Department performs physical-chemical quality control of medicaments, including:
Regular monitoring of the quality of each medicaments product marketed in the country, at least once every five years;
quality control of the first batch of the medicaments after obtaining approval for marketing;
quality control at the request of the Bureau in the process of obtaining approval for the release of the medicinal product or issue a permit at the request of the inspection;
specific quality control of specific categories of medicaments at the request of the Bureau;
quality control of medicaments in circulation for manufacturers when there is prior agreement on such cooperation.
To carry out the laboratory control is using the following techniques: high performance liquid chromatography, gas chromatography, infrared, UV and visible spectroscopy, gravimetric techniques, volumetric techniques, Karl Fischer titration, and according to specifications and methods described in the current editions of the European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP), British Pharmacopoeia (BP) and validated methods producer of the finished product.
Besides these activities there is a professional assessment in 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.
