{"id":198,"date":"2020-01-12T16:34:23","date_gmt":"2020-01-12T13:34:23","guid":{"rendered":"http:\/\/sttd.com.ua\/?p=198"},"modified":"2021-01-05T14:03:10","modified_gmt":"2021-01-05T11:03:10","slug":"skladannya-validaczijnoyi-dokumentacziyi-protokolu-ta-zvitu-validacziyi1","status":"publish","type":"post","link":"https:\/\/sttd.com.ua\/ua\/skladannya-validaczijnoyi-dokumentacziyi-protokolu-ta-zvitu-validacziyi1\/","title":{"rendered":"\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u043e\u0435 \u0434\u043e\u0441\u044c\u0435. Common Technical Document. \u041c\u043e\u0434\u0443\u043b\u044c 3 \u041a\u0430\u0447\u0435\u0441\u0442\u0432\u043e"},"content":{"rendered":"\n<ul><li>\u041c\u043e\u0434\u0443\u043b\u044c 3.2.S \u2013 \u0410\u043a\u0442\u0438\u0432\u043d\u044b\u0439 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0439 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442 (IPA), Drug Master File \u2013 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u0444\u043e\u0440\u043c\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u0438 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u0430\u0436\u0434\u043e\u043c\u0443 \u0438\u0437 \u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u0438\u0445 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435<\/li><\/ul>\n\n\n\n<ul><li>\u041c\u043e\u0434\u0443\u043b\u044c 3.2.P \u2013 \u0413\u043e\u0442\u043e\u0432\u043e\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0435 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u043e \u2013 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u0444\u043e\u0440\u043c\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u0438 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u0430\u0436\u0434\u043e\u043c\u0443 \u0438\u0437 \u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u0438\u0445 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435: 3.2.P.1. \u041e\u043f\u0438\u0441\u0430\u043d\u0438\u0435 \u0438 \u0441\u043e\u0441\u0442\u0430\u0432 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (Description and Composition of Drug Product); 3.2.P.2. \u0424\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u043a\u0430 (Pharmaceutical Development); 3.2.P.3. \u041f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u043e \u0433\u043e\u0442\u043e\u0432\u043e\u0433\u043e \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430 (Manufacture); 3.2.P.4. \u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u0432\u0441\u043f\u043e\u043c\u043e\u0433\u0430\u0442\u0435\u043b\u044c\u043d\u044b\u0445 \u0432\u0435\u0449\u0435\u0441\u0442\u0432 (Control of Excipients); 3.2.P.5. \u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u0433\u043e\u0442\u043e\u0432\u043e\u0433\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (Control of Drug Product); 3.2.P.6. \u0421\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u044b\u0435 \u043e\u0431\u0440\u0430\u0437\u0446\u044b \u0438 \u0432\u0435\u0449\u0435\u0441\u0442\u0432\u0430 (Reference Standards or Materials); 3.2.P.7. \u0421\u0438\u0441\u0442\u0435\u043c\u0430 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0430\/\u0443\u043a\u0443\u043f\u043e\u0440\u043a\u0430 (Container and Closure of the Finished Medicinal Product); 3.2.P.8. \u0421\u0442\u0430\u0431\u0438\u043b\u044c\u043d\u043e\u0441\u0442\u044c (Stability of the Finished Medicinal Product)<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p><br><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u041c\u043e\u0434\u0443\u043b\u044c 3.2.S \u2013 \u0410\u043a\u0442\u0438\u0432\u043d\u044b\u0439 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0439 \u0438\u043d\u0433\u0440\u0435\u0434\u0438\u0435\u043d\u0442 (IPA), Drug Master File \u2013 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u0444\u043e\u0440\u043c\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u0438 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u0430\u0436\u0434\u043e\u043c\u0443 \u0438\u0437 \u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u0438\u0445 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435 \u041c\u043e\u0434\u0443\u043b\u044c 3.2.P \u2013 \u0413\u043e\u0442\u043e\u0432\u043e\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0435 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u043e \u2013 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u0444\u043e\u0440\u043c\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u0438 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u0430\u0436\u0434\u043e\u043c\u0443 \u0438\u0437 \u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u0438 \u0438\u0445 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0435 \u043d\u0430\u043f\u043e\u043b\u043d\u0435\u043d\u0438\u0435: 3.2.P.1. \u041e\u043f\u0438\u0441\u0430\u043d\u0438\u0435 \u0438 \u0441\u043e\u0441\u0442\u0430\u0432 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (Description<\/p>\n","protected":false},"author":1,"featured_media":2139,"comment_status":"open","ping_status":"open","sticky":false,"template":"single-service.php","format":"standard","meta":[],"categories":[12],"tags":[235,213,232,212,145,245,233],"translation":{"provider":"WPGlobus","version":"3.0.1","language":"ua","enabled_languages":["ru","ua"],"languages":{"ru":{"title":true,"content":true,"excerpt":false},"ua":{"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>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u043e\u0435 \u0434\u043e\u0441\u044c\u0435. 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Common Technical Document. \u041c\u043e\u0434\u0443\u043b\u044c 3 \u041a\u0430\u0447\u0435\u0441\u0442\u0432\u043e \u27a2 \u041d\u0430\u0432\u0447\u0430\u0439\u0442\u0435\u0441\u044c \u043e\u043d\u043b\u0430\u0439\u043d! \u041a\u0443\u0440\u0441\u0438 \u0442\u0430 \u0432\u0435\u0431\u0456\u043d\u0430\u0440\u0438 \u0437 GMP, GDP, GLP, GQSLP, GVP, \u043c\u0456\u043a\u0440\u043e\u0431\u0456\u043e\u043b\u043e\u0433\u0456\u0457, \u043b\u0430\u0431\u043e\u0440\u0430\u0442\u043e\u0440\u043d\u0438\u0445 \u0434\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u044c \u0442\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0438. \u0421\u0435\u043c\u0456\u043d\u0430\u0440\u0438 \u0442\u0430 \u043e\u043d\u043b\u0430\u0439\u043d-\u043a\u043b\u0430\u0441\u0438 \u0434\u043b\u044f \u043f\u0440\u043e\u0444\u0435\u0441\u0456\u0439\u043d\u043e\u0433\u043e \u0440\u043e\u0437\u0432\u0438\u0442\u043a\u0443.\",\"breadcrumb\":{\"@id\":\"https:\/\/sttd.com.ua\/skladannya-validaczijnoyi-dokumentacziyi-protokolu-ta-zvitu-validacziyi1\/#breadcrumb\"},\"inLanguage\":\"uk\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/sttd.com.ua\/skladannya-validaczijnoyi-dokumentacziyi-protokolu-ta-zvitu-validacziyi1\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/sttd.com.ua\/skladannya-validaczijnoyi-dokumentacziyi-protokolu-ta-zvitu-validacziyi1\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u0413\u043b\u0430\u0432\u043d\u0430\u044f \u0441\u0442\u0440\u0430\u043d\u0438\u0446\u0430\",\"item\":\"https:\/\/sttd.com.ua\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u043e\u0435 \u0434\u043e\u0441\u044c\u0435. 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