{"id":14846,"date":"2026-05-04T12:06:28","date_gmt":"2026-05-04T09:06:28","guid":{"rendered":"https:\/\/sttd.com.ua\/?p=14846"},"modified":"2026-05-04T12:11:41","modified_gmt":"2026-05-04T09:11:41","slug":"sertifikacziya-seri%d1%97-batch-certification-dlya-vipusku-u-distribucziyu-release-for-distribution-ta-pidtverdzhennya-seri%d1%97-batch-confirmation-likarskih-zasobiv-upovnovazhenoyu-osoboyu-qp","status":"publish","type":"post","link":"https:\/\/sttd.com.ua\/ru\/sertifikacziya-seri%d1%97-batch-certification-dlya-vipusku-u-distribucziyu-release-for-distribution-ta-pidtverdzhennya-seri%d1%97-batch-confirmation-likarskih-zasobiv-upovnovazhenoyu-osoboyu-qp\/","title":{"rendered":"\u0421\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u044f \u0441\u0435\u0440\u0456\u0457 (Batch Certification) \u0434\u043b\u044f \u0432\u0438\u043f\u0443\u0441\u043a\u0443 \u0443 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u044e (release for distribution) \u0442\u0430 \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u0441\u0435\u0440\u0456\u0457 (Batch Confirmation) \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0423\u043f\u043e\u0432\u043d\u043e\u0432\u0430\u0436\u0435\u043d\u043e\u044e \u043e\u0441\u043e\u0431\u043e\u044e (QP) \u2013  \u043f\u043e\u043d\u044f\u0442\u0442\u044f \u0442\u0430 \u043e\u0441\u043d\u043e\u0432\u043d\u0456 \u0441\u043a\u043b\u0430\u0434\u043e\u0432\u0456 \u0432 \u0440\u0430\u043c\u043a\u0430\u0445 \u043f\u0440\u0430\u0432\u0438\u043b GMP \u0442\u0430 \u0456\u043d\u0448\u0438\u0445 \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u043e \u0432\u0438\u0437\u043d\u0430\u043d\u0438\u0445 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u0456\u0432 \u0443 \u0441\u0444\u0435\u0440\u0456 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432"},"content":{"rendered":"\n<p><strong>4 \u0431\u0430\u043b\u0438 \u0411\u041f\u0420<\/strong><\/p>\n\n\n\n<p><strong>\u0414\u0430\u0442\u0430:\u00a0<\/strong>03.06.2026<\/p>\n\n\n\n<p><strong>\u0427\u0430\u0441:&nbsp;<\/strong>10:00-13:00<\/p>\n\n\n\n<p><strong>\u0410\u0432\u0442\u043e\u0440 \u0442\u0430 \u043b\u0435\u043a\u0442\u043e\u0440 \\ \u0432\u0438\u043a\u043b\u0430\u0434\u0430\u0447:<\/strong> <strong>\u041d\u0456\u043a\u0456\u0442\u044e\u043a \u0412\u0430\u043b\u0435\u0440\u0456\u0439 \u0413\u0440\u0438\u0433\u043e\u0440\u043e\u0432\u0438\u0447<\/strong> \u2013 \u043a\u0430\u043d\u0434. \u0444\u0430\u0440\u043c. \u043d\u0430\u0443\u043a, Ph.D. (<em>main specialty \u2013 Pharmaceutical Sciences<\/em>), \u043d\u0435\u0437\u0430\u043b\u0435\u0436\u043d\u0438\u0439 \u0435\u043a\u0441\u043f\u0435\u0440\u0442 \\ \u0430\u0443\u0434\u0438\u0442\u043e\u0440\u0438 (\u0456\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440) \\ \u0442\u0440\u0435\u043d\u0435\u0440 (<em>coach<\/em>) GMP \/&nbsp; GDP \/ GxP, \u0456\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440 GMP\/GDP, \u0441\u0445\u0432\u0430\u043b\u0435\u043d\u0438\u0439 PIC\/S, \u0441\u043f\u0456\u0432-\u0440\u043e\u0437\u0440\u043e\u0431\u043d\u0438\u043a (\u0441\u043f\u0456\u0432-\u0430\u0432\u0442\u043e\u0440) \u043d\u0430\u0446\u0456\u043e\u043d\u0430\u043b\u044c\u043d\u043e\u0457 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0438\u0437\u0430\u0446\u0456\u0457 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457 (<em>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-1.0:2005<\/em>)<\/p>\n\n\n\n<p><strong>\u041d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u0430 \u0431\u0430\u0437\u0430<\/strong> (<em>\u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u0456 \u0442\u0430 \u043d\u0430\u0446\u0456\u043e\u043d\u0430\u043b\u044c\u043d\u0456 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u043e-\u0442\u0435\u0445\u043d\u0456\u0447\u043d\u0456 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0438, \u043f\u043e\u043b\u043e\u0436\u0435\u043d\u043d\u044f \u044f\u043a\u0438\u0445 \u0432\u0440\u0430\u0445\u043e\u0432\u0430\u043d\u0456 \u0443 \u0434\u0430\u043d\u043e\u043c\u0443 \u043d\u0430\u0432\u0447\u0430\u043b\u044c\u043d\u043e\u043c\u0443 \u0441\u0435\u043c\u0456\u043d\u0430\u0440\u0443-\u0442\u0440\u0435\u043d\u0456\u043d\u0433\u0443<\/em>) <strong>: &nbsp;&nbsp;&nbsp;<\/strong><\/p>\n\n\n\n<ul><li><strong><em>\u0414\u0438\u0440\u0435\u043a\u0442\u0438\u0432\u0430, \u0449\u043e \u0432\u0438\u0437\u043d\u0430\u0447\u0430\u0454 \u041f\u0440\u0430\u0432\u0438\u043b\u0430 \u0443\u043f\u0440\u0430\u0432\u043b\u0456\u043d\u043d\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u043c\u0438 \u0437\u0430\u0441\u043e\u0431\u0430\u043c\u0438 \u0443 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u043c\u0443 \u0421\u043e\u044e\u0437\u0456 <\/em><\/strong>\u2013 Directive 2001\\83\\EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for humane use (<em>current version<\/em>);<\/li><li><strong><em>\u043f\u0440\u0430\u0432\u0438\u043b\u0430<\/em><\/strong><strong><em> GMP EU<\/em><\/strong> \u2013 The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use (<em>current version<\/em>);<\/li><li><strong><em>\u0434\u043e\u0434\u0430\u0442\u043e\u043a 16 \u043f\u0440\u0430\u0432\u0438\u043b <\/em><\/strong><strong><em>GMP EU<\/em><\/strong> \u2013 Annex 16: Certification by a Qualified Person and Batch Release(<em>\u0447\u0438\u043d\u043d\u0430 \u0440\u0435\u0434\u0430\u043a\u0446\u0456\u044f, \u0449\u043e \u0432\u0432\u0435\u0434\u0435\u043d\u0430 \u0432 \u0434\u0456\u044e 15.04.2016<\/em>);<\/li><li><strong><em>\u043f\u0440\u0430\u0432\u0438\u043b\u0430<\/em><\/strong><strong><em> GMP PIC\/S<\/em><\/strong> \u2013 Guide to Good Manufacturing Practice for Medicinal Products, Annexes. Part I(<em>\u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442<\/em> <em>PE 009-17, <\/em><em>\u043e\u0441\u0442\u0430\u043d\u043d\u044f \u0430\u043a\u0442\u0443\u0430\u043b\u0456\u0437\u0430\u0446\u0456\u044f 25.08.2023<\/em>);<\/li><li><strong><em>\u043f\u0440\u0430\u0432\u0438\u043b\u0430 <\/em><\/strong><strong><em>GMP, <\/em><\/strong><strong><em>\u043f\u0440\u0438\u0439\u043d\u044f\u0442\u0456 \u0432 <\/em><\/strong><strong><em>\u0423\u043a\u0440\u0430\u0457\u043d\u0456<\/em><\/strong> \u2013 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-4.0:2020. \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 (<em>\u0432\u0438\u0437\u043d\u0430\u0447\u0435\u043d\u043e \u043d\u0430\u043a\u0430\u0437\u043e\u043c \u041c\u041e\u0417\u0423 \u0432\u0456\u0434 04.05.2020 \u2116 1023<\/em>);<\/li><li><strong><em>\u0432\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u0457 \u0441\u0435\u0440\u0456\u0457 