{"id":5404,"date":"2026-09-29T09:45:36","date_gmt":"2026-09-29T01:45:36","guid":{"rendered":"https:\/\/www.jianpaitech.com\/?post_type=blog&#038;p=5404"},"modified":"2026-10-08T09:45:47","modified_gmt":"2026-10-08T01:45:47","slug":"critical-compliance-factors-when-sourcing-continuous-manufacturing-services","status":"publish","type":"blog","link":"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/","title":{"rendered":"\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u3092\u8abf\u9054\u3059\u308b\u969b\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u56e0"},"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\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#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\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Why_Compliance_Matters_for_Manufacturing_Service_Sourcing\" >\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u8abf\u9054\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u91cd\u8981\u306a\u7406\u7531<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Regulatory_risks_of_non-compliant_manufacturing_services\" >\u975e\u6e96\u62e0\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306e\u898f\u5236\u30ea\u30b9\u30af<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Value_of_standard_continuous_manufacturing_compliance\" >\u6a19\u6e96\u7684\u306a\u9023\u7d9a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u4fa1\u5024<\/a><\/li><\/ul><\/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\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Core_Regulatory_Requirements_for_Pharma_Manufacturing\" >\u533b\u85ac\u54c1\u88fd\u9020\u306e\u30b3\u30a2\u898f\u5236\u8981\u4ef6<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Basic_pharmaceutical_continuous_manufacturing_rules\" >\u533b\u85ac\u54c1\u9023\u7d9a\u88fd\u9020\u57fa\u672c\u30eb\u30fc\u30eb<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#GMP_compliance_standards_for_manufacturing_sourcing\" >\u88fd\u9020\u8abf\u9054\u306eGMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Key_Compliance_Factors_for_Service_Procurement\" >\u30b5\u30fc\u30d3\u30b9\u8abf\u9054\u306e\u4e3b\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u56e0<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Process_validation_in_continuous_manufacturing_services\" >\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306b\u304a\u3051\u308b\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Data_integrity_compliance_for_continuous_production\" >\u9023\u7d9a\u751f\u7523\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Practical_Compliance_Checklist_for_Sourcing_Projects\" >\u8abf\u9054\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5b9f\u8df5\u7684\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Facility_qualification_for_continuous_manufacturing_partners\" >\u9023\u7d9a\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u65bd\u8a2d\u8cc7\u683c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Document_audit_for_compliant_manufacturing_cooperation\" >\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u88fd\u9020\u5354\u529b\u306e\u305f\u3081\u306e\u6587\u66f8\u76e3\u67fb<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Common_Compliance_Errors_and_Standard_Solutions\" >\u4e00\u822c\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a8\u30e9\u30fc\u3068\u6a19\u6e96\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#FAQs\" >FAQ<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.jianpaitech.com\/ja\/blog\/critical-compliance-factors-when-sourcing-continuous-manufacturing-services\/#Conclusion\" >\u7d50\u8ad6<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Introduction\"><\/span><b><\/b><strong><b>\u5c0e\u5165<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong><b>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/b><\/strong><\/a>\u00a0\u77ed\u3044\u30b5\u30a4\u30af\u30eb\u3068\u67d4\u8edf\u306a\u751f\u7523\u80fd\u529b\u3092\u5b9f\u73fe\u3059\u308b\u9769\u65b0\u7684\u306a\u533b\u85ac\u54c1\u751f\u7523\u30e2\u30fc\u30c9\u3067\u3059\u304c\u3001GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u306f\u7279\u5225\u306a\u8ab2\u984c\u304c\u3042\u308a\u307e\u3059\u3002\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u751f\u7523\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a55\u4fa1\u3067\u306f\u3001\u91cd\u8981\u306a\u9023\u7d9a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u7d20\u3068\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u898f\u5236\u8981\u4ef6\u304c\u898b\u843d\u3068\u3055\u308c\u304c\u3061\u3067\u3059\u3002\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u30d9\u30fc\u30b9\u306e\u8a55\u4fa1\u57fa\u6e96\u3092\u76f2\u76ee\u7684\u306b\u63a1\u7528\u3059\u308b\u3068\u3001\u691c\u67fb\u7d50\u679c\u3084\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.jianpaitech.com\/ja\" target=\"_blank\" rel=\"noopener\"><strong><b>JIANPAI<\/b><\/strong><\/a>\u00a0\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u305f\u3081\u306e\u5b8c\u5168\u306a\u6a5f\u5668\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30bd\u30fc\u30b9\u3067\u3053\u308c\u3089\u306e\u554f\u984c\u70b9\u3092\u89e3\u6c7a\u3057\u307e\u3059\u3002<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-medium