{"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\/ru\/what-are-the-difference-with-gmp-gdp-fda-dmf-and-cep\/","title":{"rendered":"\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 GMP, GDP, FDA, DMF \u0438 CEP: \u043f\u043e\u043d\u0438\u043c\u0430\u043d\u0438\u0435 \u043a\u043b\u044e\u0447\u0435\u0432\u044b\u0445 \u0440\u0430\u0437\u043b\u0438\u0447\u0438\u0439"},"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>\u0412 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0439 \u043f\u0440\u043e\u043c\u044b\u0448\u043b\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u0443\u0435\u0442\u0441\u044f \u043c\u043d\u043e\u0436\u0435\u0441\u0442\u0432\u043e \u0430\u0431\u0431\u0440\u0435\u0432\u0438\u0430\u0442\u0443\u0440. \u042d\u0442\u0438 \u0431\u0443\u043a\u0432\u044b \u043c\u043e\u0433\u0443\u0442 \u043f\u043e\u043a\u0430\u0437\u0430\u0442\u044c\u0441\u044f \u043d\u0430 \u043f\u0435\u0440\u0432\u044b\u0439 \u0432\u0437\u0433\u043b\u044f\u0434 \u0437\u0430\u043f\u0443\u0442\u0430\u043d\u043d\u044b\u043c\u0438. \u041d\u043e \u0438\u0445 \u043f\u043e\u043d\u0438\u043c\u0430\u043d\u0438\u0435 \u0432\u0430\u0436\u043d\u043e \u0434\u043b\u044f \u0432\u0441\u0435\u0445, \u043a\u0442\u043e \u0440\u0430\u0431\u043e\u0442\u0430\u0435\u0442 \u0441 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438. \u0414\u0430\u0432\u0430\u0439\u0442\u0435 \u0440\u0430\u0437\u0431\u0435\u0440\u0451\u043c \u043f\u044f\u0442\u044c \u043a\u043b\u044e\u0447\u0435\u0432\u044b\u0445 \u0442\u0435\u0440\u043c\u0438\u043d\u043e\u0432: <strong>GMP, GDP, FDA, DMF \u0438 CEP.<\/strong><\/p><h2><strong>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 GMP?<\/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 \u0441\u0442\u043e\u0438\u0442<\/span><\/a> \u041d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0430\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u0430\u044f \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430 (GMP). \u041f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u044c\u0442\u0435 \u0441\u0435\u0431\u0435 \u0441\u0432\u043e\u0434 \u043f\u0440\u0430\u0432\u0438\u043b \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0433\u043e \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432. \u042d\u0442\u0438 \u0440\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0430\u0446\u0438\u0438 \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u0443\u044e\u0442, \u0447\u0442\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u0432\u0441\u0435\u0433\u0434\u0430 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u044f\u0442\u0441\u044f \u043f\u0440\u0430\u0432\u0438\u043b\u044c\u043d\u043e.<\/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-\u043b\u043e\u0433\u043e\u0442\u0438\u043f\" 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\">\u0418\u0441\u0442\u043e\u0447\u043d\u0438\u043a \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u044f: <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>\u041d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0430\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u0430\u044f \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430 (GMP) \u043e\u0445\u0432\u0430\u0442\u044b\u0432\u0430\u0435\u0442 \u0432\u0441\u0435 \u0430\u0441\u043f\u0435\u043a\u0442\u044b \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u0432. \u042d\u0442\u043e \u0432\u043a\u043b\u044e\u0447\u0430\u0435\u0442 \u0432 \u0441\u0435\u0431\u044f: <a href=\"https:\/\/www.zonsteel.com\/clean-room\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">\u0447\u0438\u0441\u0442\u044b\u0435 \u043f\u043e\u043c\u0435\u0449\u0435\u043d\u0438\u044f<\/span><\/a>, \u043a\u0432\u0430\u043b\u0438\u0444\u0438\u0446\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0435 \u0440\u0430\u0431\u043e\u0442\u043d\u0438\u043a\u0438 \u0438 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u044e\u0449\u0435\u0435 \u043e\u0431\u043e\u0440\u0443\u0434\u043e\u0432\u0430\u043d\u0438\u0435. \u0422\u0430\u043a\u0436\u0435 \u0442\u0440\u0435\u0431\u0443\u0435\u0442\u0441\u044f <strong>\u0442\u0449\u0430\u0442\u0435\u043b\u044c\u043d\u043e\u0435 \u0432\u0435\u0434\u0435\u043d\u0438\u0435 \u0443\u0447\u0435\u0442\u0430 \u0438 \u043f\u0440\u043e\u0432\u0435\u0440\u043a\u0430 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430.