GMP

Analytical Testing on Active Pharmaceutical Ingredients and Finished Dosage Forms

In full compliance with GMP requirements (EU-GMP), we store drug substances and finished products in climatized test chambers for short- and long-term stability studies. 

The analyses are carried out in our specialized pharmaceutical control laboratory.

Analytical Services in accordance with GMP
  • Quality control tests for batch release according to specifications and pharmacopoeia
  • In-vitro dissolution tests on formulations
  • Physical tests on solid preparations (hardness, friability, disintegration)
  • Analytical assistance for validation of cleaning procedures
  • Method development and validation in accordance with GMP standards
  • Stability testing (-20°C, 2-8°C, ICH conditions)
  • Determination of elemental impurities