wp-image-5405\" src=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2026\/09\/\u5c4f\u5e55\u622a\u56fe_20-9-2026_173617_www.jianpaitech.com_-300x200.jpeg?quality=85&strip=all\" alt=\"\u7d99\u7d9a\u7684\u306a\u88fd\u9020\" width=\"300\" height=\"200\" srcset=\"https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2026\/09\/\u5c4f\u5e55\u622a\u56fe_20-9-2026_173617_www.jianpaitech.com_-300x200.jpeg?quality=85&strip=all 300w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2026\/09\/\u5c4f\u5e55\u622a\u56fe_20-9-2026_173617_www.jianpaitech.com_-768x513.jpeg?quality=85&strip=all 768w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2026\/09\/\u5c4f\u5e55\u622a\u56fe_20-9-2026_173617_www.jianpaitech.com_-18x12.jpeg?quality=85&strip=all 18w, https:\/\/i1.wp.com\/www.jianpaitech.com\/wp-content\/uploads\/2026\/09\/\u5c4f\u5e55\u622a\u56fe_20-9-2026_173617_www.jianpaitech.com_.jpeg?quality=85&strip=all 888w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_Compliance_Matters_for_Manufacturing_Service_Sourcing\"><\/span><strong><b>\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u8abf\u9054\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u91cd\u8981\u306a\u7406\u7531<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_risks_of_non-compliant_manufacturing_services\"><\/span><strong><b>\u975e\u6e96\u62e0\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306e\u898f\u5236\u30ea\u30b9\u30af<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u751f\u7523\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3068\u6bd4\u8f03\u3057\u3066\u3001\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3055\u308c\u305f\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306f\u6f5c\u5728\u7684\u306a\u898f\u5236\u30ea\u30b9\u30af\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002\u9023\u7d9a\u751f\u7523\u306f\u3001\u9014\u5207\u308c\u308b\u3053\u3068\u306e\u306a\u3044\u6750\u6599\u4f9b\u7d66\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30d7\u30ed\u30bb\u30b9\u5206\u6790\uff08PAT\uff09\u3001\u52d5\u7684\u306a\u6750\u6599\u8ee2\u63db\u3092\u63a1\u7528\u3057\u3001\u72ec\u81ea\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30ed\u30b8\u30c3\u30af\u3092\u7279\u5fb4\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u304c\u6210\u719f\u3057\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u3042\u308b\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u6b20\u3044\u3066\u3044\u308b\u5834\u5408\uff1a<\/p>\n<ol>\n<li>\u9023\u7d9a\u7684\u306a\u30de\u30c6\u30ea\u30a2\u30eb\u30d5\u30ed\u30fc\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30c1\u30a7\u30fc\u30f3\u304c\u4e0d\u5b8c\u5168\u3067\u3042\u308a\u3001\u76e3\u67fb\u3084\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u8ffd\u8de1\u304c\u56f0\u96e3\u3067\u3042\u308b\u3002<\/li>\n<li>\u691c\u8a3c\u3055\u308c\u305f\u8d77\u52d5\u304a\u3088\u3073\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u624b\u9806\u3001\u306a\u3089\u3073\u306b\u6750\u6599\u306e\u8ee2\u7528\u304a\u3088\u3073\u5ec3\u68c4\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u6b20\u5982\u3057\u3066\u304a\u308a\u3001\u975e\u6e96\u62e0\u306e\u4e2d\u9593\u4f53\u306e\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<li>FDA\/EMA\u8b66\u544a\u66f8\u306e\u30ea\u30b9\u30af\u3092\u4f34\u3046\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u7ba1\u7406\u306e\u6b20\u5982\u3002<\/li>\n<li>\u73fe\u5834\u3067\u306e\u5b9f\u52d9\u4f5c\u696d\u304c\u7533\u544a\u66f8\u985e\u3068\u4e00\u81f4\u3057\u306a\u304b\u3063\u305f\u305f\u3081\u3001\u8ca9\u58f2\u8a31\u53ef\u304c\u4ed8\u4e0e\u3055\u308c\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/li>\n<\/ol>\n<p>\u500b\u5225\u306e\u30d0\u30c3\u30c1\u8a18\u9332\u3068\u306f\u7570\u306a\u308a\u3001\u9023\u7d9a\u88fd\u9020\u3067\u306f\u5927\u91cf\u306e\u6642\u7cfb\u5217\u30c7\u30fc\u30bf\u304c\u751f\u6210\u3055\u308c\u307e\u3059\u3002\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u629c\u3051\u7a74\u304c\u751f\u3058\u308b\u3068\u3001\u9061\u53ca\u7684\u8abf\u67fb\u306e\u5b9f\u65bd\u306f\u6975\u3081\u3066\u56f0\u96e3\u306b\u306a\u308a\u3001\u533b\u85ac\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u306b\u3068\u3063\u3066\u53b3\u3057\u3044\u898f\u5236\u4e0a\u304a\u3088\u3073\u5546\u696d\u4e0a\u306e\u5f71\u97ff\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Value_of_standard_continuous_manufacturing_compliance\"><\/span><strong><b>\u6a19\u6e96\u7684\u306a\u9023\u7d9a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u4fa1\u5024<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6539\u5584\u3068\u5b9f\u65bd <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/strong><\/a> GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u306e\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u533b\u85ac\u54c1\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u306b\u591a\u5c64\u7684\u306a\u30e1\u30ea\u30c3\u30c8\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002<\/p>\n<p>\u2014\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u306b\u95a2\u3059\u308bICH