Quality Control Section

Head of Section

Agnieszka Zielińska, M. Sc.

tel. +48 22 568 26 64

The Quality Control Team carries out analysis in the field of control:

  • starting materials used for the production of active substances and drug products
  • semi products manufactured in the production process (in-process tests)
  • final products – active substances and drug products
  • the packaging materials in which the active substances are stored
  • manufacturing conditions, including cleaning processes of technological equipment

according to Ph. Eur., USP, FP in GMP standard with the issue of a quality control certificate.

The scope of the team’s activity also includes:

  • stability tests (long-term, accelerated, intermediate) carried out in accordance with the international ICH guidelines: “Stability” Q1A-Q1F;
  • aging tests a for both active substances produced by the Łukasiewicz Research Network – Industrial Chemistry Institute, as well as on medicinal products commissioned by contractors.
  • standardization of standards of active substances and their impurities used in various projects carried out by the Łukasiewicz Research Network – Institute of Industrial Chemistry and offered for commercial purposes.
  • development and validation of analytical methods in accordance with the current ICH requirement
  • transfer of analytical methods
  • development and validation of analytical methods used in the cleaning process of technological equipment used in the production of active substances and medicinal products.
  • determination of residual solvents in active substances by the classical method and Head Space.
  • pharmaceutical availability studies (release profiles).

Based on regular inspections carried out by the Chief Pharmaceutical Inspectorate (GIF), the Łukasiewicz Research Network – Industrial Chemistry Institute holds Certificates that confirm the compliance of the conditions for manufacturing active substances with GMP requirements. In addition, the Quality Control Team has a GIF license to manufacture a medicinal product in the scope of manufacturing operations: physicochemical tests in quality control. The team accepts analysis on request with the use of available techniques and after signing appropriate quality agreements.

Research potential:

The research is carried out with the use of high-class apparatus based on a wide spectrum of separation, isolation and identification techniques.

  • High Performance Liquid Chromatography (HPLC, UPLC)
  • Gas Chromatography (GC-FID, GC-HS)
  • Thin Layer Chromatography (TLC)
  • Infrared IR spectroscopy
  • Ultraviolet and visible light spectroscopy (UV-VIS)
  • Instrumental and Classical Analysis