{"id":6097,"date":"2025-08-13T02:42:46","date_gmt":"2025-08-13T02:42:46","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=6097"},"modified":"2026-03-23T02:28:28","modified_gmt":"2026-03-23T02:28:28","slug":"what-are-the-difference-with-gmp-gdp-fda-dmf-and-cep","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/what-are-the-difference-with-gmp-gdp-fda-dmf-and-cep\/","title":{"rendered":"GMP\u3001GDP\u3001FDA\u3001DMF\u3001CEP\u3068\u306f\u4f55\u304b\uff1a\u4e3b\u306a\u9055\u3044\u3092\u7406\u89e3\u3059\u308b"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"6097\" class=\"elementor elementor-6097\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u88fd\u85ac\u696d\u754c\u3067\u306f\u591a\u304f\u306e\u982d\u5b57\u8a9e\u304c\u4f7f\u308f\u308c\u3066\u3044\u307e\u3059\u3002\u4e00\u898b\u3059\u308b\u3068\u3001\u3053\u308c\u3089\u306e\u6587\u5b57\u306f\u5206\u304b\u308a\u306b\u304f\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u533b\u85ac\u54c1\u306b\u643a\u308f\u308b\u4eba\u306b\u3068\u3063\u3066\u3001\u3053\u308c\u3089\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u91cd\u8981\u3067\u3059\u30025\u3064\u306e\u91cd\u8981\u306a\u7528\u8a9e\u3092\u89e3\u8aac\u3057\u307e\u3057\u3087\u3046\u3002 <strong>GMP\u3001GDP\u3001FDA\u3001DMF\u3001CEP\u3002<\/strong><\/p><h2><strong>GMP\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2><p><a href=\"https:\/\/www.who.int\/teams\/health-product-policy-and-standards\/standards-and-specifications\/norms-and-standards\/gmp\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">GMP\u3068\u306f<\/span><\/a> \u533b\u85ac\u54c1\u3092\u5b89\u5168\u306b\u88fd\u9020\u3059\u308b\u305f\u3081\u306e\u4e00\u9023\u306e\u898f\u5247\u3068\u8003\u3048\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u308c\u3089\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u533b\u85ac\u54c1\u304c\u5e38\u306b\u6b63\u3057\u3044\u65b9\u6cd5\u3067\u88fd\u9020\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p><figure id=\"attachment_6075\" aria-describedby=\"caption-attachment-6075\" style=\"width: 520px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-6075 size-full\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/gmp-logo.jpg\" alt=\"gmp\u30ed\u30b4\" width=\"520\" height=\"320\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/gmp-logo.jpg 520w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/gmp-logo-300x185.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/gmp-logo-18x12.jpg 18w\" sizes=\"(max-width: 520px) 100vw, 520px\" \/><figcaption id=\"caption-attachment-6075\" class=\"wp-caption-text\">\u753b\u50cf\u30bd\u30fc\u30b9: <a href=\"https:\/\/gcl-intl.com.mm\/services\/good-manufacturing-practice-gmp-certification\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">https:\/\/gcl-intl.com.mm\/services\/good-manufacturing-practice-gmp-certification\/<\/span><\/a><\/figcaption><\/figure><p>GMP\u306f\u533b\u85ac\u54c1\u88fd\u9020\u306e\u3059\u3079\u3066\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002 <a href=\"https:\/\/www.zonsteel.com\/clean-room\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">\u6e05\u6f54\u306a\u65bd\u8a2d<\/span><\/a>, \u8a13\u7df4\u3092\u53d7\u3051\u305f\u52b4\u50cd\u8005\u3068\u9069\u5207\u306a\u8a2d\u5099\u304c\u5fc5\u8981\u3067\u3059\u3002\u307e\u305f\u3001 <strong>\u6ce8\u610f\u6df1\u3044\u8a18\u9332\u4fdd\u5b58\u3068\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3002<\/strong> \u4f01\u696d\u306f\u5f93\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044 <strong>GMP\u30eb\u30fc\u30eb<\/strong> \u533b\u85ac\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306b\u3001GMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff09\u304c\u5b9a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u57fa\u6e96\u306f\u3001\u6709\u5bb3\u307e\u305f\u306f\u52b9\u679c\u306e\u306a\u3044\u533b\u85ac\u54c1\u304b\u3089\u60a3\u8005\u3092\u5b88\u3063\u3066\u3044\u307e\u3059\u3002GMP\u304c\u306a\u3051\u308c\u3070\u3001\u79c1\u305f\u3061\u306f\u670d\u7528\u3059\u308b\u533b\u85ac\u54c1\u3092\u4fe1\u983c\u3067\u304d\u307e\u305b\u3093\u3002<\/p><h2><strong>GDP\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2><p><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/compliance-post-authorisation\/good-distribution-practice\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><strong>GDP<\/strong><\/span><\/a> GMP\u306f\u9069\u6b63\u6d41\u901a\u57fa\u6e96\uff08Good