Head of Section
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.
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