{"id":5041,"date":"2023-01-19T13:04:05","date_gmt":"2023-01-19T10:04:05","guid":{"rendered":"https:\/\/sttd.com.ua\/?p=5041"},"modified":"2026-01-06T17:02:52","modified_gmt":"2026-01-06T14:02:52","slug":"sterilnye-ls-gmp-annex-1-ekspress-analiz-versii-2022-goda","status":"publish","type":"post","link":"https:\/\/sttd.com.ua\/ua\/sterilnye-ls-gmp-annex-1-ekspress-analiz-versii-2022-goda\/","title":{"rendered":"\u0421\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u0456 \u041b\u0417 (GMP Annex 1+\u0430\u043d\u0430\u043b\u0456\u0437 \u0432\u0435\u0440\u0441\u0456\u0457 2022 \u0440\u043e\u043a\u0443)"},"content":{"rendered":"\n<h3><strong><span style=\"color:#0d6c1e\" class=\"has-inline-color\">\u0412\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u0438\u0445 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432. (GMP Annex 1+ \u0435\u043a\u0441\u043f\u0440\u0435\u0441-\u0430\u043d\u0430\u043b\u0456\u0437 \u0432\u0435\u0440\u0441\u0456\u0457 2022 \u0440\u043e\u043a\u0443). \u041c\u043e\u0434\u0435\u043b\u044e\u0432\u0430\u043d\u043d\u044f \u043f\u0440\u043e\u0446\u0435\u0441\u0443 \u0430\u0441\u0435\u043f\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u0437\u0430\u043f\u043e\u0432\u043d\u0435\u043d\u043d\u044f. \u041c\u043e\u043d\u0456\u0442\u043e\u0440\u0438\u043d\u0433 \u0442\u0430 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c<\/span><\/strong><\/h3>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>\u0424\u043e\u0440\u043c\u0430\u0442 \u0442\u0430 \u0442\u0440\u0438\u0432\u0430\u043b\u0456\u0441\u0442\u044c: <\/strong>3 \u0434\u043d\u0456, 12 \u0430\u043a\u0430\u0434\u0435\u043c\u0456\u0447\u043d\u0438\u0445 \u0433\u043e\u0434\u0438\u043d, \u0432\u0456\u0434\u0435\u043e\u0443\u0440\u043e\u043a\u0438 \u043d\u0430 \u043f\u043b\u0430\u0442\u0444\u043e\u0440\u043c\u0456 Google-class<\/p>\n\n\n\n<p><strong>\u0410\u0432\u0442\u043e\u0440 \u0442\u0430 \u0432\u0435\u0434\u0443\u0447\u0430:<\/strong> \u0411\u0430\u0440\u0430\u043d\u043e\u0432\u0430 \u042e\u043b\u0456\u044f &#8211; \u200b\u200b\u043d\u0430\u0447\u0430\u043b\u044c\u043d\u0438\u043a \u0432\u0456\u0434\u0434\u0456\u043b\u0443 \u0437\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0435\u043d\u043d\u044f \u044f\u043a\u043e\u0441\u0442\u0456, \u0442\u0440\u0435\u043d\u0435\u0440 \u0437 \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u043d\u0438\u043c \u0434\u043e\u0441\u0432\u0456\u0434\u043e\u043c \u0440\u043e\u0437\u0440\u043e\u0431\u043a\u0438 \u0442\u0430 \u0432\u043f\u0440\u043e\u0432\u0430\u0434\u0436\u0435\u043d\u043d\u044f \u0441\u0438\u0441\u0442\u0435\u043c \u043c\u0435\u043d\u0435\u0434\u0436\u043c\u0435\u043d\u0442\u0443 \u044f\u043a\u043e\u0441\u0442\u0456 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e \u0434\u043e \u0432\u0438\u043c\u043e\u0433 \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0456\u0432 GMP, GDP, ISO 9001, ISO 13485, ISO 22000. \u0414\u043e\u0441\u0432\u0456\u0434 \u0440\u043e\u0431\u043e\u0442\u0438 \u0443 