The Laboratory for Quality Control of Medicines of Vitebsk Medical University will undergo accreditation by Gosstandart
February 12, Vitebsk / Sergey Kotovets - BELTA/. Vitebsk State Medical University (VSMU) plans to have its university laboratory for standardization and quality control of medicines accredited by the State Committee for Standardization of the Republic of Belarus (Gosstandart) in 2010, which will significantly expand the powers of the university's structural unit in conducting control tests of medicines. This was reported to a BELTA correspondent by the head of the laboratory, Candidate of Pharmaceutical Sciences Vasily Fadeev.
The laboratory for standardization and control was established at the medical university in 2007 for conducting scientific research and development, including for the preparation of dissertations for academic degrees by university staff. In addition, the laboratory is involved in testing medicines that are developed in Belarus and are being prepared for implementation. In terms of equipment, including technological equipment, the laboratory is among the leading institutions in the country. Modern equipment allows for testing using methods of molecular infrared and ultraviolet spectroscopy, and high-performance liquid and gas chromatography. On its basis, studies of pharmaceutical equivalence of medicines are carried out using dissolution kinetics tests. The laboratory also serves as an analytical base for conducting bioequivalence tests of generic medicines.
Accreditation by Gosstandart of Belarus will confirm the competence and independence of the laboratory and will enable it to control the quality of medicines already used in pharmaceutical and medical practice. After accreditation, the VSMU laboratory will become the second such institution in the country authorized to standardize new medicines and control the quality of already used medical drugs, explained Vasily Fadeev. To undergo accreditation, the university plans to implement a set of measures, including purchasing additional equipment, updating reagents, and updating work methodologies. Preparation for accreditation is expected to be completed in the first half of the year.
The inclusion of the laboratory in the drug control system will increase the turnover rate of medicines in the domestic market. This is particularly relevant during periods of seasonal outbreaks of diseases, when it is necessary to purchase many new types of medicines and ensure their prompt quality control and certification for subsequent sale in the pharmacy network, noted Vasily Fadeev. -0-