Q13\u3001FDA\u3001EMA\u306e\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3001\u767b\u9332\u5be9\u67fb\u306e\u5186\u6ed1\u306a\u9032\u884c\u3092\u4fc3\u9032\u3057\u307e\u3059\u3002<\/p>\n<p>\u2014\u8b66\u544a\u66f8\u3001\u691c\u67fb\u6b20\u9665\u3001\u627f\u8a8d\u5f8c\u306e\u5909\u66f4\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002<\/p>\n<p>\u2014\u5b8c\u6210\u54c1\u306e\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u3092\u78ba\u4fdd\u3057\u3001\u4e0d\u826f\u54c1\u3084\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u53ef\u80fd\u6027\u3092\u4f4e\u6e1b\u3057\u307e\u3059\u3002<\/p>\n<p>\u54c1\u8cea\u5354\u5b9a\u3092\u901a\u3058\u3066\u3001\u4f01\u696d\u3068\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u8005\u306e\u9593\u306e\u54c1\u8cea\u8cac\u4efb\u306e\u5883\u754c\u3092\u660e\u78ba\u306b\u3059\u308b\u3002<\/p>\n<p>JIANPAI\u30d6\u30e9\u30f3\u30c9\u306b\u4ee3\u8868\u3055\u308c\u308b\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u6a5f\u5668\u3001\u30d7\u30ed\u30bb\u30b9\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u6587\u66f8\u5316\u30b5\u30dd\u30fc\u30c8\u3092\u540c\u6642\u306b\u63d0\u4f9b\u3057\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u521d\u671f\u6bb5\u968e\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ae\u30e3\u30c3\u30d7\u3092\u57cb\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Core_Regulatory_Requirements_for_Pharma_Manufacturing\"><\/span><strong><b>\u533b\u85ac\u54c1\u88fd\u9020\u306e\u30b3\u30a2\u898f\u5236\u8981\u4ef6<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Basic_pharmaceutical_continuous_manufacturing_rules\"><\/span><strong><b>\u533b\u85ac\u54c1\u9023\u7d9a\u88fd\u9020\u57fa\u672c\u30eb\u30fc\u30eb<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>ICH Q13\u306b\u4ee3\u8868\u3055\u308c\u308b\u56fd\u969b\u7684\u306b\u8abf\u548c\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001\u9023\u7d9a\u88fd\u9020\u306e\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u67a0\u7d44\u307f\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002FDA 21 CFR\u30d1\u30fc\u30c8211\u304a\u3088\u3073EMA GMP\u4ed8\u5c5e\u66f815\u3068\u7d50\u5408\u3055\u308c\u3066\u3001\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306e\u305f\u3081\u306e\u4e2d\u5fc3\u7684\u306a\u898f\u5236\u8981\u4ef6 <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/strong><\/a> \u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u306f<\/p>\n<p>\u2014\u9023\u7d9a\u30e2\u30fc\u30c9\u3067\u306e\u300c\u30d0\u30c3\u30c1\u300d\u306e\u5b9a\u7fa9\u3092\u660e\u78ba\u306b\u3057\u3001\u8d77\u52d5\u304b\u3089\u5b9a\u5e38\u904b\u8ee2\u3001\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u307e\u3067\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3092\u30ab\u30d0\u30fc\u3059\u308b\u5305\u62ec\u7684\u306a\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002<\/p>\n<p>\u2014\u8d77\u52d5\u3001\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u3001\u5916\u4e71\u51e6\u7406\u3001\u304a\u3088\u3073\u6750\u6599\u8ee2\u63db\u624b\u9806\u306e\u5b8c\u5168\u306a\u691c\u8a3c\uff1b<\/p>\n<p>\u2014\u91cd\u8981\u306a\u54c1\u8cea\u5c5e\u6027\uff08CQA\uff09\u3068\u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\uff08CPP\uff09\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u5b9f\u884c\u3059\u308b\u305f\u3081\u306e\u52b9\u679c\u7684\u306aPAT\u30b7\u30b9\u30c6\u30e0\u3092\u5b9f\u88c5\u3057\u307e\u3059\u3002<\/p>\n<p>\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u54c1\u8cea\u7ba1\u7406\uff08QRM\uff09\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u8a2d\u8a08\u3001\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u3001\u5546\u696d\u751f\u7523\u3092\u542b\u3080\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u53ca\u3076\u3002<\/p>\n<p>\u2014\u9023\u7d9a\u751f\u7523\u88c5\u7f6e\u306b\u3088\u3063\u3066\u751f\u6210\u3055\u308c\u305f\u30b9\u30c8\u30ea\u30fc\u30df\u30f3\u30b0\u30d7\u30ed\u30bb\u30b9\u30c7\u30fc\u30bf\u306e\u53b3\u683c\u306a\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u5236\u5fa1\u3092\u5b9f\u88c5\u3057\u307e\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"GMP_compliance_standards_for_manufacturing_sourcing\"><\/span><strong><b>\u88fd\u9020\u8abf\u9054\u306eGMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>GMP\u8981\u4ef6\u304c\u65bd\u8a2d\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306b\u9650\u5b9a\u3055\u308c\u306a\u3044\u5916\u90e8\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306e\u8abf\u9054\u3002<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"284\">GMP\u8a55\u4fa1\u30e2\u30b8\u30e5\u30fc\u30eb<\/td>\n<td width=\"284\">\u30b3\u30a2\u691c\u67fb\u5185\u5bb9<\/td>\n<td width=\"284\">\u9023\u7d9a\u88fd\u9020\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3078\u306e\u5f71\u97ff<\/td>\n<\/tr>\n<tr>\n<td width=\"284\">\u54c1\u8cea\u7d44\u7e54\u4f53\u5236<\/td>\n<td width=\"284\">\u72ec\u7acb\u3057\u305fQA\/QC\u90e8\u9580\u3001\u9023\u7d9a\u88fd\u9020\u306e\u305f\u3081\u306e\u30af\u30ed\u30b9\u30d5\u30a1\u30f3\u30af\u30b7\u30e7\u30ca\u30eb\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0<\/td>\n<td