<\/strong> \u041a\u043e\u043c\u043f\u0430\u043d\u0438\u0438 \u0434\u043e\u043b\u0436\u043d\u044b \u0441\u043b\u0435\u0434\u043e\u0432\u0430\u0442\u044c <strong>\u041f\u0440\u0430\u0432\u0438\u043b\u0430 GMP<\/strong> \u043f\u0440\u043e\u0434\u0430\u0432\u0430\u0442\u044c \u0441\u0432\u043e\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430. \u042d\u0442\u0438 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u044b \u0437\u0430\u0449\u0438\u0449\u0430\u044e\u0442 \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u043e\u0432 \u043e\u0442 \u0432\u0440\u0435\u0434\u043d\u044b\u0445 \u0438\u043b\u0438 \u043d\u0435\u044d\u0444\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u044b\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u0432. \u0411\u0435\u0437 GMP \u043c\u044b \u043d\u0435 \u043c\u043e\u0433\u043b\u0438 \u0431\u044b \u0434\u043e\u0432\u0435\u0440\u044f\u0442\u044c \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c, \u043a\u043e\u0442\u043e\u0440\u044b\u0435 \u043f\u0440\u0438\u043d\u0438\u043c\u0430\u0435\u043c.<\/p><h2><strong>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u0412\u0412\u041f?<\/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>\u0412\u0412\u041f<\/strong><\/span><\/a> GMP \u043e\u0437\u043d\u0430\u0447\u0430\u0435\u0442 \u00ab\u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0430\u044f \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u044c\u044e\u0442\u043e\u0440\u0441\u043a\u0430\u044f \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430\u00bb. \u0412 \u0442\u043e \u0432\u0440\u0435\u043c\u044f \u043a\u0430\u043a GMP \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432, GDP \u2014 \u043d\u0430 \u0438\u0445 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0439 \u0442\u0440\u0430\u043d\u0441\u043f\u043e\u0440\u0442\u0438\u0440\u043e\u0432\u043a\u0435.<\/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=\"\u0412\u0412\u041f \u0432 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0439 \u043f\u0440\u043e\u043c\u044b\u0448\u043b\u0435\u043d\u043d\u043e\u0441\u0442\u0438\" 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\">\u0418\u0441\u0442\u043e\u0447\u043d\u0438\u043a \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u044f: <a href=\"http:\/\/bit.ly\/45xAqsS\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">http:\/\/bit.ly\/45xAqsS<\/span><\/a><\/figcaption><\/figure><p>\u041f\u0440\u0430\u0432\u0438\u043b\u0430 GDP \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u0443\u044e\u0442 \u0434\u043e\u0441\u0442\u0430\u0432\u043a\u0443 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432 \u0441 \u0437\u0430\u0432\u043e\u0434\u043e\u0432 \u0432 \u0430\u043f\u0442\u0435\u043a\u0438. \u042d\u0442\u043e \u0432\u043a\u043b\u044e\u0447\u0430\u0435\u0442 \u0432 \u0441\u0435\u0431\u044f: <strong>\u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u0445\u0440\u0430\u043d\u0435\u043d\u0438\u0435, \u0442\u0440\u0430\u043d\u0441\u043f\u043e\u0440\u0442\u0438\u0440\u043e\u0432\u043a\u0430 \u0438 \u043e\u0431\u0440\u0430\u0449\u0435\u043d\u0438\u0435<\/strong>. \u0426\u0435\u043b\u044c \u2014 \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0442\u044c \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u044c \u0438 \u044d\u0444\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u043e\u0441\u0442\u044c \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432 \u0432\u043e \u0432\u0440\u0435\u043c\u044f \u0442\u0440\u0430\u043d\u0441\u043f\u043e\u0440\u0442\u0438\u0440\u043e\u0432\u043a\u0438. <strong>\u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u0442\u0435\u043c\u043f\u0435\u0440\u0430\u0442\u0443\u0440\u044b<\/strong> \u042d\u0442\u043e \u0437\u043d\u0430\u0447\u0438\u0442\u0435\u043b\u044c\u043d\u0430\u044f \u0447\u0430\u0441\u0442\u044c \u0412\u0412\u041f. \u041d\u0435\u043a\u043e\u0442\u043e\u0440\u044b\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u0442\u0440\u0435\u0431\u0443\u044e\u0442 \u0445\u0440\u0430\u043d\u0435\u043d\u0438\u044f \u0432 \u0445\u043e\u043b\u043e\u0434\u0438\u043b\u044c\u043d\u0438\u043a\u0435. \u0414\u0440\u0443\u0433\u0438\u0435 \u0434\u043e\u043b\u0436\u043d\u044b \u0431\u044b\u0442\u044c \u0441\u0443\u0445\u0438\u043c\u0438. \u0412\u0412\u041f \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0432\u0430\u0435\u0442 \u0441\u043e\u0431\u043b\u044e\u0434\u0435\u043d\u0438\u0435 \u044d\u0442\u0438\u0445 \u0443\u0441\u043b\u043e\u0432\u0438\u0439 \u043f\u043e \u0432\u0441\u0435\u0439 \u0446\u0435\u043f\u043e\u0447\u043a\u0435 \u043f\u043e\u0441\u0442\u0430\u0432\u043e\u043a.<\/p><h2><strong>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 FDA?<\/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 \u0441\u0442\u043e\u0438\u0442<\/span><\/a> \u0434\u043b\u044f \u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u044f \u043f\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0437\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430\u043c\u0438 \u043f\u0438\u0442\u0430\u043d\u0438\u044f \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438. \u042d\u0442\u043e <strong>\u043f\u0440\u0430\u0432\u0438\u0442\u0435\u043b\u044c\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0435 \u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u043e \u0421\u0428\u0410<\/strong> \u043a\u043e\u0442\u043e\u0440\u044b\u0439 \u0437\u0430\u0449\u0438\u0449\u0430\u0435\u0442 \u043e\u0431\u0449\u0435\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0435 \u0437\u0434\u043e\u0440\u043e\u0432\u044c\u0435. FDA \u0438\u043c\u0435\u0435\u0442 \u043f\u0440\u0430\u0432\u043e \u043e\u0434\u043e\u0431\u0440\u044f\u0442\u044c \u0438\u043b\u0438 \u043e\u0442\u043a\u043b\u043e\u043d\u044f\u0442\u044c \u043d\u043e\u0432\u044b\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430.<\/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 (\u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u043f\u043e \u0441\u0430\u043d\u0438\u0442\u0430\u0440\u043d\u043e\u043c\u0443 \u043d\u0430\u0434\u0437\u043e\u0440\u0443 \u0437\u0430 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u043e\u043c \u043f\u0438\u0449\u0435\u0432\u044b\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432 \u0438 \u043c\u0435\u0434\u0438\u043a\u0430\u043c\u0435\u043d\u0442\u043e\u0432)\" 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\">\u0418\u0441\u0442\u043e\u0447\u043d\u0438\u043a \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u044f: <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>\u041f\u0440\u0435\u0436\u0434\u0435 \u0447\u0435\u043c \u043a\u0430\u043a\u043e\u0439-\u043b\u0438\u0431\u043e \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442 \u043f\u043e\u043f\u0430\u0434\u0435\u0442 \u043a \u0430\u043c\u0435\u0440\u0438\u043a\u0430\u043d\u0441\u043a\u0438\u043c \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0430\u043c, <strong>FDA<\/strong> \u0414\u043e\u043b\u0436\u0435\u043d \u0441\u043a\u0430\u0437\u0430\u0442\u044c, \u0447\u0442\u043e \u044d\u0442\u043e \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e. \u041e\u043d\u0438 \u043f\u0440\u043e\u0432\u0435\u0440\u044f\u044e\u0442 <strong>\u0442\u0435\u0441\u0442\u043e\u0432\u044b\u0435 \u0434\u0430\u043d\u043d\u044b\u0435 \u0438 \u043e\u0441\u043c\u043e\u0442\u0440 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u043e\u0431\u044a\u0435\u043a\u0442\u043e\u0432.