Control Department

Control Department

Quality Control Department – Activities and Services

  • API identification
  • AQL investigations
  • EU import analyses
  • Stability studies according to ICH guidlines
  • Development and validation of analytical methods
  • Analyses of incoming materials and finished products
  • Cleaning validations
  • Microbiological monitoring of clean rooms and equipment

Quality Control Department – Pharmaceutical Tests

  • Average weight & uniformity of weight
  • Disintegration
  • Hardness and friability
  • Dissolution 1 unit equipped with sample collector
  • Loss on drying
  • Karl Fischer Titration

Quality Control Department – Chemical Tests

  • UV-Vis Spectroscopy - Quantitative and identification
  • FTIR Spectroscopy - API and polymer identification
  • 6 HPLC systems - UV-VIS, PDA, RI detection
  • 2 UPLC systems - UV-VIS detection
  • GC with Head Space and FID detection