width=\"284\">\u504f\u5dee\u3001\u5909\u66f4\u7ba1\u7406\u3001\u88fd\u54c1\u30ea\u30ea\u30fc\u30b9\u306b\u5bfe\u3059\u308b\u660e\u78ba\u306a\u8cac\u4efb<\/td>\n<\/tr>\n<tr>\n<td width=\"284\">\u8a2d\u5099\u00b7\u8a2d\u5099\u78ba\u8a8d<\/td>\n<td width=\"284\">\u9023\u7d9a\u7684\u306a\u751f\u7523\u30e9\u30a4\u30f3IQ\/OQ\/PQ\u5b8c\u4e86\u3001PAT\u30b7\u30b9\u30c6\u30e0\u691c\u8a3c<\/td>\n<td width=\"284\">\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5b89\u5b9a\u3057\u305f\u5b9f\u884c\u3092\u78ba\u4fdd\u3059\u308b\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"284\">\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td>\n<td width=\"284\">\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9SOP\u3001\u30d0\u30c3\u30c1\u5b9a\u7fa9\u6587\u66f8\u3001\u504f\u5dee\u51e6\u7406\u624b\u9806<\/td>\n<td width=\"284\">\u767b\u9332\u00b7\u73fe\u5730\u76e3\u67fb\u306e\u30b5\u30dd\u30fc\u30c8<\/td>\n<\/tr>\n<tr>\n<td width=\"284\">\u30b9\u30bf\u30c3\u30d5\u30b3\u30f3\u30d4\u30c6\u30f3\u30b7\u30fc<\/td>\n<td width=\"284\">\u9023\u7d9a\u751f\u7523\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u00b7QA\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u5411\u3051\u7814\u4fee\u5b9f\u7e3e<\/td>\n<td width=\"284\">\u9577\u6642\u9593\u904b\u8ee2\u4e2d\u306e\u4eba\u7684\u8981\u56e0\u306b\u3088\u308b\u30d7\u30ed\u30bb\u30b9\u30c9\u30ea\u30d5\u30c8\u306e\u8efd\u6e1b<\/td>\n<\/tr>\n<tr>\n<td width=\"284\">\u54c1\u8cea\u5951\u7d04\u5185\u5bb9<\/td>\n<td width=\"284\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u30c7\u30fc\u30bf\u3001\u9038\u8131\u3001\u30ea\u30b3\u30fc\u30eb\u306b\u5bfe\u3059\u308b\u8cac\u4efb\u306e\u660e\u78ba\u5316<\/td>\n<td width=\"284\">\u30e9\u30a4\u30bb\u30f3\u30b9\u5f53\u4e8b\u8005\u3068\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u9593\u306e\u6cd5\u7684\u304a\u3088\u3073\u54c1\u8cea\u306e\u5883\u754c\u3092\u5b9a\u7fa9<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>\u591a\u304f\u306e\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306f\u3001\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u751f\u7523GMP\u76e3\u67fb\u306b\u5408\u683c\u3067\u304d\u307e\u3059\u304c\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u76e3\u67fb\u30d5\u30a7\u30fc\u30ba\u3067\u614e\u91cd\u306b\u691c\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u7d99\u7d9a\u30e2\u30fc\u30c9\u306e\u6587\u66f8\u3084\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u7ba1\u7406\u306e\u5b9f\u8df5\u7684\u306a\u7d4c\u9a13\u304c\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Key_Compliance_Factors_for_Service_Procurement\"><\/span><strong><b>\u30b5\u30fc\u30d3\u30b9\u8abf\u9054\u306e\u4e3b\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u56e0<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Process_validation_in_continuous_manufacturing_services\"><\/span><strong><b>\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306b\u304a\u3051\u308b\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u9023\u7d9a\u88fd\u9020\u306e\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u306f\u30013\u6bb5\u968e\u306e\u691c\u8a3c\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\uff08\u30d7\u30ed\u30bb\u30b9\u8a2d\u8a08\u3001\u30d7\u30ed\u30bb\u30b9\u8a8d\u5b9a\u3001\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\uff09\u306b\u5f93\u3044\u307e\u3059\u304c\u3001\u9023\u7d9a\u904b\u8ee2\u306e\u7279\u6027\u306b\u9069\u5408\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u30d0\u30c3\u30c1\u751f\u7523\u306e\u691c\u8a3c\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u76f4\u63a5\u5f93\u3046\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/p>\n<p>\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u3068\u78ba\u8a8d\u3059\u308b\u4e3b\u306a\u691c\u8a3c\u6210\u679c\u7269\uff1a<\/p>\n<ol>\n<li>\u30d7\u30ed\u30bb\u30b9\u8a2d\u8a08\u6587\u66f8\uff1a\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\u3001\u8a2d\u8a08\u30b9\u30da\u30fc\u30b9\u5b9a\u7fa9\u3001CPP\/CQA\u30ea\u30b9\u30c8\u3001\u8d77\u52d5\u2014\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u2014\u969c\u5bb3\u8efd\u6e1b\u6226\u7565\uff1b<\/li>\n<li>\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u8a3c\u62e0\uff1a\u5b9a\u5e38\u904b\u8ee2\u80fd\u529b\u8a3c\u660e\u66f8\u3001\u4e0d\u9069\u5408\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u6750\u6599\u8ee2\u7528\u691c\u8a3c\uff1b<\/li>\n<li>\u9023\u7d9a\u5de5\u7a0b\u691c\u8a3c\u8a08\u753b\uff1a\u9023\u7d9a\u904b\u8ee2\u751f\u7523\u30c7\u30fc\u30bf\u306e\u9577\u671f\u30c8\u30ec\u30f3\u30c9\u5206\u6790\u306e\u305f\u3081\u306e\u30e1\u30ab\u30cb\u30ba\u30e0\uff1b<\/li>\n<li>\u6280\u8853\u79fb\u8ee2\u6587\u66f8\uff1a\u5c0f\u898f\u6a21\u00b7\u30d1\u30a4\u30ed\u30c3\u30c8\u8a66\u9a13\u304b\u3089\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306e\u30aa\u30f3\u30b5\u30a4\u30c8\u9023\u7d9a\u751f\u7523\u30e9\u30a4\u30f3\u3078\u306e\u79fb\u884c\u306b\u4f34\u3046\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8<\/li>\n<\/ol>\n<p>JIANPAI\u306f\u63d0\u4f9b\u3067\u304d\u307e\u3059 <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/strong><\/a> \u6a5f\u5668\u691c\u8a3c\u6587\u66f8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u9867\u5ba2\u3084\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u304c\u691c\u8a3c\u6587\u66f8\u3092\u8fc5\u901f\u306b\u4f5c\u6210\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Data_integrity_compliance_for_continuous_production\"><\/span><strong><b>\u9023\u7d9a\u751f\u7523\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u9023\u7d9a\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u5927\u91cf\u306e\u6642\u7cfb\u5217\u30c7\u30fc\u30bf\u304c\u751f\u6210\u3055\u308c\u307e\u3059\u3002\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u306f\u3001\u9023\u7d9a\u88fd\u9020\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u6700\u512a\u5148\u8981\u7d20\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001PAT\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u76e3\u8996\u4fe1\u53f7\u3001\u6a5f\u5668\u30d1\u30e9\u30e1\u30fc\u30bf\u30ed\u30b0\u3001\u30a2\u30e9\u30fc\u30e0\u30a4\u30d9\u30f3\u30c8\u8a18\u9332\u3001\u30de\u30c6\u30ea\u30a2\u30eb\u30d5\u30ed\u30fc\u30c8\u30e9\u30c3\u30ad\u30f3\u30b0\u30ed\u30b0\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>\u30b3\u30a2\u30c7\u30fc\u30bf\u6574\u5408\u6027\u8981\u4ef6\uff1a<\/p>\n<p>\u2014\u30c7\u30fc\u30bf\u306b\u306f\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u304c\u542b\u307e\u308c\u3001\u4e0d\u5909\u3067\u8ffd\u8de1\u53ef\u80fd\u3067\u3042\u308a\u3001ALCOA+\u306e\u539f\u5247\u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u9023\u7d9a\u904b\u8ee2\u30d7\u30ed\u30bb\u30b9\u4e2d\u306e\u30a2\u30e9\u30fc\u30e0\u30a4\u30d9\u30f3\u30c8\u5236\u5fa1\u306e\u7ba1\u7406\u6226\u7565\u306f\u660e\u78ba\u3067\u3059\u3002\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306a\u3057\u306b\u30a2\u30e9\u30fc\u30e0\u6291\u5236\u3092\u6063\u610f\u7684\u306b\u5b9f\u884c\u3057\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u2014\u9577\u671f\u4fdd\u5b58\u306e\u305f\u3081\u306e\u5305\u62ec\u7684\u306a\u30c7\u30fc\u30bf\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3068\u30a2\u30fc\u30ab\u30a4\u30d6\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3001\u898f\u5236\u691c\u67fb\u3068\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u8981\u4ef6\u3092\u6e80\u305f\u3057\u307e\u3059\u3002<\/p>\n<p><em><i>\u4e00\u90e8\u306e\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306f\u3001\u96c6\u8a08\u30ec\u30dd\u30fc\u30c8\u306e\u307f\u3092\u4fdd\u6301\u3057\u3001\u751f\u306e\u30b9\u30c8\u30ea\u30fc\u30df\u30f3\u30b0\u30c7\u30fc\u30bf\u3092\u7834\u68c4\u3057\u307e\u3059\u3002<\/i><\/em><\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Practical_Compliance_Checklist_for_Sourcing_Projects\"><\/span><strong><b>\u8abf\u9054\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5b9f\u8df5\u7684\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"Facility_qualification_for_continuous_manufacturing_partners\"><\/span><strong><b>\u9023\u7d9a\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u65bd\u8a2d\u8cc7\u683c<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u9023\u7d9a\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc<\/p>\n<p>\u6b63\u5f0f\u306b\u5354\u529b\u5951\u7d04\u3092\u7de0\u7d50\u3059\u308b\u524d\u306b\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3068\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u591a\u6b21\u5143\u8a55\u4fa1\u3092\u5b8c\u4e86\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"426\">\u76e3\u67fb\u5206\u985e<\/td>\n<td width=\"426\">\u9023\u7d9a\u88fd\u9020\u8a2d\u5099\u8a8d\u5b9a\u78ba\u8a8d\u306e\u305f\u3081\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u9805\u76ee<\/td>\n<\/tr>\n<tr>\n<td width=\"426\">\u8a2d\u5099\u00b7PAT\u30b7\u30b9\u30c6\u30e0<\/td>\n<td width=\"426\">\u9023\u7d9a\u751f\u7523\u30e9\u30a4\u30f3\u306eIQ\/OQ\/PQ\u304c\u5b8c\u6210\u3057\u307e\u3057\u305f\u3002PAT\u88c5\u7f6e\u304c\u6821\u6b63\u3055\u308c\u307e\u3057\u305f\u3002\u6750\u6599\u8ee2\u63db\u9664\u5916\u6a5f\u80fd\u304c\u691c\u8a3c\u3055\u308c\u307e\u3057\u305f\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"426\">\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u7ba1\u7406<\/td>\n<td width=\"426\">\u660e\u78ba\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u9023\u7d9a\u751f\u7523\u30d0\u30c3\u30c1\uff1b\u8d77\u52d5\u304b\u3089\u5b9a\u5e38\u904b\u8ee2\u304a\u3088\u3073\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u307e\u3067\u3001\u6750\u6599\u30d5\u30ed\u30fc\u306e\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u306b\u308f\u305f\u308b\u5305\u62ec\u7684\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"426\">\u4ea4\u5dee\u6c5a\u67d3\u30ea\u30b9\u30af\u8a55\u4fa1<\/td>\n<td width=\"426\">\u8907\u6570\u88fd\u54c1\u5171\u6709\u30e9\u30a4\u30f3\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\uff1b\u9023\u7d9a\u88c5\u7f6e\u306e\u6d17\u6d44\u691c\u8a3c\u304c\u5b8c\u4e86\u3057\u307e\u3057\u305f\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"426\">\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0<\/td>\n<td