<\/strong> \u042d\u0442\u043e\u0442 \u043f\u0440\u043e\u0446\u0435\u0441\u0441 \u043c\u043e\u0436\u0435\u0442 \u0437\u0430\u043d\u044f\u0442\u044c \u043c\u043d\u043e\u0433\u043e \u043b\u0435\u0442. FDA \u0442\u0430\u043a\u0436\u0435 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u0438\u0440\u0443\u0435\u0442 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u043f\u043e\u0441\u043b\u0435 \u0438\u0445 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u044f. \u0412 \u0441\u043b\u0443\u0447\u0430\u0435 \u0432\u043e\u0437\u043d\u0438\u043a\u043d\u043e\u0432\u0435\u043d\u0438\u044f \u043f\u0440\u043e\u0431\u043b\u0435\u043c \u043e\u043d\u0438 \u043c\u043e\u0433\u0443\u0442 \u043e\u0442\u043e\u0437\u0432\u0430\u0442\u044c \u0438\u0445. <strong>\u043e\u043f\u0430\u0441\u043d\u0430\u044f \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0438\u044f.<\/strong> \u041e\u043d\u0438 \u0440\u0430\u0431\u043e\u0442\u0430\u044e\u0442 \u043d\u0430\u0434 \u0442\u0435\u043c, \u0447\u0442\u043e\u0431\u044b \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u043e\u0432\u0430\u0442\u044c \u0430\u043c\u0435\u0440\u0438\u043a\u0430\u043d\u0446\u0430\u043c \u0434\u043e\u0441\u0442\u0443\u043f \u043a \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u043c\u0443 \u0438 \u044d\u0444\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u043e\u043c\u0443 \u043b\u0435\u0447\u0435\u043d\u0438\u044e.<\/p><h2><strong>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u0414\u041c\u0424?<\/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;\">\u0414\u041c\u0424<\/span><\/strong><\/a> \u042d\u0442\u043e \u0441\u0432\u043e\u0435\u0433\u043e \u0440\u043e\u0434\u0430 \u043f\u043e\u0434\u0440\u043e\u0431\u043d\u044b\u0439 \u0441\u043f\u0440\u0430\u0432\u043e\u0447\u043d\u0438\u043a \u0440\u0435\u0446\u0435\u043f\u0442\u043e\u0432 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432. \u041a\u043e\u043c\u043f\u0430\u043d\u0438\u0438 \u043f\u0440\u0435\u0434\u043e\u0441\u0442\u0430\u0432\u043b\u044f\u044e\u0442 <strong>DMF \u0432 FDA<\/strong> \u0434\u043b\u044f \u043e\u0431\u0437\u043e\u0440\u0430.<\/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=\"\u0421\u0442\u0430\u043d\u0434\u0430\u0440\u0442 \u0414\u041c\u0424\" 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\">\u0418\u0441\u0442\u043e\u0447\u043d\u0438\u043a \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u044f: <a href=\"http:\/\/bit.ly\/45wuUHc\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\">http:\/\/bit.ly\/45wuUHc<\/span><\/a><\/figcaption><\/figure><p>\u0424\u0430\u0439\u043b DMF \u0441\u043e\u0434\u0435\u0440\u0436\u0438\u0442 \u0441\u0435\u043a\u0440\u0435\u0442\u043d\u0443\u044e \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044e \u043e \u043f\u0440\u043e\u0446\u0435\u0441\u0441\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u043e\u0432. \u0412 \u0442\u043e\u043c \u0447\u0438\u0441\u043b\u0435:<strong> \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0435 \u043f\u0440\u043e\u0446\u0435\u0441\u0441\u044b, \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 \u0438 \u0434\u0430\u043d\u043d\u044b\u0435 \u043f\u043e \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u0438.