3001\u6b63\u3057\u304f\u8a2d\u7f6e\u3055\u308c\u3001\u4e00\u8cab\u3057\u3066\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u793a\u3059\u6587\u66f8\u5316\u3055\u308c\u305f\u79d1\u5b66\u7684\u8a3c\u62e0\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3068\u30d7\u30ed\u30b8\u30a7\u30af\u30c8 \u30a8\u30f3\u30b8\u30cb\u30a2\u306b\u3068\u3063\u3066\u3001\u6a5f\u5668\u691c\u8a3c\u306e\u30a2\u30eb\u30d5\u30a1\u30d9\u30c3\u30c8 \u30b9\u30fc\u30d7\u3092\u30ca\u30d3\u30b2\u30fc\u30c8\u3059\u308b\u306b\u306f\u2014<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT\u3001SAT\u3001IQ\u3001OQ\u3001\u304a\u3088\u3073 PQ<\/span><\/strong><span class=\"ng-star-inserted\">\u2014\u6c17\u304c\u9060\u304f\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u305f\u3060\u3057\u3001\u3053\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u9069\u5207\u306a\u691c\u8a3c\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u306a\u3044\u30de\u30b7\u30f3\u306f\u3001cGMP \u74b0\u5883\u3067\u306f\u57fa\u672c\u7684\u306b\u5f79\u306b\u7acb\u3061\u307e\u305b\u3093\u3002\u3053\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u7528\u8a9e\u306e\u610f\u5473\u3001\u8abf\u9054\u30d7\u30ed\u30bb\u30b9\u306b\u3068\u3063\u3066\u3053\u308c\u3089\u306e\u7528\u8a9e\u304c\u91cd\u8981\u3067\u3042\u308b\u7406\u7531\u3001\u305d\u308c\u3089\u306e\u7528\u8a9e\u304c\u3069\u306e\u3088\u3046\u306b\u6295\u8cc7\u3092\u4fdd\u8b77\u3059\u308b\u304b\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignleft size-full wp-image-3278\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2025\/05\/Model-JLB-Series-Fuild-bed-Granulating-Coating-Machine-2-e1758939891270.png?quality=85&strip=all\" alt=\"\u30e2\u30c7\u30ebJLB\u30b7\u30ea\u30fc\u30ba\u6db2\u5e8a\u9846\u7c92\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\" width=\"437\" height=\"437\" \/><\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_1_Pre-Delivery_Testing_FAT\"><\/span><span class=\"ng-star-inserted\">\u30d5\u30a7\u30fc\u30ba 1: \u914d\u4fe1\u524d\u30c6\u30b9\u30c8 (FAT)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">FAT\uff08\u5de5\u5834\u53d7\u5165\u691c\u67fb\uff09\u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT \u306f\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc (\u30d9\u30f3\u30c0\u30fc) \u306e\u65bd\u8a2d\u3067\u884c\u308f\u308c\u307e\u3059\u3002\u00a0<\/span><span class=\"ng-star-inserted\">\u524d\u306b<\/span><span class=\"ng-star-inserted\">\u00a0\u6a5f\u68b0\u306f\u68b1\u5305\u3055\u308c\u3066\u51fa\u8377\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u306e\u4ee3\u8868\u8005\u304c\u30d9\u30f3\u30c0\u30fc\u306e\u30b5\u30a4\u30c8\u3092\u8a2a\u554f\u3057\u3066\u6a5f\u5668\u3092\u691c\u67fb\u304a\u3088\u3073\u30c6\u30b9\u30c8\u3059\u308b\u5171\u540c\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u6a19\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u6a5f\u5668\u304c\u627f\u8a8d\u3055\u308c\u305f\u30e6\u30fc\u30b6\u30fc\u8981\u6c42\u4ed5\u69d8 (URS)\u3001\u6a5f\u80fd\u8a2d\u8a08\u4ed5\u69d8 (FDS)\u3001\u304a\u3088\u3073 P&amp;ID \u56f3\u9762\u306b\u5f93\u3063\u3066\u53b3\u5bc6\u306b\u69cb\u7bc9\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT \u4e2d\u306e\u4e3b\u306a\u30a2\u30af\u30c6\u30a3\u30d3\u30c6\u30a3:<\/span><\/strong><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u8996\u691c\u67fb:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5bf8\u6cd5\u3001\u8868\u9762\u4ed5\u4e0a\u3052\uff08\u305f\u3068\u3048\u3070\u3001316L \u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u306e\u63a5\u89e6\u90e8\u54c1\u304c\u6b63\u3057\u3044 Ra \u5024\u307e\u3067\u7814\u78e8\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\uff09\u3001\u6eb6\u63a5\u54c1\u8cea\u3092\u30c1\u30a7\u30c3\u30af\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u691c\u8a3c:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u3059\u3079\u3066\u306e\u30dd\u30f3\u30d7\u3001\u30e2\u30fc\u30bf\u30fc\u3001\u30bb\u30f3\u30b5\u30fc\u304c\u627f\u8a8d\u3055\u308c\u305f\u90e8\u54c1\u8868\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u57fa\u672c\u7684\u306a\u6a5f\u80fd:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u30de\u30b7\u30f3\u306e\u96fb\u6e90\u3092\u5165\u308c\u3066\u3001HMI\/PLC \u30b7\u30b9\u30c6\u30e0\u3001\u57fa\u672c\u7684\u306a\u6a5f\u68b0\u52d5\u4f5c\u3001\u304a\u3088\u3073\u5b89\u5168\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8abf\u9054\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u7406\u7531:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0FAT \u4e2d\u306b\u8a2d\u8a08\u4e0a\u306e\u6b20\u9665\u3084\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u6b20\u843d\u3092\u767a\u898b\u3057\u3066\u3082\u3001\u4fee\u6b63\u306b\u304b\u304b\u308b\u8cbb\u7528\u306f\u307b\u3068\u3093\u3069\u304b\u304b\u308a\u307e\u305b\u3093\u3002\u6a5f\u68b0\u304c\u4e16\u754c\u4e2d\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306b\u8f38\u9001\u3055\u308c\u305f\u5f8c\u306b\u540c\u3058\u30a8\u30e9\u30fc\u304c\u767a\u898b\u3055\u308c\u308b\u3068\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5927\u5e45\u306a\u9045\u5ef6\u3068\u4e88\u7b97\u306e\u8d85\u904e\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_2_Post-Delivery_Testing_SAT\"><\/span><span class=\"ng-star-inserted\">\u30d5\u30a7\u30fc\u30ba 2: \u7d0d\u54c1\u5f8c\u30c6\u30b9\u30c8 (SAT)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">SAT (\u30b5\u30a4\u30c8\u53d7\u3051\u5165\u308c\u30c6\u30b9\u30c8) \u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6a5f\u5668\u304c FAT \u306b\u5408\u683c\u3059\u308b\u3068\u3001\u88fd\u85ac\u4f1a\u793e\u306e\u65bd\u8a2d\u306b\u51fa\u8377\u3055\u308c\u307e\u3059\u3002 SAT \u306f\u3001\u30de\u30b7\u30f3\u304c\u5230\u7740\u3057\u3001\u6700\u7d42\u7684\u306a\u5834\u6240\u306b\u8a2d\u7f6e\u3055\u308c\u305f\u5f8c\u306b\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u76ee\u6a19\uff1a<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u8f38\u9001\u4e2d\u306b\u6a5f\u5668\u304c\u640d\u50b7\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3001\u304a\u3088\u3073\u65bd\u8a2d\u306e\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3 (\u96fb\u529b\u3001\u5727\u7e2e\u7a7a\u6c17\u3001\u51b7\u6c34\u3001\u84b8\u6c17) \u3068\u6b63\u3057\u304f\u63a5\u7d9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">SAT \u4e2d\u306e\u4e3b\u306a\u30a2\u30af\u30c6\u30a3\u30d3\u30c6\u30a3:<\/span><\/strong><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8f38\u9001\u6642\u306e\u640d\u50b7\u306e\u76ee\u8996\u691c\u67fb\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u51fa\u8377\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u304c\u68b1\u5305\u30ea\u30b9\u30c8\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8a2d\u5099\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u304c\u6a5f\u68b0\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6c38\u7d9a\u7684\u306a\u74b0\u5883\u3067\u30de\u30b7\u30f3\u306e\u96fb\u6e90\u3092\u30aa\u30f3\u306b\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Phase_3_The_Qualification_Lifecycle_IQ_OQ_PQ\"><\/span><span