Державна науково-дослідна лабораторія з контролю якості лікарських засобів НФаУ (ДНДЛ з КЯЛЗ) була створена у складі Національного фармацевтичного університету у відповідності до наказу МОЗ України № 134 (п. 4) від 15.09.1992 р. з метою забезпечення розробки і впровадження нових методів аналізу лікарських засобів, а також удосконалення діяльності системи контролю якості лікарських засобів в Україні. Наказом ректора НФаУ № 91 від 04.05.1995 р. на посаду завідувача лабораторією був призначений д.х.н., проф. Коваленко Сергій Миколайович. З липня 2014 р. на посаду завідувача лабораторією призначена к.фарм.н. Губарь Світлана Миколаївна.

Лабораторія є уповноваженою лабораторією та взаємодіє у своїй діяльності з Державною службою України з лікарських засобів та контролю за наркотиками

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За принципом функціонального підпорядкування Лабораторія має Сектор фармакокінетичних досліджень та біоеквівалентності.     У складі лабораторії працюють досвідчені та висококваліфіковані фахівці, серед яких професори, доктори хімічних і фармацевтичних наук, кандидати фармацевтичних і хімічних наук, співробітники з вищою фармацевтичною і вищою хімічною освітою, провізори вищої категорії.

Лабораторія постійно приймає участь в міжлабораторних програмах професійного тестування лабораторій з питань забезпечення якості лікарських засобів з метою перевірки виконання належної професійної практики і забезпечення якості робіт, які виконуються лабораторією.

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