<\/strong> \u0418\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044f \u043e\u0441\u0442\u0430\u0451\u0442\u0441\u044f \u043a\u043e\u043d\u0444\u0438\u0434\u0435\u043d\u0446\u0438\u0430\u043b\u044c\u043d\u043e\u0439. \u041a\u043e\u0433\u0434\u0430 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u044f \u0445\u043e\u0447\u0435\u0442 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u0442\u044c \u043a\u0430\u043a\u043e\u0439-\u043b\u0438\u0431\u043e \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442, \u043e\u043d\u0430 \u0441\u0441\u044b\u043b\u0430\u0435\u0442\u0441\u044f \u043d\u0430 \u0414\u041c\u0424. FDA \u043c\u043e\u0436\u0435\u0442 \u0440\u0430\u0441\u0441\u043c\u043e\u0442\u0440\u0435\u0442\u044c \u043e\u0431\u0430 \u0432\u0430\u0440\u0438\u0430\u043d\u0442\u0430. <strong>\u0437\u0430\u044f\u0432\u043a\u0430 \u043d\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0439 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442 \u0438 \u0444\u0430\u0439\u043b \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u043e\u0432<\/strong>. \u042d\u0442\u0430 \u0441\u0438\u0441\u0442\u0435\u043c\u0430 \u0437\u0430\u0449\u0438\u0449\u0430\u0435\u0442 \u043a\u043e\u043c\u043c\u0435\u0440\u0447\u0435\u0441\u043a\u0443\u044e \u0442\u0430\u0439\u043d\u0443, \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0432\u0430\u044f \u043f\u0440\u0438 \u044d\u0442\u043e\u043c \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u044c.<\/p><h2><strong>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u041a\u042d\u041f?<\/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>\u0441\u0442\u0435\u043d\u0434\u044b \u041a\u042d\u041f<\/strong><\/span><\/a> \u0421\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u044f. \u042d\u0442\u043e \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u0439 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442, \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u044e\u0449\u0438\u0439 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u0430 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u043c \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430.<\/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=\"\u0431\u0435\u043b\u044b\u0439 \u0433\u0440\u0438\u0431-\u043d\u0430-\u0433\u043b\u0430\u0437\" 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\">\u0418\u0441\u0442\u043e\u0447\u043d\u0438\u043a \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u044f: <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>\u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u0439 \u0434\u0438\u0440\u0435\u043a\u0442\u043e\u0440\u0430\u0442 \u043f\u043e \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0443 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 (CEP) \u0432\u044b\u0434\u0430\u0435\u0442 \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442\u044b \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 (CEP). \u041a\u043e\u043c\u043f\u0430\u043d\u0438\u0438 \u043f\u0440\u0435\u0434\u043e\u0441\u0442\u0430\u0432\u043b\u044f\u044e\u0442 \u043f\u043e\u0434\u0440\u043e\u0431\u043d\u0443\u044e \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044e \u043e \u0441\u043e\u0441\u0442\u0430\u0432\u0435 \u0441\u0432\u043e\u0438\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432. \u0412 \u0441\u043b\u0443\u0447\u0430\u0435 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u044f \u043e\u043d\u0438 \u043f\u043e\u043b\u0443\u0447\u0430\u044e\u0442 \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442. CEP \u0440\u0430\u0431\u043e\u0442\u0430\u0435\u0442 \u043a\u0430\u043a <strong>\u043f\u0430\u0441\u043f\u043e\u0440\u0442 \u043d\u0430 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u044b \u0432 \u0415\u0432\u0440\u043e\u043f\u0435<\/strong>\u042d\u0442\u043e \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u0435\u0442 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u044c \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u0430 \u0438 \u0435\u0433\u043e \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u043c \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u043c. \u042d\u0442\u043e \u0443\u0441\u043a\u043e\u0440\u044f\u0435\u0442 \u0438 \u0443\u043f\u0440\u043e\u0449\u0430\u0435\u0442 \u043f\u0440\u043e\u0446\u0435\u0441\u0441 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430.