Quality & Certificates at Leverkusen (Dynamit Nobel)

For over 100 years Dynamit Nobel has been meeting the challenge of making top performance and products quality a part of its daily routine.
 
Certification and quality management assist its integrated environmental protection concept.

Overview of the integration of the quality unit at Dynamit Nobel

Dynamit Nobel is providing active pharmaceutical ingredients or advanced intermediates to the pharmaceutical industry.

Dynamit Nobel is committed to high standards of Quality to ensure patients safety and compliance with legal requirements, in particular those detailed in the ICH Q7A.

Overview of the quality management system of Dynamit Nobel

The involvement of everyone at Dynamit Nobel guarantees the efficiency of our Quality system and that our products are manufactured to the highest standards, meeting regulatory and customer requirements.

Regulatory affairs

DMFs have been registered with the different regulatory authorities for several APIs produced by Dynamit Nobel.

Regulatory compliance

Dynamit Nobel has been successfully inspected several times by the US FDA since 1984 in addition to local inspections.
It was last inspected by the FDA in 2004 and by the German “Bezirksregierung Köln” in 2007.
Furthermore, Dynamit nobel has been successfully ISO 9001/14001 certified.
Compliance with regulatory requirements is also assessed during the numerous customer and internal audits.

Download ISO 9001/14001 certificate

Download cGMP certificate