width=\"426\">\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9\u306e\u5b89\u5b9a\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u91cd\u8981\u306a\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u30b5\u30fc\u30d3\u30b9\uff08\u6e29\u5ea6\u5236\u5fa1\u3055\u308c\u305f\u6c34\u3001\u5727\u7e2e\u7a7a\u6c17\uff09\u306e\u5b89\u5b9a\u6027\u78ba\u8a8d\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>\u76e3\u67fb\u306f\u3001\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306e\u72b6\u614b\u3060\u3051\u3067\u306a\u304f\u3001\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u9038\u8131\u3084\u30a2\u30e9\u30fc\u30e0\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3078\u306e\u5bfe\u5fdc\u306b\u95a2\u3059\u308b\u62c5\u5f53\u8005\u306e\u5b9f\u52d9\u7d4c\u9a13\u306e\u8a55\u4fa1\u306b\u3082\u91cd\u70b9\u3092\u7f6e\u304f\u3079\u304d\u3067\u3059\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Document_audit_for_compliant_manufacturing_cooperation\"><\/span><strong><b>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u88fd\u9020\u5354\u529b\u306e\u305f\u3081\u306e\u6587\u66f8\u76e3\u67fb<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6587\u66f8\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u3001\u767b\u9332\u3068\u7533\u8acb\u3001\u306a\u3089\u3073\u306b\u73fe\u5730\u691c\u67fb\u306e\u4e3b\u8981\u306a\u8a3c\u62e0\u3068\u306a\u308a\u3001\u6587\u66f8\u306e\u96c6\u4e2d\u7684\u306a\u30ec\u30d3\u30e5\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<ol>\n<li>\u7f72\u540d\u3055\u308c\u305f\u6709\u52b9\u306a\u54c1\u8cea\u5951\u7d04\uff1a\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u3001\u30c7\u30fc\u30bf\u30a2\u30fc\u30ab\u30a4\u30d6\u3001\u9038\u8131\u51e6\u7406\u3001\u5909\u66f4\u7ba1\u7406\u3001\u30ea\u30ea\u30fc\u30b9\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u8cac\u4efb\u3092\u660e\u78ba\u306b\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>SOP\u6587\u66f8\u306e\u5b8c\u5168\u306a\u30bb\u30c3\u30c8\uff1a\u9023\u7d9a\u751f\u7523\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3001PAT\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u6750\u6599\u8ee2\u63db\u3001\u9038\u8131\u3001\u5909\u66f4\u3001\u6d17\u6d44\u691c\u8a3c\u30d7\u30ed\u30c8\u30b3\u30eb\uff1b<\/li>\n<li>\u904e\u53bb\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u53c2\u8003\u6587\u732e\uff1aPrevious <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/strong><\/a> \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u691c\u8a3c\u5831\u544a\u66f8\u95a2\u9023\u691c\u67fb\u8a18\u9332<\/li>\n<li>\u30c7\u30fc\u30bf\u7ba1\u7406\u30d7\u30ed\u30c8\u30b3\u30eb\uff1a\u751f\u306e\u30b9\u30c8\u30ea\u30fc\u30df\u30f3\u30b0\u30c7\u30fc\u30bf\u306e\u30b9\u30c8\u30ec\u30fc\u30b8\u3001\u30a8\u30af\u30b9\u30dd\u30fc\u30c8\u3001\u304a\u3088\u3073\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u6226\u7565\u306e\u305f\u3081\u306eALCOA+\u539f\u5247\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>JIANPAI\u306e\u9023\u7d9a\u88fd\u9020\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u306f\u3001SOP\u53c2\u7167\u30a2\u30a6\u30c8\u30e9\u30a4\u30f3\u3068\u6a5f\u5668\u95a2\u9023\u306e\u691c\u8a3c\u6587\u66f8\u304c\u542b\u307e\u308c\u3066\u304a\u308a\u3001\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u306e\u6587\u66f8\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306b\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Common_Compliance_Errors_and_Standard_Solutions\"><\/span><b><\/b><strong><b>\u4e00\u822c\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30a8\u30e9\u30fc\u3068\u6a19\u6e96\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><b><\/b><strong><b>\u00a0\u30a8\u30e9\u30fc<\/b><\/strong>\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u751f\u7523\u691c\u8a3c\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u9023\u7d9a\u88fd\u9020\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u76f4\u63a5\u9069\u7528\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n<p><strong><b>\u89e3\u6c7a\uff1a<\/b><\/strong>\u00a0ICH Q 13\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3063\u3066\u3001\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9\u306e\u7279\u6027\u306b\u5408\u308f\u305b\u305f\u691c\u8a3c\u6587\u66f8\u3092\u4f5c\u6210\u3057\u3001\u4e0d\u9069\u5408\u6750\u6599\u306e\u8d77\u52d5\u3001\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u3001\u8ee2\u7528\u306a\u3069\u306e\u30b7\u30ca\u30ea\u30aa\u3092\u5fb9\u5e95\u7684\u306b\u8a55\u4fa1\u3057\u307e\u3059\u3002<\/p>\n<ol start=\"2\">\n<li><b><\/b><strong><b>\u30a8\u30e9\u30fc<\/b><\/strong>\u5143\u306e\u30b9\u30c8\u30ea\u30fc\u30df\u30f3\u30b0\u30c7\u30fc\u30bf\u3092\u7121\u8996\u3057\u3001\u51e6\u7406\u3055\u308c\u305f\u30b5\u30de\u30ea\u30fc\u30ec\u30dd\u30fc\u30c8\u306e\u307f\u3092\u4fdd\u5b58\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n<p><strong><b>\u89e3\u6c7a\uff1a<\/b><\/strong>\u00a0\u54c1\u8cea\u5951\u7d04\u3067\u306f\u3001\u751f\u6642\u7cfb\u5217\u30c7\u30fc\u30bf\u3092ALCOA+\u306b\u5f93\u3063\u3066\u30a2\u30fc\u30ab\u30a4\u30d6\u3059\u308b\u3053\u3068\u3068\u3001\u30c7\u30fc\u30bf\u4fdd\u5b58\u671f\u9593\u3092\u660e\u8a18\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ol