<\/p><h2><strong>\u041e\u0431\u044a\u044f\u0441\u043d\u0435\u043d\u0438\u0435 \u043a\u043b\u044e\u0447\u0435\u0432\u044b\u0445 \u0440\u0430\u0437\u043b\u0438\u0447\u0438\u0439<\/strong><\/h2><p>\u0422\u0435\u043f\u0435\u0440\u044c \u0434\u0430\u0432\u0430\u0439\u0442\u0435 \u043f\u043e\u0441\u043c\u043e\u0442\u0440\u0438\u043c, \u0447\u0435\u043c \u043e\u0442\u043b\u0438\u0447\u0430\u044e\u0442\u0441\u044f \u044d\u0442\u0438 \u0442\u0435\u0440\u043c\u0438\u043d\u044b: <strong>\u041e\u0431\u044a\u0435\u043c:<\/strong> GMP \u0438 GDP \u2014 \u044d\u0442\u043e \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430. FDA \u2014 \u044d\u0442\u043e \u043e\u0440\u0433\u0430\u043d\u0438\u0437\u0430\u0446\u0438\u044f. DMF \u0438 CEP \u2014 \u044d\u0442\u043e \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u044b. <strong>\u0426\u0435\u043b\u044c:<\/strong> GMP \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u0443\u0435\u0442 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u043e. GDP \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u0443\u0435\u0442 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0435\u043d\u043d\u0443\u044e \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0438\u044e. FDA \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u0443\u0435\u0442 \u043e\u0442\u0440\u0430\u0441\u043b\u044c. DMF \u0437\u0430\u0449\u0438\u0449\u0430\u0435\u0442 \u0441\u0435\u043a\u0440\u0435\u0442\u044b \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u043e\u0432. CEP \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u0435\u0442 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u043c \u043d\u043e\u0440\u043c\u0430\u043c. <strong>\u0413\u0435\u043e\u0433\u0440\u0430\u0444\u0438\u044f:<\/strong> FDA \u0438 DMF \u2014 \u0430\u043c\u0435\u0440\u0438\u043a\u0430\u043d\u0441\u043a\u0438\u0435 \u0441\u0438\u0441\u0442\u0435\u043c\u044b. CEP \u2014 \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0430\u044f. GMP \u0438 GDP \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u0443\u044e\u0442\u0441\u044f \u0432\u043e \u0432\u0441\u0435\u043c \u043c\u0438\u0440\u0435. <strong>\u0424\u043e\u043a\u0443\u0441:<\/strong> GMP \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432. GDP \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u0438\u0445 \u0440\u0435\u0430\u043b\u0438\u0437\u0430\u0446\u0438\u0438. FDA \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0438 \u0438 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u0438. DMF \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442\u0430\u0445. CEP \u0444\u043e\u043a\u0443\u0441\u0438\u0440\u0443\u0435\u0442\u0441\u044f \u043d\u0430 \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u0445 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u0445.<\/p><h2><strong>\u041f\u043e\u0447\u0435\u043c\u0443 \u044d\u0442\u043e \u0432\u0430\u0436\u043d\u043e<\/strong><\/h2><p>\u042d\u0442\u0438 \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u0440\u0430\u0431\u043e\u0442\u0430\u044e\u0442 \u0432\u043c\u0435\u0441\u0442\u0435, \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0432\u0430\u044f \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u044c \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432. <strong>GMP \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u0443\u0435\u0442 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u043e \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0438\u0438. GDP \u043f\u043e\u0434\u0434\u0435\u0440\u0436\u0438\u0432\u0430\u0435\u0442 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u043e \u043f\u0440\u0438 \u0442\u0440\u0430\u043d\u0441\u043f\u043e\u0440\u0442\u0438\u0440\u043e\u0432\u043a\u0435. FDA \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0432\u0430\u0435\u0442 \u043d\u0430\u0434\u0437\u043e\u0440 \u0438 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435. DMF \u0437\u0430\u0449\u0438\u0449\u0430\u0435\u0442 \u0446\u0435\u043d\u043d\u0443\u044e \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044e. CEP \u043e\u043f\u0442\u0438\u043c\u0438\u0437\u0438\u0440\u0443\u0435\u0442 \u0435\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u0438\u0435 \u043f\u0440\u043e\u0446\u0435\u0441\u0441\u044b.<\/strong> \u041f\u043e\u043d\u0438\u043c\u0430\u043d\u0438\u0435 \u044d\u0442\u0438\u0445 \u0440\u0430\u0437\u043b\u0438\u0447\u0438\u0439 \u043f\u043e\u043b\u0435\u0437\u043d\u043e \u0432\u0441\u0435\u043c \u0432 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u043c \u043c\u0438\u0440\u0435. \u041d\u0435\u0437\u0430\u0432\u0438\u0441\u0438\u043c\u043e \u043e\u0442 \u0442\u043e\u0433\u043e, \u044f\u0432\u043b\u044f\u0435\u0442\u0435\u0441\u044c \u043b\u0438 \u0432\u044b \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u0435\u043c, \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u044c\u044e\u0442\u043e\u0440\u043e\u043c \u0438\u043b\u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u043c \u0440\u0430\u0431\u043e\u0442\u043d\u0438\u043a\u043e\u043c, \u044d\u0442\u0438 \u043a\u043e\u043d\u0446\u0435\u043f\u0446\u0438\u0438 \u0432\u043b\u0438\u044f\u044e\u0442 \u043d\u0430 \u0432\u0430\u0448\u0443 \u043f\u043e\u0432\u0441\u0435\u0434\u043d\u0435\u0432\u043d\u0443\u044e \u0440\u0430\u0431\u043e\u0442\u0443. <strong>\u0426\u0435\u043b\u044c \u043f\u0440\u043e\u0441\u0442\u0430:<\/strong> \u041e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0442\u044c \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u044b\u0435 \u0438 \u044d\u0444\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u044b\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430 \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u0430\u043c, \u043a\u043e\u0442\u043e\u0440\u044b\u0435 \u0432 \u043d\u0438\u0445 \u043d\u0443\u0436\u0434\u0430\u044e\u0442\u0441\u044f. \u042d\u0442\u0438 \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u0434\u0435\u043b\u0430\u044e\u0442 \u044d\u0442\u043e \u0432\u043e\u0437\u043c\u043e\u0436\u043d\u044b\u043c.<\/p><h2><strong>\u0420\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0443\u0435\u043c\u0430\u044f \u043b\u0438\u0442\u0435\u0440\u0430\u0442\u0443\u0440\u0430:<\/strong><\/h2><ol><li><a href=\"https:\/\/safetyculture.com\/topics\/gmp\/\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><em>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 GMP?<\/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;\">\u041d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0430\u044f \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u044f (GDP) \u0432 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0439 \u043e\u0442\u0440\u0430\u0441\u043b\u0438.<\/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;\">\u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0437\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430\u043c\u0438 \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438<\/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>\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u043e\u0441\u043d\u043e\u0432\u043d\u043e\u0435 \u0434\u043e\u0441\u044c\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0430 (DMF)?