{"id":3241,"date":"2020-05-07T15:52:39","date_gmt":"2020-05-07T13:52:39","guid":{"rendered":"http:\/\/estetmed.org\/?p=3241"},"modified":"2020-05-07T16:11:17","modified_gmt":"2020-05-07T14:11:17","slug":"zatverdzheno-onovleni-zghidno-z-vymoha","status":"publish","type":"post","link":"https:\/\/estetmed.org\/?p=3241","title":{"rendered":"\u0417\u0410\u0422\u0412\u0415\u0420\u0414\u0416\u0415\u041d\u041e \u041e\u041d\u041e\u0412\u041b\u0415\u041d\u0406 \u0417\u0413\u0406\u0414\u041d\u041e \u0417 \u0412\u0418\u041c\u041e\u0413\u0410\u041c\u0418 GMP \u0404\u0421 \u041d\u0410\u0421\u0422\u0410\u041d\u041e\u0412\u0423 \u00ab\u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0406 \u0417\u0410\u0421\u041e\u0411\u0418. \u041d\u0410\u041b\u0415\u0416\u041d\u0410 \u0412\u0418\u0420\u041e\u0411\u041d\u0418\u0427\u0410 \u041f\u0420\u0410\u041a\u0422\u0418\u041a\u0410\u00bb \u0422\u0410 \u041d\u0410\u0421\u0422\u0410\u041d\u041e\u0412\u0423 \u00ab\u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0406 \u0417\u0410\u0421\u041e\u0411\u0418. \u041f\u0420\u0418\u041d\u0426\u0418\u041f\u0418 \u041d\u0410\u041b\u0415\u0416\u041d\u041e\u0407 \u041f\u0420\u0410\u041a\u0422\u0418\u041a\u0418 \u0414\u0418\u0421\u0422\u0420\u0418\u0411\u0423\u0426\u0406\u0407 \u0414\u0406\u042e\u0427\u0418\u0425 \u0420\u0415\u0427\u041e\u0412\u0418\u041d \u0414\u041b\u042f \u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0418\u0425 \u0417\u0410\u0421\u041e\u0411\u0406\u0412 \u0414\u041b\u042f \u041b\u042e\u0414\u0418\u041d\u0418\u00bb"},"content":{"rendered":"<div style=\"padding-bottom:20px; padding-top:10px;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img decoding=\"async\" src=\"https:\/\/static.hupso.com\/share\/buttons\/share-small.png\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google Plus\",\"Linkedin\",\"VKontakte\",\"Email\",\"Print\");var hupso_background_t=\"#EAF4FF\";var hupso_border_t=\"#66CCFF\";var hupso_toolbar_size_t=\"small\";var hupso_image_folder_url = \"\";var hupso_url_t=\"\";var hupso_title_t=\"%D0%97%D0%90%D0%A2%D0%92%D0%95%D0%A0%D0%94%D0%96%D0%95%D0%9D%D0%9E%20%D0%9E%D0%9D%D0%9E%D0%92%D0%9B%D0%95%D0%9D%D0%86%20%D0%97%D0%93%D0%86%D0%94%D0%9D%D0%9E%20%D0%97%20%D0%92%D0%98%D0%9C%D0%9E%D0%93%D0%90%D0%9C%D0%98%20GMP%20%D0%84%D0%A1%20%D0%9D%D0%90%D0%A1%D0%A2%D0%90%D0%9D%D0%9E%D0%92%D0%A3%20%C2%AB%D0%9B%D0%86%D0%9A%D0%90%D0%A0%D0%A1%D0%AC%D0%9A%D0%86%20%D0%97%D0%90%D0%A1%D0%9E%D0%91%D0%98.%20%D0%9D%D0%90%D0%9B%D0%95%D0%96%D0%9D%D0%90%20%D0%92%D0%98%D0%A0%D0%9E%D0%91%D0%9D%D0%98%D0%A7%D0%90%20%D0%9F%D0%A0%D0%90%D0%9A%D0%A2%D0%98%D0%9A%D0%90%C2%BB%20%D0%A2%D0%90%20%D0%9D%D0%90%D0%A1%D0%A2%D0%90%D0%9D%D0%9E%D0%92%D0%A3%20%C2%AB%D0%9B%D0%86%D0%9A%D0%90%D0%A0%D0%A1%D0%AC%D0%9A%D0%86%20%D0%97%D0%90%D0%A1%D0%9E%D0%91%D0%98.%20%D0%9F%D0%A0%D0%98%D0%9D%D0%A6%D0%98%D0%9F%D0%98%20%D0%9D%D0%90%D0%9B%D0%95%D0%96%D0%9D%D0%9E%D0%87%20%D0%9F%D0%A0%D0%90%D0%9A%D0%A2%D0%98%D0%9A%D0%98%20%D0%94%D0%98%D0%A1%D0%A2%D0%A0%D0%98%D0%91%D0%A3%D0%A6%D0%86%D0%87%20%D0%94%D0%86%D0%AE%D0%A7%D0%98%D0%A5%20%D0%A0%D0%95%D0%A7%D0%9E%D0%92%D0%98%D0%9D%20%D0%94%D0%9B%D0%AF%20%D0%9B%D0%86%D0%9A%D0%90%D0%A0%D0%A1%D0%AC%D0%9A%D0%98%D0%A5%20%D0%97%D0%90%D0%A1%D0%9E%D0%91%D0%86%D0%92%20%D0%94%D0%9B%D0%AF%20%D0%9B%D0%AE%D0%94%D0%98%D0%9D%D0%98%C2%BB\";<\/script><script type=\"text\/javascript\" src=\"https:\/\/static.hupso.com\/share\/js\/share_toolbar.js\"><\/script><!