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0456\u0439 \u0433\u0430\u043b\u0443\u0437\u0456 \u043f\u043e\u043d\u0430\u0434 20 \u0440\u043e\u043a\u0456\u0432, \u0443 \u0442\u043e\u043c\u0443 \u0447\u0438\u0441\u043b\u0456 \u0443 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0456 \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u0438\u0445, \u0456\u043c\u0443\u043d\u043e\u0431\u0456\u043e\u043b\u043e\u0433\u0456\u0447\u043d\u0438\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432, \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432 \u0431\u0456\u043e\u043b\u043e\u0433\u0456\u0447\u043d\u043e\u0433\u043e \u043f\u043e\u0445\u043e\u0434\u0436\u0435\u043d\u043d\u044f, \u0442\u0435\u0445\u043d\u0456\u0447\u043d\u0438\u0439 \u0435\u043a\u0441\u043f\u0435\u0440\u0442 \u0414\u041f \u00ab\u0425\u0430\u0440\u043a\u0456\u0432\u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043c\u0435\u0442\u0440\u043e\u043b\u043e\u0433\u0456\u044f\u00bb.<\/p>\n\n\n\n<p><em><strong>\u041c\u0435\u0442\u0430<\/strong> <strong>\u0456\u043d\u0442\u0435\u0440\u0430\u043a\u0442\u0438\u0432\u043d\u043e\u0433\u043e \u043a\u0443\u0440\u0441\u0443: <\/strong>\u043e\u0437\u043d\u0430\u0439\u043e\u043c\u043b\u0435\u043d\u043d\u044f \u0441\u043b\u0443\u0445\u0430\u0447\u0456\u0432 \u0437 \u0430\u043a\u0442\u0443\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0438\u043c\u0438 \u0432\u0438\u043c\u043e\u0433\u0430\u043c\u0438 \u0414\u043e\u0434\u0430\u0442\u043a\u0430 1 GMP, \u043e\u0442\u0440\u0438\u043c\u0430\u043d\u043d\u044f \u0442\u0435\u043e\u0440\u0435\u0442\u0438\u0447\u043d\u0438\u0445 \u0442\u0430 \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u043d\u0438\u0445 \u0437\u043d\u0430\u043d\u044c \u0449\u043e\u0434\u043e \u0432\u0438\u043c\u043e\u0433 \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 \u0434\u043e \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457. \u041e\u0437\u043d\u0430\u0439\u043e\u043c\u043b\u0435\u043d\u043d\u044f \u0456\u0437 \u043a\u043b\u044e\u0447\u043e\u0432\u0438\u043c\u0438 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0430\u043c\u0438 \u0437\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0435\u043d\u043d\u044f \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0441\u0442\u0456 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432. \u0412\u0438\u0432\u0447\u0435\u043d\u043d\u044f \u043e\u0441\u043d\u043e\u0432\u043d\u0438\u0445 \u0430\u0441\u043f\u0435\u043a\u0442\u0456\u0432 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457 \u0442\u0430 \u043c\u043e\u043d\u0456\u0442\u043e\u0440\u0438\u043d\u0433\u0443 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430. \u0417\u0434\u043e\u0431\u0443\u0442\u0442\u044f \u043f\u0440\u0430\u043a\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u0434\u043e\u0441\u0432\u0456\u0434\u0443 \u0443 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u0456 \u043c\u043e\u0434\u0435\u043b\u044e\u0432\u0430\u043d\u043d\u044f \u0430\u0441\u0435\u043f\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u043d\u0430\u043f\u043e\u0432\u043d\u0435\u043d\u043d\u044f.