Activities that the Department performed:
-examination presence / absence of bacterial endotoxin in parenteral preparations imunoserumi for human use, preparations for irrigation, vaccines for human use and containers for pharmaceutical use due to breakdown of possibly present Gram (-) bacteria with negative application of qualitative or quantitative LAL test (Gel-cloth method and Chromogen-kinetic method);
-examination presence / absence of viral markers such as HBsAg, HIV and HCV in blood products and blood derivatives of origin (ELISA technique);
Besides these activities there is a professional assessment delivered pharmaceutical-chemical and biological documentation in order to obtain a marketing authorization for the medicinal product, renewal of authorization of the medicinal product, application of variation and more.