-- Hupso Share Buttons --><\/div><p><strong><a href=\"http:\/\/estetmed.org\/wp-content\/uploads\/2020\/05\/96140671_3292575500753752_5354469387858345984_n.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-3242\" src=\"http:\/\/estetmed.org\/wp-content\/uploads\/2020\/05\/96140671_3292575500753752_5354469387858345984_n-300x160.jpg\" alt=\"\" width=\"245\" height=\"138\" \/><\/a>\u0417\u0410\u0422\u0412\u0415\u0420\u0414\u0416\u0415\u041d\u041e \u041e\u041d\u041e\u0412\u041b\u0415\u041d\u0406 \u0417\u0413\u0406\u0414\u041d\u041e \u0417 \u0412\u0418\u041c\u041e\u0413\u0410\u041c\u0418 GMP \u0404\u0421 \u041d\u0410\u0421\u0422\u0410\u041d\u041e\u0412\u0423 \u00ab\u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0406 \u0417\u0410\u0421\u041e\u0411\u0418. \u041d\u0410\u041b\u0415\u0416\u041d\u0410 \u0412\u0418\u0420\u041e\u0411\u041d\u0418\u0427\u0410 \u041f\u0420\u0410\u041a\u0422\u0418\u041a\u0410\u00bb \u0422\u0410 \u041d\u0410\u0421\u0422\u0410\u041d\u041e\u0412\u0423 \u00ab\u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0406 \u0417\u0410\u0421\u041e\u0411\u0418. \u041f\u0420\u0418\u041d\u0426\u0418\u041f\u0418 \u041d\u0410\u041b\u0415\u0416\u041d\u041e\u0407 \u041f\u0420\u0410\u041a\u0422\u0418\u041a\u0418 \u0414\u0418\u0421\u0422\u0420\u0418\u0411\u0423\u0426\u0406\u0407 \u0414\u0406\u042e\u0427\u0418\u0425 \u0420\u0415\u0427\u041e\u0412\u0418\u041d \u0414\u041b\u042f \u041b\u0406\u041a\u0410\u0420\u0421\u042c\u041a\u0418\u0425 \u0417\u0410\u0421\u041e\u0411\u0406\u0412 \u0414\u041b\u042f \u041b\u042e\u0414\u0418\u041d\u0418\u00bb<\/strong><\/p>\n<p>\u0414\u0435\u0440\u0436\u043b\u0456\u043a\u0441\u043b\u0443\u0436\u0431\u0430 \u043f\u043e\u0432\u0456\u0434\u043e\u043c\u043b\u044f\u0454, \u0449\u043e \u043d\u0430\u043a\u0430\u0437\u043e\u043c \u041c\u0456\u043d\u0456\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u0430 \u043e\u0445\u043e\u0440\u043e\u043d\u0438 \u0437\u0434\u043e\u0440\u043e\u0432\u2019\u044f \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 04 \u0442\u0440\u0430\u0432\u043d\u044f 2020 \u0440\u043e\u043a\u0443 \u2116 1023 \u0437\u0430\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043e\u00a0<strong>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-4.0:2020 \u00ab\u041b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438. \u041d\u0430\u043b\u0435\u0436\u043d\u0430 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u0430 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430<\/strong>\u00bb, \u044f\u043a\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u0454 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0443 \u00abThe Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use\u00bb (\u00ab\u041f\u0440\u0430\u0432\u0438\u043b\u0430, \u0449\u043e \u0440\u0435\u0433\u0443\u043b\u044e\u044e\u0442\u044c \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438 \u0432 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u043c\u0443 \u0421\u043e\u044e\u0437\u0456. \u0422\u043e\u043c 4. \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0456 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 \u0437 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0434\u043b\u044f \u043b\u044e\u0434\u0438\u043d\u0438 \u0442\u0430 \u0437\u0430\u0441\u0442\u043e\u0441\u0443\u0432\u0430\u043d\u043d\u044f \u0443 \u0432\u0435\u0442\u0435\u0440\u0438\u043d\u0430\u0440\u0456\u0457\u00bb), \u0442\u0430\u00a0<strong>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-5.2:2020 \u00ab\u041b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438. \u041f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u0457 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0434\u043b\u044f \u043b\u044e\u0434\u0438\u043d\u0438\u00bb,<\/strong>\u00a0\u044f\u043a\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u0454 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0443 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u0457 \u041a\u043e\u043c\u0456\u0441\u0456\u0457 (European Commission) \u00abGuidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015\/C 95\/01)\u00bb (\u00ab\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0432\u0456\u0434 19 \u0431\u0435\u0440\u0435\u0437\u043d\u044f 2015 \u0440\u043e\u043a\u0443 \u0437 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0456\u0432 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u0457 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0434\u043b\u044f \u0437\u0430\u0441\u0442\u043e\u0441\u0443\u0432\u0430\u043d\u043d\u044f \u043b\u044e\u0434\u0438\u043d\u043e\u044e (2015\/C 95\/01)\u00bb).<\/p>\n<p>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-4.0:2020 \u043f\u0440\u0438\u0439\u043d\u044f\u0442\u0430 \u0437 \u043c\u0435\u0442\u043e\u044e \u0430\u043a\u0442\u0443\u0430\u043b\u0456\u0437\u0430\u0446\u0456\u0457, \u043e\u0441\u043a\u0456\u043b\u044c\u043a\u0438 \u0432 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0456 \u0437 GMP \u0404\u0421 \u0431\u0443\u043b\u043e \u043f\u0435\u0440\u0435\u0433\u043b\u044f\u043d\u0443\u0442\u043e \u0434\u043e\u0434\u0430\u0442\u043e\u043a 2 \u0456 \u0434\u043e\u0434\u0430\u0442\u043e\u043a 17, \u0430 \u0442\u0430\u043a\u043e\u0436 \u0432\u0432\u0435\u0434\u0435\u043d\u043e \u0447\u0430\u0441\u0442\u0438\u043d\u0443 \u0406V \u00abGMP requirements for Advanced Therapy Medicinal Product\u00bb (\u00ab\u0412\u0438\u043c\u043e\u0433\u0438 GMP \u0441\u0442\u043e\u0441\u043e\u0432\u043d\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u043f\u0435\u0440\u0435\u0434\u043e\u0432\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457\u00bb), \u0449\u043e \u043c\u0456\u0441\u0442\u0438\u0442\u044c \u043d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u0457 \u041a\u043e\u043c\u0456\u0441\u0456\u0457 \u00abGuidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products\u00bb (\u00ab\u0421\u043f\u0435\u0446\u0456\u0430\u043b\u044c\u043d\u0456 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u043f\u0435\u0440\u0435\u0434\u043e\u0432\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457\u00bb), \u0432\u0432\u0435\u0434\u0435\u043d\u0443 \u0432 \u0404\u0421 \u0437 22 \u0442\u0440\u0430\u0432\u043d\u044f 2018 \u0440.<!--more--><\/p>\n<p>\u0412 \u0447\u0430\u0441\u0442\u0438\u043d\u0456 \u0406V \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u0437 GMP \u0404\u0421 \u0432\u0438\u043a\u043b\u0430\u0434\u0435\u043d\u0456 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u0442\u0430 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 GMP, \u0437\u0430\u0441\u0442\u043e\u0441\u043e\u0432\u043d\u0456 \u0434\u043e \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u043f\u0435\u0440\u0435\u0434\u043e\u0432\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457, \u0434\u043e \u044f\u043a\u0438\u0445 \u0432\u0456\u0434\u043d\u0435\u0441\u0435\u043d\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438 \u0434\u043b\u044f \u0433\u0435\u043d\u043d\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457 (gene therapy medicinal products), \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438 \u0434\u043b\u044f \u0442\u0435\u0440\u0430\u043f\u0456\u0457 \u0441\u043e\u043c\u0430\u0442\u0438\u0447\u043d\u0438\u043c\u0438 \u043a\u043b\u0456\u0442\u0438\u043d\u0430\u043c\u0438 (somatic cell therapy medicinal products) \u0442\u0430 \u0442\u043a\u0430\u043d\u0438\u043d\u043d\u043e-\u0456\u043d\u0436\u0435\u043d\u0435\u0440\u043d\u0456 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0438 (tissue engineered products). \u0412 \u0430\u043a\u0442\u0443\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0438\u0445 \u0434\u043e\u0434\u0430\u0442\u043a\u0430\u0445 2 \u0456 17 \u043d\u0430\u0434\u0430\u043d\u0456 \u043d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u0449\u043e\u0434\u043e \u0456\u043d\u0442\u0435\u0440\u043f\u0440\u0435\u0442\u0430\u0446\u0456\u0457 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0456\u0432 \u0442\u0430 \u043f\u0440\u0430\u0432\u0438\u043b GMP \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432, \u0449\u043e \u0432\u0441\u0442\u0430\u043d\u043e\u0432\u043b\u0435\u043d\u043e \u0414\u0438\u0440\u0435\u043a\u0442\u0438\u0432\u043e\u044e 2003\/94\/\u0415\u0421.<\/p>\n<p>\u0414\u043e\u0434\u0430\u0442\u043e\u043a 2 \u0431\u0443\u043b\u043e \u043f\u0435\u0440\u0435\u0433\u043b\u044f\u043d\u0443\u0442\u043e \u0432 \u0404\u0421 \u0432\u043d\u0430\u0441\u043b\u0456\u0434\u043e\u043a \u043f\u0440\u0438\u0439\u043d\u044f\u0442\u0442\u044f \u043d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u00abGuidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products\u00bb, \u043e\u0441\u043a\u0456\u043b\u044c\u043a\u0438 \u0441\u0430\u043c\u0435 \u0432 \u043f\u043e\u043f\u0435\u0440\u0435\u0434\u043d\u0456\u0439 \u0432\u0435\u0440\u0441\u0456\u0457 \u0434\u043e\u0434\u0430\u0442\u043a\u0430 2 \u0432\u0438\u0437\u043d\u0430\u0447\u0430\u043b\u0438\u0441\u044c \u0441\u043f\u0435\u0446\u0438\u0444\u0456\u0447\u043d\u0456 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 GMP \u0441\u0442\u043e\u0441\u043e\u0432\u043d\u043e \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u043f\u0435\u0440\u0435\u0434\u043e\u0432\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457. \u041a\u0440\u0456\u043c \u0442\u043e\u0433\u043e, \u0456\u043d\u0448\u0456 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u0456 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0438, \u0449\u043e \u0440\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442\u0443\u044e\u0442\u044c \u0432\u0438\u043c\u043e\u0433\u0438 GMP \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432, \u043d\u0435 \u043c\u043e\u0436\u0443\u0442\u044c \u0431\u0443\u0442\u0438 \u0437\u0430\u0441\u0442\u043e\u0441\u043e\u0432\u0430\u043d\u0456 \u0434\u043b\u044f \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u043f\u0435\u0440\u0435\u0434\u043e\u0432\u043e\u0457 \u0442\u0435\u0440\u0430\u043f\u0456\u0457, \u044f\u043a\u0449\u043e \u0446\u0435 \u0441\u043f\u0435\u0446\u0456\u0430\u043b\u044c\u043d\u043e \u043d\u0435 \u043e\u0431\u0443\u043c\u043e\u0432\u043b\u0435\u043d\u043e \u0432 \u043d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0456 \u00abGuidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products\u00bb.