class=\"ng-star-inserted\">\u30d5\u30a7\u30fc\u30ba 3: \u8cc7\u683c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb (IQ\u3001OQ\u3001PQ)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">FAT \u3068 SAT \u306f\u91cd\u8981\u306a\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u3067\u3059\u304c\u3001\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8a8d\u5b9a\u30d5\u30a7\u30fc\u30ba (IQ\u3001OQ\u3001PQ)<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0cGMP \u898f\u5236\u76e3\u67fb\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u5fc5\u8981\u306a\u3001\u6b63\u5f0f\u3067\u6587\u66f8\u5316\u3055\u308c\u305f\u624b\u9806\u3067\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">1. \u8a2d\u7f6e\u8cc7\u683c (IQ)<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u300c\u4ed5\u69d8\u901a\u308a\u306b\u53d6\u308a\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u304b\uff1f\u300d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">IQ \u306f\u3001\u6a5f\u5668\u304c\u30e1\u30fc\u30ab\u30fc\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u5b89\u5168\u898f\u5236\u306b\u5f93\u3063\u3066\u7d0d\u54c1\u304a\u3088\u3073\u8a2d\u7f6e\u3055\u308c\u305f\u3053\u3068\u3092\u6587\u66f8\u5316\u3057\u305f\u8a3c\u62e0\u3067\u3059\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u691c\u8a3c\u3055\u308c\u308b\u5185\u5bb9:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u914d\u7dda\u3001\u914d\u7ba1\u63a5\u7d9a\u3001\u6a5f\u68b0\u306e\u6c34\u5e73\u8abf\u6574\u3001\u3059\u3079\u3066\u306e\u30e6\u30fc\u30b6\u30fc\u30de\u30cb\u30e5\u30a2\u30eb\u306e\u5b58\u5728\u3001\u6750\u6599\u8a3c\u660e\u66f8 (\u92fc\u304c\u5b9f\u969b\u306b\u533b\u85ac\u54c1\u30b0\u30ec\u30fc\u30c9\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e) \u304a\u3088\u3073\u3059\u3079\u3066\u306e\u30b2\u30fc\u30b8\u306e\u6821\u6b63\u8a3c\u660e\u66f8\u306e\u30b3\u30ec\u30af\u30b7\u30e7\u30f3\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">2. \u904b\u7528\u8cc7\u683c (OQ)<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u300c\u8a2d\u8a08\u3069\u304a\u308a\u306b\u6b63\u78ba\u306b\u52d5\u4f5c\u3057\u307e\u3059\u304b\uff1f\u300d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">OQ \u306f\u30de\u30b7\u30f3\u306e\u6a5f\u80fd\u80fd\u529b\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u901a\u5e38\u3001\u7a7a\u306e\u30de\u30b7\u30f3\u3092\u4f7f\u7528\u3059\u308b\u304b\u3001\u30d7\u30e9\u30bb\u30dc (\u6c34\u3084\u7a7a\u306e\u8ce6\u5f62\u5264\u306a\u3069) \u3092\u4f7f\u7528\u3057\u3066\u3001\u6a5f\u5668\u306e\u6975\u9650\u9650\u754c\u3092\u30c6\u30b9\u30c8\u3059\u308b\u305f\u3081\u306b\u884c\u308f\u308c\u307e\u3059\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30c6\u30b9\u30c8\u3055\u308c\u308b\u5185\u5bb9:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u9ad8\u305b\u3093\u65ad\u30df\u30ad\u30b5\u30fc\u304c 3000 RPM \u3067\u52d5\u4f5c\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001OQ \u306f\u5b9f\u969b\u306b\u30b9\u30e0\u30fc\u30ba\u306b 3000 RPM \u306b\u9054\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002\u505c\u96fb\u56de\u5fa9\u3001\u975e\u5e38\u505c\u6b62 (\u7dca\u6025\u505c\u6b62)\u3001\u30a2\u30e9\u30fc\u30e0\u3001\u30d1\u30b9\u30ef\u30fc\u30c9 \u30bb\u30ad\u30e5\u30ea\u30c6\u30a3 \u30ec\u30d9\u30eb (21 CFR Part 11 \u6e96\u62e0)\u3001\u304a\u3088\u3073\u52a0\u71b1\/\u51b7\u5374\u30b8\u30e3\u30b1\u30c3\u30c8\u306e\u52b9\u7387\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p class=\"ng-star-inserted\"><strong><span class=\"ng-star-inserted\">3. \u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u9069\u683c\u6027\u8a55\u4fa1 (PQ)<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u300c\u305d\u308c\u306f\u79c1\u306e\u7279\u5b9a\u306e\u88fd\u54c1\u3092\u4e00\u8cab\u3057\u3066\u751f\u7523\u3057\u307e\u3059\u304b?