Quality Systems

Quality systems regulating the production of drugs and APIs have been successfully established in the European Union. These current Good Manufacturing Practices (cGMPs) guaranty the safety of pharmaceutical products and their compliance with the quality requirements described by international pharmacopoeias (e.g. BP, EP, JP, USP etc.).

Dempharma appreciates the new AMWHV as the transfer of Directive 2004/27/EC into German law demanding the implementation of the GMP Regulations for APIs in accordance with part II of the European GMP Guideline and ICH Q7A.
The implementation of the new regulation demands certain provisions in order to comply with the current German legislation.


DEM Pharma GmbH
Potsdamer Platz 5
10785 Berlin

Phone: +49 30 209 65 96 70