<\/em><\/p>\n\n\n\n<p><strong>\u041a\u0443\u0440\u0441 \u043f\u0440\u0438\u0437\u043d\u0430\u0447\u0435\u043d\u0438\u0439 \u0434\u043b\u044f: <\/strong>\u043a\u0435\u0440\u0456\u0432\u043d\u0438\u043a\u0456\u0432 \u0442\u0430 \u0441\u043f\u0456\u0432\u0440\u043e\u0431\u0456\u0442\u043d\u0438\u043a\u0456\u0432 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0447\u0438\u0445 \u043f\u0456\u0434\u0440\u043e\u0437\u0434\u0456\u043b\u0456\u0432, \u0432\u0456\u0434\u0434\u0456\u043b\u0443 \u0437\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0435\u043d\u043d\u044f \u044f\u043a\u043e\u0441\u0442\u0456, \u0432\u0456\u0434\u0434\u0456\u043b\u0443 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u044f\u043a\u043e\u0441\u0442\u0456, \u0430 \u0442\u0430\u043a\u043e\u0436 \u0434\u043b\u044f \u0444\u0430\u0445\u0456\u0432\u0446\u0456\u0432, \u0437\u0430\u0439\u043d\u044f\u0442\u0438\u0445 \u0443 \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0456 \u0442\u0430 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u0456 \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457.<\/p>\n\n\n\n<p><strong>\u0414\u043b\u044f \u0443\u0447\u0430\u0441\u0442\u0456 \u043f\u043e\u0442\u0440\u0456\u0431\u043d\u0430 <span class=\"has-inline-color has-vivid-red-color\">gmail-\u0430\u0434\u0440\u0435\u0441\u0430 \u0443\u0447\u0430\u0441\u043d\u0438\u043a\u0430<\/span>.<\/strong><\/p>\n\n\n\n<h2 class=\"has-text-align-center\"><strong>\u0421\u0442\u0440\u0443\u043a\u0442\u0443\u0440\u0430 \u043a\u0443\u0440\u0441\u0443:<\/strong><\/h2>\n\n\n\n<p>1. \u0410\u043a\u0442\u0443\u0430\u043b\u0456\u0437\u043e\u0432\u0430\u043d\u0456 \u0432\u0438\u043c\u043e\u0433\u0438 Annex 1 \u0434\u043e \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0433\u043e \u0432\u0438\u0440\u043e\u0431\u043d\u0438\u0446\u0442\u0432\u0430 (\u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0430 \u0441\u0438\u0441\u0442\u0435\u043c\u0430 \u044f\u043a\u043e\u0441\u0442\u0456, \u043f\u0440\u0438\u043c\u0456\u0449\u0435\u043d\u043d\u044f, \u043e\u0431\u043b\u0430\u0434\u043d\u0430\u043d\u043d\u044f).<\/p>\n\n\n\n<p>2. \u041e\u0441\u043d\u043e\u0432\u043d\u0456 \u0432\u0438\u043c\u043e\u0433\u0438 \u0434\u043e \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0456\u0447\u043d\u043e\u0433\u043e \u043f\u0440\u043e\u0446\u0435\u0441\u0443 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u043d\u043e \u0434\u043e G\u041cP: \u0437\u0430\u043f\u043e\u0431\u0456\u0433\u0430\u043d\u043d\u044f \u043f\u0435\u0440\u0435\u0445\u0440\u0435\u0441\u043d\u043e\u0457 \u043a\u043e\u043d\u0442\u0430\u043c\u0456\u043d\u0430\u0446\u0456\u0457, \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u043c\u0456\u043a\u0440\u043e\u0431\u0456\u043e\u043b\u043e\u0433\u0456\u0447\u043d\u043e\u0457 \u0447\u0438\u0441\u0442\u043e\u0442\u0438 \u043f\u0456\u0434\u0433\u043e\u0442\u043e\u0432\u043b\u0435\u043d\u043e\u0433\u043e \u043f\u043e\u0432\u0456\u0442\u0440\u044f \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c\u043e\u0432\u0430\u043d\u0438\u0445 \u0437\u043e\u043d \u0442\u0430 \u043f\u0440\u0438\u043c\u0456\u0449\u0435\u043d\u044c, \u043e\u0431\u043b\u0430\u0434\u043d\u0430\u043d\u043d\u044f, \u043e\u0434\u044f\u0433\u0443 \u0442\u0430 \u0440\u0443\u043a \u043f\u0435\u0440\u0441\u043e\u043d\u0430\u043b\u0443, \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u0447\u0430\u0441\u0442\u043e\u043a \u0443 \u043f\u043e\u0432\u0456\u0442\u0440\u0456 \u0447\u0438\u0441\u0442\u0438\u0445 \u043f\u0440\u0438\u043c\u0456\u0449\u0435\u043d\u044c \u0442\u0430 \u0447\u0438\u0441\u0442\u0438\u0445 \u0437\u043e\u043d.<\/p>\n\n\n\n<p>3. \u041f\u0435\u0440\u0441\u043e\u043d\u0430\u043b \u043f\u0456\u0434\u043f\u0440\u0438\u0454\u043c\u0441\u0442\u0432\u0430 \u0413\u0456\u0433\u0456\u0454\u043d\u0456\u0447\u043d\u0456 \u0432\u0438\u043c\u043e\u0433\u0438 \u0442\u0430 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 \u043f\u043e\u0432\u0435\u0434\u0456\u043d\u043a\u0438 \u0443 \u0447\u0438\u0441\u0442\u0438\u0445 \u043f\u0440\u0438\u043c\u0456\u0449\u0435\u043d\u043d\u044f\u0445. \u0422\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0456\u0447\u043d\u0438\u0439 \u043e\u0434\u044f\u0433 \u0442\u0430 \u043f\u043e\u0440\u044f\u0434\u043e\u043a \u043f\u0435\u0440\u0435\u0432\u0434\u044f\u0433\u0430\u043d\u043d\u044f.<\/p>\n\n\n\n<p>4. \u041c\u043e\u0434\u0435\u043b\u044e\u0432\u0430\u043d\u043d\u044f \u043f\u0440\u043e\u0446\u0435\u0441\u0443 \u0430\u0441\u0435\u043f\u0442\u0438\u0447\u043d\u043e\u0433\u043e \u043d\u0430\u043f\u043e\u0432\u043d\u0435\u043d\u043d\u044f (\u041cFT). \u041e\u0441\u043d\u043e\u0432\u043d\u0456 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e. \u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u0441\u0442\u0435\u0440\u0438\u043b\u044c\u043d\u043e\u0441\u0442\u0456 (\u043c\u0435\u0442\u043e\u0434 \u043c\u0435\u043c\u0431\u0440\u0430\u043d\u043d\u043e\u0457 \u0444\u0456\u043b\u044c\u0442\u0440\u0430\u0446\u0456\u0457, \u043f\u0440\u044f\u043c\u043e\u0433\u043e \u043f\u043e\u0441\u0456\u0432\u0443).<\/p>\n\n\n\n<p><strong>\u041f\u043e \u043a\u043e\u0436\u043d\u043e\u043c\u0443 \u0440\u043e\u0437\u0434\u0456\u043b\u0443:<\/strong><\/p>\n\n\n\n<ul><li>\u0412\u0456\u0434\u0435\u043e\u043f\u0440\u0435\u0437\u0435\u043d\u0442\u0430\u0446\u0456\u044f<\/li><li>\u041f\u0440\u0435\u0437\u0435\u043d\u0442\u0430\u0446\u0456\u044f \u0443 pdf<\/li><li>\u0414\u043e\u0434\u0430\u0442\u043a\u043e\u0432\u0430 \u043e\u043d\u043b\u0430\u0439\u043d-\u043b\u0456\u0442\u0435\u0440\u0430\u0442\u0443\u0440\u0430<\/li><li>\u0417\u0430\u043f\u0438\u0442\u0430\u043d\u043d\u044f \u0432\u0438\u043a\u043b\u0430\u0434\u0430\u0447\u0435\u0432\u0456<\/li><li>\u0417\u0430\u0432\u0434\u0430\u043d\u043d\u044f \u0437 \u0443\u0441\u0456\u0445 \u0442\u0435\u043c.<\/li><\/ul>\n\n\n\n<p>\ud83d\udcb0 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