<\/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>\u0421\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442 \u043f\u043e \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0438 \u0444\u0430\u0440\u043c\u0430\u043a\u043e\u043d\u0430\u0434\u0437\u043e\u0440\u0443 (CEF)<\/em><\/span><\/a>.<\/li><\/ol><h2><b>\u0423\u0432\u0435\u0434\u043e\u043c\u043b\u0435\u043d\u0438\u0435 \u043e\u0431 \u0430\u0432\u0442\u043e\u0440\u0441\u043a\u0438\u0445 \u043f\u0440\u0430\u0432\u0430\u0445:\u00a0<\/b><\/h2><p>\u0412\u044b \u043d\u0435 \u0438\u043c\u0435\u0435\u0442\u0435 \u043f\u0440\u0430\u0432\u0430 \u0432\u043e\u0441\u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u044c, \u0438\u0437\u043c\u0435\u043d\u044f\u0442\u044c, \u043f\u0443\u0431\u043b\u0438\u043a\u043e\u0432\u0430\u0442\u044c, \u043f\u043e\u043a\u0430\u0437\u044b\u0432\u0430\u0442\u044c, \u043f\u0435\u0440\u0435\u0434\u0430\u0432\u0430\u0442\u044c \u0438\u043b\u0438 \u043a\u0430\u043a\u0438\u043c-\u043b\u0438\u0431\u043e \u043e\u0431\u0440\u0430\u0437\u043e\u043c \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u0442\u044c \u043b\u044e\u0431\u043e\u0435 \u0441\u043e\u0434\u0435\u0440\u0436\u0438\u043c\u043e\u0435 \u0434\u0430\u043d\u043d\u043e\u0433\u043e \u0441\u0430\u0439\u0442\u0430, \u0430 \u0442\u0430\u043a\u0436\u0435 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u0442\u044c \u0435\u0433\u043e \u0434\u043b\u044f \u0441\u043e\u0437\u0434\u0430\u043d\u0438\u044f \u043b\u044e\u0431\u043e\u0439 \u0431\u0430\u0437\u044b \u0434\u0430\u043d\u043d\u044b\u0445 \u0431\u0435\u0437 \u043f\u0440\u0435\u0434\u0432\u0430\u0440\u0438\u0442\u0435\u043b\u044c\u043d\u043e\u0433\u043e \u043f\u0438\u0441\u044c\u043c\u0435\u043d\u043d\u043e\u0433\u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0438 Finetech Group. \u0414\u043b\u044f \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f \u043d\u0430 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435 \u043a\u043e\u043d\u0442\u0435\u043d\u0442\u0430, \u043f\u043e\u0436\u0430\u043b\u0443\u0439\u0441\u0442\u0430, \u0441\u0432\u044f\u0436\u0438\u0442\u0435\u0441\u044c \u0441: <a href=\"mailto:info@pharmamachinecn.com\"><span style=\"text-decoration: underline;\">info@pharmamachinecn.com<\/span><\/a><\/p><h2><b>\u041e\u0442\u043a\u0430\u0437 \u043e\u0442 \u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0441\u0442\u0438:<\/b><\/h2><p>\u0418\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u044f, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u0449\u0430\u044f\u0441\u044f \u0432 \u0434\u0430\u043d\u043d\u043e\u0439 \u0441\u0442\u0430\u0442\u044c\u0435, \u043f\u0440\u0435\u0434\u043d\u0430\u0437\u043d\u0430\u0447\u0435\u043d\u0430 \u0442\u043e\u043b\u044c\u043a\u043e \u0434\u043b\u044f \u043e\u0431\u0449\u0435\u0433\u043e \u043e\u0437\u043d\u0430\u043a\u043e\u043c\u043b\u0435\u043d\u0438\u044f. \u041a\u043e\u043c\u043f\u0430\u043d\u0438\u044f \u043d\u0435 \u0433\u0430\u0440\u0430\u043d\u0442\u0438\u0440\u0443\u0435\u0442 \u0442\u043e\u0447\u043d\u043e\u0441\u0442\u044c, \u0430\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u043e\u0441\u0442\u044c, \u0441\u0432\u043e\u0435\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u043e\u0441\u0442\u044c \u0438\u043b\u0438 \u043f\u043e\u043b\u043d\u043e\u0442\u0443 \u043b\u044e\u0431\u043e\u0439 \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u0438, \u0438 \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u044f \u043d\u0435 \u043d\u0435\u0441\u0435\u0442 \u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0441\u0442\u0438 \u0437\u0430 \u043e\u0448\u0438\u0431\u043a\u0438 \u0438\u043b\u0438 \u0443\u043f\u0443\u0449\u0435\u043d\u0438\u044f \u0432 \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0438 \u0434\u0430\u043d\u043d\u043e\u0439 \u0441\u0442\u0430\u0442\u044c\u0438.<\/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. 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