Quality Management

Quality is the fulfilment of requirements and expectations for lasting customer satisfaction.

It is the basis of the business relationships with our customers, to whom we supply medicinal products, active ingredients, biochemicals and for whom we provide services.

We work according to international standards

Our site is certified according to cGMP (the Good Manufacturing Practice).

National regulations such as the German Medicines Act (AMG) and the Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) as well as the European Guidelines on Good Manufacturing Practice and other national and international regulations provide the framework conditions. These include pharmacopoeias, DIN EN ISO standards, guidelines of the US Food and Drug Administration (FDA), CFRs, etc.


We operate in a strictly regulated cGMP environment. This means: our benchmark is the latest state of good manufacturing practice. This is confirmed to us in regular audits by international regulatory authorities. It ensures the quality of our products and ultimately serves the safety of patients.

Andrea Bretschneider, Director Quality Management

Dr. Claus Middelberg, Director Certification and Release 


Our quality system lives through well-trained employees

The quality assurance system is based on Standard Operating Procedures (SOPs) with written procedural instructions that describe all quality-relevant processes.

Our quality manual covers everything from general guidelines for all plants to specific operational instructions. We regularly check all instructions to make sure they are up-to-date, adapt them if necessary and communicate them to our employees in training courses. This is how we ensure consistent quality.

We continuously develop our processes and procedures according to the state of the art in science and technology.

Our QA system, including the manufacturing plants and control facilities, is regularly audited by authorities, customers or ourselves. We ensure the efficiency of this system with qualified and continuously trained employees.