Distribution Practice\uff09\u306e\u7565\u3067\u3059\u3002GMP\u306f\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u308b\u306e\u306b\u5bfe\u3057\u3001GDP\u306f\u533b\u85ac\u54c1\u3092\u5b89\u5168\u306b\u8f38\u9001\u3059\u308b\u3053\u3068\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002<\/p><figure id=\"attachment_6076\" aria-describedby=\"caption-attachment-6076\" style=\"width: 688px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"wp-image-6076 size-full\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/GDP-in-Pharmaceutical-industry.png\" alt=\"\u88fd\u85ac\u696d\u754c\u306eGDP\" width=\"688\" height=\"473\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/GDP-in-Pharmaceutical-industry.png 688w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/GDP-in-Pharmaceutical-industry-300x206.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/GDP-in-Pharmaceutical-industry-18x12.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/GDP-in-Pharmaceutical-industry-600x413.png 600w\" sizes=\"(max-width: 688px) 100vw, 688px\" \/><figcaption id=\"caption-attachment-6076\" class=\"wp-caption-text\">\u753b\u50cf\u30bd\u30fc\u30b9: <a href=\"http:\/\/bit.ly\/45xAqsS\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">http:\/\/bit.ly\/45xAqsS<\/span><\/a><\/figcaption><\/figure><p>GDP\u898f\u5247\u306f\u3001\u533b\u85ac\u54c1\u304c\u5de5\u5834\u304b\u3089\u85ac\u5c40\u307e\u3067\u3069\u306e\u3088\u3046\u306b\u8f38\u9001\u3055\u308c\u308b\u304b\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002 <strong>\u9069\u5207\u306a\u4fdd\u7ba1\u3001\u8f38\u9001\u3001\u53d6\u308a\u6271\u3044<\/strong>\u76ee\u6a19\u306f\u3001\u8f38\u9001\u4e2d\u306b\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u3067\u3059\u3002 <strong>\u6e29\u5ea6\u5236\u5fa1<\/strong> GDP\u306e\u5927\u304d\u306a\u90e8\u5206\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\u533b\u85ac\u54c1\u306e\u4e2d\u306b\u306f\u51b7\u8535\u4fdd\u5b58\u304c\u5fc5\u8981\u306a\u3082\u306e\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u4e7e\u71e5\u3057\u305f\u72b6\u614b\u3092\u4fdd\u3064\u5fc5\u8981\u304c\u3042\u308b\u3082\u306e\u3082\u3042\u308a\u307e\u3059\u3002GDP\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u5168\u4f53\u3067\u3053\u308c\u3089\u306e\u6761\u4ef6\u304c\u6e80\u305f\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p><h2><strong>FDA\u3068\u306f\u4f55\u3067\u3059\u304b?<\/strong><\/h2><p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfstandards\/search.cfm\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">FDA\u306f<\/span><\/a> \u98df\u54c1\u533b\u85ac\u54c1\u5c40\u5411\u3051\u3067\u3059\u3002 <strong>\u7c73\u56fd\u653f\u5e9c\u6a5f\u95a2<\/strong> \u516c\u8846\u885b\u751f\u3092\u5b88\u308b\u6a5f\u95a2\u3067\u3059\u3002FDA\u306f\u65b0\u85ac\u306e\u627f\u8a8d\u307e\u305f\u306f\u5374\u4e0b\u3092\u6c7a\u5b9a\u3059\u308b\u6a29\u9650\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002<\/p><figure id=\"attachment_6077\" aria-describedby=\"caption-attachment-6077\" style=\"width: 800px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"wp-image-6077 size-full\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960.png\" alt=\"FDA\" width=\"800\" height=\"413\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960.png 800w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960-300x155.png 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960-768x396.png 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960-18x9.png 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/fda-logo.width-960-600x310.png 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><figcaption id=\"caption-attachment-6077\" class=\"wp-caption-text\">\u753b\u50cf\u51fa\u5178: <a href=\"https:\/\/www.rxtrace.com\/tag\/fda-de\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">https:\/\/www.rxtrace.com\/tag\/fda-de\/<\/span><\/a><\/figcaption><\/figure><p>\u30a2\u30e1\u30ea\u30ab\u306e\u60a3\u8005\u306b\u85ac\u304c\u5c4a\u304f\u524d\u306b\u3001 <strong>FDA<\/strong> \u5b89\u5168\u3060\u3068\u8a00\u308f\u3056\u308b\u3092\u5f97\u306a\u3044\u3002\u5f7c\u3089\u306f <strong>\u30c7\u30fc\u30bf\u3092\u30c6\u30b9\u30c8\u3057\u3001\u88fd\u9020\u8a2d\u5099\u3092\u691c\u67fb\u3057\u307e\u3059\u3002<\/strong> \u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u4f55\u5e74\u3082\u304b\u304b\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002FDA\u306f\u627f\u8a8d\u5f8c\u3082\u533b\u85ac\u54c1\u3092\u76e3\u8996\u3057\u3066\u304a\u308a\u3001\u554f\u984c\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306b\u306f\u56de\u53ce\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <strong>\u5371\u967a\u306a\u88fd\u54c1\u3002<\/strong> \u5f7c\u3089\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u4eba\u304c\u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u6cbb\u7642\u3092\u53d7\u3051\u3089\u308c\u308b\u3088\u3046\u306b\u5c3d\u529b\u3057\u3066\u3044\u307e\u3059\u3002<\/p><h2><strong>DMF\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong><\/h2><p><a href=\"https:\/\/www.fda.gov\/drugs\/forms-submission-requirements\/drug-master-files-dmfs\" target=\"_blank\" rel=\"noopener\"><strong><span style=\"text-decoration: underline;\">DMF<\/span><\/strong><\/a> \u30c9\u30e9\u30c3\u30b0\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u3068\u306f\u3001\u533b\u85ac\u54c1\u306e\u6210\u5206\u3092\u8a73\u7d30\u306b\u8a18\u9332\u3057\u305f\u30ec\u30b7\u30d4\u96c6\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3059\u3002\u4f01\u696d\u306f <strong>FDA\u3078\u306eDMF<\/strong> \u30ec\u30d3\u30e5\u30fc\u7528\u3002<\/p><figure id=\"attachment_6078\" aria-describedby=\"caption-attachment-6078\" style=\"width: 300px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-6078 size-full\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/drug-master-file.jpg\" alt=\"DMF\u6a19\u6e96\" width=\"300\" height=\"246\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/drug-master-file.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/drug-master-file-15x12.jpg 15w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><figcaption id=\"caption-attachment-6078\" class=\"wp-caption-text\">\u753b\u50cf\u51fa\u5178: <a href=\"http:\/\/bit.ly\/45wuUHc\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">http:\/\/bit.ly\/45wuUHc<\/span><\/a><\/figcaption><\/figure><p>DMF\u306b\u306f\u3001\u539f\u6750\u6599\u306e\u88fd\u9020\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u79d8\u5bc6\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002<strong> \u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u3002<\/strong> \u60c5\u5831\u306f\u6a5f\u5bc6\u6271\u3044\u3055\u308c\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u304c\u6210\u5206\u306e\u4f7f\u7528\u3092\u5e0c\u671b\u3059\u308b\u5834\u5408\u3001DMF\u3092\u53c2\u7167\u3057\u307e\u3059\u3002FDA\u306fDMF\u3068DMF\u306e\u4e21\u65b9\u3092\u5be9\u67fb\u3067\u304d\u307e\u3059\u3002 <strong>\u533b\u85ac\u54c1\u7533\u8acb\u3068\u6210\u5206\u30d5\u30a1\u30a4\u30eb<\/strong>\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u4f01\u696d\u79d8\u5bc6\u3092\u4fdd\u8b77\u3057\u307e\u3059\u3002<\/p><h2><strong>CEP\u3068\u306f\u4f55\u3067\u3059\u304b?<\/strong><\/h2><p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/presentation\/presentation-european-directorate-quality-medicines-and-healthcare-edqm-european-pharmacopoeia-and-certificates-suitability-cep-andrew-mcmath_en.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><strong>CEP\u306f<\/strong><\/span><\/a> \u9069\u5408\u8a3c\u660e\u66f8\u3068\u306f\u3001\u539f\u6750\u6599\u304c\u54c1\u8cea\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u6b27\u5dde\u306e\u6587\u66f8\u3067\u3059\u3002<\/p><figure id=\"attachment_6082\" aria-describedby=\"caption-attachment-6082\" style=\"width: 870px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-6082 size-full\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance.jpg\" alt=\"cep\u4e00\u76ee\u3067\u308f\u304b\u308b\" width=\"870\" height=\"489\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance.jpg 870w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance-300x169.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance-768x432.