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0432 \u0440\u0430\u043c\u043a\u0430\u0445 \u043f\u0440\u0430\u0432\u0438\u043b <\/em><\/strong><strong><em>GMP<\/em><\/strong><strong><em> <\/em><\/strong><strong><em>PIC<\/em><\/strong><strong><em>\/<\/em><\/strong><strong><em>S<\/em><\/strong> \u2013 Certification by the Authorised Person and Batch Release (<em>\u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442<\/em> <em>PE<\/em><em> 009-17, \u043d\u043e\u0432\u0438\u0439 \u0434\u043e\u0434\u0430\u0442\u043e\u043a \u0432\u0456\u0434 01.02.2022<\/em>);<\/li><li><strong><em>\u043d\u043e\u0432\u0430 \u0441\u043f\u0435\u0446\u0456\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0430 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 <\/em><\/strong><strong><em>EMA<\/em><\/strong><em> <\/em><em>\u2013 <\/em>Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders (MAH) (<em>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430<\/em> <em>EMA\/419571\/2021 \u0432\u0456\u0434 10.02.2022<\/em>);<\/li><li><strong><em>\u043e\u043d\u043e\u0432\u043b\u0435\u043d\u0430 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 <\/em><\/strong><strong><em>EMA<\/em><\/strong><strong><em> \u0449\u043e\u0434\u043e <\/em><\/strong><strong><em>CTD<\/em><\/strong><strong><em>-\u0444\u043e\u0440\u043c\u0430\u0442\u0443 \u0440\u0435\u0454\u0441\u0442\u0440\u0430\u0446\u0456\u0439\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u044c\u0454 <\/em><\/strong>\u2013<strong><em> <\/em><\/strong>ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use &#8212; organisation of CTD (<em>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430<\/em> <em>EMA\/CPMP\/ICH\/2887\/1999 \u0432\u0456\u0434 19.03.2021<\/em>);<\/li><li><strong><em>\u0441\u043f\u0435\u0446\u0456\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0430 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 <\/em><\/strong><strong><em>WHO<\/em><\/strong><em>, \u0449\u043e \u0432\u0438\u0437\u043d\u0430\u0447\u0430\u0454 \u0432\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0421\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0442\u0456\u0432 \u0430\u043d\u0430\u043b\u0456\u0437\u0456\u0432 (\u044f\u043a\u043e\u0441\u0442\u0456) \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432<\/em> \u2013 WHO Model Certificate of Analysis \u2013 CoA (<em>TRS<\/em><em> <\/em><em>\u2116&nbsp;1010, 2018; <\/em><em>TRS<\/em><em> <\/em><em>\u2116 1052, 2024<\/em>);<\/li><li><strong><em>\u0441\u043f\u0435\u0446\u0456\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0430 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 <\/em><\/strong><strong><em>EMA<\/em><\/strong><em> \u0449\u043e\u0434\u043e \u0433\u0430\u0440\u043c\u043e\u043d\u0456\u0437\u043e\u0432\u0430\u043d\u0438\u0445 \u0432\u0438\u043c\u043e\u0433 \u0434\u043e \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u0457 \u0441\u0435\u0440\u0456\u0457 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432<\/em> \u2013&nbsp; Internationally harmonized requirements for batch certification (<em>\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 <\/em><em>EMA<\/em><em>\/<\/em><em>INS<\/em><em>\/<\/em><em>MRA<\/em><em>\/387218\/2011 \u0432\u0456\u0434 01.06.2011<\/em>);<\/li><li>\u0456\u043d\u0448\u0456 \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u043e \u0432\u0438\u0437\u043d\u0430\u043d\u0456 \u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0438, \u0432\u0438\u043c\u043e\u0433\u0438, \u043f\u0440\u0430\u0432\u0438\u043b\u0430, \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0438, \u0440\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0430\u0446\u0456\u0457, \u043a\u043e\u043c\u043f\u0435\u043d\u0434\u0456\u0443\u043c\u0438, \u0442\u043e\u0449\u043e.