<\/p>\n<p>\u0423\u0441\u043f\u0456\u0445\u0438 \u0432 \u0437\u0430\u0441\u0442\u043e\u0441\u0443\u0432\u0430\u043d\u043d\u0456 \u043f\u0440\u0438 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0456\u0439 \u0440\u043e\u0437\u0440\u043e\u0431\u0446\u0456 \u0442\u0430 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0456 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432 \u043f\u0440\u043e\u0446\u0435\u0441\u043d\u043e-\u0430\u043d\u0430\u043b\u0456\u0442\u0438\u0447\u043d\u043e\u0457 \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0456\u0457 (PAT), \u043f\u0456\u0434\u0445\u043e\u0434\u0443 \u00ab\u044f\u043a\u0456\u0441\u0442\u044c \u0448\u043b\u044f\u0445\u043e\u043c \u0440\u043e\u0437\u0440\u043e\u0431\u043a\u0438\u00bb (QbD) \u0442\u0430 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0456\u0432 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u0440\u0438\u0437\u0438\u043a\u0430\u043c\u0438 \u0434\u043b\u044f \u044f\u043a\u043e\u0441\u0442\u0456 (QRM) \u043f\u043e\u043a\u0430\u0437\u0430\u043b\u0438, \u0449\u043e \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u0435 \u043f\u043e\u0454\u0434\u043d\u0430\u043d\u043d\u044f \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0432 \u043f\u0440\u043e\u0446\u0435\u0441\u0456 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 \u0440\u0430\u0437\u043e\u043c \u0456\u0437 \u0441\u0432\u043e\u0454\u0447\u0430\u0441\u043d\u0438\u043c \u043c\u043e\u043d\u0456\u0442\u043e\u0440\u0438\u043d\u0433\u043e\u043c \u0442\u0430 \u043f\u0435\u0440\u0435\u0432\u0456\u0440\u043a\u043e\u044e \u043f\u043e\u043f\u0435\u0440\u0435\u0434\u043d\u044c\u043e \u0432\u0441\u0442\u0430\u043d\u043e\u0432\u043b\u0435\u043d\u0438\u0445 \u043f\u043e\u043a\u0430\u0437\u043d\u0438\u043a\u0456\u0432 \u043c\u0430\u0442\u0435\u0440\u0456\u0430\u043b\u0456\u0432 \u0437\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0443\u044e\u0442\u044c \u0431\u0456\u043b\u044c\u0448\u0443 \u0433\u0430\u0440\u0430\u043d\u0442\u0456\u044e \u044f\u043a\u043e\u0441\u0442\u0456 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432, \u043d\u0456\u0436 \u0441\u0430\u043c\u0456 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u0433\u043e\u0442\u043e\u0432\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457. \u0426\u0435 \u0439 \u0441\u043f\u0440\u0438\u044f\u043b\u043e \u043f\u0435\u0440\u0435\u0433\u043b\u044f\u0434\u0443 \u0434\u043e\u0434\u0430\u0442\u043a\u0430 17, \u043f\u0440\u0438 \u044f\u043a\u043e\u043c\u0443 \u0431\u0443\u043b\u043e \u0432\u0440\u0430\u0445\u043e\u0432\u0430\u043d\u043e \u0437\u043c\u0456\u043d\u0438 \u0432\u043d\u0435\u0441\u0435\u043d\u0456 \u0434\u043e \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438 \u0437 GMP \u0404\u0421.<\/p>\n<p>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0421\u0422-\u041d\u00a0\u041c\u041e\u0417\u0423 42-5.2:2020 \u00ab\u041b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438. \u041f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u0457 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0434\u043b\u044f \u043b\u044e\u0434\u0438\u043d\u0438\u00bb \u0437\u0430\u0441\u0442\u043e\u0441\u043e\u0432\u0443\u044e\u0442\u044c \u043f\u0440\u0438 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u0457 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d, \u0449\u043e \u0432\u0438\u0440\u043e\u0431\u043b\u044f\u044e\u0442\u044c\u0441\u044f \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456 \u0434\u043b\u044f \u043f\u0440\u043e\u0434\u0430\u0436\u0443 \u043d\u0430 \u0432\u043d\u0443\u0442\u0440\u0456\u0448\u043d\u044c\u043e\u043c\u0443 \u0440\u0438\u043d\u043a\u0443 \u0442\u0430 \u0437 \u043c\u0435\u0442\u043e\u044e \u0435\u043a\u0441\u043f\u043e\u0440\u0442\u0443, \u0430 \u0442\u0430\u043a\u043e\u0436 \u043f\u0440\u0438 \u0456\u043c\u043f\u043e\u0440\u0442\u0456 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0443. \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u043f\u043e\u0448\u0438\u0440\u044e\u0454\u0442\u044c\u0441\u044f \u043d\u0430 \u0441\u0443\u0431\u2019\u0454\u043a\u0442\u0456\u0432 \u0433\u043e\u0441\u043f\u043e\u0434\u0430\u0440\u044e\u0432\u0430\u043d\u043d\u044f, \u044f\u043a\u0456 \u0437\u0434\u0456\u0439\u0441\u043d\u044e\u044e\u0442\u044c \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u044e \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d, \u0432\u043a\u043b\u044e\u0447\u0430\u044e\u0447\u0438 \u043f\u0456\u0434\u043f\u0440\u0438\u0454\u043c\u0441\u0442\u0432\u0430, \u0449\u043e \u0457\u0445 \u0432\u0438\u0440\u043e\u0431\u043b\u044f\u044e\u0442\u044c.<\/p>\n<p><em>\u00a0<\/em>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-4.0:2020 \u00ab\u041b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438. \u041d\u0430\u043b\u0435\u0436\u043d\u0430 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u0430 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430\u00bb \u0440\u043e\u0437\u043c\u0456\u0449\u0435\u043d\u043e\u00a0<a href=\"http:\/\/dls.gov.ua\/wp-content\/uploads\/2020\/05\/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%A1%D0%A2-%D0%9D-%D0%9C%D0%9E%D0%97%D0%A3-42-4.0_2020.pdf\">http:\/\/dls.gov.ua\/wp-content\/uploads\/2020\/05\/\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430-\u0421\u0422-\u041d-\u041c\u041e\u0417\u0423-42-4.0_2020.pdf<\/a><\/p>\n<p>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0443 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-5.2:2020 \u00ab\u041b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438. \u041f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u043d\u0430\u043b\u0435\u0436\u043d\u043e\u0457 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0438 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u0457 \u0434\u0456\u044e\u0447\u0438\u0445 \u0440\u0435\u0447\u043e\u0432\u0438\u043d \u0434\u043b\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0434\u043b\u044f \u043b\u044e\u0434\u0438\u043d\u0438\u00bb \u0440\u043e\u0437\u043c\u0456\u0449\u0435\u043d\u043e\u00a0<a href=\"http:\/\/dls.gov.ua\/wp-content\/uploads\/2020\/05\/111%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%A1%D0%A2-%D0%9C%D0%9E%D0%97%D0%A3-42-5.2_2020.pdf\">http:\/\/dls.gov.ua\/wp-content\/uploads\/2020\/05\/111\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430-\u0421\u0422-\u041c\u041e\u0417\u0423-42-5.2_2020.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<div style=\"padding-bottom:20px; padding-top:10px;\" class=\"hupso-share-buttons\"><!-- Hupso Share Buttons - https:\/\/www.hupso.com\/share\/ --><a class=\"hupso_toolbar\" href=\"https:\/\/www.hupso.com\/share\/\"><img src=\"https:\/\/static.hupso.com\/share\/buttons\/share-small.png\" style=\"border:0px; padding-top: 5px; float:left;\" alt=\"Share Button\"\/><\/a><script type=\"text\/javascript\">var hupso_services_t=new Array(\"Twitter\",\"Facebook\",\"Google 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