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance-18x10.jpg 18w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2025\/08\/cep-at-a-glance-600x337.jpg 600w\" sizes=\"(max-width: 870px) 100vw, 870px\" \/><figcaption id=\"caption-attachment-6082\" class=\"wp-caption-text\">\u753b\u50cf\u51fa\u5178: <a href=\"https:\/\/www.edqm.eu\/en\/certification\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">https:\/\/www.edqm.eu\/en\/certification<\/span><\/a><\/figcaption><\/figure><p>\u6b27\u5dde\u533b\u85ac\u54c1\u54c1\u8cea\u5c40\uff08ECQM\uff09\u306fCEP\u3092\u767a\u884c\u3057\u307e\u3059\u3002\u4f01\u696d\u306f\u6210\u5206\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u60c5\u5831\u3092\u63d0\u51fa\u3057\u3001\u627f\u8a8d\u3055\u308c\u308b\u3068\u8a3c\u660e\u66f8\u304c\u767a\u884c\u3055\u308c\u307e\u3059\u3002CEP\u306f\u3001 <strong>\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u533b\u85ac\u54c1\u539f\u6599\u30d1\u30b9\u30dd\u30fc\u30c8<\/strong>\u6210\u5206\u304c\u5b89\u5168\u3067\u3042\u308a\u3001\u6b27\u5dde\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3082\u306e\u3067\u3001\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u304c\u8fc5\u901f\u304b\u3064\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002<\/p><h2><strong>\u4e3b\u306a\u9055\u3044\u306e\u8aac\u660e<\/strong><\/h2><p>\u6b21\u306b\u3001\u3053\u308c\u3089\u306e\u7528\u8a9e\u306e\u9055\u3044\u3092\u898b\u3066\u307f\u307e\u3057\u3087\u3046\u3002 <strong>\u7bc4\u56f2\uff1a<\/strong> GMP\u3068GDP\u306f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u3059\u3002FDA\u306f\u7d44\u7e54\u3067\u3059\u3002DMF\u3068CEP\u306f\u6587\u66f8\u3067\u3059\u3002 <strong>\u76ee\u7684\uff1a<\/strong> GMP\u306f\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3092\u4fdd\u8a3c\u3057\u3001GDP\u306f\u9069\u6b63\u306a\u6d41\u901a\u57fa\u6e96\u3092\u4fdd\u8a3c\u3057\u3001FDA\u306f\u696d\u754c\u3092\u898f\u5236\u3057\u3001DMF\u306f\u539f\u6599\u306e\u79d8\u5bc6\u3092\u5b88\u308a\u3001CEP\u306f\u6b27\u5dde\u306e\u898f\u5236\u57fa\u6e96\u3078\u306e\u9069\u5408\u6027\u3092\u8a3c\u660e\u3057\u307e\u3059\u3002 <strong>\u5730\u7406\uff1a<\/strong> FDA\u3068DMF\u306f\u30a2\u30e1\u30ea\u30ab\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002CEP\u306f\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002GMP\u3068GDP\u306f\u4e16\u754c\u4e2d\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <strong>\u96c6\u4e2d\uff1a<\/strong> GMP\u306f\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002GDP\u306f\u533b\u85ac\u54c1\u306e\u8f38\u9001\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002FDA\u306f\u627f\u8a8d\u3068\u5b89\u5168\u6027\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002DMF\u306f\u6210\u5206\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002CEP\u306f\u6b27\u5dde\u57fa\u6e96\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002<\/p><h2><strong>\u3053\u308c\u3089\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u304b<\/strong><\/h2><p>\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u9023\u643a\u3057\u3066\u533b\u85ac\u54c1\u306e\u5b89\u5168\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002 <strong>GMP\u306f\u9ad8\u54c1\u8cea\u306a\u88fd\u9020\u3092\u4fdd\u8a3c\u3057\u3001GDP\u306f\u8f38\u9001\u4e2d\u306e\u54c1\u8cea\u3092\u7dad\u6301\u3057\u307e\u3059\u3002FDA\u306f\u76e3\u7763\u3068\u627f\u8a8d\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002DMF\u306f\u8cb4\u91cd\u306a\u60c5\u5831\u3092\u4fdd\u8b77\u3057\u307e\u3059\u3002CEP\u306f\u6b27\u5dde\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u307e\u3059\u3002<\/strong> \u3053\u308c\u3089\u306e\u9055\u3044\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u88fd\u85ac\u696d\u754c\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u4eba\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u88fd\u9020\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u3001\u533b\u7642\u5f93\u4e8b\u8005\u306a\u3069\u3001\u8ab0\u3067\u3042\u3063\u3066\u3082\u3001\u3053\u308c\u3089\u306e\u6982\u5ff5\u306f\u65e5\u3005\u306e\u696d\u52d9\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u3002 <strong>\u76ee\u6a19\u306f\u30b7\u30f3\u30d7\u30eb\u3067\u3059\u3002<\/strong> \u5b89\u5168\u3067\u52b9\u679c\u7684\u306a\u533b\u85ac\u54c1\u3092\u3001\u5fc5\u8981\u3068\u3059\u308b\u60a3\u8005\u306b\u5c4a\u3051\u308b\u3053\u3068\u3002\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u304c\u305d\u308c\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/p><h2><strong>\u304a\u3059\u3059\u3081\u306e\u8aad\u307f\u7269:<\/strong><\/h2><ol><li><a href=\"https:\/\/safetyculture.com\/topics\/gmp\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em>GMP\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/em><\/span><\/a><\/li><li><a href=\"https:\/\/www.pharmaguideline.com\/2011\/06\/good-documentation-practices.html\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">\u533b\u85ac\u54c1\u306b\u304a\u3051\u308b\u9069\u6b63\u6587\u66f8\u7ba1\u7406\u57fa\u6e96 (GDP)\u3002<\/span><\/a><\/li><li><a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\" target=\"_blank\" rel=\"noopener\"><em><span style=\"text-decoration: underline;\">\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/span><\/em><\/a>.<\/li><li><a href=\"https:\/\/www.freyrsolutions.com\/what-is-a-drug-master-file-dmf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em>\u30c9\u30e9\u30c3\u30b0\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb (DMF) \u3068\u306f\u4f55\u3067\u3059\u304b?<\/em><\/span><\/a><\/li><li><a href=\"http:\/\/hkuspace.hku.hk\/prog\/cert-in-drug-safety-and-pharmacovigilance\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em>\u533b\u85ac\u54c1\u5b89\u5168\u6027\u304a\u3088\u3073\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306b\u95a2\u3059\u308b\u8a3c\u660e\u66f8\uff08CEF\uff09<\/em><\/span><\/a>.<\/li><\/ol><h2><b>\u8457\u4f5c\u6a29\u306b\u3064\u3044\u3066\u00a0<\/b><\/h2><p>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u30fb\u30b0\u30eb\u30fc\u30d7\u306e\u66f8\u9762\u306b\u3088\u308b\u4e8b\u524d\u306e\u660e\u793a\u7684\u306a\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u672c\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u4e0a\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u8907\u88fd\u3001\u5909\u66f4\u3001\u516c\u958b\u3001\u8868\u793a\u3001\u9001\u4fe1\u3001\u305d\u306e\u4ed6\u306e\u65b9\u6cd5\u3067\u5229\u7528\u3057\u305f\u308a\u3001\u305d\u306e\u3088\u3046\u306a\u30b3\u30f3\u30c6\u30f3\u30c4\u3092\u4f7f\u7528\u3057\u3066\u4f55\u3089\u304b\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u69cb\u7bc9\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u4f7f\u7528\u8a31\u53ef\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u307e\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a <a href=\"mailto:info@pharmamachinecn.com\"><span style=\"text-decoration: underline;\">info@pharmamachinecn.com<\/span><\/a><\/p><h2><b>\u514d\u8cac\u4e8b\u9805:<\/b><\/h2><p>\u672c\u8a18\u4e8b\u306b\u542b\u307e\u308c\u308b\u60c5\u5831\u306f\u3001\u4e00\u822c\u7684\u306a\u60c5\u5831\u63d0\u4f9b\u306e\u307f\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u793e\u306f\u3001\u3044\u304b\u306a\u308b\u60c5\u5831\u306b\u3064\u3044\u3066\u3082\u3001\u305d\u306e\u6b63\u78ba\u6027\u3001\u59a5\u5f53\u6027\u3001\u9069\u6642\u6027\u3001\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u307e\u305f\u3001\u672c\u8a18\u4e8b\u306e\u5185\u5bb9\u306e\u8aa4\u8b2c\u307e\u305f\u306f\u8131\u6f0f\u306b\u3064\u3044\u3066\u4e00\u5207\u306e\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u305b\u3093\u3002.<\/p><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 uses many acronyms. These letters can seem confusing at first. But understanding them is important for anyone [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6072,"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-6097","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\/6097","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=6097"}],"version-history":[{"count":14,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/6097\/revisions"}],"predecessor-version":[{"id":13677,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/6097\/revisions\/13677"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/6072"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=6097"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=6097"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=6097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}