\u300d<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">PQ\u306f\u6700\u5f8c\u306e\u30cf\u30fc\u30c9\u30eb\u3067\u3059\u3002\u65bd\u8a2d\u3001\u6a5f\u5668\u3001\u4eba\u54e1\u3001\u305d\u3057\u3066\u5b9f\u969b\u306e\u88fd\u5264\u3092\u7d71\u5408\u3057\u307e\u3059\u3002<\/span><\/p>\n<ul class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30c6\u30b9\u30c8\u3055\u308c\u308b\u5185\u5bb9:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u3053\u306e\u6a5f\u68b0\u306f\u3001\u5b9f\u969b\u306e\u533b\u85ac\u54c1\u6709\u52b9\u6210\u5206 (API) \u3068\u30d0\u30c3\u30c1\u30ec\u30b7\u30d4\u3092\u4f7f\u7528\u3057\u3066\u3001\u901a\u5e38\u306e\u65e5\u5e38\u7684\u306a\u88fd\u9020\u6761\u4ef6\u4e0b\u3067\u7a3c\u50cd\u3057\u307e\u3059\u3002\u76ee\u6a19\u306f\u3001\u8907\u6570\u306e\u5b9f\u884c\u306b\u308f\u305f\u3063\u3066\u30d0\u30c3\u30c1\u9593\u306e\u4e00\u8cab\u6027\u3001\u5185\u5bb9\u306e\u5747\u4e00\u6027\u3001\u304a\u3088\u3073\u6700\u7d42\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u00a0<\/span><span class=\"ng-star-inserted\">(\u6ce8: \u30d9\u30f3\u30c0\u30fc\u306f IQ\/OQ \u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001PQ \u306f\u901a\u5e38\u3001\u88fd\u85ac\u4f1a\u793e\u306b\u3088\u3063\u3066\u4f5c\u6210\u304a\u3088\u3073\u5b9f\u884c\u3055\u308c\u307e\u3059)\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Why_Documentation_is_the_Real_Bottleneck_in_Procurement\"><\/span><span class=\"ng-star-inserted\">\u306a\u305c\u6587\u66f8\u5316\u304c\u8abf\u9054\u306b\u304a\u3051\u308b\u672c\u5f53\u306e\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u306a\u306e\u304b<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u8abf\u9054\u306e\u5c02\u9580\u5bb6\u306b\u3068\u3063\u3066\u3001\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306e\u4fa1\u683c\u4ea4\u6e09\u306f\u6226\u3044\u306e\u534a\u5206\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u88fd\u85ac\u6a5f\u5668\u306e\u96a0\u308c\u305f\u30b3\u30b9\u30c8\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u691c\u8a3c\u30d7\u30ed\u30c8\u30b3\u30eb\u3002<\/span><\/strong><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30d9\u30f3\u30c0\u30fc\u304c\u30de\u30b7\u30f3\u3092\u7d0d\u5165\u3057\u3066\u3082\u3001\u4e0d\u5341\u5206\u3001\u4e0d\u5b8c\u5168\u3001\u307e\u305f\u306f\u7ffb\u8a33\u4e0d\u53ef\u80fd\u306a IQ\/OQ \u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u63d0\u4f9b\u3055\u308c\u305f\u5834\u5408\u3001\u793e\u5185\u306e QA \u30c1\u30fc\u30e0\u306f\u4f55\u767e\u6642\u9593\u3082\u304b\u3051\u3066\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3092\u66f8\u304d\u76f4\u3059\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u751f\u7523\u30e9\u30a4\u30f3\u306e\u300c\u7a3c\u50cd\u958b\u59cb\u300d\u65e5\u304c\u9045\u308c\u3001\u533b\u85ac\u54c1\u5e02\u5834\u3078\u306e\u53ce\u76ca\u306e\u9045\u5ef6\u306b\u3088\u308a\u540c\u793e\u306b\u6570\u767e\u4e07\u30c9\u30eb\u306e\u640d\u5931\u304c\u767a\u751f\u3057\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3092\u8a55\u4fa1\u3059\u308b\u5834\u5408\u3001\u8abf\u9054\u7ba1\u7406\u8005\u306f\u6b21\u306e\u3053\u3068\u3092\u5c0b\u306d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><span class=\"ng-star-inserted\">\u300c\u3059\u3050\u306b\u5b9f\u884c\u3067\u304d\u308b\u5305\u62ec\u7684\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8 \u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304b?