<\/li><\/ul>\n\n\n\n<h2 class=\"has-text-align-center\"><strong>\u041f\u0440\u043e\u0433\u0440\u0430\u043c\u0430<\/strong><\/h2>\n\n\n\n<ul><li>\u0417\u043d\u0430\u0439\u043e\u043c\u0441\u0442\u0432\u043e \u0437 \u0430\u0443\u0434\u0438\u0442\u043e\u0440\u0456\u0454\u044e. \u0412\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u0443 \u041f\u0440\u043e\u0433\u0440\u0430\u043c\u0443.<\/li><li>\u0421\u0443\u0447\u0430\u0441\u043d\u0435 \u0440\u043e\u0437\u0443\u043c\u0456\u043d\u043d\u044f \u0442\u0430 \u043f\u043e\u043d\u044f\u0442\u0442\u044f \u043a\u0440\u0438\u0442\u0435\u0440\u0456\u0457\u0432 \u0442\u0430 \u0445\u0430\u0440\u0430\u043a\u0442\u0435\u0440\u0438\u0441\u0442\u0438\u043a \u044f\u043a\u043e\u0441\u0442\u0456 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432 (<em>\u0437\u043e\u043a\u0440\u0435\u043c\u0430, \u043f\u043e\u043d\u044f\u0442\u0442\u044f <\/em><em>Quality<\/em><em> \u044f\u043a \u0442\u0430\u043a\u0435, \u0430 \u0442\u0430\u043a\u043e\u0436 \u043f\u043e\u043d\u044f\u0442\u0442\u044f QTPP, CQA<\/em><em>s<\/em><em>, CPP<\/em><em>s<\/em><em>, \u0442\u043e\u0449\u043e<\/em>). \u0420\u043e\u0437\u0443\u043c\u0456\u043d\u043d\u044f \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e\u0441\u0442\u0456 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u043e\u0433\u043e \u0437\u0430\u0441\u043e\u0431\u0443 \u0432\u0438\u043c\u043e\u0433\u0430\u043c \u0420\u0435\u0454\u0441\u0442\u0440\u0430\u0446\u0456\u0439\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u044c\u0454 = \u0422\u043e\u0440\u0433\u043e\u0432\u043e\u0457 \u043b\u0456\u0446\u0435\u043d\u0437\u0456\u0457 (<em>Marketing<\/em><em> <\/em><em>Authorization<\/em>) \u0442\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u0456\u0441\u0442\u044c \u043f\u0440\u0430\u0432\u0438\u043b\u0430\u043c GMP \u0456 GxP. \u0420\u043e\u0437\u043f\u043e\u0434\u0456\u043b \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u043b\u044c\u043d\u043e\u0441\u0442\u0456 (<em>responsibility<\/em>) \u0437\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0439 \u0437\u0430\u0441\u0456\u0431 \u0442\u0430 \u0435\u0442\u0430\u043f\u0438 \u0439\u043e\u0433\u043e \u0436\u0438\u0442\u0442\u0454\u0432\u043e\u0433\u043e \u0446\u0438\u043a\u043b\u0443 (<em>product<\/em><em> <\/em><em>life<\/em><em> <\/em><em>cycle<\/em>).<\/li><li>\u0421\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u044f \u043a\u043e\u043c\u0435\u0440\u0446\u0456\u0439\u043d\u0438\u0445 \u0441\u0435\u0440\u0456\u0439 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \\ \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432 \u0434\u043b\u044f \u0432\u0438\u043f\u0443\u0441\u043a\u0443 \u0443 \u0440\u0435\u0430\u043b\u0456\u0437\u0430\u0446\u0456\u044e (\u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u044e) \u0442\u0430\\\u0430\u0431\u043e \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e\u0441\u0442\u0456 \u0441\u0435\u0440\u0456\u0439 \u0423\u043f\u043e\u0432\u043d\u043e\u0432\u0430\u0436\u0435\u043d\u043e\u044e \u043e\u0441\u043e\u0431\u043e\u044e \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0457 \u043a\u043e\u043c\u043f\u0430\u043d\u0456\u0457 (\u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u043e\u0457 \u0434\u0456\u043b\u044c\u043d\u0438\u0446\u0456 \\ \u043f\u043b\u043e\u0449\u0430\u0434\u043a\u0438):<\/li><li>\u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0442 \u0441\u0435\u0440\u0456\u0457 (<em>Batch<\/em><em> <\/em><em>Certificate<\/em>), \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0442 \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e\u0441\u0442\u0456 \u043d\u0435\u043a\u0456\u043d\u0446\u0435\u0432\u043e\u0433\u043e \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0443 (<em>Confirmation<\/em><em> <\/em><em>of<\/em><em> <\/em><em>the<\/em><em> <\/em><em>partial<\/em><em> <\/em><em>manufacturing<\/em><em> <\/em><em>of<\/em><em> <\/em><em>a<\/em><em> <\/em><em>medicinal<\/em><em> <\/em><em>product<\/em>), \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0442 \u044f\u043a\u043e\u0441\u0442\u0456 (<em>CoA<\/em><em> \u2013 <\/em><em>Certificate<\/em><em> <\/em><em>of<\/em><em> <\/em><em>Analysis<\/em>) \u2013 \u0437\u0433\u0456\u0434\u043d\u043e \u0430\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u0438\u0445 \u0432\u0438\u043c\u043e\u0433, \u0432\u0438\u0437\u043d\u0430\u0447\u0435\u043d\u0438\u0445 \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u0438\u043c\u0438 \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u0430\u043c\u0438;<\/li><li>\u0433\u043e\u043b\u043e\u0432\u043d\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u043b\u044c\u043d\u0456\u0441\u0442\u044c \u0423\u043f\u043e\u0432\u043d\u043e\u0432\u0430\u0436\u0435\u043d\u043e\u0457 \u043e\u0441\u043e\u0431\u0438 (<em>QP \u2013 <\/em><em>Qualified<\/em><em> <\/em><em>Person<\/em>) \\ \u0410\u0432\u0442\u043e\u0440\u0438\u0437\u043e\u0432\u0430\u043d\u043e\u0457 \u043e\u0441\u043e\u0431\u0438 (<em>AP<\/em><em> \u2013 <\/em><em>Authorized<\/em><em> <\/em><em>Person<\/em>) \u0442\u0430 \u0447\u043e\u043c\u0443 QP (AP) \u043d\u0435 \u043f\u043e\u0432\u0438\u043d\u043d\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u0442\u0438 \u0437\u0430 \u0441\u0438\u0441\u0442\u0435\u043c\u0443 \u044f\u043a\u043e\u0441\u0442\u0456;<\/li><li>\u0434\u043e\u0434\u0430\u0442\u043a\u043e\u0432\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u043b\u044c\u043d\u043e\u0441\u0442\u0456 QP (AP) \u043f\u0440\u0438 \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u0457 \u0441\u0435\u0440\u0456\u0457 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432 (<em>Batch<\/em><em> <\/em><em>Certification<\/em>) \u0430\u0431\u043e \u043f\u0440\u0438 \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u0456 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e\u0441\u0442\u0456 \u0441\u0435\u0440\u0456\u0439 (<em>Batch<\/em><em> <\/em><em>Confirmation<\/em>) \u0437\u0433\u0456\u0434\u043d\u043e \u043f\u043e\u043b\u043e\u0436\u0435\u043d\u044c \u043f\u0440\u0430\u0432\u0438\u043b GMP EU \u0442\u0430 GMP PIC\/S;<\/li><li>\u0441\u043f\u0435\u0446\u0438\u0444\u0456\u043a\u0430 \u043e\u0446\u0456\u043d\u043a\u0438 \u0434\u043e\u0441\u044c\u0454 \u0441\u0435\u0440\u0456\u0439 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432 \u0437 \u043c\u0435\u0442\u043e\u044e \u043d\u0430\u0434\u0430\u043d\u043d\u044f \u0434\u043e\u0437\u0432\u043e\u043b\u0443 \u043d\u0430 \u0457\u0445 \u0440\u0435\u0430\u043b\u0456\u0437\u0430\u0446\u0456\u044e (<em>Batch<\/em><em> <\/em><em>Release<\/em>), \u0430\u043a\u0446\u0435\u043d\u0442\u0438 \u0443\u0432\u0430\u0433\u0438 \u043f\u0456\u0434 \u0447\u0430\u0441 \u043e\u0433\u043b\u044f\u0434\u0443 \u0434\u043e\u0441\u044c\u0454 (<em>review<\/em><em> <\/em><em>of<\/em><em> <\/em><em>batch<\/em><em> <\/em><em>records<\/em>) \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u043b\u044c\u043d\u0438\u043c\u0438 (\u0432\u0438\u0437\u043d\u0430\u0447\u0435\u043d\u0438\u043c\u0438) \u043e\u0441\u043e\u0431\u0430\u043c\u0438 \u0442\u0430 \u0423\u043f\u043e\u0432\u043d\u043e\u0432\u0430\u0436\u0435\u043d\u043e\u044e \u043e\u0441\u043e\u0431\u043e\u044e \u0449\u043e\u0434\u043e \u043a\u0440\u0438\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0430\u0440\u0430\u043c\u0435\u0442\u0440\u0456\u0432 \u043f\u0440\u043e\u0446\u0435\u0441\u0443 (<em>CPPs<\/em><em> \u2013 <\/em><em>Critical<\/em><em> <\/em><em>Process<\/em><em> <\/em><em>Parameters<\/em>) \u0442\u0430 \u043a\u0440\u0438\u0442\u0438\u0447\u043d\u0438\u0445 \u0430\u0442\u0440\u0438\u0431\u0443\u0442\u0456\u0432 \u044f\u043a\u043e\u0441\u0442\u0456 (<em>CQAs<\/em><em> \u2013 <\/em><em>Critical<\/em><em> <\/em><em>Quality<\/em><em> <\/em><em>Attributes<\/em>);<ul><li>\u0434\u0435\u044f\u043a\u0456 \u0434\u043e\u0434\u0430\u0442\u043a\u043e\u0432\u0456 \u0430\u0441\u043f\u0435\u043a\u0442\u0438 \u043e\u0433\u043b\u044f\u0434\u0443 \u0434\u043e\u0441\u044c\u0454 \u0441\u0435\u0440\u0456\u0439 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432 \u043f\u0440\u0438 \u0457\u0445 \u0441\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u0457 \u0430\u0431\u043e \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u0456 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e\u0441\u0442\u0456.<\/li><\/ul><\/li><li>\u041c\u0456\u043d\u0456-\u0442\u0440\u0435\u043d\u0456\u043d\u0433\u0438 \u043f\u043e \u0445\u043e\u0434\u0443 \u041f\u0440\u043e\u0433\u0440\u0430\u043c\u0438 \u0443 \u0444\u043e\u0440\u043c\u0456 \u00ab\u0431\u043b\u0456\u0446-\u043f\u0438\u0442\u0430\u043d\u044c \u0432\u0456\u0434 \u0442\u0440\u0435\u043d\u0435\u0440\u0443 \\ \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0456 \u0441\u043b\u0443\u0445\u0430\u0447\u0456\u0432\u00bb.<\/li><li>\u0412\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0456 \u043d\u0430 \u0434\u0438\u0441\u043a\u0443\u0441\u0456\u0439\u043d\u0456 \u043f\u0438\u0442\u0430\u043d\u043d\u044f \u0441\u043b\u0443\u0445\u0430\u0447\u0456\u0432 (<em>\u043f\u043e \u0445\u043e\u0434\u0443 \u0441\u0435\u043c\u0456\u043d\u0430\u0440\u0443 \u0442\u0430 \u0432 \u043c\u0435\u0436\u0430\u0445 \u0442\u0435\u043c\u0430\u0442\u0438\u043a\u0438<\/em>).<\/li><li>\u0417\u0430\u0432\u0435\u0440\u0448\u0435\u043d\u043d\u044f \u041f\u0440\u043e\u0433\u0440\u0430\u043c\u0438.