Head of Team
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