start=\"3\">\n<li><b><\/b><strong><b>\u30a8\u30e9\u30fc<\/b><\/strong>\u6750\u6599\u306e\u9023\u7d9a\u751f\u7523\u306e\u30d0\u30c3\u30c1\u5b9a\u7fa9\u306f\u4e0d\u660e\u78ba\u3067\u3059\u3002<\/li>\n<\/ol>\n<p><strong><b>\u89e3\u6c7a\uff1a<\/b><\/strong>\u00a0\u751f\u7523\u958b\u59cb\u524d\u306b\u66f8\u9762\u306b\u3088\u308b\u30d0\u30c3\u30c1\u5b9a\u7fa9\u6587\u66f8\u3092\u78ba\u8a8d\u3057\u3001\u5b9a\u5e38\u6750\u6599\u3068\u8d77\u52d5\u00b7\u505c\u6b62\u79fb\u884c\u671f\u9593\u4e2d\u306e\u6750\u6599\u306e\u5206\u985e\u30eb\u30fc\u30eb\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<ol start=\"4\">\n<li><b><\/b><strong><b>\u30a8\u30e9\u30fc<\/b><\/strong>\u54c1\u8cea\u5951\u7d04\u306f\u3001\u9023\u7d9a\u88fd\u9020\u306e\u6392\u4ed6\u7684\u8cac\u4efb\u3068\u6a29\u9650\u3092\u88dc\u5b8c\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u30d0\u30c3\u30c1\u751f\u7523\u6761\u9805\u3092\u76f4\u63a5\u30b3\u30d4\u30fc\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n<p><strong><b>\u89e3\u6c7a\uff1a<\/b><\/strong>\u00a0\u54c1\u8cea\u5951\u7d04\u6761\u9805\u306b\u304a\u3051\u308b\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001PAT\u30a2\u30e9\u30fc\u30e0\u51e6\u7406\u3001\u304a\u3088\u3073CPV\u8cac\u4efb\u6539\u8a02\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002<\/p>\n<ol start=\"5\">\n<li><b><\/b><strong><b>\u30a8\u30e9\u30fc <\/b><\/strong>\u30d0\u30c3\u30c1\u751f\u7523\u306e\u8a13\u7df4\u3092\u53d7\u3051\u305f\u30b9\u30bf\u30c3\u30d5\u3092\u4f7f\u7528\u3057\u3066\u9023\u7d9a\u751f\u7523\u30e9\u30a4\u30f3\u3092\u76f4\u63a5\u64cd\u4f5c\u3057\u3001\u4eba\u54e1\u80fd\u529b\u3092\u904e\u5c0f\u8a55\u4fa1\u3059\u308b\u3002<\/li>\n<\/ol>\n<p><strong><b>\u89e3\u6c7a\uff1a <\/b><\/strong>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u76e3\u67fb\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001QA\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3001\u751f\u7523\u62c5\u5f53\u8005\u306b\u3088\u308b\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u305f\u3081\u306e\u5c02\u9580\u7684\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8a18\u9332\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"FAQs\"><\/span><b><\/b><strong><b>FAQ<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong><b>Q 1\uff1a\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u3092\u8abf\u9054\u3059\u308b\u969b\u306b\u5f93\u3046\u3079\u304d\u4e3b\u8981\u306a\u898f\u5236\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u4f55\u3067\u3059\u304b\uff1f<\/b><\/strong><\/p>\n<p><strong><b>A1<\/b><\/strong>\u00a0\u4e3b\u306bICH Q 13\u3001FDA 21 CFR Part 211\u3001\u304a\u3088\u3073EMA GMP Annex 15\u306b\u57fa\u3065\u304d\u3001\u30bf\u30fc\u30b2\u30c3\u30c8\u3068\u3059\u308b\u73fe\u5730\u5e02\u5834\u306b\u56fa\u6709\u306e\u88dc\u8db3\u7684\u306a\u898f\u5236\u8981\u4ef6\u3082\u7d44\u307f\u8fbc\u3093\u3067\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><b>Q 2\uff1a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u5be9\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u969b\u3001\u6700\u512a\u5148\u306e\u7d99\u7d9a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u7d20\u306f\u4f55\u3067\u3059\u304b\uff1f<\/b><\/strong><\/p>\n<p><strong><b>A2 <\/b><\/strong>\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u30b7\u30b9\u30c6\u30e0\u3001ALCOA+\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u5236\u5fa1\u3001\u9023\u7d9a\u30e2\u30fc\u30c9\u30d0\u30c3\u30c1\u5b9a\u7fa9\u3001\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30e1\u30ab\u30cb\u30ba\u30e0\u3001\u304a\u3088\u3073\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u306a\u80fd\u529b\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><b>Q 3\uff1a\u30d0\u30c3\u30c1\u751f\u7523GMP\u6587\u66f8\u3092\u9023\u7d9a\u88fd\u9020\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306b\u76f4\u63a5\u9069\u7528\u3059\u308b\u3068\u3001\u3069\u306e\u3088\u3046\u306a\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/b><\/strong><\/p>\n<p><strong><b>A3<\/b><\/strong>\u00a0\u4e0d\u5408\u7406\u306a\u691c\u8a3c\u30ed\u30b8\u30c3\u30af\u3001\u4e0d\u660e\u78ba\u306a\u30d0\u30c3\u30c1\u5206\u5272\u3001\u8d77\u52d5\u2014\u505c\u6b62\u2014\u8ee2\u63db\u30b7\u30ca\u30ea\u30aa\u306e\u5236\u5fa1\u306e\u6b20\u5982\u3001\u304a\u3088\u3073\u30c7\u30fc\u30bf\u6574\u5408\u6027\u306e\u8106\u5f31\u6027\u306f\u3001\u691c\u67fb\u6b20\u9665\u3084\u767b\u9332\u30ec\u30d3\u30e5\u30fc\u306e\u554f\u984c\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><b>Q 4\uff1a\u7d99\u7d9a\u7684\u306a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306e\u54c1\u8cea\u5951\u7d04\u3067\u306f\u3001\u3069\u306e\u3088\u3046\u306a\u91cd\u8981\u306a\u8981\u7d20\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/b><\/strong><\/p>\n<p><strong><b>A4<\/b><\/strong>\u00a0\u9023\u7d9a\u30d7\u30ed\u30bb\u30b9\u30d0\u30c3\u30c1\u306e\u5b9a\u7fa9\u3001\u751f\u30c7\u30fc\u30bf\u30a2\u30fc\u30ab\u30a4\u30d6\u306e\u8981\u4ef6\u3001\u504f\u5dee\u3068\u30a2\u30e9\u30fc\u30e0\u306e\u51e6\u7406\u3001CPV\u5b9f\u88c5\u8cac\u4efb\u3001\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u30ea\u30b3\u30fc\u30eb\u8abf\u6574\u30e1\u30ab\u30cb\u30ba\u30e0\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><b>Q 5\uff1a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u95a2\u9023\u306e\u6210\u679c\u7269\u3068\u306f <\/b><\/strong><strong><b>JIANPAI<\/b><\/strong><strong><b>\u00a0\u7d99\u7d9a\u7684\u306a\u88fd\u9020\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u63d0\u4f9b\u3059\u308b\u304b\uff1f<\/b><\/strong><\/p>\n<p><strong><b>A5<\/b><\/strong>\u00a0\u9023\u7d9a\u88fd\u9020\u88c5\u7f6e\u7528\u306eIQ\/OQ\/PQ\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3001PAT\u30b7\u30b9\u30c6\u30e0\u691c\u8a3c\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3001SOP\u30a2\u30a6\u30c8\u30e9\u30a4\u30f3\u3001\u9867\u5ba2\u304a\u3088\u3073\u751f\u7523\u30b5\u30fc\u30d3\u30b9\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u5411\u3051\u306e\u6280\u8853\u30ea\u30b9\u30af\u8a55\u4fa1\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><b><\/b><strong><b>\u7d50\u8ad6<\/b><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u3092\u8abf\u9054\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u56e0\u306f\u3001\u5b89\u5168\u306a\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306e\u57fa\u790e\u3092\u7bc9\u304d\u307e\u3059\u3002\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306f\u3001GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002 <a href=\"https:\/\/www.jianpaitech.com\/ja\/product_category\/continuous-manufacturing\/#uc_owl_sliding_thumbs_gallery_elementor_540732c_item1\" target=\"_blank\" rel=\"noopener\"><strong><b>\u7d99\u7d9a\u7684\u306a\u88fd\u9020<\/b><\/strong><\/a>\u00a0\u4f01\u696d\u306f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a55\u4fa1\u3057\u3001\u691c\u8a3c\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3001\u6587\u66f8\u306e\u6210\u719f\u5ea6\u3092\u8a55\u4fa1\u3059\u308b\u3002 <a href=\"https:\/\/www.jianpaitech.com\/ja\" target=\"_blank\" rel=\"noopener\"><strong><b>JIANPAI <\/b><\/strong><\/a>\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u6a5f\u5668\u3068\u30b5\u30dd\u30fc\u30c8\u6750\u6599\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u81ea\u793e\u30e9\u30a4\u30f3\u306e\u69cb\u7bc9\u3084\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u306e\u9078\u629e\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u5f53\u793e\u306e\u30ea\u30bd\u30fc\u30b9\u306f\u304a\u5ba2\u69d8\u306e\u7d99\u7d9a\u7684\u306a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4f5c\u696d\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u306f\u3058\u3081\u306b\u9023\u7d9a\u88fd\u9020\u306f\u3001\u77ed\u3044\u30b5\u30a4\u30af\u30eb\u3068\u67d4\u8edf\u306a\u751f\u7523\u80fd\u529b\u3092\u5b9f\u73fe\u3059\u308b\u9769\u65b0\u7684\u306a\u533b\u85ac\u54c1\u751f\u7523\u30e2\u30fc\u30c9\u3067\u3059\u304c\u3001GMP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u7279\u5225\u306a\u8ab2\u984c\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u751f\u7523\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a55\u4fa1\u3067\u306f\u3001\u91cd\u8981\u306a\u9023\u7d9a\u88fd\u9020\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u7d20\u3068\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u898f\u5236\u8981\u4ef6\u304c\u898b\u843d\u3068\u3055\u308c\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u30d9\u30fc\u30b9\u306e\u8a55\u4fa1\u57fa\u6e96\u3092\u76f2\u76ee\u7684\u306b\u63a1\u7528\u3059\u308b\u3068\u3001 JIANPAI\u306f\u3001\u533b\u85ac\u54c1\u306e\u9023\u7d9a\u88fd\u9020\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u305f\u3081\u306e\u5b8c\u5168\u306a\u8a2d\u5099\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30bd\u30fc\u30b9\u3092\u4f7f\u7528\u3057\u3066\u3001\u3053\u308c\u3089\u306e\u554f\u984c\u70b9\u3092\u89e3\u6c7a\u3057\u307e\u3059\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306e\u8abf\u9054\u306b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u91cd\u8981\u306a\u7406\u7531\u975e\u6e96\u62e0\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306e\u898f\u5236\u30ea\u30b9\u30af\u5f93\u6765\u306e\u30d0\u30c3\u30c1\u751f\u7523\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3068\u6bd4\u8f03\u3057\u3066\u3001\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u3055\u308c\u305f\u9023\u7d9a\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u6f5c\u5728\u7684\u306a\u898f\u5236\u30ea\u30b9\u30af\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002 \u751f\u7523\u306f\u3001\u4e2d\u65ad\u306e\u306a\u3044\u6750\u6599\u4f9b\u7d66\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30d7\u30ed\u30bb\u30b9\u5206\u6790\uff08PAT\uff09\u3001\u304a\u3088\u3073\u52d5\u7684[]<\/p>","protected":false},"featured_media":5436,"template":"","meta":{"_acf_changed":false,"footnotes":""},"blog_category":[16],"class_list":["post-5404","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\/5404","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":2,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5404\/revisions"}],"predecessor-version":[{"id":5407,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog\/5404\/revisions\/5407"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media\/5436"}],"wp:attachment":[{"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/media?parent=5404"}],"wp:term":[{"taxonomy":"blog_category","embeddable":true,"href":"https:\/\/www.jianpaitech.com\/ja\/wp-json\/wp\/v2\/blog_category?post=5404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}