\u300d<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Seamless_Compliance_with_JIANPAI_Pharmaceutical_Equipment\"><\/span><span class=\"ng-star-inserted\">JIANPAI\u88fd\u85ac\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u30b7\u30fc\u30e0\u30ec\u30b9\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u3067\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">JIANPAI<\/span><\/strong><span class=\"ng-star-inserted\">\u3001\u79c1\u305f\u3061\u306f\u5358\u306b\u6a5f\u68b0\u3092\u4f9b\u7d66\u3057\u3066\u3044\u308b\u3060\u3051\u3067\u306f\u306a\u3044\u3053\u3068\u3092\u7406\u89e3\u3057\u3066\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u5b89\u5fc3\u3092\u304a\u5c4a\u3051\u3057\u307e\u3059\u3002\u30c8\u30c3\u30d7\u30af\u30e9\u30b9\u306e\u56fa\u4f53\u6295\u4e0e\u88c5\u7f6e\u306e\u4fe1\u983c\u3067\u304d\u308b\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u3001 <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/tablet-coating\/\" target=\"_blank\" rel=\"noopener\"><strong>\u30bf\u30d6\u30ec\u30c3\u30c8\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u30de\u30b7\u30f3<\/strong><\/a>, <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong>\u30cf\u30a4\u305b\u3093\u65ad\u30df\u30ad\u30b5\u30fc<\/strong><\/a>\u3001 \u305d\u3057\u3066 <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/high-shear-mixer\/\" target=\"_blank\" rel=\"noopener\"><strong>\u6d41\u52d5\u5e8a\u30b7\u30b9\u30c6\u30e0<\/strong><\/a>\u2014\u79c1\u305f\u3061\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u3042\u3089\u3086\u308b\u6bb5\u968e\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7d44\u307f\u8fbc\u3093\u3067\u3044\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">JIANPAI \u3068\u63d0\u643a\u3059\u308b\u3068\u3001\u771f\u306e\u7279\u5178\u3092\u53d7\u3051\u53d6\u308a\u307e\u3059\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u30bf\u30fc\u30f3\u30ad\u30fc\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/span><\/strong><span class=\"ng-star-inserted\">:<\/span><\/p>\n<ol class=\"ng-star-inserted\">\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u900f\u904e\u7684\u306a FAT \u5b9f\u884c:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306f\u3001\u53b3\u683c\u3067\u5b8c\u5168\u306b\u6587\u66f8\u5316\u3055\u308c\u305f\u5de5\u5834\u53d7\u3051\u5165\u308c\u30c6\u30b9\u30c8\u3092\u884c\u3046\u305f\u3081\u306e\u6700\u5148\u7aef\u306e\u65bd\u8a2d\u306b\u4e16\u754c\u4e2d\u306e\u9867\u5ba2\u3092\u6b53\u8fce\u3057\u307e\u3059\u3002 (\u30d3\u30c7\u30aa FAT \u306f\u30ea\u30e2\u30fc\u30c8 \u30c1\u30fc\u30e0\u3067\u3082\u5229\u7528\u3067\u304d\u307e\u3059)\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u5305\u62ec\u7684\u306a\u691c\u8a3c\u30d1\u30c3\u30b1\u30fc\u30b8:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306f\u3001\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u6750\u6599\u8a3c\u660e\u66f8\u3001\u6eb6\u63a5\u30ed\u30b0\u3001\u6821\u6b63\u8a18\u9332\u3068\u3068\u3082\u306b\u3001\u7d30\u5fc3\u306e\u6ce8\u610f\u3092\u6255\u3063\u3066\u4f5c\u6210\u3055\u308c\u305f\u82f1\u8a9e\u306e IQ \u304a\u3088\u3073 OQ \u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<li class=\"ng-star-inserted\">\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">21 