ОАО "Biosintez"
Within the limits of certified audit the estimation of observance of requirements GMP on an industrial site, and also an estimation of functioning of a control system by quality at the enterprise as a whole has been spent. Check has been concentrated to documentation systems, validation, quality managements, training of the personnel, storage of raw materials and finished goods, the equipment, the organization of productions, the monitoring system of quality, self-inspection. According to "Biosintez" management, the new line on manufacture of powders for injections has been executed by Miass Factory of Medical Equipment and the line has started to be maintained in January, 2007. Initially is designed according to operating state standards and the international standards GMP.
Farmacevticheskij VESTNIK№ 27 (474) on August, 28th, 2007
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