Laboratory of Production Quality and Safety Control
The Analytical Control Group was established on the basis of the Laboratory of Ecological and Hygienic Safety in 1993, in 2004 it became the lndependent Laboratory of Production Quality and Safety Control.
N.V. Ostanina (ORCID: https://orcid.org/0000-0002-6459-7219), Candidate of Sciences (Economics), is a head of the Laboratory.
Tel.: +38(044)513-71-33, +38(044)292-14-17, e-mail: druglab@ukr.net
The main scientific activities:
The State Scientific-and-Research Laboratory of Medicines Quality Control was set upon the basis of the Laboratory of Production Quality Control, the Laboratory of Sanitary Microbiology and the Clinics of the Experimental Animals. At present it performs testing and research of the quality control of:
- medicines;
- active substances;
- excipients;
- medicinal herbs;
- special foodstuffs (additives);
- medical devices
and other products allowed for sale in pharmacies and their structural units.
The most significant scientific achievements of the Laboratory:
The researchers of the Laboratory :
- proved a necessity of the improvement of the existing legislative base on the production, quality control and final realization of dietary additives in Ukraine and its harmonization with the requirements of the international standards;
- substantiated a necessity of the development and establishment of the state program that would contain the requirements to the performance of sanitary-and-epidemiological and clinical-and-pharmacological examination of the dietary additives, to the performance of the state registration, for the establishment of the association of the production to the existing legislative and normative statements on quality and safety;
- confirmed a need of the development and improvement of the methods for the identification and quantification of the active ingredients of dietary additives on the basis of the analysis of national and international normative documents;
- proved that a qualification of standard (reference) sample affect directly the result of quantitative determination of a specific vitamin or other components;
- performed identification and determination of the quantitative content of active ingredients by HPLC method using validated U.S.P. methods (methods 1 and 2) in nine samples of vitamin dietary additives that had the certificates of sanitary-epidemiological examination and were realized in Ukraine;
- proved practically that a method of atomic absorption spectrometry is the most rapid, precise and modern one for the determination of the quantitative content of selenium in studied samples of dietary additives because it does not require a special test preparation;
- developed and submitted the general article “Dietary Additives” to the State Pharmacopoeia of Ukraine.