CFR \u30d1\u30fc\u30c8 11 \u6e96\u5099\u5b8c\u4e86:<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306e\u9ad8\u5ea6\u306a PLC\/HMI \u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u96fb\u5b50\u7f72\u540d\u3001\u5b89\u5168\u306a\u30ec\u30b7\u30d4\u7ba1\u7406\u304c\u7d44\u307f\u8fbc\u307e\u308c\u3066\u304a\u308a\u3001\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u304c FDA \u307e\u305f\u306f EMA \u306e\u691c\u67fb\u306b\u7c21\u5358\u306b\u5408\u683c\u3059\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n<p class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">\u691c\u8a3c\u306e\u30cf\u30fc\u30c9\u30eb\u306b\u3088\u3063\u3066\u6b21\u306e\u751f\u7523\u30e9\u30a4\u30f3\u304c\u9045\u308c\u306a\u3044\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">[\u4eca\u3059\u3050 JIANPAI \u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30c1\u30fc\u30e0\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044]<\/span><\/strong><span class=\"ng-star-inserted\">\u00a0\u5f53\u793e\u306e\u5805\u7262\u306a\u6a5f\u5668\u3068\u6587\u66f8\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u6b21\u306e\u8abf\u9054\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u3069\u306e\u3088\u3046\u306b\u5408\u7406\u5316\u3067\u304d\u308b\u304b\u306b\u3064\u3044\u3066\u8a71\u3057\u5408\u3044\u307e\u3059\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 class=\"ng-star-inserted\"><span class=\"ez-toc-section\" id=\"Frequently_Asked_Questions_FAQs\"><\/span><span class=\"ng-star-inserted\">\u3088\u304f\u3042\u308b\u8cea\u554f (FAQ)<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q1: FAT 100% \u304c\u6210\u529f\u3057\u305f\u5834\u5408\u3001SAT \u3092\u30b9\u30ad\u30c3\u30d7\u3067\u304d\u307e\u3059\u304b?<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u3044\u3044\u3048\u3001SAT \u306f\u5fc5\u9808\u3067\u3059\u3002\u914d\u9001\u6642\u306e\u632f\u52d5\u3001\u6e29\u5ea6\u5909\u5316\u3001\u65bd\u8a2d\u3067\u306e\u518d\u7d44\u307f\u7acb\u3066\u306b\u3088\u308a\u3001\u6a5f\u68b0\u306e\u72b6\u614b\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30de\u30b7\u30f3\u306f\u65bd\u8a2d\u306e\u7279\u5b9a\u306e\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3 (FAT \u4e2d\u306b\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3055\u308c\u305f) \u306b\u5bfe\u3057\u3066\u30c6\u30b9\u30c8\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q2: IQ \u3068 OQ \u306e\u5b9f\u884c\u8cac\u4efb\u8005\u306f\u8ab0\u3067\u3059\u304b?<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u901a\u5e38\u3001\u6a5f\u5668\u30d9\u30f3\u30c0\u30fc (JIANPAI \u306a\u3069) \u306f\u3001\u7a7a\u767d\u306e IQ\/OQ \u30d7\u30ed\u30c8\u30b3\u30eb\u6587\u66f8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u901a\u5e38\u3001\u5b9f\u884c\u306f\u5171\u540c\u4f5c\u696d\u3067\u884c\u308f\u308c\u307e\u3059\u3002\u30d9\u30f3\u30c0\u30fc\u306e\u8a66\u904b\u8ee2\u30a8\u30f3\u30b8\u30cb\u30a2\u304c\u73fe\u5834\u3067\u30c6\u30b9\u30c8\u3092\u5b9f\u884c\u3057\u3001\u88fd\u85ac\u4f1a\u793e\u306e QA \u62c5\u5f53\u8005\u304c\u7d50\u679c\u3092\u7acb\u4f1a\u3044\u3001\u627f\u8a8d\u3057\u307e\u3059\u3002<\/span><\/p>\n<p class=\"ng-star-inserted\"><strong class=\"ng-star-inserted\"><span class=\"ng-star-inserted\">Q3: PQ\u306f\u6a5f\u5668\u30d9\u30f3\u30c0\u30fc\u304c\u5bfe\u5fdc\u3057\u3066\u304f\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/span><\/strong><br class=\"ng-star-inserted\" \/><span class=\"ng-star-inserted\">\u901a\u5e38\u306f\u3001\u3044\u3044\u3048\u3002\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1 (PQ) \u306b\u306f\u88fd\u85ac\u4f1a\u793e\u72ec\u81ea\u306e\u88fd\u5264\u3001\u6709\u52b9\u6210\u5206\u3001\u7279\u5b9a\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806 (SOP) \u304c\u542b\u307e\u308c\u308b\u305f\u3081\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306e\u691c\u8a3c\u30c1\u30fc\u30e0\u304c PQ \u306e\u4f5c\u6210\u3068\u5b9f\u884c\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u6a5f\u68b0\u306e\u8abf\u6574\u304c\u5fc5\u8981\u306a\u5834\u5408\u306f\u3001\u4fe1\u983c\u3067\u304d\u308b\u30d9\u30f3\u30c0\u30fc\u304c\u3053\u306e\u6bb5\u968e\u3067\u6280\u8853\u30b5\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u306f\u3058\u3081\u306b \u533b\u85ac\u54c1\u88fd\u9020\u696d\u754c\u3067\u306f\u3001\u9ad8\u305b\u3093\u65ad\u30df\u30ad\u30b5\u30fc\u3001\u6d41\u52d5\u5e8a\u4e7e\u71e5\u6a5f\u3001\u9320\u5264\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u6a5f\u306a\u3069\u3001\u65b0\u3057\u3044\u6a5f\u5668\u3092\u8cfc\u5165\u3059\u308b\u3053\u3068\u306f\u3001\u6a19\u6e96\u7684\u306a\u7523\u696d\u6a5f\u68b0\u3092\u8cfc\u5165\u3059\u308b\u3053\u3068\u3068\u306f\u6839\u672c\u7684\u306b\u7570\u306a\u308a\u307e\u3059\u3002\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3068\u30e2\u30fc\u30bf\u30fc\u3092\u8cfc\u5165\u3059\u308b\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3042\u306a\u305f\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u8cb7\u3063\u3066\u3044\u308b\u306e\u3067\u3059\u3002 FDA\u3001EMA\u3001WHO \u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u306f\u3001\u6a5f\u68b0\u304c\u4ed5\u69d8\u306b\u5f93\u3063\u3066\u69cb\u7bc9\u3055\u308c\u3001\u6b63\u3057\u304f\u8a2d\u7f6e\u3055\u308c\u3001\u4e00\u8cab\u3057\u3066\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u793a\u3059\u6587\u66f8\u5316\u3055\u308c\u305f\u79d1\u5b66\u7684\u8a3c\u62e0\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3084\u30d7\u30ed\u30b8\u30a7\u30af\u30c8 \u30a8\u30f3\u30b8\u30cb\u30a2\u306b\u3068\u3063\u3066\u3001FAT\u3001SAT\u3001IQ\u3001OQ\u3001PQ \u306a\u3069\u3001\u6a5f\u5668\u691c\u8a3c\u306e\u30a2\u30eb\u30d5\u30a1\u30d9\u30c3\u30c8\u306e\u30b9\u30fc\u30d7\u3092\u30ca\u30d3\u30b2\u30fc\u30c8\u3059\u308b\u306e\u306f\u56f0\u96e3\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u3053\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u9069\u5207\u306a\u691c\u8a3c\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u306a\u3044\u30de\u30b7\u30f3\u306f\u3001cGMP \u74b0\u5883\u3067\u306f\u57fa\u672c\u7684\u306b\u5f79\u306b\u7acb\u3061\u307e\u305b\u3093\u3002 [\u2026]<\/p>","protected":false},"featured_media":5097,"template":"","meta":{"_acf_changed":false,"footnotes":""},"blog_category":[16],"class_list":["post-5096","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog_category-industry-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5096","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/types\/blog"}],"version-history":[{"count":1,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5096\/revisions"}],"predecessor-version":[{"id":5098,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5096\/revisions\/5098"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media\/5097"}],"wp:attachment":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media?parent=5096"}],"wp:term":[{"taxonomy":"blog_category","embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog_category?post=5096"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}