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>4 \u0431\u0430\u043b\u0438 \u0411\u041f\u0420 \u0414\u0430\u0442\u0430:\u00a003.06.2026 \u0427\u0430\u0441:&nbsp;10:00-13:00 \u0410\u0432\u0442\u043e\u0440 \u0442\u0430 \u043b\u0435\u043a\u0442\u043e\u0440 \\ \u0432\u0438\u043a\u043b\u0430\u0434\u0430\u0447: \u041d\u0456\u043a\u0456\u0442\u044e\u043a \u0412\u0430\u043b\u0435\u0440\u0456\u0439 \u0413\u0440\u0438\u0433\u043e\u0440\u043e\u0432\u0438\u0447 \u2013 \u043a\u0430\u043d\u0434. \u0444\u0430\u0440\u043c. \u043d\u0430\u0443\u043a, Ph.D. (main specialty \u2013 Pharmaceutical Sciences), \u043d\u0435\u0437\u0430\u043b\u0435\u0436\u043d\u0438\u0439 \u0435\u043a\u0441\u043f\u0435\u0440\u0442 \\ \u0430\u0443\u0434\u0438\u0442\u043e\u0440\u0438 (\u0456\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440) \\ \u0442\u0440\u0435\u043d\u0435\u0440 (coach) GMP \/&nbsp; GDP \/ GxP, \u0456\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440 GMP\/GDP, \u0441\u0445\u0432\u0430\u043b\u0435\u043d\u0438\u0439 PIC\/S, \u0441\u043f\u0456\u0432-\u0440\u043e\u0437\u0440\u043e\u0431\u043d\u0438\u043a (\u0441\u043f\u0456\u0432-\u0430\u0432\u0442\u043e\u0440) \u043d\u0430\u0446\u0456\u043e\u043d\u0430\u043b\u044c\u043d\u043e\u0457 \u0421\u0438\u0441\u0442\u0435\u043c\u0438 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0438\u0437\u0430\u0446\u0456\u0457 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457 (\u041d\u0430\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0421\u0422-\u041d \u041c\u041e\u0417\u0423 42-1.0:2005) \u041d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043d\u0430 \u0431\u0430\u0437\u0430 (\u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u0456 \u0442\u0430<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"single-service.php","format":"standard","meta":[],"categories":[12],"tags":[],"translation":{"provider":"WPGlobus","version":"3.0.1","language":"ru","enabled_languages":["ua","ru"],"languages":{"ua":{"title":true,"content":true,"excerpt":false},"ru":{"title":false,"content":false,"excerpt":false}}},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u0421\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0446\u0456\u044f \u0441\u0435\u0440\u0456\u0457 (Batch Certification) \u0434\u043b\u044f \u0432\u0438\u043f\u0443\u0441\u043a\u0443 \u0443 \u0434\u0438\u0441\u0442\u0440\u0438\u0431\u0443\u0446\u0456\u044e (release for distribution) \u0442\u0430 \u043f\u0456\u0434\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u0441\u0435\u0440\u0456\u0457 (Batch Confirmation) \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0423\u043f\u043e\u0432\u043d\u043e\u0432\u0430\u0436\u0435\u043d\u043e\u044e \u043e\u0441\u043e\u0431\u043e\u044e (QP) \u2013 \u043f\u043e\u043d\u044f\u0442\u0442\u044f \u0442\u0430 \u043e\u0441\u043d\u043e\u0432\u043d\u0456 \u0441\u043a\u043b\u0430\u0434\u043e\u0432\u0456 \u0432 \u0440\u0430\u043c\u043a\u0430\u0445 \u043f\u0440\u0430\u0432\u0438\u043b GMP \u0442\u0430 \u0456\u043d\u0448\u0438\u0445 \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u043e \u0432\u0438\u0437\u043d\u0430\u043d\u0438\u0445 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u0456\u0432 \u0443 \u0441\u0444\u0435\u0440\u0456 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0456\u0432<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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