Pharmaceutical quality control

Pharmaceutical quality control

General information

Physical and Chemical Quality Control Department of the National Anti-Doping Laboratory provides a wide range of services for manufacturers of pharmaceuticals and veterinary drugs.

In our work we are guided by the requirements of GOST ISO/IEC 17025-2019 "General requirements for the competence of testing and calibration laboratories" and TCP 2010-2017 (33050) "Good manufacturing practice", the requirements and recommendations of ICH and EDQM. High qualification of our specialists and excellent technical equipment allow us to quickly solve tasks arising during the production, development and registration of pharmaceuticals. Our customers are all major pharmaceutical manufacturers of the Republic of Belarus and young pharmaceutical companies that launch their own production of pharmaceuticals, as well as a number of transnational manufacturers. We are very responsive to the demands of our customers and are open for cooperation regardless of whether a simple test, non-standard analysis or a research project is required.

Our services:

  • Routine quality control tests of synthetic, biological and biotechnological pharmaceuticals, pharmaceutical substances, raw materials and other materials, veterinary drugs;
  • Development, validation, transfer of test methods;
  • Tests and research in the pharmaceutical development;
  • Comparative Dissolution Kinetics Tests;
  • Stability studies of pharmaceuticals, storage of pharmaceuticals in climate chambers in conditions for the long-term and accelerated stability testing;
  • Sample analysis during validation of equipment cleaning processes;
  • Sample selection.

Our methods:

  • Liquid chromatography (ultra and high performance):
    • diode array detector;
    • fluorimetric detector;
    • refractometric detector;
    • conductometric detector.
  • Gas chromatography (flame ionization detector):
    • direct injection;
    • headspace injection.
  • Mass spectrometry:
    • HPLC-MS;
    • GC-MS.
  • Thin layer chromatography;
  • Capillary electrophoresis;
  • Ultraviolet/Visible light absorption spectrophotometry;
  • Infrared absorption spectrophotometry;
  • Inductively coupled plasma atomic emission spectroscopy;
  • Optical microscopy;
  • Melting point determination by instrumental method;
  • Determination of relative density using oscillation-type density meter;
  • Pharmaceutical quality control according to the indicators “Description”, “Packaging”, “Labeling”;
  • Classical pharmacopoeial tests (clarity and degree of opalescence of liquids, degree of coloration, loss on drying, heavy metals, sulphated ash and others).

Additional Information

The National Anti-Doping Laboratory is a testing laboratory accredited in the accreditation system of the Republic of Belarus for testing pharmaceuticals and pharmaceutical substances registered in the Republic of Belarus prior to selling in accordance with Resolution of the Ministry of Health of the Republic of Belarus of 1 March 2010 No. 20.

The National Anti-Doping Laboratory conducts approbation of methods for quality control of pharmaceuticals and pharmaceutical substances submitted for state registration (confirmation of state registration) according on referral of Center for Examinations and Tests in Health Service in accordance with Resolution of the Council of Ministers of the Republic of Belarus No. 254 of 1 April 2015.

 The decision rule for conformity assessment