Quality Management and Regulatory Affairs
Quality Control / Quality Assurance
The department of Quality Control/Quality Assurance is responsible for the examination and release of the final products. The monitoring of the quality is supplemented by continuous stability tests and the examination of raw materials.
A team of specialists develops and validates analytical methods. All common analytical methods are implemented, furthermore nuclear magnetic resonance (NMR), mass spectrometry (MS), calorimetry and measurement of particle size and distribution.
All guidelines, like cGMP, ICH Q7A and EU/FDA-Guidelines are carefully applied. Chemical Operations Mannheim is inspected regularly by national and international supervisory authorities.
The preparation of all necessary regulatory documentation (DMFs, CTD-Dossiers, INDs, NDAs) is done in compliance with the relevant guidelines with close contact to the responsible authorities.